Background Robotic surgery may improve surgical performance during minimally invasive pancreatoduodenectomy as compared to 3D- and 2D-laparoscopy but comparative studies are lacking. This study... Show moreBackground Robotic surgery may improve surgical performance during minimally invasive pancreatoduodenectomy as compared to 3D- and 2D-laparoscopy but comparative studies are lacking. This study assessed the impact of robotic surgery versus 3D- and 2D-laparoscopy on surgical performance and operative time using a standardized biotissue model for pancreatico- and hepatico-jejunostomy using pooled data from two randomized controlled crossover trials (RCTs). Methods Pooled analysis of data from two RCTs with 60 participants (36 surgeons, 24 residents) from 11 countries (December 2017-July 2019) was conducted. Each included participant completed two pancreatico- and two hepatico-jejunostomies in biotissue using 3D-robotic surgery, 3D-laparoscopy, or 2D-laparoscopy. Primary outcomes were the objective structured assessment of technical skills (OSATS: 12-60) rating, scored by observers blinded for 3D/2D and the operative time required to complete both anastomoses. Sensitivity analysis excluded participants with excess experience compared to others. Results A total of 220 anastomoses were completed (robotic 80, 3D-laparoscopy 70, 2D-laparoscopy 70). Participants in the robotic group had less surgical experience [median 1 (0-2) versus 6 years (4-12), p < 0.001], as compared to the laparoscopic group. Robotic surgery resulted in higher OSATS ratings (50, 43, 39 points, p = .021 and p < .001) and shorter operative time (56.5, 65.0, 81.5 min, p = .055 and p < .001), as compared to 3D- and 2D-laparoscopy, respectively, which remained in the sensitivity analysis. Conclusion In a pooled analysis of two RCTs in a biotissue model, robotic surgery resulted in better surgical performance scores and shorter operative time for biotissue pancreatic and biliary anastomoses, as compared to 3D- and 2D-laparoscopy. Show less
BackgroundPancreatic 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... Show moreBackgroundPancreatic 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/designPACAP-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.DiscussionThe 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 registrationClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018. Show less
Background: Nationwide audits facilitate quality and outcome assessment of pancreatoduodenectomy. Differences may exist between countries but studies comparing nationwide outcomes of... Show moreBackground: 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 pancreasspecific complications. Show less
Braak, R.R.J.C. van den; Rijssen, L.B. van; Kleef, J.J. van; Vink, G.R.; Berbee, M.; Henegouwen, M.I.V.; ... ; PLCRC Working Grp 2018
