Local Cancer Recurrence: The Realities, Challenges, and Opportunities for New Therapies.

Locoregional recurrence negatively impacts both long-term survival and quality of life for several malignancies. For appropriate-risk patients with an isolated, resectable, local recurrence, surgery represents the only potentially curative therapy. However, oncologic outcomes remain inferior for patients with locally recurrent disease even after macroscopically complete resection. Unfortunately, these operations are often extensive, with significant perioperative morbidity and mortality. This review highlights selected malignancies (mesothelioma, sarcoma, lung cancer, breast cancer, rectal cancer, and peritoneal surface malignancies) in which surgical resection is a key treatment modality and local recurrence plays a significant role in overall oncologic outcome with regard to survival and quality of life. For each type of cancer, the current, state-of-the-art treatment strategies and their outcomes are assessed. The need for additional therapeutic options is presented given the limitations of the current standard therapies. New and emerging treatment modalities, including polymer films and nanoparticles, are highlighted as potential future solutions for both prevention and treatment of locally recurrent cancers. Finally, the authors identify additional clinical and research opportunities and propose future research strategies based on the various patterns of local recurrence among the different cancers.

Extended Pharmacologic Prophylaxis for Venous Thromboembolism after Colon Cancer Surgery is Associated with Improved Long-term Survival: A Natural Experiment in the Chemotherapeutic Benefit of Heparin Derivatives.

OBJECTIVE: This large database study assessed whether extended pharmacologic prophylaxis for venous thromboembolism after colon cancer resection was associated with improved oncologic survival. BACKGROUND: Heparin-derivatives may confer an anti-neoplastic effect via a variety of mechanisms (e.g. inhibiting angiogenesis in the tumor microenvironment). Studies evaluating the oncologic benefit of heparin and its derivatives have been limited in post-surgical patients. Multiple society guidelines recommend consideration of 30-day treatment with low molecular weight heparin to reduce venous thromboembolism risk after abdominopelvic cancer surgery. However, utilization of extended prophylaxis remains low. METHODS: Surveillance, Epidemiology, and End Results-Medicare data were used to identify patients (age 65+) undergoing resection for non-metastatic colon cancer from 2016-2017. The primary outcomes were overall and cancer-specific survival. Log-rank testing and multivariable Cox regression compared survival in patients who received extended prophylaxis versus those that did not in an inverse propensity treatment weighted cohort. RESULTS: 20,102 patients were included in propensity-weighting and analyzed. 800 (3.98%) received extended pharmacologic prophylaxis. Overall and cancer-specific survival were significantly higher in patients receiving prophylaxis on log-rank tests (P=0.0017 overall, P=0.0200 cancer-specific). Multivariable Cox regression showed improved overall survival [aHR 0.66 (0.56-0.78)] and cancer-specific survival [aHR 0.56 (0.39-0.81)] with prophylaxis after controlling for patient, treatment, and hospital factors. CONCLUSIONS: Extended pharmacologic prophylaxis after colon cancer resection was independently associated with improved overall and cancer-specific survival. These results suggest a potential anti-neoplastic effect from heparin derivatives when used in the context of preventing post-surgical venous thromboembolism.

Impact of Obesity on Risk of Hypocalcemia After Total Thyroidectomy: Targeted National Surgical Quality Improvement Program Analysis of 16,277 Patients.

