Laparoscopic versus robot-assisted left-sided pancreas removal for benign and premalignant lesions

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

This trial will randomize adults needing elective left-sided pancreas removal for benign or premalignant lesions to laparoscopic or robot-assisted minimally invasive surgery to see if one approach leads to faster recovery and fewer complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 256 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 1 site (Amsterdam)
• Trial ID: NCT06939023 on ClinicalTrials.gov

What this trial studies

The DIPLOMA-3 trial is an international, multicenter, patient-blinded randomized controlled comparison of laparoscopic and robot-assisted left-sided pancreatectomy for benign or premalignant lesions in the body or tail of the pancreas. Eligible adults are randomized to undergo either laparoscopic or robot-assisted minimally invasive resection, with both spleen-preserving and non-preserving procedures allowed where appropriate. Surgeons must deem both approaches technically feasible for each patient, and standard perioperative care and follow-up protocols are applied across participating centers. Outcomes focus on perioperative complications, recovery metrics, and surgical safety to determine whether one minimally invasive approach has clinical advantages.

Who should consider this trial

Good fit: Adults (≥18) with benign or premalignant lesions in the pancreas body or tail who are fit for elective left-sided pancreatectomy, for whom both laparoscopic and robot-assisted approaches are technically feasible, and who provide informed consent.

Not a fit: Patients with suspected pancreatic ductal adenocarcinoma, tumors larger than 8 cm, major vascular involvement, need for resection/ablation of other organs, pregnancy, BMI >40 kg/m2, or participation in conflicting trials are excluded and unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, the trial could clarify whether robot-assisted or laparoscopic techniques lead to fewer complications, quicker recovery, or better spleen preservation after left-sided pancreas removal.

How similar studies have performed: Laparoscopic distal pancreatectomy has demonstrated safety and effectiveness in prior studies and robot-assisted techniques have encouraging observational results, but randomized evidence directly comparing the two approaches is limited.

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

Where this trial is running

Amsterdam

• Amsterdam UMC — Amsterdam, Netherlands (Recruiting)

Study contacts

• Principal investigator: Prof. Mohammad Abu Hilal, MD PhD — University of Jordan
• Study coordinator: Charlotte Baggerman van Houweninge, MD

Conditions Pancreatectomy; Distal Pancreatectomy; Pancreatic Neoplasms; Pancreatic Adenoma; Pancreatic Cyst; Pancreatic Cystadenoma; Surgery; Minimally Invasive Surgical Technique