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

Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3): an International Multicenter Patient-blinded Randomized Controlled Trial

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.

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