INTRODUCTION: Hypocalcemia following total thyroidectomy (TT) is common due to postoperative parathyroid dysfunction and vitamin D deficiency. Given the association between obesity and vitamin D deficiency, we sought to correlate body mass index (BMI) with hypocalcemia after TT. METHODS: Patients undergoing TT between 2016 and 2020 were identified from the American College of Surgeons National Surgical Quality Improvement Program thyroidectomy-targeted database. Univariable and multivariable regressions, stratified by BMI category (normal, overweight, obese), identified factors associated with hypocalcemia prior to discharge, within 30 d, and severe hypocalcemic events (emergent evaluation, intravenous calcium supplementation, or readmission). RESULTS: Sixteen thousand two hundred seventy seven TT were performed with available BMI data. Three thousand five hundred thirty one (21.7%) patients had normal BMI, 4823 (29.6%) were overweight, and 7772 (47.7%) were obese. Patients with BMI ≥ 25 had decreased risk of hypocalcemia before discharge (9.8% versus 13%, odds ratio [OR] 0.73, P < 0.001), 30 d (8.1% versus 10.4%, OR 0.76, P < 0.001), and severe hypocalcemic events (5.5% versus 6.4%, OR 0.84, P = 0.029) compared to normal BMI patients. On multivariable analysis for normal BMI patients, age < 45 y was a risk factor for hypocalcemia before discharge, 30 d, and severe hypocalcemic events (P < 0.05 for all). Additional risk factors in this group for 30-d hypocalcemia included parathyroid autotransplant and central neck dissection (P < 0.05) and recurrent laryngeal nerve injury for severe hypocalcemic events (P = 0.01). CONCLUSIONS: Younger patients with BMI < 25 are at an increased risk for hypocalcemia and severe hypocalcemic events after TT. These patients may benefit from preoperative counseling and increased calcium/vitamin D supplementation to reduce prolonged hospitalization and mitigate morbidity.

Gender Disparities in Presentations at the Society of Surgical Oncology (SSO) Meetings From 2014 to 2019.

BACKGROUND: Participation in surgical society meetings serves as a proxy for academic success and is important for career development. This study aimed to investigate and report the gender breakdown of presenters at recent Society of Surgical Oncology (SSO) meetings. METHODS: Genders of presenters for poster, parallel, plenary, and video sessions at SSO meetings from 2014 through 2019 were collected. These data were broken down to first-last authorship relationships including female-female, female-male, male-female, and male-male. The proportions of female-to-male presenters were compared for each session type. Statistical significance was set at p value lower than 0.05. RESULTS: From 2014 through 2019, the SSO had 2920 presenters, and 47% were female. Women were listed as first authors more often for the poster session (48%) than for other sessions (parallel, plenary, and video) (p = 0.003). Women also were listed more often as senior authors for the poster session (31%) than for other sessions (p = 0.004). Female senior authors were fewer than male senior authors across all session types. Female first authors had the highest representation in breast (75%), endocrine (48%), and cutaneous (46%) specialties (p < 0.001). The most common combination of first and senior authors was male-male (43%), followed by female-male (28%), female-female (19%), and male-female (10%). CONCLUSION: Overall, female presentation at SSO is comparable with society demographics, and female first authorship is relatively equal to male first authorship in poster sessions. Whereas female first authorship improved over time, female senior authorship remained relatively flat. Opportunities to improve gender equality in senior authorship positions should be explored.

Increased Body Mass Index is Associated With Lower Risk of Hypocalcemia in Total Thyroidectomy Patients.

INTRODUCTION: Hypocalcemia following total thyroidectomy is common due to postoperative parathyroid dysfunction. We sought to identify the impact of obesity on postthyroidectomy hypocalcemia. METHODS: We performed a single-center retrospective study of all total thyroidectomies performed from 2016 to 2019 after implementation of an updated calcium supplementation protocol. Patient characteristics and outcomes were measured including body mass index (BMI), postoperative hypocalcemia (Ca <8.3), and hypocalcemic symptoms. RESULTS: Overall, 559 total thyroidectomies were performed. A total of 146 patients (26.2%) developed hypocalcemia requiring supplementation adjustment and 116 patients (20.8%) developed mild hypocalcemia symptoms. On multivariable analysis, younger patients, patients with lower preoperative calcium, and lower BMI were more likely to develop postoperative hypocalcemia (all P < 0.05). Similarly, younger patients and patients with BMI <25 were more likely to develop hypocalcemic symptoms (all P < 0.05). CONCLUSIONS: Younger age and lower BMI were associated with increased risk of hypocalcemia after total thyroidectomy. These patients may benefit from preoperative and/or increased postoperative supplementation.

