Neoadjuvant Therapy for Duodenal and Ampullary Adenocarcinoma: A Systematic Review.

BACKGROUND: The role of systemic therapy in the management of ampullary (AA) and duodenal adenocarcinoma (DA) remains poorly understood. This study sought to synthesize current evidence supporting the use of neoadjuvant therapy (NAT) in AA and DA. METHODS: The study searched PubMed, Cochrane Library (Wiley), Embase (Elsevier), CINAHL (EBSCO), and ClinicalTrials.gov databases for observational or randomized studies published between 2002 and 2022 evaluating survival outcomes for patients with non-metastatic AA or DA who received systemic therapy and surgical resection. The data extracted included overall survival, progression-free survival, and pathologic response (PR) rate. RESULTS: From the 347 abstracts identified in this study, 29 reports were reviewed in full, and 15 were included in the final review. The selected studies published from 2007 to 2022 were retrospective. Eight were single-center studies; five used the National Cancer Database (NCDB); and two were European multicenter/national studies. Overall, no studies identified survival differences between NAT and upfront surgery (with or without adjuvant therapy). Two NCDB studies reported longer survival with NAT/AT than with surgery. Five single-center studies reported a significant portion of NAT patients who achieved PR, and one study identified major PR as an independent predictor of survival. Other outcomes associated with NAT included conversion from unresectable to resectable disease, reduced lymph node positivity, and decreased local recurrence rate. CONCLUSION: Evidence supporting the use of NAT in AA and DA is weak. No randomized studies exist, and observational data show mixed results. For patients with DA and AA, NAT appears safe, but better evidence is needed to understand the preferred multidisciplinary management of DA and AA periampullary malignancies.

Association Between Biliary Pathogens, Surgical Site Infection, and Pancreatic Fistula: Results of a Randomized Trial of Perioperative Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy.

OBJECTIVE: To establish the association between bactibilia and postoperative complications when stratified by perioperative antibiotic prophylaxis. BACKGROUND: Patients undergoing pancreatoduodenectomy experience high rates of surgical site infection (SSI) and clinically relevant postoperative pancreatic fistula (CR-POPF). Contaminated bile is known to be associated with SSI, but the role of antibiotic prophylaxis in mitigation of infectious risks is ill-defined. METHODS: Intraoperative bile cultures (IOBCs) were collected as an adjunct to a randomized phase 3 clinical trial comparing piperacillin-tazobactam with cefoxitin as perioperative prophylaxis in patients undergoing pancreatoduodenectomy. After compilation of IOBC data, associations between culture results, SSI, and CR-POPF were assessed using logistic regression stratified by the presence of a preoperative biliary stent. RESULTS: Of 778 participants in the clinical trial, IOBC were available for 247 participants. Overall, 68 (27.5%) grew no organisms, 37 (15.0%) grew 1 organism, and 142 (57.5%) were polymicrobial. Organisms resistant to cefoxitin but not piperacillin-tazobactam were present in 95 patients (45.2%). The presence of cefoxitin-resistant organisms, 92.6% of which contained either Enterobacter spp. or Enterococcus spp., was associated with the development of SSI in participants treated with cefoxitin [53.5% vs 25.0%; odds ratio (OR)=3.44, 95% CI: 1.50-7.91; P =0.004] but not those treated with piperacillin-tazobactam (13.5% vs 27.0%; OR=0.42, 95% CI: 0.14-1.29; P =0.128). Similarly, cefoxitin-resistant organisms were associated with CR-POPF in participants treated with cefoxitin (24.1% vs 5.8%; OR=3.45, 95% CI: 1.22-9.74; P =0.017) but not those treated with piperacillin-tazobactam (5.4% vs 4.8%; OR=0.92, 95% CI: 0.30-2.80; P =0.888). CONCLUSIONS: Previously observed reductions in SSI and CR-POPF in patients that received piperacillin-tazobactam antibiotic prophylaxis are potentially mediated by biliary pathogens that are cefoxitin resistant, specifically Enterobacter spp. and Enterococcus spp.

Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial.

