Minimally Invasive vs Open Left Pancreatectomy for Resectable Pancreatic Cancer
C.L. Bruna, Jony van Hilst, Maarten Korrel, L. Jones, Gianpaolo Balzano, Bergþór Björnsson, Ugo Boggi, Svein Olav Bratlie, Olivier R. Busch, Giovanni Butturini, Giovanni Capretti, Riccardo Casadei, Safi Dokmak, Bjørn Edwin, Alessandro Esposito, Massimo Falconi, Giovanni Ferrari, Thilo Hackert, Geert Kazemier, Bas Groot Koerkamp, Ruben H. de Kleine, Tobias Keck, D. Kleive, Arto Kokkola, David A. Kooby, Daan J. Lips, Misha Luyer, Martina Guerra, Ravi Marudanayagam, Krishna Menon, I. Quintus Molenaar, Matteo De Pastena, Nicolò Pecorelli, John N. Primrose, Cláudio Ricci, Olivier Saint Marc, Roberto Salvia, Per Sandström, Aleš Tomažič, Ulrich F. Wellner, Vincent Yip, Alessandro Zerbi, Mahsoem Ali, Marcel G. W. Dijkgraaf, 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, Viacheslay Grinevich, Stefano Gobbo, Scott Helton, Marius C. van den Heuvel, Clement Huijsentruijt, Mar Iglesias, Casper Jansen, Igor Khatkov, Marco Lena, Claudio Luchini, Patrick Michenet, Anna Nedkova, Andrea Pietrabissa, G. Mihaela Raicu, Rushda Rajak, Branislava Rankovic, Aniko Rendek, Benjamin Riviere, Antonio Sa Cunha, Patricia Sanchez Velazquez, Donatella Santini, Aldo Scarpa, Mylene Sebagh, Donald Sears, Mihir Shah, Zahir Soonawalla, Paola Spaggiari, Lars Tharun, Tore Tholfsen, Alessandro Vanoli, Caroline S. Verbeke, Joanne Verheij, Moritz Von Winterfeld, Roeland F. de Wilde, Yoh Zen
Abstract
Importance: The DIPLOMA trial showed comparable radical resection rates after minimally invasive left pancreatectomy (MILP) and open left pancreatectomy (OLP) in patients with upfront resectable pancreatic cancer. Data on long-term overall survival (OS) and disease-free survival (DFS) are currently lacking, but are required before the oncological efficacy of MILP can be confirmed. Objective: To determine the long-term oncological outcome, including OS and DFS, of MILP vs OLP in patients with upfront resectable left-sided pancreatic cancer in the DIPLOMA trial. Design, Setting, and Participants: The randomized, patient-blinded and pathologist-blinded DIPLOMA trial was conducted between 2018 and 2021, with a follow-up duration of at least 36 months. It was a multicenter international trial that took place in 35 centers in 12 countries worldwide. Patients with upfront resectable pancreatic ductal adenocarcinoma of the body or tail of the pancreas were included. Interventions: Participants were randomly assigned to undergo MILP (laparoscopic and robotic) or OLP. Patients were blinded for the surgical approach. Main Outcomes and Measures: Main outcomes included OS and DFS. Other outcomes include receipt of adjuvant therapy and time to start of adjuvant therapy. Results: Between May 2018 and May 2021, 258 patients were randomized to the MILP (131 patients) and OLP (127 patients) groups. After a median follow-up of 38 (IQR 36-46) months, 134 patients (52%) had died and 127 patients (55%) experienced disease recurrence. OS did not differ significantly between the MILP and OLP groups (median, 32 vs 34 months; stratified hazard ratio, 1.02; 95% CI, 0.72-1.44; P = .92). Also, DFS did not significantly differ between the MILP and OLP groups (median, 21 vs 17 months; stratified hazard ratio, 0.96; 95% CI, 0.68-1.35; P = .81). Adjuvant therapy was administered in 79 patients after MILP (79 of 113 [70%]) and 79 patients after OLP (79 of 110 [72%]) (P = .63). Time to adjuvant therapy was comparable between groups (median 59 vs 56 days; P = .92). Conclusions and Relevance: In this long-term follow-up of the randomized DIPLOMA trial in patients with upfront resectable pancreatic cancer, oncological outcomes after MILP and OLP did not differ significantly, confirming the oncological safety of MILP. Trial Registration: International Standard Registered Clinical/Social Study Number Registry Identifier: ISRCTN44897265.