Associations of gender, race, and ethnicity with disparities in short-term adverse outcomes after pancreatic resection for cancer.

BACKGROUND: Several studies have identified disparities in pancreatic cancer treatment associated with gender, race, and ethnicity. There are limited data examining disparities in short-term adverse outcomes after pancreatic resection for cancer. The aim of this study is to evaluate associations of gender, race, and ethnicity with morbidity and mortality after pancreatic resection for malignancy. METHODS: The American College of Surgeons National Surgical Quality Improvement database was retrospectively reviewed. The χ2 test and Student's t-test were used for univariable analysis and hierarchical logistic regression for multivariable analysis. RESULTS: Morbidity and major morbidity after pancreaticoduodenectomy are associated with male gender, Asian race, and Hispanic ethnicity, whereas 30-day mortality is associated with the male gender. Morbidity and major morbidity after distal pancreatectomy are associated with the male gender. Morbidity after pancreaticoduodenectomy is independently associated with male gender, Asian race, and Hispanic ethnicity; major morbidity is independently associated with male gender and Asian race, and mortality is independently associated with Hispanic ethnicity. CONCLUSIONS: Gender, race, and ethnicity are independently associated with morbidity after pancreaticoduodenectomy for cancer; gender and race are independently associated with major morbidity; and ethnicity is independently associated with mortality. Further studies are warranted to determine the basis of these associations.

The improvement in post-operative mortality following pancreaticoduodenectomy between 2006 and 2016 is associated with an improvement in the ability to rescue patients after major morbidity, not in the rate of major morbidity.

BACKGROUND: The postoperative mortality rate of pancreaticoduodenectomy is decreasing over time. It is unknown whether this is related to reduction in incidence of major morbidity or failure to rescue. We aimed to make this determination. METHODS: ACS-NSQIP was retrospectively reviewed from 2006 to 2016. Comparisons were assessed with Spearman's rank-order correlation test, chi-square test with linear-by-linear association, and multivariable hierarchical logistic regression. RESULTS: Mortality decreased significantly from 2.9% to 1.5% (p < 0.001). This decrease was independent of preoperative variables on multivariable analysis (odds ratio [OR] 2.55, 95% confidence interval [CI] 1.55-5.21, p < 0.001). In contrast, no change in incidence of major morbidity was seen on univariable (26.8% to 25.9%, p = 1.00) or multivariable analysis (OR 1.22, 95% CI 1.03-1.45, p = 0.060). Failure to rescue was observed to decrease on univariable (9.8% to 4.1%, p < 0.001) and multivariable analysis (OR 3.65, 95% CI 2.07-6.76, p < 0.001). CONCLUSION: There has been a sizeable reduction in the mortality rate after pancreaticoduodenectomy from 2006 to 2016. This predominantly results from a reduction in failure to rescue rate rather than a decrease in incidence of major morbidity.

Discharge destination following rectal cancer resection: an analysis of preoperative and intraoperative factors.

PURPOSE: Rectal cancer resections can be associated with long and complicated postoperative recoveries. Many patients undergoing these operations are discharged to rehabilitation or skilled nursing facilities. The purpose of this study was to identify preoperative and intraoperative factors associated with increased risk for non-home discharge after rectal cancer resection. METHODS: Rectal cancer resections were identified in the National Surgical Quality Improvement Program Targeted Proctectomy Dataset (years 2016 through 2017) by ICD code. Patients with unknown discharge destination or who experienced in-hospital mortality were excluded. Univariate and multivariate logistic regression analyses were performed to identify preoperative and intraoperative variables associated with non-home discharge destination. Multiple imputation was used to account for missing values. RESULTS: Among the 3637 patients comprising the study sample, 292 (8.0%) patients were discharged to rehabilitation, skilled care, or acute care facilities. Preoperative factors associated with non-home discharge on multivariate analysis included older age, non-independent functional status, insulin-dependent diabetes, and hypoalbuminemia (all p < 0.05). Having received neoadjuvant chemotherapy was associated with home discharge (OR 0.625, 95% CI 0.427-0.914, p = 0.015). Intraoperative factors associated with non-home discharge on multivariate analysis were concurrent cystectomy (p = 0.004) and myocutaneous flap reconstruction (p < 0.001). Patients discharged to non-home facilities had longer initial lengths of stay (14.1 versus 7.0 days, p < 0.001) and higher reoperation rates (12.7 versus 5.0%, p < 0.001), but similar readmission rates (14.7 versus 15.0%, p = 1.0). CONCLUSION: Several preoperative and intraoperative factors are associated with increased risk for non-home discharge after rectal cancer resection. These data can aid in perioperative planning and discharge optimization.

