Actively Recruiting
Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3): an International Multicenter Patient-blinded Randomized Controlled Trial
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-09-04
256
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
L
Leiden University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
The DIPLOMA-3 trial is an international, multicenter, patient-blinded randomized controlled study comparing two surgical methods for patients needing elective left-sided pancreatectomy due to benign or premalignant lesions in the pancreas body or tail. The trial aims to evaluate the differences between laparoscopic and robot-assisted pancreatectomy procedures. Eligible patients will be randomly assigned to one of the two minimally invasive surgical techniques. Participants will receive either laparoscopic minimally invasive left-sided pancreatectomy or robot-assisted minimally invasive left-sided pancreatectomy. Both spleen-preserving and non-preserving resections are possible. The study will monitor outcomes up to 90 days after surgery, focusing on a composite pancreatic surgery score and other measures related to surgery and recovery. During the trial, patients will be evaluated for surgery-related complications and the rate and technique of spleen preservation. Hospital-related costs over 90 days will also be assessed. The study involves patient blinding and random assignment to treatment groups, with follow-up visits and assessments to collect data on surgical outcomes and safety over the 90-day period.
CONDITIONS
Brief Title
Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at least 18 years
- Indication for elective left-sided pancreatectomy for proven or suspected benign or premalignant disease
- Both laparoscopic and robot-assisted left-sided pancreatectomy must be technically feasible
- Fit to undergo left-sided pancreatectomy as assessed by surgeon and anaesthesiologist
- Provided written informed consent
You will not qualify if you...
- Suspected pancreatic ductal adenocarcinoma
- Tumor or cyst larger than 8 cm
- Need for 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 over 40 kg/m2
- Participation in another study that interferes with study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Hospital stay period
Participants undergo either laparoscopic or robot-assisted minimally invasive left-sided pancreatectomy followed by immediate post-operative care.
1 surgical procedure and hospital stay
Duration - Up to 90 days after surgery
Participants are monitored for recovery, complications, and surgical outcomes after discharge from the hospital.
Approximately 3 follow-up visits
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
C
Charlotte Baggerman van Houweninge, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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