32.06 The Clinical Impact of Lung Biopsy in Children for Non-Metastasis-Related Indications

Posted on December 22, 2014

I. J. Zamora1, S. C. Fallon1, T. J. Vece2, J. Rama2, D. L. Palazzi2, J. A. Coss Bu2, M. Hicks3, M. E. Lopez1, J. G. Nuchtern1,2, M. DeGuzman2, R. P. Guillerman4, F. Sheikh1, P. Lau1, D. L. Cass1,2  1Texas Children’s Hospital, Baylor College Of Medicine,Michael E. DeBakey Department Of Surgery,Houston, TX, USA 2Texas Children’s Hospital, Baylor College Of Medicine,Department Of Pediatrics,Houston, TX, USA 3Texas Children’s Hospital, Baylor College Of Medicine,Department Of Pathology,Houston, TX, USA 4Texas Children’s Hospital, Baylor College Of Medicine,Department Of Radiology,Houston, TX, USA

Introduction:

Pediatric surgeons are consulted for parenchymal lung biopsy in complicated patients with respiratory and immunologic illnesses, and occasionally compromised healing abilities.  Biopsy poses risks, and results may be non-diagnostic. The purpose of this study was to assess the risk-to-benefit ratio of lung biopsy by determining the operative complications and impact on clinical management.

 

Methods:

A retrospective chart review was performed for all children who underwent diagnostic lung biopsy from 1/2009-12/2013. Patients who had blebectomy for spontaneous pneumothorax, or biopsy post lung transplant or for suspected cancer metastasis, were excluded.  The indication for biopsy was classified as: those with new primary lung disease of unclear cause; known immunologic condition or history of organ transplant; known cancer; or those with bone marrow transplant.  Biopsy results were classified as: (1)-new diagnosis, (2)-helpful, diagnosis confirmed or disease ruled-out, (3)-unhelpful, or (4)-insufficient.  The primary outcome assessed was whether the biopsy led to a change in management.  Secondary outcomes included biopsy-related complications, number of chest tube days, and whether the specimen was adequate or diagnostic. Statistical analysis included chi-square and ANOVA.

 

Results:

Eighty-three patients were identified (53% male, mean age 8.3±6.7 years). The majority (64%) underwent thoracoscopic biopsy; 19% had thoracotomy, and 17% had image-guided needle-based procedures.  Comparisons of outcomes based on biopsy indication are presented in the Table.  Overall, biopsy results were classified as: (1)-33(40%), (2)-41(49%), (3)-5(6%), (4)-4(5%), and led to a change in management in 33/83 (40%) children.  Postoperatively, 16 (19%) patients were transferred to a higher level of care, and 27 (33%) experienced complications, including air-leak (n=20, 19%), need for reoperation (n=5; 4%), or bleeding (n=2, 2%). Eleven (13%) patients died, one directly attributable to surgical complications.  Fifty-eight children (70%) had a chest tube postoperatively; 5 (6%) required additional tubes, and the median duration of chest tube use was 4 (range, 1-19) days.

 

Conclusion:

The risk-benefit ratio of lung biopsy in children with complicated respiratory and immunologic conditions appears to be favorable, in that clinically useful information is identified in nearly 90% of cases.  Nevertheless, the procedure carries risks that must be considered in each patient by a multidisciplinary care team. 

 

32.07 When is it Safe to Forgo Abdominal CT Scan in Blunt Injured Children?

Posted on December 22, 2014

S. N. Acker1, C. L. Stewart1, G. E. Roosevelt3, D. A. Partrick1, D. D. Bensard1,2  1Children’s Hospital Colorado,Pediatric Surgery,Aurora, CO, USA 2Denver Health Medical Center,Department Of Surgery,Aurora, CO, USA 3Denver Health Medical Center,Pediatric Emergency Medicine,Aurora, CO, USA

Introduction: CT scan is the gold standard to diagnose solid organ injury following blunt trauma.  However, the radiation risks associated with abdominal CT scan include a 2-3:1000 risk of cancer, with younger age correlating to higher malignancy risk. We hypothesized that there are patient specific factors, including GCS on presentation, pediatric age adjusted shock index (heart rate/systolic blood pressure) (SIPA), and mechanism of injury, that can help identify those patients with low-grade injury who can be treated safely without need for a CT diagnosis.  We have previously shown that SIPA accurately identifies severely injured children following blunt trauma and hypothesized that SIPA would help to identify children with severe solid organ injury at high risk of requiring intervention.

Methods: We performed a retrospective review of all children admitted to two pediatric trauma centers following blunt trauma with any grade liver or spleen injury from 1/09-12/13.  Data collected include SIPA and GCS on presentation, mechanism of injury, injury severity score (ISS), need for interventions including red blood cell (PRBC) transfusion or laparotomy, and outcomes such as hospital length of stay (LOS) and discharge disposition.  The Low Risk Group was defined as GCS 15 with normal SIPA on presentation, and injury attributable to a single, non-motorized, blunt force to the abdomen.  The Non-Low Risk Group did not meet these criteria.  

Results:101 out of 206 children met the low risk criteria.  Patients in the Low Risk Group were older than those in Non-Low Risk Group (median age 11 years vs 9 years, p=0.01), were more likely to be male (75% vs 60%; p=0.02) and have a lower ISS (median 9 versus 17; p<0.001). 

Conclusion:Children, who present to the emergency department following blunt abdominal trauma by a non-motorized force with a normal GCS and SIPA, are unlikely to have a solid organ injury that will require intervention.  When treating patients who meet these criteria, clinicians can have an open dialogue with a child’s parents regarding the necessity of abdominal CT and the potential yield, particularly with regard to whether the CT scan will lead to a change in patient management.  Moreover, in children with normal SIPA and GCS on presentation, our pilot study suggests that this group may be managed with a period of observation, imaging only for changes in clinical parameters, and recommendations for a short period of activity restriction following discharge thus, obviating the need for abdominal CT reducing cost and radiation exposure.

 

32.08 Suction Rectal Biopsy is Diagnostically Equivalent to Full Thickness Rectal Biopsy in Children

Posted on December 22, 2014

E. D. Muise1, S. Hardee2, R. A. Morotti2, R. A. Cowles1  1Yale University School Of Medicine,Pediatric Surgery,New Haven, CT, USA 2Yale University School Of Medicine,Pathology,New Haven, CT, USA

Introduction: Rectal biopsy with evaluation by surgical pathology is considered the most accurate test when evaluating infants and children for Hirschsprung’s Disease (HD). The biopsy site and the percentage of submucosa in the biopsy sample are felt to be important for establishing a pathologic diagnosis. The ability for certain biopsy techniques to obtain adequate tissue, especially in older children, has been questioned. While both suction (SRB) and full-thickness (FTRB) rectal biopsy are commonly employed, no studies have described and compared the quality of the tissue samples obtained using these two techniques. We hypothesized that SRB and FTRB yield tissue specimens of different size, but that these specimens are equally diagnostic after pathologic analysis.   

 

Methods: Records of all children who underwent rectal biopsy to evaluate for HD between January 2007 and July 2014 were reviewed. Demographic data and details of the specimen and pathologic analysis were obtained. Volume of specimen, depth of submucosa, %submucosa, and diagnostic accuracy were compared between biopsy techniques and the effect of age on biopsy quality was assessed. Data were analyzed by mixed effects models with covariate adjustment for age at biopsy, and Fisher’s exact test.