Twenty-Three-Hour-Stay Colectomy Without Increased Readmissions: An Analysis of 1905 Cases from the National Surgical Quality Improvement Program.

BACKGROUND: Isolated case series from highly specialized centers suggest the feasibility of a 23-h hospital stay after colectomy. We sought to determine preoperative variables associated with discharge within 23 h after colectomy to identify patients best suited for a short-stay model. METHODS: The American College of Surgeons NSQIP Colectomy-Targeted database was used to identify patients who underwent elective colectomy from 2012 to 2017. All cases with missing length of stay or inpatient death were excluded. Patients with a postoperative hospital stay ≤1 day were identified. Univariate and multivariate analyses were conducted to identify factors associated with early discharge. RESULTS: A total of 1905 patients were discharged within 23 h after surgery (1.6%). These patients were noted to be younger (59 versus 61 years, p < 0.001) and less likely to have insulin-dependent diabetes (3.0 versus 4.4%, p < 0.001), preoperative dyspnea (2.2 versus 6.0%, p < 0.001), COPD (3.0 versus 4.2%, p = 0.011), and hypertension (40.7 versus 46.9%, p < 0.001) than patients who stayed longer. Shorter operative time (OR 0.986, 95% CI 0.985-0.987, p < 0.001), minimally invasive techniques (OR 2.969, 95% CI 2.686-3.282, p < 0.001), lack of ostomy (OR 0.614, 95% CI 0.478-0.788, p < 0.001), and lack of ureteral stenting (OR 0.641, 95% CI 0.500-0.821, p < 0.001) were associated with early discharge in multivariable analysis. There was no increased incidence of readmission in patients discharged within 23 h. CONCLUSIONS: Twenty-three-hour-stay colectomy is feasible on a national level and does not result in an increased incidence of readmission. Patients undergoing elective procedures without significant medical comorbidities may be eligible for early discharge. Preoperative factors may be used to select patients best suited for this short-stay model.

National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training.

BACKGROUND: Concerns persist regarding the effect of current surgical resident duty-hour policies on patient outcomes, resident education, and resident well-being. METHODS: We conducted a national, cluster-randomized, pragmatic, noninferiority trial involving 117 general surgery residency programs in the United States (2014-2015 academic year). Programs were randomly assigned to current Accreditation Council for Graduate Medical Education (ACGME) duty-hour policies (standard-policy group) or more flexible policies that waived rules on maximum shift lengths and time off between shifts (flexible-policy group). Outcomes included the 30-day rate of postoperative death or serious complications (primary outcome), other postoperative complications, and resident perceptions and satisfaction regarding their well-being, education, and patient care. RESULTS: In an analysis of data from 138,691 patients, flexible, less-restrictive duty-hour policies were not associated with an increased rate of death or serious complications (9.1% in the flexible-policy group and 9.0% in the standard-policy group, P=0.92; unadjusted odds ratio for the flexible-policy group, 0.96; 92% confidence interval, 0.87 to 1.06; P=0.44; noninferiority criteria satisfied) or of any secondary postoperative outcomes studied. Among 4330 residents, those in programs assigned to flexible policies did not report significantly greater dissatisfaction with overall education quality (11.0% in the flexible-policy group and 10.7% in the standard-policy group, P=0.86) or well-being (14.9% and 12.0%, respectively; P=0.10). Residents under flexible policies were less likely than those under standard policies to perceive negative effects of duty-hour policies on multiple aspects of patient safety, continuity of care, professionalism, and resident education but were more likely to perceive negative effects on personal activities. There were no significant differences between study groups in resident-reported perception of the effect of fatigue on personal or patient safety. Residents in the flexible-policy group were less likely than those in the standard-policy group to report leaving during an operation (7.0% vs. 13.2%, P<0.001) or handing off active patient issues (32.0% vs. 46.3%, P<0.001). CONCLUSIONS: As compared with standard duty-hour policies, flexible, less-restrictive duty-hour policies for surgical residents were associated with noninferior patient outcomes and no significant difference in residents' satisfaction with overall well-being and education quality. (FIRST ClinicalTrials.gov number, NCT02050789.).