Importance: Despite improvements in perioperative mortality, the incidence of postoperative surgical site infection (SSI) remains high after pancreatoduodenectomy. The effect of broad-spectrum antimicrobial surgical prophylaxis in reducing SSI is poorly understood. Objective: To define the effect of broad-spectrum perioperative antimicrobial prophylaxis on postoperative SSI incidence compared with standard care antibiotics. Design, Setting, and Participants: Pragmatic, open-label, multicenter, randomized phase 3 clinical trial at 26 hospitals across the US and Canada. Participants were enrolled between November 2017 and August 2021, with follow-up through December 2021. Adults undergoing open pancreatoduodenectomy for any indication were eligible. Individuals were excluded if they had allergies to study medications, active infections, chronic steroid use, significant kidney dysfunction, or were pregnant or breastfeeding. Participants were block randomized in a 1:1 ratio and stratified by the presence of a preoperative biliary stent. Participants, investigators, and statisticians analyzing trial data were unblinded to treatment assignment. Intervention: The intervention group received piperacillin-tazobactam (3.375 or 4 g intravenously) as perioperative antimicrobial prophylaxis, while the control group received cefoxitin (2 g intravenously; standard care). Main Outcomes and Measures: The primary outcome was development of postoperative SSI within 30 days. Secondary end points included 30-day mortality, development of clinically relevant postoperative pancreatic fistula, and sepsis. All data were collected as part of the American College of Surgeons National Surgical Quality Improvement Program. Results: The trial was terminated at an interim analysis on the basis of a predefined stopping rule. Of 778 participants (378 in the piperacillin-tazobactam group [median age, 66.8 y; 233 {61.6%} men] and 400 in the cefoxitin group [median age, 68.0 y; 223 {55.8%} men]), the percentage with SSI at 30 days was lower in the perioperative piperacillin-tazobactam vs cefoxitin group (19.8% vs 32.8%; absolute difference, -13.0% [95% CI, -19.1% to -6.9%]; P < .001). Participants treated with piperacillin-tazobactam, vs cefoxitin, had lower rates of postoperative sepsis (4.2% vs 7.5%; difference, -3.3% [95% CI, -6.6% to 0.0%]; P = .02) and clinically relevant postoperative pancreatic fistula (12.7% vs 19.0%; difference, -6.3% [95% CI, -11.4% to -1.2%]; P = .03). Mortality rates at 30 days were 1.3% (5/378) among participants treated with piperacillin-tazobactam and 2.5% (10/400) among those receiving cefoxitin (difference, -1.2% [95% CI, -3.1% to 0.7%]; P = .32). Conclusions and Relevance: In participants undergoing open pancreatoduodenectomy, use of piperacillin-tazobactam as perioperative prophylaxis reduced postoperative SSI, pancreatic fistula, and multiple downstream sequelae of SSI. The findings support the use of piperacillin-tazobactam as standard care for open pancreatoduodenectomy. Trial Registration: ClinicalTrials.gov Identifier: NCT03269994.

Management of Locally Advanced Pancreatic Cancer: Results of an International Survey of Current Practice.

OBJECTIVE: The aim of this study was to investigate surgeon preferences for the management of patients with locally advanced pancreatic cancer (LAPC). BACKGROUND: Select patients with LAPC may become candidates for curative resection following neoadjuvant therapy, and recent reports of survival are encouraging. Yet the optimal management approach remains unclear. METHODS: An extensive electronic survey was systematically distributed by email to an international cohort of pancreas surgeons. Data collected included practice characteristics, management preferences, attitudes regarding contraindications to surgery, and 6 clinical vignettes of patients that ultimately received a margin negative resection (with detailed videos of post-neoadjuvant imaging) to assess propensity for surgical exploration if resection status is not known. RESULTS: A total of 153 eligible responses were received from 4 continents. Median duration of practice is 12 years (interquartile range 6-20) and 77% work in a university setting. Most surgeons (86%) are considered high volume (>10 resections/yr), 33% offer a minimally-invasive approach, and 50% offer arterial resections in select patients. Most (72%) always recommend neoadjuvant chemotherapy, and 65% prefer FOLFIRINOX. Preferences for the duration of chemotherapy varied widely: 39% prefer ≥2 months, 43% prefer ≥4 months, and 11% prefer ≥6 months. Forty-one percent frequently recommend neoadjuvant radiotherapy, and 53% prefer 5 to 6 weeks of chemoradiation. The proportion of surgeons favoring exploration following neoadjuvant varied extensively across 5 vignettes of LAPC, from 14% to 53%. In a vignette of oligometastatic liver metastases, 31% would offer exploration if a favorable therapy response is observed. CONCLUSIONS: In an international cohort of pancreas surgeons, there is substantial variation in management preferences, perceived contraindications to surgery, and the propensity to consider exploration in LAPC. These results emphasize the importance of a robust and nuanced multidisciplinary discussion for each patient, and suggest an evolving concept of "resectability."

Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma: Propensity-Matched Analysis of Postoperative Complications Using ACS-NSQIP.

BACKGROUND: The use of neoadjuvant therapy (NAT) for pancreatic ductal adenocarcinoma (PDAC) is increasing. While there is an association between NAT and improved post-pancreatectomy complication rates in limited patient populations, the strength of the relationship and its applicability to a broader and modern pancreatectomy cohort remains unclear. METHODS: We used the 2014-2018 American College of Surgeons National Surgical Quality Improvement Project to evaluate NAT use for PDAC patients undergoing pancreatectomy. We also used propensity score matching techniques to compare 30-day postoperative outcomes, including clinically relevant postoperative pancreatic fistula (CR-POPF) and delayed gastric emptying (DGE), between patients selected for NAT versus upfront surgery. RESULTS: Patients receiving NAT were more likely to undergo vascular resections (33% vs. 16%, p < 0.001), have perioperative transfusions (18% vs. 12%, p < 0.001), and undergo longer procedures. Rates of CR-POPF (6%, vs. 10%, p < 0.001), DGE (11% vs. 13%, p = 0.016), postoperative percutaneous drainage (9% vs. 12%, p < 0.001), and SSI (15% vs. 18%, p < 0.001) were lower for patients selected for NAT. The association of NAT with CR-POPF remained statistically significant (adjusted odds ratio 0.52, 95% CI 0.42-0.66) after adjustment for operative technique, gland texture, and need for vascular resection for patients undergoing pancreaticoduodenectomy, but not for patients undergoing distal pancreatectomy. CONCLUSIONS: Among PDAC patients undergoing resection, selection for NAT is associated with fewer CR-POPFs, postoperative procedural interventions, and infectious complications, particularly for patients undergoing pancreaticoduodenectomy. These associations should be considered in discussions of multidisciplinary treatment sequencing for patients with PDAC.

Association of gravity drainage and complications following Whipple: an analysis of the ACS-NSQIP targeted database.

BACKGROUND: The optimal type of operative drainage following pancreaticoduodenectomy (PD) remains unclear. Our objective is to investigate risk associated with closed drainage techniques (passive [gravity] vs. suction) after PD. METHODS: We assessed operative drainage techniques utilized in patients undergoing PD in the ACS-NSQIP pancreas-targeted database from 2016 to 2018. Using multivariable logistic regression to adjust for characteristics of the patient, procedure, and pancreas, we examined the association between use of gravity drainage and postoperative outcomes. RESULTS: We identified 9665 patients with drains following PD from 2016 to 2018, of which 12.7% received gravity drainage. 61.0% had a diagnosis of adenocarcinoma or pancreatitis, 26.5% had a duct <3 mm, and 43.5% had a soft or intermediate gland. After multivariable adjustment, gravity drainage was associated with decreased rates of postoperative pancreatic fistula (odds ratio [OR] 0.779, 95% confidence interval [CI] 0.653-0.930, p=0.006), delayed gastric emptying (OR 0.830, 95% CI 0.693-0.988, p=0.036), superficial SSI (OR 0.741, 95% CI 0.572-0.959, p=0.023), organ space SSI (OR 0.791, 95% CI 0.658-0.951, p=0.012), and readmission (OR 0.807, 95% CI 0.679-0.958, p=0.014) following PD. CONCLUSIONS: Gravity drainage is independently associated with decreased rates of CR-POPF, DGE, SSI, and readmission following PD. Additional prospective research is necessary to better understand the preferred drainage technique following PD.

