Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trial

• DOI: 10.1016/j.lanepe.2023.100673
• Publication Date: 2023-07-06T21:41:26Z
• Authors: Maarten Korrel; Leia R. Jones; Jony van Hilst; Gianpaolo Balzano; Bergthor Björnsson; Ugo Boggi; Svein Olav Bratlie; Olivier R. Busch; Giovanni Butturini; Giovanni Capretti; Riccardo Casadei; Bjørn Edwin; Anouk M.L.H. Emmen; Alessandro Esposito; Massimo Falconi; Bas Groot Koerkamp; Tobias Keck; Ruben H.J. de Kleine; Dyre B. Kleive; Arto Kokkola; Daan J. Lips; Sanne Lof; Misha D.P. Luyer; Alberto Manzoni; Ravi Marudanayagam; Matteo de Pastena; Nicolò Pecorelli; John N. Primrose; Claudio Ricci; Roberto Salvia; Per Sandström; Frederique L.I.M....; Ulrich F. Wellner; Alessandro Zerbi; Marcel G.W. Dijkg...; Marc G. Besselink; Mohammad Abu Hilal; Adnan Alseidi; Constanza Aquilano; Johanna Arola; Denise Bianchi; Rachel Brown; Daniela Campani; Joanne ChinAleong; Jerome Cros; Lyubomira Dimitrova; Claudio Doglioni; Safi Dokmak; Russell Dorer; Michael Doukas; Jean Michel Fabre; Giovanni Ferrari; Viacheslay Grinevich; Stefano Gobbo; Thilo Hackert; Marius van den He...; Clement Huijsentr...; Mar Iglesias; Casper Jansen; Igor Khatkov; David Kooby; Marco Lena; Claudio Luchini; Krishna Menon; Patrick Michenet; Quintus Molenaar; Anna Nedkova; Andrea Pietrabissa; Mihaela Raicu; Rushda Rajak; Branislava Rankovic; Aniko Rendek; Benjamin Riviere; Antonio Sa Cunha; Olivier Saint Marc; Patricia Sanchez ...; Donatella Santini; Aldo Scarpa; Mylene Sebagh; Donald Sears; Mihir Shah; Zahir Soonawalla; Paola Spaggiari; Lars Tharun; Tore Tholfsen; Ales Tomazic; Alessandro Vanoli; Caroline Verbeke; Joanne Verheij; Moritz Von Winter...; Roeland de Wilde; Vincent Yip; Yoh Zen
• Keywords: Clinical endpoint; Resection margin; Distal pancreatectomy

The oncological safety of minimally invasive surgery has been questioned for several abdominal cancers. Concerns also exist regarding the use distal pancreatectomy (MIDP) in patients with resectable pancreatic cancer as randomised trials are lacking.In this international non-inferiority trial, we recruited adults from 35 centres 12 countries. Patients were randomly assigned to either MIDP (laparoscopic or robotic) open (ODP). Both and pathologists blinded approach. Primary endpoint was radical resection (R0, ≥1 mm free margin) who had ultimately undergone resection. Analyses primary by modified intention-to-treat, excluding missing data on endpoint. pre-defined margin -7% compared lower limit two-sided 90% confidence interval (CI) absolute difference This trial is registered ISRCTN registry (ISRCTN44897265).Between May 8, 2018 7, 2021, 258 (131 patients) ODP (127 patients). Modified intention-to-treat analysis included 114 group 110 group. An R0 occurred 83 (73%) 76 (69%) (difference 3.7%, CI -6.2 13.6%; pnon-inferiority = 0.039). Median lymph node yield comparable (22.0 [16.0-30.0] vs 23.0 [14.0-32.0] nodes, p 0.86), rate intraperitoneal recurrence (41% 38%, 0.45). follow-up 23.5 (interquartile range 17.0-30.0) months. Other postoperative outcomes comparable, including median time functional recovery (5 [95% 4.5-5.5] 5 4.7-5.3] days; 0.22) overall survival (HR 0.99, 95% 0.67-1.46, 0.94). Serious adverse events reported 23 (18%) 131 28 (22%) 127 group.This provides evidence rates cancer. present findings support applicability left-sided cancer.Medtronic Covidien AG, Johnson & Medical Limited, Dutch Gastroenterology Society.