Comparing Laparoscopic and Robot-assisted Left-sided Pancreatectomy for Benign and Premalignant Pancreatic Lesions in Adults

What this Trial Is About

The DIPLOMA-3 trial is an international, multicenter, patient-blinded randomized controlled study comparing two surgical methods for patients needing elective left-sided pancreatectomy due to benign or premalignant lesions in the pancreas body or tail. The trial aims to evaluate the differences between laparoscopic and robot-assisted pancreatectomy procedures. Eligible patients will be randomly assigned to one of the two minimally invasive surgical techniques. Participants will receive either laparoscopic minimally invasive left-sided pancreatectomy or robot-assisted minimally invasive left-sided pancreatectomy. Both spleen-preserving and non-preserving resections are possible. The study will monitor outcomes up to 90 days after surgery, focusing on a composite pancreatic surgery score and other measures related to surgery and recovery. During the trial, patients will be evaluated for surgery-related complications and the rate and technique of spleen preservation. Hospital-related costs over 90 days will also be assessed. The study involves patient blinding and random assignment to treatment groups, with follow-up visits and assessments to collect data on surgical outcomes and safety over the 90-day period.

Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)