Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial

Recently, the first randomized trials comparing minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) for non-malignant and malignant disease showed a 2-day reduction in time to functional recovery after MIDP. However, for pancreatic ductal adenocarcinoma (PDAC), conc...

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Main Authors: Hilst, Jony van (Author) , Hackert, Thilo (Author)
Format: Article (Journal)
Language:English
Published: 9 September 2021
In: Trials
Year: 2021, Volume: 22, Pages: 1-11
ISSN:1468-6694
DOI:10.1186/s13063-021-05506-z
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1186/s13063-021-05506-z
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Author Notes:Jony van Hilst, Maarten Korrel, Sanne Lof, Thijs de Rooij, Frederique Vissers, Bilal Al-Sarireh, Adnan Alseidi, Adrian C. Bateman, Bergthor Björnsson, Ugo Boggi, Svein Olav Bratlie, Olivier Busch, Giovanni Butturini, Riccardo Casadei, Frederike Dijk, Safi Dokmak, Bjorn Edwin, Casper van Eijck, Alessandro Esposito, Jean-Michel Fabre, Massimo Falconi, Giovanni Ferrari, David Fuks, Bas Groot Koerkamp, Thilo Hackert, Tobias Keck, Igor Khatkov, Ruben de Kleine, Arto Kokkola, David A. Kooby, Daan Lips, Misha Luyer, Ravi Marudanayagam, Krishna Menon, Quintus Molenaar, Matteo de Pastena, Andrea Pietrabissa, Rushda Rajak, Edoardo Rosso, Patricia Sanchez Velazquez, Olivier Saint Marc, Mihir Shah, Zahir Soonawalla, Ales Tomazic, Caroline Verbeke, Joanne Verheij, Steven White, Hanneke W. Wilmink, Alessandro Zerbi, Marcel G. Dijkgraaf, Marc G. Besselink, Mohammad Abu Hilal and for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS)

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520 |a Recently, the first randomized trials comparing minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) for non-malignant and malignant disease showed a 2-day reduction in time to functional recovery after MIDP. However, for pancreatic ductal adenocarcinoma (PDAC), concerns have been raised regarding the oncologic safety (i.e., radical resection, lymph node retrieval, and survival) of MIDP, as compared to ODP. Therefore, a randomized controlled trial comparing MIDP and ODP in PDAC regarding oncological safety is warranted. We hypothesize that the microscopically radical resection (R0) rate is non-inferior for MIDP, as compared to ODP. 
650 4 |a Distal pancreatectomy 
650 4 |a Laparoscopic 
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650 4 |a Pancreatic cancer 
650 4 |a Pancreatic ductal adenocarcinoma 
650 4 |a Pancreatic surgery 
650 4 |a Pancreatic tail resection 
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