Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): An international randomised trial.

Abstract

4163 Background: In the absence of randomised trials, the oncological safety of minimally invasive distal pancreatectomy (MIDP) in patients with pancreatic cancer continues to be a matter of debate. Methods: An international randomised non-inferiority trial including patients with resectable pancreatic cancer from 35 centres in 12 countries. Patients were randomly assigned to either MIDP (laparoscopic or robotic) or open distal pancreatectomy (ODP). Both patients and pathologists were blinded to the assigned approach. Primary endpoint was radical resection (R0, <1mm free margin) in patients who had ultimately undergone resection. Analyses for the primary endpoint were by modified intention-to-treat, excluding patients who did not undergo a resection. The pre-defined non-inferiority margin was set at -7%. Results: Between May 8, 2018 and May 7, 2021, 258 patients were randomly assigned to MIDP (131 patients) or ODP (127 patients). The modified intention-to-treat population included 117 patients in the MIDP group and 114 patients in the ODP group. An R0 resection occurred in 83 (73%) patients in the MIDP group and in 76 (69%) patients in the ODP group (difference 4%, 90% CI -6 to 14%; p=0.039). Median lymph node yield was comparable (22.0 [16.0-30.0] vs 23.0 [14.0-32.0] nodes, p=0.86), as was the rate of intraperitoneal recurrence (41% vs 38%, p=0.45). Other postoperative outcomes were comparable. Conclusions: In this trial, the rate of radical resection following MIDP was non-inferior compared to ODP. This confirms the oncological validity of the minimally invasive approach in patients with resectable pancreatic cancer. Clinical trial information: ISRCTN44897265 .