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

Mackay, Tara M; Smits, F. Jasmijn; Latenstein, Anouk E J; Bogte, Auke; Bonsing, Bert A.; Bos, Hayley; Bosscha, K.; Brosens, Lodewijk A.A.; Hol, Lieke; Busch, Olivier R.; Creemers, G.J.; Curvers, Wouter L.; Dulk, Marcel den; Driel, Lydi M.J.W. van; Festen, Sebastiaan; Geenen, Erwin J M van; Geest, Lydia G. van der; Groot, Derk Jan A. de; Groot, Jan Willem B. de; Mohammad, Nadia Haj; Haberkorn, Brigitte C M; Haver, J. T.; Harst, Erwin van der; Hemmink, Gerrit J.; Hingh, Ignace H. J. T. de; Hoge, Chantal; Homs, Marjolein Y.V.; Huijgevoort, N. C. van; Jacobs, M. A. J. M.; Kerver, Emile D.; Liem, Mike S L; Los, Maartje; Lubbinge, Hans; Luelmo, Saskia; Meijer, Vincent E de; Mekenkamp, L.; Molenaar, I. Quintus; Oijen, Martijn G.H. van; Patijn, Gijs A.; Quispel, Rutger; Rijssen, L.B. van; Römkens, Tessa E H; Santvoort, Hjalmar C. van; Schreinemakers, Jennifer M. J.; Schut, H.; Seerden, Tom; Stommel, Martijn W J; Tije, Albert J. ten; Venneman, Niels G.; Verdonk, Robert C.; Verheij, Joanne; Vilsteren, Frederike G.I. van; Vos‐Geelen, Judith de; Vulink, Annelie; Wientjes, Caroline; Wit, Fennie; Wessels, Frank J.; Zonderhuis, B.; Werkhoven, Cornelis H. van; Hooft, Jeanin E. van; Eijck, Casper H.J. van; Wilmink, Johanna W.; Laarhoven, Hanneke W. M. van; Besselink, Marc G.

doi:10.1186/s13063-020-4180-z

Cited by 15 publications

(14 citation statements)

References 28 publications

(26 reference statements)

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“…The differences in survival demonstrate that regionalization should be further improved. A step towards this improvement could be obtained via the nationwide PACAP-1 trial (NCT03513705) which aimed to enhance implementation of best practices in pancreatic cancer care 28 . Results from this nationwide stepped-wedge cluster randomized trial are not yet available, but the trial operated within pancreatic cancer networks and implemented several best practices (regarding chemotherapy, exocrine pancreatic insufficiency, and biliary drainage) with the aim of equalizing and improving patient outcomes throughout the Netherlands.…”

Section: Discussionmentioning

confidence: 99%

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

Latenstein

Mackay

Geest

et al. 2021

British Journal of Surgery

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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.

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Section: Discussionmentioning

confidence: 99%

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

Latenstein

Mackay

Geest

et al. 2021

British Journal of Surgery

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“…Pain and quality of life will be assessed using validated visual analog score (VAS) questionnaires and Quality of Life Questionnaires (QLQ) at baseline and every threemonths as part of the PACAP-trial (NCT03513705) [61].…”

Section: Questionnairesmentioning

confidence: 99%

Irreversible Electroporation and Nivolumab Combined with Intratumoral Administration of a Toll-Like Receptor Ligand, as a Means of In Vivo Vaccination for Metastatic Pancreatic Ductal Adenocarcinoma (PANFIRE-III). A Phase-I Study Protocol

Geboers

Timmer

Ruarus

et al. 2021

Cancers

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Irreversible electroporation (IRE) is a novel image-guided tumor ablation technique with the ability to generate a window for the establishment of systemic antitumor immunity. IRE transiently alters the tumor’s immunosuppressive microenvironment while simultaneously generating antigen release, thereby instigating an adaptive immune response. Combining IRE with immunotherapeutic drugs, i.e., electroimmunotherapy, has synergistic potential and might induce a durable antitumor response. The primary objective of this study is to assess the safety of the combination of IRE with IMO-2125 (a toll-like receptor 9 ligand) and/or nivolumab in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). In this randomized controlled phase I clinical trial, 18 patients with mPDAC pretreated with chemotherapy will be enrolled in one of three study arms: A (control): nivolumab monotherapy; B: percutaneous IRE of the primary tumor followed by nivolumab; or C: intratumoral injection of IMO-2125 followed by percutaneous IRE of the primary tumor and nivolumab. Assessments include contrast enhanced computed tomography (ceCT), 18F-FDG and 18F-BMS-986192 (PD-L1) positron emission tomography (PET)-CT, biopsies of the primary tumor and metastases, peripheral blood samples, and quality of life and pain questionnaires. There is no curative treatment option for patients with mPDAC, and palliative chemotherapy regimens only moderately improve survival. Consequently, there is an urgent need for innovative and radically different treatment approaches. Should electroimmunotherapy establish an effective and durable anti-tumor response, it may ultimately improve PDAC’s dismal prognosis.

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“…8,34 Only one study included a systematic correction of exocrine and endocrine pancreatic insufficiency in patients undergoing pancreatic surgery as part of their prehabilitation program. 19 This is now considered best practice, 35 and should probably be part of any prehabilitation program that includes patient with pancreatic cancer. 36 Regarding the context and contents of physical exercise training interventions, heterogeneity is again a major concern.…”

Section: Lessons Learned From Included Studiesmentioning

confidence: 99%

The effect of prehabilitation on postoperative complications and postoperative hospital stay in hepatopancreatobiliary surgery a systematic review

Dewulf

Verrips

Coolsen

et al. 2021

HPB

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Background: Increasing numbers of high-risk (older and/or frail) patients are undergoing hepatopancreatobiliary (HPB) surgery. Therefore, optimization of the patient's psychophysiological capacity by prehabilitation is rapidly gaining importance. The aim of this study was to collect all available evidence on prehabilitation in HPB surgery and determine its effects on postoperative complications and length of hospital stay.Methods: A systematic review was performed according to PRISMA guidelines. The electronic databases MEDLINE, Web of Science, Embase, CENTRAL, clinicaltrials.gov, and the international clinical trials registry platform (ICTRP) were searched from inception to April 2020. Methodological quality of included studies was assessed using the Cochrane Collaboration's tool for assessing risk of bias and the ROBINS-I tool.Results: Seven articles including a total of 1377 patients were included in the quality analysis. A trend towards less complications and a shorter hospital stay was seen in the prehabilitation group, but current evidence fails to demonstrate a statistically significant difference between groups. Risk of bias in included studies was variable, and was generally scored as moderate. Conclusion:Strong evidence for the beneficial effect of prehabilitation on clinical outcomes in HPB surgery is lacking. A trend towards less complications and shorter hospital stay was seen in the prehabilitation group.

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

Cited by 15 publications

References 28 publications

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

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

Irreversible Electroporation and Nivolumab Combined with Intratumoral Administration of a Toll-Like Receptor Ligand, as a Means of In Vivo Vaccination for Metastatic Pancreatic Ductal Adenocarcinoma (PANFIRE-III). A Phase-I Study Protocol

The effect of prehabilitation on postoperative complications and postoperative hospital stay in hepatopancreatobiliary surgery a systematic review

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