Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)
Trial Parameters
Brief Summary
The DIPLOMA-3 trial is an international, multicenter, patient-blinded randomized controlled trial comparing laparoscopic and robot-assisted left-sided pancreatectomy. Patients with an indication for elective left-sided pancreatecomy for benign or premalignant lesions in the body or tail of the pancreas and considered eligible will be randomized between laparoscopic and robot-assisted resection.
Eligibility Criteria
Inclusion Criteria: * Age at least 18 years; * Indication for elective left-sided pancreatectomy, either spleen-preserving or non-preserving (because of proven or suspected left-sided benign or premalignant disease); * Both robot-assisted and laparoscopic left-sided pancreatectomy are technically feasible for resection, according to the local treatment team; * Fit to undergo left-sided pancreatectomy according to the surgeon and anaesthesiologist; * Written informed consent Exclusion Criteria: * Suspected pancreatic ductal adenocarcinoma; * Tumor or cyst larger than 8 cm; * Required resection or ablation of organs other than pancreas and spleen; * Tumor involvement or abutment of major vessels (celiac trunk, mesenteric artery or vena cava); * Pregnancy; * Body mass index \>40 kg/m2; * Participation in another study with interference of study outcomes