Effect of centralization and regionalization of pancreatic surgery on resection rates and survival.

BACKGROUND: Centralization of pancreatic surgery in the Netherlands has been ongoing since 2011. The aim of this study was to assess how centralization has affected the likelihood of resection and survival of patients with non-metastatic pancreatic head and periampullary cancer, diagnosed in hospitals with and without pancreatic surgery services. METHODS: An observational cohort study was performed on nationwide data from the Netherlands Cancer Registry (2009-2017), including patients diagnosed with non-metastatic pancreatic head or periampullary cancer. The period of diagnosis was divided into three time intervals: 2009-2011, 2012-2014 and 2015-2017. Hospital of diagnosis was classified as a pancreatic or non-pancreatic surgery centre. Analyses were performed using multivariable logistic and Cox regression models. RESULTS: In total, 10 079 patients were included, of whom 3114 (30.9 per cent) were diagnosed in pancreatic surgery centres. Between 2009-2011 and 2015-2017, the number of patients undergoing resection increased from 1267 of 3169 (40.0 per cent) to 1705 of 3566 (47.8 per cent) (P for trend < 0.001). In multivariable analysis, in 2015-2017, unlike the previous periods, patients diagnosed in pancreatic and non-pancreatic surgery centres had a similar likelihood of resection (odds ratio 1.08, 95 per cent c.i. 0.90 to 1.28; P = 0.422). In this period, however, overall survival was higher in patients diagnosed in pancreatic surgery than in those diagnosed in non-pancreatic surgery centres (hazard ratio 0.92, 95 per cent c.i. 0.85 to 0.99; P = 0.047). CONCLUSION: After centralization of pancreatic surgery, the resection rate for patients with pancreatic head and periampullary cancer diagnosed in non-pancreatic surgery centres increased and became similar to that in pancreatic surgery centres. Overall survival remained higher in patients diagnosed in pancreatic surgery centres.

Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial.

BACKGROUND: Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life. METHODS/DESIGN: PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide. DISCUSSION: The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.

Variation in pancreatoduodenectomy as delivered in two national audits.

BACKGROUND: Nationwide audits facilitate quality and outcome assessment of pancreatoduodenectomy. Differences may exist between countries but studies comparing nationwide outcomes of pancreatoduodenectomy based on audits are lacking. This study aimed to compare the German and Dutch audits for external data validation. METHODS: Anonymized data from patients undergoing pancreatoduodenectomy between 2014 and 2016 were extracted from the German Society for General and Visceral Surgery StuDoQ|Pancreas and Dutch Pancreatic Cancer Audit, and compared using descriptive statistics. Univariable and multivariable risk analyses were undertaken. RESULTS: Overall, 4495 patients were included, 2489 in Germany and 2006 in the Netherlands. Adenocarcinoma was a more frequent indication for pancreatoduodenectomy in the Netherlands. German patients had worse ASA fitness grades, but Dutch patients had more pulmonary co-morbidity. Dutch patients underwent more minimally invasive surgery and venous resections, but fewer multivisceral resections. No difference was found in rates of grade B/C postoperative pancreatic fistula, grade C postpancreatectomy haemorrhage and in-hospital mortality. There was more centralization in the Netherlands (1·3 versus 13·3 per cent of pancreatoduodenectomies in very low-volume centres; P < 0·001). In multivariable analysis, both hospital stay (difference 2·49 (95 per cent c.i. 1·18 to 3·80) days) and risk of reoperation (odds ratio (OR) 1·55, 95 per cent c.i. 1·22 to 1·97) were higher in the German audit, whereas risk of postoperative pneumonia (OR 0·57, 0·37 to 0·88) and readmission (OR 0·38, 0·30 to 0·49) were lower. Several baseline and surgical characteristics, including hospital volume, but not country, predicted mortality. CONCLUSION: This comparison of the German and Dutch audits showed variation in case mix, surgical technique and centralization for pancreatoduodenectomy, but no difference in mortality and pancreas-specific complications.