 

Results: Forty-seven children, 28 male and 19 female, underwent a total of 58 rectal biopsies, 45 SRB and 13 FTRB. Thirty-two biopsies were performed after 12 months of age, 26 before 12 months (range 0-141months). Volume of SRB specimens was significantly smaller than FTRB across all ages (14.8mm3+/- 7.8 vs 121.3mm3 +/- 13.8, p=0.0001). Percent submucosa did not differ significantly between SRB and FTRB specimens across all ages (63.8% +/- 2.7 vs 66.5%+/-4.3, p=0.58). Volume of SRB specimens did not differ significantly when performed before or after 12 months of age (11.3mm3 +/- 2.5 vs 21.0mm3 +/-3.9, p=0.28). SRB compared with FTRB demonstrated no significant differences in volume when performed before 12 months  (12.2mm3 +/-3.6 vs 58.9mm3 +/- 11.2, p=0.16), and significant differences when performed after 12 months (18.7mm3 +/-20.0 vs 150.5mm3 +/-21.9, p=0.003). However, percent submucosa in SRB and FTRB performed both before 12 months of age (64.9%+/-3.3 vs 74.8%+/-6.7, p=0.36) and after 12 months of age (62.6%+/-5.1 vs 64.9%+/-5.3, p=0.70) was not significantly different. The number of inadequate biopsies was not significantly different when performed before or after 12 months (p=0.41). The diagnostic accuracy for both SRB and FTRB was 100% and there were no complications.

 

Conclusions: Tissue specimens obtained by SRB are smaller than those obtained by FTRB, especially in older children. SRB and FTRB appear equivalent in their ability to provide adequate submucosa for analysis and both provide highly diagnostic tissue for evaluation. Differences in cost and patient satisfaction between these two rectal biopsy techniques should be studied to further define the best overall technique.

32.09 Prenatal Counseling: Does it Alleviate Parental Mental Distress?

Posted on December 22, 2014

C. Sanner1, E. Lima1, K. H. Parker1, A. Lavery2, E. Perrone3, C. L. Neece1, E. P. Tagge3  1Loma Linda University,Behavioral Medicine,Loma Linda, CA, USA 2Loma Linda University Children’s Hospital,Pediatrics,Loma Linda, CA, USA 3Loma Linda University Children’s Hospital,Pediatric Surgery/Surgery,Loma Linda, CA, USA

Introduction:
Prenatal counseling attempts to educate families about diagnoses, likely outcomes and potential management options for their unborn child. An assumed additional benefit is to provide psychosocial support to parents, thus ameliorating emotional distress. Many authors have stated that prenatal counseling limits stress on both parent and baby. However objective documentation of such stress reduction is difficult to find. Taking advantage of our large prospective database on NICU parental mental health factors, we sought to examine the impact of prenatal counseling on a variety of psychology parameters. 

Methods:
Data were abstracted from a large prospective data set created to examine the relationship between parental mental health and NICU infant outcomes. Parents of our Level III NICU infants completed an hour-long questionnaire which included basic demographic questions as well as a variety of validated psychological instruments including 1) The Brief COPE Inventory; 2) Parental Stressor Scale: NICU (PSS: NICU); 3) The Psychological Well-Being Scale; 4) The Pediatric Inventory for Parenting (PIP); 5) Center for Epidemiologic Studies-Depression Scale (CES-D); 6) Stanford Acute Stress Questionnaire.

Results:
Completed questionnaires from parents of 77 infants managed in our Level III NICU were analyzed. The majority of the families were low income, less than half of the mothers were married and the majority of parents disclosed that their pregnancy was not planned. The mean CES-D depression score indicated that large portion of parents endorsed clinical levels of depression. A large percentage of parents met the clinical cut-offs for the hallmark symptoms of Acute Stress Disorder: dissociation (9.5%), anxiety (66.7%), avoidance (23.8%), and re-experiencing (28.6%). Parents endorsed a mean stress level score of 2.52 on the 4-point PSS: NICU scale, indicating moderate to high levels of stress. When patients were compared (one way anova) between prenatal counseling and no prenatal counseling, there was no significant difference in the results of the Stanford Acute Stress Questionnaire, the CES-D score, none of the 4 subscales of the PIP, coping mechanisms as evaluated in the Brief Cope Inventory, or overall stress as measured by the PSS:NICU.

Conclusion:
Significant mental health issues exist among parents of NICU babies, particularly depression and high stress levels. Prenatal counseling was not seen to impact any of a variety of psychology evaluations. This data suggests that perinatologists and pediatric surgeons should consider referring families for psychology support services if there is significant emotional distress noted at their prenatal counseling visit.
 

32.10 Early Closure of Gastroschisis Correlates with Earlier Initiation of and Progression to Full Feeds

Posted on December 22, 2014

J. C. Harris1, J. Poirier1, D. Selip2, S. Pillai1, A. N. Shah1, C. Jackson3, B. Chiu1  1Rush University Medical Center,General Surgery,Chicago, IL, USA 2Rush University Medical Center Fetal And Neonatal Medicine Center,Pediatrics,Chicago, IL, USA 3Tufts Medical Center,Pediatric Surgery,Boston, MA, USA

Introduction: Gastroschisis is a congenital anomaly affecting 1-6/10,000 live births. Return of bowel function after closure and time to initiation of enteral feeds are highly variable.  Previous studies show initiation of enteral feeds within 7 days after closure decreases hospital stay and predicts improved outcomes.  This study aims to identify factors associated with initiation of earlier enteral feeds. We hypothesize that post-natal management strategies that minimize intestinal irritation can lead to earlier enteral feed initiation.

Methods: A retrospective review of patients with gastroschisis treated between 2005-2014 at a single institution was performed.  Data points included: mother’s age, ethnicity, simple versus complex gastroschisis (defined by necrosis, atresia, or volvulus), gestational age, gender, ventilator days, length of stay, mortality, days to closure, time to first and full enteral feeds. The data were analyzed using both Spearman’s rho and the Kruskal-Wallis rank sum test where appropriate, and p value <0.05 was considered significant.

Results:  The charts of 43 patients (24 males, 19 females) born with gastroschisis were reviewed.  7 out of 43 were classified as complex gastroschisis.  Average gestational age at delivery was 35 weeks (28-39 weeks).  Overall survival rate was 88% (38/43).  The mean hospitalization was 88 days (0-498 days). Average maternal age was 19.5 years.  Maternal race was 35% Hispanic, 33% Caucasian, 30% African American, and 2% American Indian.   Average days on the ventilator were 12.9 days.  5 patients were closed on day of life (DOL) 0.  Mean days to closure were 7.3 (0 to 85) days.   First feeds, on average began DOL 20.5, and full feeds achieved on day 35.1.  If closed before DOL 5, first feed was intiated on average DOL 13; if closed after DOL 5, feeds began on DOL 28.

Average birth weight was 2620 grams.  This did not correlate with the time to definitive closure of the gastroschisis (p=0.6) nor was there an association with time to first feeding (p=0.52). Additionally, time to first feeds was not significantly different among ethnic groups (p=0.42), but there was a possible trend when analyzing time to definitive closure of the gastroschisis between ethnic groups (p=0.073).  However, early closure of gastroschisis was correlated with early initiation of feeds (p=0.0001) and shorter time to full feeds (p=0.04).

