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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: c.e.baggermanvanhouweninge@amsterdamUMC.nl
• Phone: +31618037377

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.