Risk factors for anastomotic leak after esophagectomy for cancer: A NSQIP procedure-targeted analysis.

BACKGROUND: Anastomotic leak is the most common major complication after esophagectomy. We investigated the 2016 American College of Surgeons National Surgical Quality Improvement Program esophagectomy targeted database to identify risk factors for anastomotic leak. METHODS: Patients who underwent esophagectomy for cancer were included. Patients experiencing an anstomotic leak were identified, and univariate and multivariable logistic regression was performed to identify variables independently associated with anastomotic leak. RESULTS: Of 915 patients included, 83% were male and the median age was 64 years. Patients with anastomotic leak more frequently had additional complications (87% vs 36%, P < .001). Rates of reoperation (64% vs 11%, P < .001) and mortality (8% vs 2%, P = .001) were higher in patients with anastomotic leak. After adjusting for patient and procedure characteristics, prolonged operative time (for each additional 30-minutes; adjusted odds ratios (AOR) 1.068, 95% CI, 1.022-1.115, P = .003), increased preoperative WBC count (for each 3000/µL increase; AOR 1.323, 95% CI, 1.048-1.670, P = .019), pre-existing diabetes (AOR 1.601, 95% CI, 1.012-2.534, P = .045), and perioperative transfusion (AOR 1.777, 95% CI, 1.064-2.965, P = .028) were independently associated with anastomotic leak. CONCLUSION: Both patient and procedure-related factors are associated with anastomotic leak. Though frequently non-modifiable, these findings could facilitate risk stratification and early detection of anastomotic leak to reduce associated morbidity.

Comparing the long-term outcomes among patients with stomach and small intestine gastrointestinal stromal tumors: An analysis of the National Cancer Database.

BACKGROUND AND OBJECTIVES: Gastrointestinal stromal tumors (GIST) are the most common sarcoma arising from the gastrointestinal tract. Data regrading long-term prognosis based on tumor location (stomach vs small intestine) are mixed, so we aimed to analyze their outcomes using a large national oncology database. METHODS: The National Cancer Database was queried for cases of stomach and small intestine GIST between the years 2004 and 2014. Survival analysis was performed using the Kaplan-Meier method, and factors related to survival were compared using the Cox proportional hazards model. RESULTS: Of 18 900 total patients, those with small intestine GIST had larger median tumor size (6.2 cm; interquartile range [IQR], 3.8 to 10.0 vs stomach: 5.0 cm; IQR, 3.0 to 9.0; P < 0.001) and a higher incidence of tumors with ≥5 mitoses/50 HPF (29.3% vs stomach: 24.2%; P < 0.001). Unadjusted median overall survival (OS) was longer for patients with stomach GIST (10.3 years) as compared to small intestine GIST (9.4 years) (P = 0.01). After controlling for patient and tumor-related factors, however, OS did not differ between stomach and small intestine GIST (hazard ratio, 1.19; 95% confidence interval, 0.88 to 1.61; P = 0.26). CONCLUSIONS: Patients with small intestine GIST more commonly have larger, high mitotic rate tumors, but despite these worse prognostic features, tumor location did not independently impact OS.

Resection of retroperitoneal sarcoma en-bloc with inferior vena cava: 20 year outcomes of a single institution.

