Status:
RECRUITING
Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Leiden University Medical Center
Catharina Ziekenhuis Eindhoven
Conditions:
Pancreatectomy
Distal Pancreatectomy (DP)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT06939023
Start Date
June 1 2025
End Date
June 1 2028
Last Update
September 4 2025
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, Netherlands