Utility of Level III Axillary Node Dissection in Melanoma Patients with Palpable Axillary Lymph Node Disease.

BACKGROUND: The Multicenter Selective Lymphadenectomy Trial II results suggest that future radical axillary lymphadenectomy (ALND) will be performed for bulkier metastatic disease. The utility of level III lymph node (LN) dissection in melanoma patients with palpable metastatic axillary disease was assessed. METHODS: We performed a retrospective chart review of patients who underwent ALND (levels I-III) for metastatic melanoma from 2005 to 2017. We assessed the frequency of level III positive nodes in patients undergoing radical axillary lymphadenectomy (ALND) for metastatic melanoma as well as the prognostic role and factors predictive of level III LN positivity. RESULTS: A total of 190 patients underwent ALND during the study period. Of these, 85 patients had palpable axillary disease, of which 71 had separate level III pathologic assessment. Level III LNs were positive in 16.9% of patients with palpable disease versus 0% with positive sentinel LN. The 1-, 3-, and 5-year overall survival (OS) for patients with palpable disease was 82.9%, 58.9%, and 39.0%, respectively. Median disease-free survival was 26.8 months, and the axillary recurrence rate was 8.2%. High level I/II LN ratio, BRAF mutation, and total LN examined were significant predictors of level III positivity (all p ≤ 0.05). Patients with positive level III LN had significantly worse OS (median 18.6 months vs. not reached, p = 0.001). No preoperative factors were predictive of level III LN positivity. CONCLUSIONS: Level III axillary disease is not uncommon in melanoma patients with clinically palpable nodal disease and provides useful prognostic information for OS. We recommend that full level I-III ALND be considered in this patient cohort.

Fast-Track Pancreaticoduodenectomy: Factors Associated with Early Discharge.

BACKGROUND: Pancreaticoduodenectomy is a complex surgery frequently associated with prolonged hospitalizations. However, there are a subset of patients discharged within 5 days from surgery; the preoperative and intraoperative characteristics of this subset are unknown. METHODS: The NSQIP Targeted Pancreatectomy Dataset was used from 2014 to 2016. Patients who died within 30 days were excluded. A total of 10,741 patients undergoing pancreaticoduodenectomy were identified. Univariable and multivariable logistic regression analyses were performed for preoperative and intraoperative ACS-NSQIP variables to identify predictors of early discharge. Early discharge was defined as discharge 3-5 days after surgery. RESULTS: A total of 1105 patients (10.3%) were discharged within 5 days following pancreaticoduodenectomy. On multivariable analysis, preoperative factors associated with early discharge included younger age (OR 0.988, p < 0.001), non-obesity (OR 0.737, p = 0.001), those receiving neoadjuvant chemotherapy (OR 1.424, p < 0.001), and lack of COPD (OR 0.489, p = 0.005) or hypertension (OR 0.805, p = 0.007). Intraoperative factors associated with early discharge on multivariable analysis were shorter operation duration (OR 0.999, p = 0.002), minimally invasive surgery (OR 3.537, p < 0.001), and hard pancreatic texture (OR 1.480, p < 0.001). Intraoperative factors associated with non-early discharge were epidural placement (OR 0.485, p < 0.001), drain placement (OR 0.308, p < 0.001), and jejunostomy tube placement (OR 0.278, p < 0.001). Patients discharged within 5 days had a 14.7% readmission rate compared to 17.0% for later discharges (p = 0.047). CONCLUSIONS: Multiple preoperative and intraoperative factors, including some that are potentially modifiable, were significantly associated with early discharge after pancreaticoduodenectomy. Patients with these characteristics may benefit from enhanced recovery after surgery programs and expedited disposition planning postoperatively.