Conclusion:  Early closure of gastroschisis was associated with early feed initiation and shorter time to full feeds.  Returning bowel into the abdominal cavity sooner may minimize intestinal irritation, leading to earlier return of bowel function.  Based on these findings, early definitive closure may improve the outcome of patients with gastroschisis.

33.01 A population-based randomized controlled trial of breast cancer screening with alternate mammography and ultrasound for women aged 40 to 49 years in Taiwan

Posted on December 22, 2014

C. Huang1, C. Fann1, G. Hsu1, M. Ho1, S. Chen1, S. Chen1, C. Chen1, S. Sheen-Chen1, H. Chang1, D. Yeh1, D. Chen1, K. Chang1, S. Kon1, A. Ming-Fang1, Y.、L. Chen1, S. Chiu1, H. Chen1  1Breast Cancer Screening Group of Taiwan Breast Cancer Consortium

Background: The efficacy of mammography screening in young women aged 40-49 is not established. As the sensitivity of mammography is poorer in dense breasts, commonly seen in young women, and the performance of ultrasound is not affected by breast density, we conducted a randomized trial to investigate whether annual screening with alternating mammography and ultrasound could detect more breast cancers and earlier than no screening.

Methods:
A total of 79,690 women aged 40-49 years were invited from community in Taiwan since late 2003. These participants were randomly assigned to the study group (n=40127) to receive alternating mammography or ultrasound annually or to the control group (n=39563). The study group was further randomized to receive either mammography (the M-U group) or ultrasound (the U-M group) for the first year screen. Detection rate and sensitivity using one minus annual incidence rate of interval cancer as a percentage of the control group were compared between mammography and ultrasound based on two cross -over designed group. The excess of breast cancers detected by the combined study groups in comparison with the control group was estimated by the comparison of two cumulative incidence of breast cancer curves. The relative rate of reducing stageII+ breast cancers was also estimated using the Poisson regression model.

Results:
The attendance rate of the first -year screen was 59% (11921/20040) and 56% (11249/20087) for the M-U group and the U -M group, respectively. The repeated attendance rate of both groups was 85% in the second round and 91% in the third round. In the first round of screening, the detection rate of breast cancer for the mammography group (0.34%) was 1.5 -fold compared with the ultrasound group (0.22%). In the first three rounds, we found that the detection rates for invasive caner or all cancer by mammography were higher than their counterparts with ultrasound. The alternative screening tool design enables us to estimate the additional benefit of ultrasound, 28.6% for all breast cancer and 38.6% for invasive carcinoma. It was noted that in the fourth round, ultrasound can detect more invasive cancer with detection rate of 0.15% than 3 mammography (0.08%), as well as more early invasive cancers (stage I) (7 by ultrasound vs. 3 by mammography), although mammography consistently detects more in situ cancers than ultrasound (12 vs. 1). The combined study groups led to a marginally statistically significant 18% (Relative rate=0.82 (95% CI: 0.65 -1.02)) reduction of incidence in stageII+ breast cancers compared with the control group.

Conclusion:
The current randomized controlled trial not only demonstrated higher detection rate and performance using mammography but also indicated the complementary role of ultrasound applied to young Taiwanese women. These findings provide valuable information on mass screening modality for young women in Asian country.
 

33.02 Related Risk of Postoperative Myocardial Infarction and Blood Transfusion

Posted on December 22, 2014

R. H. Hollis1,2, J. T. McMurtrie1,2, L. A. Graham1,2, J. S. Richman1,2, T. M. Maddox4, K. M. Itani3, M. T. Hawn1,2  1Birmingham Veterans Administration Hospital,Center For Surgical, Medical Acute Care Research And Transitions (C-SMART),Birmingham, AL, USA 2University Of Alabama At Birmingham,Section Of Gastrointestinal Surgery, Department Of Surgery,Birmingham, AL, USA 3Boston University And Harvard Medical School,Department Of Surgery, VA Boston Health Care System,Boston, MA, USA 4University Of Colorado School Of Medicine,VA Eastern Colorado Health Care System,Denver, CO, USA

Introduction:   Patients with cardiac risk factors undergoing surgery are not only at increased risk of myocardial infarction (MI) but are often exposed to an increased risk of bleeding from perioperative antiplatelet therapy or from the need for therapeutic anticoagulation.  Patients who receive blood transfusions in the setting of MI are associated with worse outcomes.  However, the temporal relationship and related risk of postoperative myocardial infarction and blood transfusions are not well established.
 

Methods:   We matched patients with coronary stents who underwent inpatient non-cardiac surgery within two years of stent placement to two patients with similar cardiac risk and surgical procedures without coronary stents.  Our independent variable of interest was peri-operative transfusion and patients receiving preoperative transfusions were excluded.  Our outcome variables were MI and death at thirty-days post-operatively.  The relationship between timing of MI and transfusion was assessed.  MI time was determined by postoperative time to first troponin lab value meeting threshold 0.04 ng/ml. Time to transfusion was defined as time to receipt of first blood transfusion, with time zero assigned to intraoperative transfusions. GEE model was employed to adjust for risk factors for mortality and to determine predictors of MI.  Statistical analysis was performed by chi-square test and Wilcox t-test.
 

Results:  We identified16,807 patients with cardiac risk factors undergoing inpatient non-cardiac surgery, of which 327 (1.9%) experienced postop MI.  Of those patients with MI, 50% received a blood transfusion.  The overall median postoperative time to transfusion was sooner than MI (1 vs. 36 hrs).  Mortality was higher following MI compared to transfusion or no MI or transfusion (17.7% vs. 5.3% vs. 1.5%; P < 0.001).  Of patients with both outcomes of MI and transfusion, 57% (97/169) received a transfusion prior to MI and were at increased mortality compared to patients with first transfusion after MI on unadjusted (22.7 and 11.1%; P <0.05) and adjusted analysis(OR=2.4, 95% CI 0.9-6.2). Of all patients with a perioperative transfusion, only a history of a cardiac stent was significantly associated with MI (OR=1.8, 95% CI 1.4-2.5).
 

Conclusion:  The occurrence of a transfusion prior to MI is associated with increased mortality.  Cardiac stent placement is a predictor of MI in patients receiving a blood transfusion, suggesting that peri-operative bleeding may be in the causal pathway for post-operative MI in this patient population.

33.03 Randomised Controlled Trial of Perioperative Simvastatin Therapy in Major Colorectal Surgery

Posted on December 22, 2014

P. Singh1, D. Lemanu1, M. Soop1, I. Bissett1, J. Harrison2, A. Hill1  1University Of Auckland,Surgery,Auckland, -, New Zealand 2University Of Auckland,Pharmacy,Auckland, -, New Zealand

Introduction:

Statins (HMG-CoA reductase inhibitors) have been shown to have numerous benefits relevant to abdominal surgery, such as decreasing peritoneal inflammation and improving survival in abdominal sepsis. In clinical studies, their use has been associated with a reduction in the systemic inflammatory response syndrome (SIRS), wound infection and anastomotic leak following colorectal surgery. However, this clinical evidence is limited to retrospective studies. This study aimed to investigate whether perioperative statin therapy can attenuate the surgical pro-inflammatory response and reduce complications following major colorectal surgery.