BACKGROUND: Margin negative resection offers the best chance of long-term survival in retroperitoneal sarcoma (RPS). En-bloc resection of adjacent structures, including the inferior vena cava (IVC), is often required to achieve negative margins. We review our 20-year experience of en-bloc IVC and RPS resection. METHODS: Retrospective review of patients with RPS resection involving the IVC were matched 1:3 by age and histology to RPS without IVC resection. Prognostic factors for overall survival (OS) and disease free survival (DFS) were assessed. RESULTS: Thirty-two patients underwent RPS resection en-bloc with IVC. They were matched with 96 cases of RPS without IVC resection. Median OS of 59 months and DFS 18 months in IVC resection group was comparable to RPS resection without vascular involvement: median OS 65 months, DFS 18 months (P = 0.519, P = 0.604). On multivariate analyses, R2 margin (OS: HR = 6.52 [95%CI: 1.18-36.09], P = 0.032) was associated with inferior OS. R2 margin and increased number of organs resected (DFS: HR = 5.07, [1.15-22.27], P = 0.031, HR = 1.28 [1.01-1.62], P = 0.014) were associated with inferior DFS. Reconstructions included graft (n = 19, 59%), patch (n = 4, 13%), primary repair (n = 6, 19%), and ligation (n = 4, 13%). CONCLUSIONS: RPS resection en-bloc with IVC can achieve equivalent rates of DFS and OS to patients without vascular involvement.

Cytoreductive debulking surgery among patients with neuroendocrine liver metastasis: a multi-institutional analysis.

BACKGROUND: Management of neuroendocrine liver metastasis (NELM) in the setting of unresectable disease is poorly defined and the role of debulking remains controversial. The objective of the current study was to define outcomes following non-curative intent liver-directed therapy (debulking) among patients with NELM. METHODS: 612 patients were identified who underwent liver-directed therapy of NELM from a multi-institutional database. Outcomes were stratified according to curative (R0/R1) versus non-curative ≥ 80% debulking (R2). RESULTS: 179 (29.2%) patients had an R2/debulking procedure. Patients undergoing debulking more commonly had more aggressive high-grade tumors (R0/R1: 12.8% vs. R2: 35.0%; P < 0.001) or liver disease burden that was bilateral (R0/R1: 52.8% vs. R2: 75.6%; P < 0.001). After a median follow-up of 51 months, median (R0/R1: not reached vs. R2: 87 months; P < 0.001) and 5-year survival (R0/R1: 85.2% vs. R2: 60.7%; P < 0.001) was higher among patients who underwent an R0/R1 resection compared with patients who underwent a debulking operation. Among patients with ≥50% NELM liver involvement, median and 5-year survival following debulking was 55.4 months and 40.6%, respectively. CONCLUSION: Debulking operations for NELM provided reasonable long-term survival. Hepatic debulking for patients with NELM is a reasonable therapeutic option for patients with grossly unresectable disease that may provide a survival benefit.

Impact of major vascular resection on outcomes and survival in patients with intrahepatic cholangiocarcinoma: A multi-institutional analysis.

BACKGROUND: Major vascular involvement (IVC or portal vein) for intrahepatic cholangiocarcinoma (ICC) has traditionally been considered a contraindication to resection. We sought to define perioperative outcomes and survival of ICC patients undergoing hepatectomy with major vascular resection in a large international multi-institutional database. METHODS: A total of 1087 ICC patients who underwent curative-intent hepatectomy between 1990 and 2016 were identified from 13 institutions. Multivariable logistic and cox regressions were used to determine the impact of major vascular resection on perioperative and survival outcomes. RESULTS: Of 1087 patients who underwent resection, 128 (11.8%) also underwent major vascular resection (21 [16.4%] IVC resections, 98 [76.6%] PV resections, 9 [7.0%] combined resections). Despite more advanced disease, major vascular resection was not associated with the risk of any complication (OR = 0.68, 95%CI 0.32-1.45) or major complications (OR = 0.95, 95%CI 0.49-2.00). Post-operative mortality was also comparable between groups (OR = 1.05, 95%CI 0.32-3.47). In addition, median recurrence-free (14.0 vs 14.7 months, HR = 0.737, 95%CI 0.49-1.10) and overall (33.4 vs 40.2 months, HR = 0.71, 95%CI 0.359-1.40) survival were similar among patients who did and did not undergo major vascular resection (both P > 0.05). CONCLUSION: Among patients with ICC, major vascular resection was not associated with worse perioperative or oncologic outcomes. Concurrent major vascular resection should be considered in appropriately selected patients with ICC undergoing hepatectomy.

