Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions… (NCT06939023) | Clinical Trial Compass
RecruitingNot Applicable
Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)
Netherlands256 participantsStarted 2025-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing laparoscopic surgery to robot-assisted surgery for removing part of the pancreas — given my specific diagnosis, which of those two approaches would my surgeon normally recommend, and is it worth discussing whether this trial might be relevant to my situation?
2The trial is measuring something called a 'COMPOS-panc left score' as its main outcome — can you explain what that score actually measures, and why it matters for judging how well a distal pancreatectomy goes?
3Since this trial is listed as 'Phase NA,' meaning it's comparing two already-established surgical techniques rather than testing a brand-new treatment, does that change what we know about the safety and risks of each approach compared to a typical early-phase drug trial?
4If I were to discuss this trial with my care team, what would the logistics look like — for example, how many visits, which hospital would perform the surgery, and would my regular follow-up care stay the same regardless of which surgical arm I was assigned to?
5Before considering this trial, are there standard non-surgical options or watchful waiting approaches for my type of pancreatic lesion that might be worth trying first, or is surgery already considered the best path forward for my case?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
COMPOS-panc left score
Timeframe: 90 days
Trial details
NCT IDNCT06939023
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)