Methods:

A prospective, multi-centre, double blind, parallel-group, randomised controlled trial was conducted at three public tertiary hospitals in New Zealand (Middlemore Hospital/Manukau Surgery Centre, Auckland City Hospital, and North Shore Hospital) between October 2011 and August 2013. Patients undergoing elective colorectal resection for any indication or reversal of Hartmann’s procedure were randomised to receive either 40mg oral simvastatin or an identical-appearing placebo once daily for 3-7 days before surgery till 14 days after surgery. The primary outcome was the total incidence of complications for 30-days postoperatively. Secondary outcomes included the systemic and peritoneal cytokine response (IL-1α, IL-1β, IL-6, IL-8, IL-10, and TNFα), measured in venous blood and samples of abdominal drain fluid on postoperative day 1, respectively. Concentrations of C-reactive protein (CRP) and the presence of SIRS were evaluated on postoperative days 1 to 3.

Results:

There were 132 patients included in the study, with 65 patients allocated to the simvastatin group and 67 patients to the placebo group. There were no significant differences between the two groups at baseline with regards to patient, operation and disease characteristics. There were no significant differences between the two groups in the incidence, grade and type of postoperative complications. Systemic levels of IL-6, IL-8 and TNFα, and peritoneal concentrations of IL-6 and IL-8, were significantly lower in the simvastatin group postoperatively. CRP levels were significantly lower in the simvastatin group on postoperative days 1 to 3. A lower number of patients in the simvastatin group exhibited SIRS on day 1 and 2 postoperatively, but this difference did not reach statistical significance.

Conclusion:

Perioperative simvastatin therapy in major colorectal surgery attenuates the early pro-inflammatory response to surgery but does not reduce postoperative complications.

33.04 Does IV Ibuprofen Decrease Postoperative Narcotic Use in Patients Undergoing Elective Hernia Repair?

Posted on December 22, 2014

L. S. Sparber1, T. Vialet1, R. S. Chamberlain1,2,3  1Saint Barnabas Medical Center,Department Of Surgery,Livingston, NJ, USA 2St. George’s School Of Medicine,St. George’s, , Grenada 3New Jersey Medical School,Rutgers University – Department Of Surgery,Newark, NJ, USA

Introduction: Inguinal and umbilical hernia repair are among the most common surgical procedures performed in the US. Optimal perioperative pain control regimens remain challenging and opioid analgesics are commonly used.  NSAIDs have been shown to reduce narcotic requirements in several procedures if given prior to anesthesia induction purportedly by blocking the inflammatory cascade. This study sought to evaluate the efficacy of perioperative IV ibuprofen on postoperative pain level and narcotic use in patients undergoing open or laparoscopic inguinal and/or umbilical hernia repair.

Methods: A single center, randomized, double-blind placebo-controlled trial involving a total of 48 adult male patients aged 20-75 years undergoing inguinal and/or combined umbilical hernia repair was performed. Patients were randomized to receive 800 mg of IV ibuprofen or placebo (NS) preoperatively. Postoperative pain was managed with IV hydromorphone, or oral oxycodone/acetaminophen, acetaminophen only or ibuprofen. The primary endpoint was the number of patients that experienced a >20% decrease in postoperative narcotic and a decreased Visual Analog Scale (VAS) Pain Score within the first 2 hours.

Results: 48 male patients aged 20-75 years underwent inguinal and/or umbilical hernia repair (Table 1).  Laparoscopic inguinal hernia repair was the most common procedure in both groups (72.0% ibuprofen, 78.3% placebo, p=.437).   Patients receiving IV ibuprofen used more oxycodone/acetaminophen (32% vs 13%, p=.556) and IV hydromorphone (12% vs 8.7%, p=.556) than the placebo group in the first 2 hour period following surgery.  Conversely, patients receiving placebo used more combinations of pain medications (65.2% vs 44%, p=.556) in the same period. The IV ibuprofen group had more patients (28%, p=.358) pain free at two hours postoperatively compared to the placebo group (8.7%, p=.358) and the mean/median VAS score was also significantly lower in the IV ibuprofen group. Pain levels recorded on patient completed questionnaires showed similar levels of pain at 1, 3, and 7 days post-surgery and similar use of rescue medications.

Conclusion: Pre-operative administration of IV ibuprofen in patients undergoing elective hernia repair resulted in less pain 2 hours following the procedure, and a higher percentage of patients who were pain free compared to placebo.  Considerable variability in the postoperative narcotic analgesic requirement was noted, and a larger study is needed to better understand the narcotic analgesic requirements associated with IV ibuprofen in hernia repair patients.  IV ibuprofen should be considered as a safe option for the reduction of pain as an adjunct to standard pain therapy in this patient population.

 

33.05 IORT with CT-Guided HDR Brachytherapy for the Treatment of Early-Stage Breast Cancer

Posted on December 22, 2014

S. L. Showalter1, D. R. Brenin1, A. Schroen1, M. Morris2, B. Libby2, G. Petroni3, T. N. Showalter2  1University Of Virginia,Surgical Oncology/Surgery,Charlottesville, VA, USA 2University Of Virginia,Radiation Oncology,Charlottesville, VA, USA 3University Of Virginia,Public Health Sciences,Charlottesville, VA, USA

Introduction:  Intraoperative radiation therapy (IORT) is an increasingly popular choice as an alternative to whole breast irradiation in patients with early-stage breast cancer. Currently available breast IORT systems have been criticized for their inability to directly image the lumpectomy cavity, “one size fits most” radiation dose planning, and the poor dosimetry provided by superficial photons.  At the University of Virginia, an integrated high dose-rate (HDR) brachytherapy suite with CT-on-rails imaging permits IORT with superior target volume coverage compared to other methods of IORT, while maintaining doses within tolerance limits for normal tissues, including the heart and ribs.

Methods:  We designed a single-arm, pilot study to demonstrate the safety and feasibility of IORT with CT-guided HDR brachytherapy for the adjuvant treatment of breast cancer, with a planned total sample of 28 evaluable patients.  Eligibility criteria include biopsy proven invasive ductal (IDC) or lobular carcinoma (ILC), ductal carcinoma in situ (DCIS), age > 50 years, tumor < 3cm, and N0 disease.  Patients may be eligible prior to receiving BCS or within 30 days of receiving breast surgery.  Exclusion criteria include multicentric disease, history of ipsilateral breast cancer, skin invasion or nodal involvement.  Surgery is performed in the brachytherapy suite.  After removal of the cancer, a multi-lumen balloon catheter is placed in the lumpectomy cavity.  CT imaging is obtained, radiation planning is performed, HDR brachytherapy is delivered and then the catheter is removed and the skin closure is completed.   A dose of 12.5 Gy is prescribed to cover the target volume.  Primary endpoints are IORT treatment interval (time from acquisition of CT until IORT is complete) and safety.  Secondary endpoints include dosimetry, cosmesis, patient-reported quality of life, toxicity and safety.  

Results:  In the first 8 months of the study, 9 patients with early-stage breast cancer were accrued, including: 4 with IDC, 4 with DCIS and 1 with ILC.  Median time required for IORT treatment planning and delivery is 68 minutes.  Median follow-up time is 4 months [Interquartile Range (IQR): 2.4, 6.7]. Target volume coverage met protocol objectives: median D90% (dose covering 90% of volume) is 99.3% (IQR: 98.78, 101.1); V100% (volume covered by the prescription dose) is 89.2% (IQR 88.23, 91.54).  Normal tissue structure planning objectives were met: median heart dose is 2.9% of the prescription dose (IQR 0, 7.15), and median maximum rib dose is 100.5% of the prescription dose (IQR 63.3, 138.44).  There have been no adverse events attributable to study treatment.  

