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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
256 participants
Jun 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria7
- 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
Interventions
Laparoscopic minimally invasive left-sided pancreatecomy
Robot-assisted minimally invasive left-sided pancreatecomy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06939023