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. 2025 Oct 8:e254054.
doi: 10.1001/jamasurg.2025.4054. Online ahead of print.

Minimally Invasive vs Open Left Pancreatectomy for Resectable Pancreatic Cancer: Long-Term Results of the Randomized DIPLOMA Trial

Caro L Bruna  1   2   3 , Jony van Hilst  1   2   4 , Maarten Korrel  1   2 , Leia R Jones  1   2 , Gianpaolo Balzano  5   6 , Bergthor Björnsson  7 , Ugo Boggi  8 , Svein Olav Bratlie  9 , Olivier R Busch  1   2 , Giovanni Butturini  10 , Giovanni Capretti  11   12 , Riccardo Casadei  13 , Safi Dokmak  14 , Bjørn Edwin  15 , Alessandro Esposito  16 , Massimo Falconi  5 , Giovanni Ferrari  17 , Thilo Hackert  18   19 , Geert Kazemier  2   20 , Bas Groot Koerkamp  21 , Ruben H de Kleine  22 , Tobias Keck  23 , Dyre B Kleive  24 , Arto Kokkola  25 , David Kooby  26 , Daan J Lips  27 , Misha D P Luyer  28 , Martina Guerra  3 , Ravi Marudanayagam  29 , Krishna Menon  30 , I Quintus Molenaar  31 , Matteo de Pastena  16 , Nicolò Pecorelli  5 , John N Primrose  32 , Claudio Ricci  13 , Olivier Saint Marc  33 , Roberto Salvia  16 , Per Sandström  7 , Ales Tomazic  34 , Ulrich F Wellner  23 , Vincent S Yip  35 , Alessandro Zerbi  11   12 , Mahsoem Ali  3   20 , Marcel G W Dijkgraaf  36 , Marc G Besselink  1   2 , Mohammad Abu Hilal  3   32   37 ; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS)
Collaborators, Affiliations

Minimally Invasive vs Open Left Pancreatectomy for Resectable Pancreatic Cancer: Long-Term Results of the Randomized DIPLOMA Trial

Caro L Bruna et al. JAMA Surg. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Bruna reported grants from Medtronic and Johnson & Johnson during the conduct of the study and grants from the Intuitive Foundation and the Dutch Cancer Foundation outside the submitted work. Dr Lips reported personal fees from Intuitive Proctorship outside the submitted work. Dr Luyer reported grants from Medtronic and Galvani outside the submitted work. Dr Besselink reported grants from Medtronic during the conduct of the study and grants from Intuitive Surgical outside the submitted work. No other disclosures were reported.

Comment in

  • doi: 10.1001/jamasurg.2025.4068

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