Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)
NCT06939023 · NA · Amsterdam, Netherlands
- Condition
- Pancreatic Cancer
- Disease stage
- Stage I-IV
- Phase
- NA
- Study type
- PROCEDURE
- Intervention
- Laparoscopic minimally invasive left-sided pancreatecomy
- Age
- 18 Years to
- Gender
- All
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Research institution
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Facility
- Amsterdam UMC
- Research center
- Amsterdam UMC
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.
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
Primary outcomes
COMPOS-panc left score
Secondary outcomes
Total hospital-related costs; Spleen-preservation rate and spleen-preservation technique; Pancreatic surgery specific complications