Results from the international, randomized DIPLOMA trial (ClinicalTrials.gov identifier NCT04483726) comparing minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) in patients with pancreatic ductal adenocarcinoma showed that the rate of radical resection following MIDP was noninferior to ODP. According to the study authors, these results confirm the safety and oncologic validity of the minimally invasive approach to treating patients with resectable pancreatic cancer. The study by Hilal et al was presented during the 2023 ASCO Annual Meeting (Abstract 4163).
Study Methodology
Between May 8, 2018, and May 7, 2021, 258 patients with pancreatic ductal adenocarcinoma were randomly assigned to undergo minimally invasive distal pancreatectomy—laparoscopic or robotic—(131 patients) or open distal pancreatectomy (127 patients). Both the patients and pathologists were blinded to the assigned approach.
The primary endpoint was radical resection (R0, > 1 mm 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.
KEY POINTS
- Minimally invasive distal pancreatectomy is safely applicable in patients with resectable pancreatic cancer.
- Radical resection rates, lymph node yield, and survival are comparable between minimally invasive distal pancreatectomy and open distal pancreatectomy.
Key Results
The researchers found that a radical resection occurred in 83 patients (73%) in the MIDP group and in 76 patients (69%) in the ODP group (difference = 4%, 90% confidence interval [CI] –6% to 14%; P = .039). Median lymph node yield was comparable (22.0 nodes, 90% CI = 16.0–30.0 nodes vs 23.0 nodes, 90% CI = 14.0–32.0 nodes; P = .86), as was the rate of intraperitoneal recurrence (41% vs 38%, P = .45).
Other postoperative outcomes, including serious adverse events, were comparable. The benefit of shorter time to functional recovery could not be confirmed in this study.
“In this trial, the rate of radical resection following MIDP was noninferior compared to ODP. This confirms the oncologic validity of the minimally invasive approach in patients with resectable pancreatic cancer,” concluded the study authors.
Disclosure: Funding for this study was provided by Medtronic and Ethicon. For full disclosures of the study authors, visit meetings.asco.org.