Conclusion:  Preliminary data suggest IORT with CT-guided HDR brachytherapy is safe and feasible.  This IORT approach provides excellent target volume coverage and normal tissue sparing, and is deliverable within a reasonable amount of operative time.

 

33.06 Risk Factors and Post Operative Outcomes of Blood Transfusion after Adrenalectomy- A NSQIP Analysis

Posted on December 22, 2014

R. Venkat1, M. A. Guerrero1  1University Of Arizona,Division Of Surgical Oncology, Department Of Surgery,Tucson, AZ, USA

Introduction:  Blood transfusion has been shown to be associated with adverse long- and short-term outcomes. We sought to evaluate the preoperative risk factors associated with blood transfusion and its effects on post-operative outcomes after adrenalectomy. 

Methods:  We performed a retrospective analysis of 3219 adrenalectomies (2484 laparoscopic and 735 open) from 2005-2010 using the NSQIP database. Data on preoperative risk factors and post operative morbidity and mortality was evaluated. 

Results: Median age and BMI were 53 years and 29.1Kg/m2, respectively. Majority of patients were female (61.3%). 62.5% patients had ASA (American Society of Anesthesiologists) score > 3. On multivariate analysis, open adrenalectomy (OR: 14.3, p<0.001), preoperative hematocrit<10 (OR: 6.3, p<0.001) and operative time >150min (OR: 3.7, p<0.001) were associated with an increased need for intraoperative blood transfusions.  Interestingly, an increase in BMI was seen to be protective against the need for transfusions (OR: 0.97, p=0.042). The need for intraoperative blood transfusions was an independent predictor of post operative superficial skin infections (OR: 2.6, p=0.02), wound dehiscence(OR: 6.0, p=0.05), pneumonia (OR: 2.8, p=0.008), prolonged intubation>48hrs (OR: 8.0, p<0.001), sepsis (OR:2.9, p=0.008), septic shock (OR: 9.6, p<0.001), reoperation (OR: 3.2, p=0.001) and mortality (OR: 9.3, p<0.001). There was an incremental increase in septic complications, reoperation and mortality with each unit of blood transfused (p<0.05)

Conclusion: Open surgery, preoperative anemia, ASA, and prolonged operative time are associated with an increased need for blood transfusions in laparoscopic and open adrenalectomy. BMI was seen to be protective against the need for blood transfusions. Intraoperative transfusion was seen to independently and incrementally associated with significant morbidity and mortality after laparoscopic and open adrenalectomy.
 

33.07 VASQIP Risk Assessment, Surgical Apgar Score and Intra-Operative Performance During Major Surgery.

Posted on December 22, 2014

M. Melis1,2, A. Masi1,2, I. Hatzaras1,2, G. Ballantyne1,2, A. Pinna1,2, A. Rosman1, D. Neihaus1, S. Cohen1,2, J. K. Saunders1,2, E. Newman1,2, R. S. Berman1,2, H. Pachter1,2  1New York Harbor Healthcare System VAMC,New York, NY, USA 2New York University School Of Medicine,New York, NY, USA

Background: The VASQIP (Veteran Affairs Surgical Quality Improvement Program) risk calculator may predict post-operative morbidity and mortality (M&M) of non-emergent procedures based on pre-existing patient conditions and magnitude of surgery. The Surgical Apgar Score (SAS) may predict M&M based on three simple intra-operative measurements. Unlike VASQIP, which is calculated pre-operatively, SAS is entirely dependent on intra-operative variables and may be influenced by the performance of a surgical team. We hypothesized that SAS could potentially be used as a measure of intra-operative performance across patients with similar VASQIP risk undergoing major surgery of the alimentary tract.

Methods: We categorized patients undergoing major surgery of the alimentary tract at the NY Harbor VAMC in 3 risk categories (low, average, high risk) according to their VASQIP score. We then evaluated whether SAS could predict MM within each VASQIP risk category. Multivariate logistic regression was used to assess the effect of SAS on the study’s two end-points: postoperative morbidity and mortality.

Results: From October 2006 to July 2011, 560 patients underwent major surgery of the alimentary tract. There were 545 (97.3%) men and 15 (2.7%) women. Average age was 68.4 ± 12 years. According to the pre-operative VASQIP estimate for risk of complications, the following study groups were identified: low risk (n=19), average risk (n=156), high risk (n=385). Of note, all patients with SAS <4 were clustered in the VASQIP high-risk group. Overall morbidity was 37.5% and overall mortality was 5.7%. M&M were 56.2% and 25% for SAS <4 and 23.1% and 0% for SAS >8, respectively. In high risk patients SAS was strongly correlated with morbidity (56.2% vs. 32%, p<0.05) and mortality (25% vs. 0%, p<0.05). Within the high-risk group low SAS accurately predicted M&M: [for SAS <6, OR= 1.86, 95% CI (1.18, 2.92), p= 0.007]. Also, within the high risk group, a high SAS was “protective” toward M&M: [for SAS >8, OR=0.47, 95%CI (0.28, 0.81), p=0.006]. Across low and average risk groups SAS did not influence M&M: however, lack of correlation in those two groups is likely secondary to a type II error.

Conclusions: SAS is strongly associated with increased morbidity and mortality in patients classified as high risk for complications by VASQIP. In fact, SAS is a sensitive tool that can differentiate patients at highest risk of postoperative M&M, even within the highest preoperative risk assessment by VASQUIP. In this way SAS offers supplemental information that can direct patient disposition and further care. Additional studies are needed to validate this concept and establish SAS as a surgical quality measurement. 

33.08 Young-Onset Colorectal Cancer In Australia: A Population-Based Study

Posted on December 22, 2014

P. Sirimanna1, Y. Y. Lee1, M. K. Suen1, N. Nassar1,2, M. A. Gladman1  1Sydney Medical School – Concord, University Of Sydney,Academic Colorectal Unit,Sydney, NSW, Australia 2The Kolling Institute, University Of Sydney,Clinical And Population Perinatal Health Research,Sydney, NSW, Australia

Introduction:
Young-onset colorectal cancer (yCRC) has been shown to be increasing in incidence in population-based studies performed in North America. Further, such studies have shown that it occurs more commonly on the left side and is more advanced at presentation. However, there are limited population-based studies of yCRC in Australia. Therefore, the aim of this study was to determine the incidence, trends, tumor location and stage and survival of patients with yCRC in Australia.

Methods:
We conducted a population-based cohort study of all CRC diagnosed in New South Wales, Australia, 2001-2008. Data was ascertained via record-linkage of statutory Cancer Registry and Registered Deaths data collections. yCRC was defined as CRC in patients <50 years and their characteristics and tumor-related factors compared with patients diagnosed with CRC and aged 50+ years. Age-sex standardized incidence rates and trends were examined using Poisson regression analysis. The five-year cancer-specific survival rate for yCRC patients was compared to that aged 50+ years, and then stratified by tumor stage and within various age groups of yCRC patients.