Impact of adjuvant chemotherapy on survival in patients with intrahepatic cholangiocarcinoma: a multi-institutional analysis.

BACKGROUND: The benefit of adjuvant chemotherapy for resected intrahepatic cholangiocarcinoma (ICC) is unclear. The aim of the current study was to investigate the impact of adjuvant chemotherapy on survival among patients undergoing resection of ICC using a multi-institutional database. METHODS: 1154 ICC patients undergoing curative-intent hepatectomy between 1990 and 2015 were identified from 14 institutions. Cox proportional hazard modeling was used to determine the impact of adjuvant chemotherapy on overall survival (OS). RESULTS: Following resection, 347 (30%) patients received adjuvant chemotherapy, most commonly a gemcitabine-based regimen (n = 184, 52%). Patients with T2/T3/T4 disease were more likely to receive adjuvant therapy compared with patients with T1a/T1b disease (OR 2.5, 95%CI 1.89-3.23; P < 0.001). Among patients who did and did not receive adjuvant therapy, patients with T2/T3/T4 tumors had a 5-year OS of 37% (95%CI 28.9-44.4) versus 30% (95%CI 23.8-35.6), respectively (p = 0.006). Similarly patients with N1 disease who received adjuvant chemotherapy tended to have improved 5-year OS (18.3%, 95%CI 9.0-30.1 vs. no adjuvant therapy 12%, 95%CI 3.9-24.4; P = 0.050). CONCLUSIONS: While adjuvant chemotherapy did not influence the prognosis of all ICC patients following surgical resection, it was associated with a potential survival benefit in subgroups of patients at increased risk for recurrence, such as those with advanced tumors.

National trends in resection of cystic lesions of the pancreas.

BACKGROUND: Management of cystic lesions of the pancreas (CLP) is controversial. In this study, we sought to evaluate national changes in the resection of CLP over time, to better understand the impact of evolving guidelines on CLP management. METHODS: We used Medicare data to examine CLP resection among patients undergoing pancreatic resection between 2001 and 2012. Patients with a diagnosis of CLP were identified and compared to patients with non-CLP indications. We then examined changes over time in patient and hospital characteristics and outcomes among patients with a CLP diagnosis. RESULTS: We identified 56,419 Medicare patients undergoing pancreatic resection, of which 2129 had a CLP diagnosis. The annual number of CLP resections, and proportion of all resections performed for CLP increased significantly during the period, from 2.1% (65/3072) resections in 2001, to 4.5% (286/6348) in 2012 (p < 0.001). The proportion of CLP resections with a malignant diagnosis did not change (15.5% in 2001-2003 vs. 13.1% in 2010-2012, p = 0.4). Overall rates of 30-day mortality decreased significantly during the period (9.6% in 2001-2003 vs. 5.5% in 2010-2012, p < 0.001). DISCUSSION: CLP resections were performed with increasing frequency in Medicare patients between 2001 and 2012, but this did not correspond to increased diagnosis of malignancy. Additional research is needed to understand the influence of recent guidelines on management of CLP.

Critical evaluation of the scientific content in clinical practice guidelines.

BACKGROUND: Increasing pressures to provide high-quality evidence-based cancer care have driven the rapid proliferation of clinical practice guidelines (CPGs). The quality and validity of CPGs have been questioned, and adherence to guidelines is relatively low. The purpose of this study was to critically evaluate the development process and scientific content of CPGs. METHODS: CPGs addressing management of rectal cancer were evaluated. We quantitatively assessed guideline quality with the validated Appraisal of Guidelines Research & Evaluation (AGREE II) instrument. We identified 21 independent processes of care using the nominal group technique. We then compared the evidence base and scientific agreement for the management recommendations for these processes of care. RESULTS: The quality and content of rectal cancer CPGs varied widely. Mean overall AGREE II scores ranged from 27% to 90%. Across the 5 CPGs, average scores were highest for the clarity of presentation domain (85%; range, 58% to 99%) and lowest for the applicability domain (21%; range, 8% to 56%). Randomized controlled trials represented a small proportion of citations (median, 18%; range, 13%-35%), 78% of the recommendations were based on low- or moderate-quality evidence, and the CPGs only had 11 references in common with the highest-rated CPG. There were conflicting recommendations for 13 of the 21 care processes assessed (62%). CONCLUSIONS: There is significant variation in CPG development processes and scientific content. With conflicting recommendations between CPGs, there is no reliable resource to guide high-quality evidence-based cancer care. The quality and consistency of CPGs are in need of improvement.