Prediction of Discharge Destination Following Major Hepatectomy.

BACKGROUND: Anatomic hepatectomies can be associated with complicated post-operative recoveries, often with discharge to post-acute care facilities. This study identifies preoperative and intraoperative factors associated with increased risk for non-home discharge destination after major hepatectomy. METHODS: Patients undergoing major hepatectomy were identified in the NSQIP Targeted Hepatectomy Dataset (2014-2016). Multivariable logistic regression was performed. Patients from 2014 to 2015 were used for training cohort with nomogram generation and 2016 for validation cohort. RESULTS: Overall, 226 of 3750 patients (6.0%) were discharged to rehab, skilled care, or acute care facilities. Preoperative factors associated with non-home discharge on multivariable analysis were outside patient transfers, older age, presence of ascites, ASA physical status 3 or higher, and low preoperative hematocrit (all p < 0.05). Intraoperative factors significantly predictive were concurrent lysis of adhesions, Pringle maneuver, and biliary reconstruction (all p < 0.05). Predictors from testing cohort were validated in validation cohort. Nomograms based on preoperative variables alone and both preoperative and intraoperative variables were generated. CONCLUSION: We identify several preoperative and intraoperative factors that are associated with increased risk for non-home discharge after major hepatectomy. Preoperative anemia represents a potentially modifiable risk factor. Nomograms for preoperative planning as well as immediately following surgery were generated.

Pilot trial of the hu14.18-IL2 immunocytokine in patients with completely resectable recurrent stage III or stage IV melanoma.

Phase I testing of the hu14.18-IL2 immunocytokine (IC) in melanoma patients showed immune activation, reversible toxicities, and a maximal tolerated dose of 7.5 mg/m2/day. Preclinical data in IC-treated tumor-bearing mice with low tumor burden documented striking antitumor effects. Patients with completely resectable recurrent stage III or stage IV melanoma were scheduled to receive 3 courses of IC at 6 mg/m2/day i.v. on days 1, 2 and 3 of each 28-day course. Patients were randomized to complete surgical resection either following neoadjuvant (Group A) or prior to adjuvant (Group B) IC course 1. Primary objectives were to: (1) evaluate histological evidence of anti-tumor activity and (2) evaluate recurrence-free survival (RFS) and OS. Twenty melanoma patients were randomized to Group A (11 patients) or B (9 patients). Two Group B patients did not receive IC due to persistent disease following surgery. Six of 18 IC-treated patients remained free of recurrence, with a median RFS of 5.7 months (95% confidence interval (CI) 1.8-not reached). The 24-month RFS rate was 38.9% (95% CI 17.5-60.0%). The median follow-up of surviving patients was 50.0 months (range: 31.8-70.4). The 24-month OS rate was 65.0% (95% CI 40.3-81.5%). Toxicities were similar to those previously reported. Exploratory tumor-infiltrating lymphocyte (TIL) analyses suggest prognostic value of TILs from Group A patients. Prolonged tumor-free survival was seen in some melanoma patients at high risk for recurrence who were treated with IC.

Enhanced local and systemic anti-melanoma CD8+ T cell responses after memory T cell-based adoptive immunotherapy in mice.