Results:
Overall, there were 34,119 patients diagnosed with CRC in 2001-2008. yCRC occurred in 6.2% of cases (n=2,128; 1,101 males [51.7%]), whilst the remaining 31,991 cases (n=17,860, 55.8% males) were diagnosed in patients aged 50+ years. The incidence of yCRC declined slightly throughout the study period from 13.7 per 100,000 in 2001 to 11.8 per 100,000 in 2008; P=0.57). Inflammatory bowel disease was present in 3.3% (n=70) of patients with yCRC compared to 1.2% (n=395) of patients aged 50+ years (P<0.001). The tumor was located in the right colon in only 19.2% (n=408) of yCRC patients (versus 28.2% [n=9,029] in 50+ years), instead favoring the rectum (34.6% [n=736] versus 26.1% [n=8,342] in 50+ year olds, P<0.001). Five-year cancer-specific survival was superior in yCRC patients (68.9%; 95% CI 66.3%-71.2%) compared with patients 50+ years (65.8%; 95% CI 65.1%-66.5%; P<0.001), despite more metastatic disease at presentation (21.9% [n=466] versus 15.2% [n=4,873] in 50+ years, P<0.001). Further stratification revealed that five-year cancer-specific survival was similar in yCRC patients aged <40yrs (68.0%; 95% CI 62.9%-72.5%) and patients aged 40-50yrs (69.2%; 95% CI 66.2%-71.9%) (P=0.68).

Conclusion:
This population-based study has revealed that, unlike in North America, the incidence of yCRC is not increasing in Australia. Consistent with North American studies, yCRC tends to occur more commonly in the rectum than in the proximal colon and is more advanced at presentation in Australia. Cancer-specific survival is superior compared to older patients. 
 

33.09 Normohormonal Primary Hyperparathyroidism: Clinical Presentation and Surgical Outcomes

Posted on December 22, 2014

J. C. Morrison1, H. Wachtel1, S. Zaheer1, L. E. Kuo1, I. Cerullo1, G. C. Karakousis1, R. R. Kelz1, D. L. Fraker1  1University Of Pennsylvania,Endocrine And Oncologic Surgery,Philadelphia, PA, USA

Introduction: Primary hyperparathyroidism (PHP) is a common endocrine diagnosis. While many studies have focused on normocalcemic hyperparathyroidism, less is known about normohormonal primary hyperparathyroidism (NHPHP). NHPHP is characterized by symptomatic hypercalcemia in the presence of normal parathyroid hormone (PTH) levels. We sought to examine the clinical presentation and surgical outcomes of patients with NHPHP in comparison to those of typical patients with PHP (TPHP).

 

Methods: We identified patients enrolled in our prospective endocrine surgery registry (1997-2013) who underwent a parathyroidectomy for PHP for potential inclusion in the study. Patients were excluded if they had Multiple Endocrine Neoplasia 1 or 2, secondary or tertiary hyperparathyroidism, parathyroid carcinoma, or if they did not have 6 month(6m) follow up data. Patients were classified by pre-operative PTH values as normohormonal (PTH 15-65 pg/mL) or typical (PTH>65 pg/mL). Variables analyzed included age, gender, presence of symptoms (nephrolithiasis, osteopenia, osteoporosis), percent drop in intraoperative PTH (IOPTH), cure by IOPTH (defined as >50% drop in IOPTH and ending within the normal range), and operative findings. The primary outcome of interest was biochemcial cure defined by serum PTH and calcium levels six months post-surgery. Univariate analysis was performed using the Wilcoxon rank sum and the Fisher’s exact test, as appropriate.

 

Results: We identified 78 NHPHP and 466 TPHP patients for study inclusion. Compared to TPHP patients, NHPHP patients had lower preoperative PTH levels (50.8 vs 136 pg/mL, p<0.01) but equivalent calcium levels (11.1 vs 11.0 mg/dL, p=0.13). There was no significant difference in sex, age, reported symptoms or preoperative localization (via Sestamibi scan) between the two groups. Compared to TPHP patients, NHPHP patients had lower initial IOPTH values (122+/-135 vs 225+/-292  pg/mL, p<0.05). However, NHPHP patients experienced a smaller drop in IOPTH during surgery, and thus had final IOPTH values equivalent to those of TPHP patients (22.9+/-17.8 vs 30.0+/-31.8 pg/mL, p=0.12). Cure by IOPTH standards was lower for NHPHP patients (86% vs 95%, p<0.05). Six months after surgery, there was no difference in PTH levels across the two groups (62.0+/-84.3 vs 58.6+/-63.4 pg/mL, p=0.27), but there was a small clinically insignificant difference in the calcium levels (9.7+/-0.7 vs 9.5+/-0.6 mg/dL, p<0.05). Biochemical cure rates at 6m were statistically equivalent at 92% NHPHP and 97% TPHP(p=0.06).

 

Conclusion: The cure rate following parathyroidectomy for NHPHP patients is lower using IOPTH criteria than standard criteria at six month follow-up. Moreover, while cure rates (immediate IOPTH cure and biochemical cure at 6m follow up) following parathyroidectomy for NHPHP may be slightly lower than those for TPHP patients, they all exceed 85%. Parathyroidectomy should be strongly considered in patients with NHPHP.

30.06 Node-negative Rectal Cancer after neoadjuvant therapy: How many lymph nodes should be removed?

Posted on December 22, 2014

M. Raoof1, V. N. Nfonsam1, J. Warneke1, R. Krouse1,2  1University Of Arizona College Of Medicine,Surgical Oncology,Tucson, AZ, USA 2Southern Arizona Veterans Affairs Health Care System,Surgical Care Line,Tucson, AZ, USA

Introduction:  Neoadjuvant therapy for locally advanced rectal cancer reduces the yield of lymph node (LN) sampling.  In the setting of pathologically negative LNs after neoadjuvant therapy, the significance of the number of LNs retrieved is unclear. Studies in the literature have reported conflicting results. We hypothesized that the number of negative lymph nodes harvested is related to long-term survival.

Methods:  This is a study of a contemporary cohort from NCI’s SEER database over a 7-year period (Jan, 2004- Nov, 2010).  Patients with locally advanced rectal adenocarcinoma who underwent neoadjuvant therapy and had pathologically negative LNs in resected specimens were included. The collaborative staging fields in the SEER database record worst T-stage (i.e. clinical T-stage unless pathological T-stage was worse, in which case pathological T-stage is recorded). This allowed a unique opportunity to distinguish T-stage progression vs. T-stage stable disease or regression. Pathologic LN stage was available for all patients and by inclusion criteria were N0. Clinical LN status was available for 73% of patients. Survival analysis was performed using the Kaplan-Meier method. Inferential statistics were performed using a Cox-proportional hazard model.

Results: Of the total 3864 patients that met the strict inclusion criteria, 65% were males, 82% were white and 51% were ≥60 years of age. Majority had T3 (T1, 9%; T2, 19%; T3, 67%, T4 5%), clinical LN positive (Positive, 44%; Negative, 29%; Unknown, 27%) and moderately differentiated (G1, 6%; G2, 71%; G3, 10%; G4, 0.5%) tumors. Median lymph nodes retrieved were 12 (IQR 7-16). Median follow-up was 28 months (IQR 12-47). Using the minimum p-value approach we identified a cut-off of 7 LNs provides oprtimal stratification of patients in terms of overall survival (Figure). A multivariate Cox-proportional hazard model adjusted for age, race, T-stage, grade, clinical LN status and T-stage response to neoadjuvant therapy demonstrated that patients who have >7 LNs examined have a better overall (hazard ratio 0.66; 95% CI 0.53-0.81; p < .0001) and cancer-specific survival (hazard ratio 0.64; 95% CI 0.50-0.83; p = 0.001) compared with patients who had ≤7 LNs examined.

Conclusion: This is the largest study to date that demonstrates the prognostic significance of LN sampling in patients with rectal cancer after neoadjuvant therapy.  Patients with less than seven LNs harvested have worse survival and should be considered for more aggressive adjuvant therapy and follow-up strategy.
 

