Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)

Not Applicable

Not yet recruiting

• Conditions: Pancreatectomy; Pancreatic Neoplasms; Distal Pancreatectomy (DP); Pancreatic Adenoma; Pancreatic Cyst; Pancreatic Cystadenoma; Surgery; Minimally Invasive Surgical Technique; Minimally Invasive Distal Pancreatectomy; Minimally Invasive Surgery

• Registration Number: NCT06939023
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Study Start: 2025-06-01
• Primary Completion: 2027-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
COMPOS-panc left score	90 days	The COMPOS-panc left score is a recently developed, severity-weighted composite outcome measure for pancreatic surgery. It combines perioperative and postoperative outcomes into a single composite outcome measure. This score includes the following parameters, measured at 90-days postoperative: unplanned blood transfusion, emergency conversion to open surgery, postoperative pancreatic fistula (POPF), postpancreatectomy hemorrhage (PPH), other complications requiring intervention, multi-organ failure, mortality, length of hospital stay and readmission requiring intervention.

Secondary Outcome Measures

Name	Time	Method
Spleen-preservation rate and spleen-preservation technique	Surgery	Compare L-MILP and R-MILP for spleen-preservation rate and spleen-reservation technique (Kimura versus Warshaw technique)
Pancreatic surgery specific complications	90 days	Complications including pancreatic fistula, delayed gastric emptying, postoperative bleeding, wound infection, other gastrointestinal leakage, re-interventions (radiographic, endoscopic, surgical), ICU admission, in hospital, 30- and 90-day mortality.
Total hospital-related costs	90 days	To examine total hospital-related costs, the following costs will be considered up to 90 days postoperative: 1. Direct cost of the operation; 2. Direct cost of the post-operative hospital stay; 3. Direct cost of follow-up period, including readmission, outpatient visits, emergency room visits and reintervention