Adoptive cell transfer (ACT) melanoma immunotherapy typically employs acutely activated effector CD8+ T cells for their ability to rapidly recognize and clear antigen. We have previously observed that effector CD8+ T cells are highly susceptible to melanoma-induced suppression, whereas memory CD8+ T cells are not. Although memory T cells have been presumed to be potentially advantageous for ACT, the kinetics of local and systemic T cell responses after effector and memory ACT have not been compared. B16F10 melanoma cells stably transfected to express very low levels of the lymphocytic choriomeningitis virus (LCMV) peptide GP33 (B16GP33) were inoculated into syngeneic C57BL/6 mice. Equal numbers of bona fide naïve, effector, or memory phenotype GP33-specific CD8+ T cells were adoptively transferred into mice 1 day after B16GP33 inoculation. The efficacy of ACT immunotherapy was kinetically assessed using serial tumor measurements and flow cytometric analyses of local and systemic CD8+ T cell responses. Control of B16GP33 tumor growth, persistence of adoptively transferred CD8+ cells, intratumoral infiltration of CD8+ T cells, and systemic CD8+ T cell responsiveness to GP33 were strongest after ACT of memory CD8+ T cells. Following surgical tumor resection and melanoma tumor challenge, only mice receiving memory T cell-based ACT immunotherapy exhibited durable tumor-specific immunity. These findings demonstrate how the use of non-expanded memory CD8+ T cells may enhance ACT immunotherapeutic efficacy.

ERCP in potentially resectable malignant biliary obstruction is frequently unsuccessful when performed outside of a comprehensive pancreaticobiliary center.

BACKGROUND AND OBJECTIVES: ERCP prior to pancreaticoduodenectomy is unnecessary in select patients. When performed, it should be in conjunction with endoscopic ultrasound (EUS) to increase diagnostic sensitivity and allow for metal stent placement. The aim of this study was to determine differences in endoscopic practice patterns at community medical centers (CMC) and a comprehensive pancreaticobiliary referral center (PBRC). METHODS: Retrospective cohort study of all patients seen at a PBRC for endoscopic and/or surgical management of potentially resectable malignant distal biliary obstruction from 1/2011 to 6/2014. RESULTS: Of 75 patients, 30 underwent endoscopic management at a CMC and 45 were initially managed at our PBRC. ERCP was attempted in 92% of patients. EUS was performed more frequently (100% vs. 13.3 %, P < 0.0001), ERCP was more successful (93% vs. 69%, P = 0.02), and metal stent placement more likely (41% vs. 5%, P = 0.005) at our PBRC compared to a CMC. The majority (81%) of patients undergoing initial endoscopy at a CMC required repeat endoscopy at our PBRC. CONCLUSIONS: Patients who are candidates for pancreaticoduodenectomy frequently undergo ERCP. At a CMC, ERCP is often unsuccessful, is rarely accompanied by EUS, and often requires repeat endoscopy. Our findings support regionalizing the management of suspected pancreatic malignancy into dedicated specialty centers. J. Surg. Oncol. 2016;113:647-651. © 2016 Wiley Periodicals, Inc.

Association between hospital imaging use and venous thromboembolism events rates based on clinical data.

OBJECTIVE: The objective was to assess the presence and extent of venous thromboembolic (VTE) surveillance bias using high-quality clinical data. BACKGROUND: Hospital VTE rates are publicly reported and used in pay-for-performance programs. Prior work suggested surveillance bias: hospitals that look more for VTE with imaging studies find more VTE, thereby incorrectly seem to have worse performance. However, these results have been questioned as the risk adjustment and VTE measurement relied on administrative data. METHODS: Data (2009-2010) from 208 hospitals were available for analysis. Hospitals were divided into quartiles according to VTE imaging use rates (Medicare claims). Observed and risk-adjusted postoperative VTE event rates (regression models using American College of Surgeons National Surgical Quality Improvement Project data) were examined across VTE imaging use rate quartiles. Multivariable linear regression models were developed to assess the impact of hospital characteristics (American Hospital Association) and hospital imaging use rates on VTE event rates. RESULTS: The mean risk-adjusted VTE event rates at 30 days after surgery increased across VTE imaging use rate quartiles: 1.13% in the lowest quartile to 1.92% in the highest quartile (P < 0.001). This statistically significant trend remained when examining only the inpatient period. Hospital VTE imaging use rate was the dominant driver of hospital VTE event rates (P < 0.001), as no other hospital characteristics had significant associations. CONCLUSIONS: Even when examined with clinically ascertained outcomes and detailed risk adjustment, VTE rates reflect hospital imaging use and perhaps signify vigilant, high-quality care. The VTE outcome measure may not be an accurate quality indicator and should likely not be used in public reporting or pay-for-performance programs.