30.07 Increased Malignancy Rates in Surgical Patients with Incidentally-Discovered Thyroid Nodules

Posted on December 22, 2014

A. R. Marcadis1, M. Rodriguez1, S. Liu1, B. Wang1, J. I. Lew1  1University Of Miami Miller School Of Medicine,Division Of Endocrine Surgery,Miami, FL, USA

Introduction: With the advent of better imaging technology and its widespread utilization in the clinic setting, incidental thyroid nodules are often discovered while evaluating patients for unrelated disease. If the risk of underlying thyroid malignancy in such incidental nodules is common, further evaluation is required. However, if thyroid cancers are exceedingly rare in such incidentally discovered thyroid nodules, further costly evaluations can be avoided. The purpose of this study is to compare the rate of malignancy in incidentally-discovered thyroid nodules (IDTN) by imaging to nonincidentally-discovered thyroid nodules (NDTN) in surgical patients.

Methods: A retrospective review of prospectively collected data of 1370 patients who underwent thyroidectomy at a single institution was performed. Before surgical resection, all patients underwent surgeon-performed ultrasound (SUS) and fine-needle aspiration (FNA). Patients who had IDTN by imaging studies for unrelated reasons (n=536) and patients who had NDTN (n=834) were further stratified according to age, gender, FNA results, SUS characteristics and final pathology. Rates of malignancy in IDTN and NDTN were calculated and statistical significance was determined by  two-tailed Z-test.

Results: Of 1370 patients, 536 presented with IDTN by imaging and 306 (57%) were found to have malignancy on final pathology. Of patients with IDTN found to have malignancy, 92% (n=283) had papillary thyroid cancer, 5% (n=14) medullary thyroid cancer, and 3% (n=9) follicular thyroid cancer. Of the patients with NDTN, 401 (48%) were found to have malignancy following surgery with 44% (n=366) papillary thyroid cancer (PTC), 2.2% (n=18) medullary thyroid cancer, 2% (n=14) follicular thyroid cancer, and <1% anaplastic thyroid cancer (n=3). The rate of PTC on final pathology for IDTN was statistically higher than the rate of PTC found in NDTN (p<0.05). Patients with IDTN had statistically higher rates of microcalcifications (34%), hypoechogenicity (60%), and irregular borders (35%) by SUS compared to patients with NDTN (p<0.05). There was also a significantly higher rate of patients with IDTN who had all three SUS features together (14%) compared to patients with NDTN (10%) (p<0.05). There was no significant difference in percentage of malignant FNA results between patients with IDTN and NDTN.

Conclusion: For IDTN, malignancy rates may be higher than expected in surgical patients. Furthermore, certain characteristics of SUS may help predict malignancy in IDTN. The high rate of malignancy suggests that total thyroidectomy by an experienced surgeon should be strongly considered when managing such patients with IDTN.

 

30.08 Stoma Creation and Reversal after Cytoreductive Surgery with Heated Intraperitoneal Chemotherapy

Posted on December 22, 2014

A. N. Doud1, N. Fitzgerald2, E. Levine1, P. Shen1, J. Stewart1, K. Votanopoulos1  1Wake Forest University,Department Of General Surgery, Surgical Oncology Service,Winston-Salem, NC, USA 2Wake Forest University,Division Of Public Health Sciences, Department Of Biostatistical Sciences,Winston-Salem, NC, USA

Introduction:  

Stoma creation is often included as a part of Cytoreductive Surgery with Heated Intraperitoneal Chemotherapy (CRS/HIPEC).  Herein, we evaluate the indications for stoma creation during CRS/HIPEC procedures as well as the morbidity and mortality associated with stoma reversal after CRS/HIPEC procedures.

Methods:  

A retrospective analysis of a prospective database of 1149 CRS/HIPEC procedures was performed.  Patient demographics, type of malignancy, comorbidities, Clavien-graded morbidity, mortality and overall survival were abstracted.  Patients were grouped into those with and without stoma creation and documented indications for stoma creation and reversal were recorded and analyzed.

Results: 

16% (186/1149) of CRS/HIPEC procedures included stoma creation, while 1.1% (11/963) of patients without stoma creation during CRS/HIPEC developed anastomotic leaks requiring reoperation with stoma formation.  This resulted in 197 stomas after CRS/HIPEC, of which 37.6% (74/197) were end ileostomies, 27.9% (55/197) were loop ileostomies, 23.9% (47/197) were end colostomies and 8.6% (17/197) were loop colostomies.  Patients requiring stoma at initial operation had worse preoperative performance status (ECOG 0/1: 77.2% vs 86.11%, p=0.002), worse preoperative nutrition (mean albumin 3.69 vs 3.78, p=0.03), greater burden of disease (PCI 18.57 vs. 12.90, p<0.0001) and were more likely to have R2 resections (74.19% vs 48.69%, p<0.0001) than those without stoma creation.  18.6% (36/197) of the stomas were intended to be permanent.  Of the 161 patients with potentially reversible ostomies, only 26.7% (43/161) had their ostomies reversed.   Patients undergoing reversal were more likely to have complete cytoreductions than those not undergoing reversal (41.9% vs 23.7%, p=0.0007).  The most common reasons for failure to reverse were disease progression (43/161, 26.7%) and death (40/161, 24.8%).  After reversal, 27.9% (12/43) suffered a Clavien I/II minor morbidity, 27.9% (12/43) suffered Clavien III/IV major morbidity, and 30 day mortality was 4.7% (2/43). Anastomotic leak occurred after 9% (3/33) of ileostomy and 10% (1/10) of colostomy reversals.

Conclusion: 

Stoma creation during CRS/HIPEC is more common in patients with higher burden of disease, incomplete CRS and poor functional status.  Less than half of the patients with complete CRS will have their stomas reversed.  Stoma reversal after CRS/HIPEC has a significant risk of major morbidity that should be taken into consideration especially if postoperative systemic chemotherapy is part of the treatment strategy.  Patients with high burden of disease and poor functional status should be counseled prior to CRS/HIPEC as to their increased risk of stoma creation and their low likelihood of successful reversal.

 

30.09 The Utility of Afirma Gene Expression Classifier in the Management of Indeterminate Thyroid Nodules

Posted on December 22, 2014

L. Zhou1, K. Patel1  1New York University School Of Medicine,Endocrine Surgery,New York, NY, USA

Introduction:
The Afirma® Gene Expression Classifier (AGEC) has been designed to identify benign thyroid nodules among those classified as cytologically indeterminate with a negative predictive value of 94%–95%. This test therefore has the potential of avoiding unnecessary surgery on cytologically indeterminate nodules which are likely to be benign. The objective of this study was to examine the impact of AGEC on the management of thyroid nodules at a single institution and appreciate the importance of how institutional malignancy rates may affect clinical decision making and patient counseling.

Methods:
A retrospective cohort analysis of all patients treated by the authors with thyroid nodules classified as Bethesda category III or IV, who had AGEC testing. Only patients with cytologic diagnosis, AGEC and final pathology were included. Cytology was categorized according to the Bethesda classification system. The dataset was analyzed to determine the benefit of AGEC testing in our patient population.

