Minimally Invasive Versus Open Left Pancreatectomy for Resectable Pancreatic Cancer: Long-Term Results of the Randomized Diploma Trial
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Authors
Bruna C.
Van Hilst J.
Korrel M.
Jones L.
Balzano G.
Bjornsson B.
Boggi U.
Bratlie S.O.
Busch O.R.
Butturini G.
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2025
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Introduction: The DIPLOMA-trial showed comparable R0 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 and disease-free survival (OS, DFS) are currently lacking but are required before the oncological efficacy of MILP can be confirmed Aims & Methods: The international randomized non-inferiority DIPLOMA trial included patients with upfront resectable pancreatic cancer from 35 centers in 12 countries. Participants were randomly assigned to undergo MILP (laparoscopic and robotic) or OLP. Patients were blinded for the surgical approach. The primary endpoint of the trial was radical resection (R0) rate in patients who ultimately underwent resection. The current study describes OS and DFS after a minimum follow-up of 36 months. Result(s): Between May 2018 and May 2021, 258 patients were randomized to MILP (131 patients) and OLP (127 patients). After a median follow-up of 38 months (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 [95% CI], 1.02 [0.72-1.44]; p=0.92). Also, DFS did not significantly differ between MILP and OLP (median, 21 vs 17 months; stratified hazard ratio [95% CI], 0.96 [0.68-1.35]; p=0.81). Adjuvant therapy was administered in 79 patients after MILP (79/113 [70%]) and 79 patients after OLP (79/110 [72%], p=0.63). Time to adjuvant therapy was comparable between groups (median 59 vs 56 days; p=0.92). Conclusion(s): In the long-term follow-up of the DIPLOMA trial, OS and DFS did not differ significantly between MILP and OLP confirming the oncological safety of MILP in patients with upfront resectable pancreatic cancer.
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United.Eur.Gastroenterol.J.