Neoadjuvant Chemotherapy is Associated With Decreased Survival in Early-Stage Gastric Cancer.

BACKGROUND: Although randomized controlled trials on neoadjuvant chemotherapy for gastric cancer have included some T1-staged tumors, overall survival (OS) has not been analyzed for this subset. Due to the low negative predictive value of clinical staging and the benefits of neoadjuvant chemotherapy for locally advanced disease, identifying patient groups with early-stage gastric cancer that may benefit from neoadjuvant chemotherapy is of merit. AIMS: The objective of this study was to evaluate the relationship between OS and sequence of surgical therapy for clinical T1 gastric cancer. METHODS: The 2017 National Cancer Database was used to compare patients who had surgery-first and those who received neoadjuvant chemotherapy for T1-stage gastric cancer. OS was analyzed using a parametric regression survival-time model adjusted for covariates. The effects of these covariates on OS based on surgical sequence were examined. RESULTS: 11,219 patients were included, of which 10,191 underwent surgery as their first or only treatment. When adjusted for covariates, neoadjuvant chemotherapy followed by curative-intent surgery was significantly associated with increased risk of death (HR 1.15, 95% CI 1.01-1.31, P = .030). In multivariate analysis, clinical N0 stage, non-minorities, and patients with high socioeconomic status had improved OS if they did not have neoadjuvant chemotherapy and instead had upfront surgery. CONCLUSION: Neoadjuvant chemotherapy is associated with decreased OS for early-stage gastric adenocarcinoma, even for patients with clinically positive nodal disease. In addition, the lack of survival improvement with a surgery-first approach in patients with disparities deserves further study.

Surgeons' perceptions of public reporting of hospital and individual surgeon quality.

BACKGROUND: Hospital-specific and surgeon-specific public reporting of performance measures is expanding largely due to calls for transparency from the public and oversight agencies. Surgeons continue to voice concerns regarding public reporting. Surgeons' perceptions of hospital-level and individual-level public reporting have not been assessed. This study (1) evaluated surgeons' perceptions of public reporting of surgical quality; and (2) identified specific barriers to surgeons' acceptance of public reporting. METHODS: All surgeons (n=185) at 4 hospitals (university, children's, 2 community hospitals), representing all surgical specialties, received a 41-item anonymous Internet-based survey. Twenty follow-up qualitative interviews were conducted to assess surgeons' interpretation of findings. RESULTS: The survey response rate was 66% (n=122). Most surgeons supported public reporting of quality metrics at the hospital level (80%), but opposed individual reporting (53%, P<0.01). Fewer surgeons expected that individual (26%) or hospital (47%) public reporting would improve outcomes (P<0.01). Few indicated that their practice would change with hospital (11%) or individual (18%) public reporting (P=0.20). Primary concerns regarding public reporting at the hospital level included patients misinterpreting data, surgeons refusing high-risk patients, and outcome metric validity. Individual-surgeon level concerns included outcome metric validity, adequate sample sizes, and patients misinterpreting data. To make public reporting more acceptable, surgeons recommended patient education, simplified data presentation, continued risk-adjustment refinement, and internal review before public reporting. CONCLUSIONS: Surgeons expressed concerns about public reporting of quality metrics, particularly reporting of individual surgeon performance. These concerns must be addressed to gain surgeons' acceptance and to use public reporting to improve health care quality.