Surgical Referral for Colorectal Liver Metastases: A Population-Based Survey.

BACKGROUND: Surgical resection is underutilized for patients with colorectal liver metastases (CLM). Although the causes of underutilization are poorly understood, provider attitudes towards surgical referral may be contributory. We sought to understand medical oncologists' perspectives on referral for CLM. METHODS: Medical oncologists who treat colorectal cancer in the US state of Michigan were surveyed. We characterized respondents' attitudes regarding clinical and tumor-related contraindications to liver resection for CLM, as well as referral and treatment preferences using case-based scenarios. We then evaluated practice characteristics and treatment preferences between physicians. RESULTS: A total of 112 eligible responses were received (46 % response rate). Nearly 40 % of respondents reported having no liver surgeons in their practice area. Commonly perceived contraindications to liver resection included extrahepatic disease (80.3 %), poor performance status (77.7 %), the presence of >4 metastases (62.5 %), bilobar metastases (43.8 %), and metastasis size >5 cm (40.2 %). Compared with high-referring physicians, low-referring physicians were just as likely to refer a patient with very low recurrence risk (89.3 vs. 98.3 %; p = 0.099), but much less likely to refer a patient with moderate risk (0 vs. 82.8 %; p < 0.001). High-referring physicians were more likely to consider resection for scenarios consistent with higher recurrence risk (31.0 vs. 10.7 %; p = 0.05). CONCLUSIONS: We found wide variation in surgical referral patterns for CLM. Many felt that bilobar disease and tumor size were contraindications to liver-directed therapy despite a lack of supporting data. These findings suggest an urgent need to increase dissemination of evidence and guidance regarding management for CLM, perhaps through increased specialist participation in tumor boards.

Evaluation of the Effectiveness of a Surgical Checklist in Medicare Patients.

BACKGROUND: Surgical checklists are increasingly used to improve compliance with evidence-based processes in the perioperative period. Although enthusiasm exists for using checklists to improve outcomes, recent studies have questioned their effectiveness in large populations. OBJECTIVE: We sought to examine the association of Keystone Surgery, a statewide implementation of an evidence-based checklist and Comprehensive Unit-based Safety Program, on surgical outcomes and health care costs. METHODS: We performed a study using national Medicare claims data for patients undergoing general and vascular surgery (n=1,002,241) from 2006 to 2011. A difference-in-differences approach was used to evaluate whether implementation was associated with improved surgical outcomes and decreased costs when compared with a national cohort of nonparticipating hospitals. Propensity score matching was used to select 10 control hospitals for each participating hospital. Costs were assessed using price-standardized 30-day Medicare payments for acute hospitalizations, readmissions, and high-cost outliers. RESULTS: Keystone Surgery implementation in participating centers (N=95 hospitals) was not associated with improved outcomes. Difference-in-differences analysis accounting for trends in nonparticipating hospitals (N=950 hospitals) revealed no differences in adjusted rates of 30-day mortality [relative risk (RR)=1.03; 95% confidence intervals (CI), 0.97-1.10], any complication (RR=1.03; 95% CI, 0.99-1.07), reoperations (RR=0.89; 95% CI, 0.56-1.22), or readmissions (RR=1.01; 95% CI, 0.97-1.05). Medicare payments for the index admission increased following implementation ($516 average increase in payments; 95% CI, $210-$823 increase), as did readmission payments ($564 increase; 95% CI, $89-$1040 increase). High-outlier payments ($965 increase; 95% CI, $974decrease to $2904 increase) did not change. CONCLUSIONS: Implementation of Keystone Surgery in Michigan was not associated with improved outcomes or decreased costs in Medicare patients.