Results:
A total of 54 patients were included in the study. 44 had initial cytologic diagnosis categorized as Bethesda III and 10 were categorized as Bethesda IV. Of the 54 GECs performed, 15 were benign and 39 were suspicious. 13/15 (86.7%) patients with benign GEC testing opted for close observation and 2/15 (13.3%) opted for surgery, both had benign disease on final pathology. Surgery was avoided in 13/54 (24%) patients. 23/39 (59.0%) patients with suspicious GEC testing have had surgery and their pathology is as follows: 11/23 (47.8%) benign, 5/23 (21.7%) papillary thyroid cancer (PTC), and 7/23 (30.4%) follicular variant PTC. The PPV of AGEC “suspicious” in our patient population is 52.2%. The historical prevalence of malignancy amongst cytologically indeterminate lesions (Bethesda III and IV) at NYU is 35%. Based on this, the NPV of AGEC at our institution is closer to 91%.

Conclusion:
Malignancy rates in cytologically indeterminate thyroid nodules vary widely across institutions. Utilization of the AGEC helped avoid surgery in 24% of patients with cytologically indeterminate thyroid nodules. However, given our center’s higher prevalence of malignancy in indeterminate nodules, slightly higher PPV and slightly lower NPV were observed compared to previously published rates. This information must be taken into consideration when making clinical decisions and counseling patients in regards to AGEC testing.
 

30.10 Signet Ring Carcinoma of the Pancreas: A Case Series of 621 Patients

Posted on December 22, 2014

K. Mahendraraj1,2, J. Chabot2, M. Kluger2  1Saint Barnabas Medical Center,Department Of Surgery,Livingston, NJ, USA 2Columbia University College Of Physicians And Surgeons,Department Of Surgery,New York, NY, USA

Introduction:
Signet ring carcinoma of the pancreas (SRC) is a rare and aggressive mucin-producing exocrine pancreatic malignancy, comprising less than 1% of all pancreatic carcinoma. Clinical information relating to this disease is scant and derived primarily from several case reports. This study sexamines a large cohort of SRC in order to determine characteristic demographic and pathologic factors of SRC and compare them to the relatively more common pancreatic ductal adenocarcinoma (PDAC). 

Methods:
Demographic and clinical data on 103,341 patients with pancreatic cancer was abstracted from the SEER database (1973-2010). 621 SRC and 102,720 PDAC patients formed the study groups. Data was analyzed using standard statistical methodoloy. 

Results:
SRC comprised 0.6% of all pancreatic cancers identified. The mean age of the SRC and PDAC patients were similar (67.5±12 vs. 68.2±11.7). Both SRC and PDAC were more common in males (54.1% and 51.1% (PDAC), p=0.08), Caucasians (74.1% and 74.7% (PDAC), p=0.005) and in the head of the pancreas (48.8% and 50.9% (PDAC), p<0.005). SRC was more often poorly differentiated (81.3%), undifferentiated (7.1%), had more lymph node positivity (50.4%), and presented more often with metastatic disease (68.1%), p<0.001. The majority of SRC and PDAC patients were not treated at all (70% and 71.8% (PDAC)), and surgery was used more often than radiotherapy to treat SRC (14% vs. 10.4%). Mean survival for SRC was significantly lower than PDAC (0.47±0.1 years vs. 0.85±0 years; p<0.05). Furthermore, mean survival for SRC patients treated with primary surgical therapy or combination surgery and radiotherapy were also significantly inferior to PDAC despite receiving equivalent therapy, p<0.001. However, SRC patients benefited more from primary radiotherapy than PDAC patients (1.05±0.17 vs. 0.93±0.02 years, p<0.001). Multivariate analysis identified tumor size over 2 cm (OR 1.4), metastatic disease (OR 1.8), and poor or undifferentiated grade (OR 2.3) as risk factors for mortality for SRC, p<0.005. A survival advantage for SRC was seen in patients treated with surgical resection (OR 0.36), p<0.005

Conclusion:
Pancreatic SRC is a rare malignancy that presents with larger tumor size, a more undifferentiated histology, greater lymph node positivity, and a higher rate of metastatic disease than PDAC, features which were associated with increased mortality. Despite these aggressive features, surgical resection with or without radiotherapy was associated with the longest survival for SRC. Surgical resection and radiotherapy should be considered in all SRC patients with resectable disease.

31.01 Splenectomy is Associated with Hypercoagulable TEG Values and Increased Risk of Thromboembolism

Posted on December 22, 2014

M. J. Pommerening1, E. Rahbar1, K. M. Minei1, J. B. Holcomb1, M. A. Schreiber2, M. J. Cohen3, S. Underwood2, M. Nelson3, B. A. Cotton1  1University Of Texas Health Science Center At Houston,Houston, TX, USA 2Oregon Health And Science University,Portland, OR, USA 3University Of California – San Francisco,San Francisco, CA, USA

Introduction:  Previous investigators have demonstrated that post-injury thrombocytosis is associated with an increase in thromboembolic (TE) risk. Increased rates of thrombocytosis have been found specifically in patients following splenectomy for trauma. We hypothesized that patients undergoing splenectomy (1) would demonstrate a more hypercoagulable profile during their hospital stay and (2) that this hypercoagulable state would be associated with increased TE events. 

Methods:  A 14-month, prospective, observational trial evaluating serial rapid thrombelastography (rTEG) was conducted at three ACS-verified, level-1 trauma centers. Inclusion criteria: highest-level trauma activation, arrival within 6 hours of injury, 18 years of age or older. Serial rTEG (ACT, k-time, α-angle, mA, LY-30) and traditional coagulation testing (PT, PTT, fibrinogen and platelet count) was obtained at 0, 3, 6, 12, 24, 48, 72, 96 and 120 hours. Thromboembolic complications were defined as in-hospital DVT, PE, acute MI, or ischemic stroke. Patients were stratified into splenectomy versus non-splenectomy cohorts. Univariate analysis was perfomed, followed by longitudinal analysis using an adjusted generalized estimating equations (GEE) to evaluate the effects of time, splenectomy, and group-time interactions on changes in rTEG and traditional coagulation testing. For TE risk, we employed a multiple logistic regression. Both models controlled for age, gender, injury severity, and admission blood pressure, base deficit, and hemoglobin. 

Results: 1242 patients were enrolled. Of these, 605 patients had >24 hours of serial rTEG values post-admission and were analyzed (40 splenectomy, 565 non-splenectomy patients). Splenectomy patients were younger (median 30 vs. 38 years), more hypotensive (median systolic 100 vs. 130 mmHg) and more in shock on arrival (median base value -7 vs. -2); all p<0.001. While there was no difference in 24-hour (8 vs. 5%; p=0.348) or 30-day mortality (13 vs. 7%; p=0.129), splenectomy patients were more likely to develop TE events (17.5 vs. 7.5%; p=0.015). Logistic regression confirmed this risk, finding splenectomy was associated with an increased risk of TE events (OR 3.4, 95% C.I. 1.14-9.96, p=0.028).  GEE modeling demonstrated that rTEG values of α-angle and mA are significantly higher (more hypercoagulable) in splenectomy patients at 48, 72, 96 and 120-hours; all p<0.05. The GEE model also demonstrated that platelet counts were significantly higher in splenectomy patients beginning at 72 hours and continuing through 120 hours; p<0.05.

Conclusion: This multicenter study demonstrates that patients undergoing splenectomy are more hypercoagulable than other trauma patients. This hypercoagulable state (identified through higher TEG α-angle and mA values) begins at approximately 48 hours post-injury and continues through at least day 5. Moreover, this hypercoagulable state is associated with 3-fold increased risk of TE complications.

 

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