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

August 28, 2025 updated by: M.G. Besselink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3): an International Multicenter Patient-blinded Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic minimally invasive left-sided pancreatecomy
Procedure: Laparoscopic minimally invasive left-sided pancreatecomy
Laparoscopic minimally invasive left-sided pancreatecomy
Experimental: Robot-assisted minimally invasive left-sided pancreatecomy
Procedure: Robot-assisted minimally invasive left-sided pancreatecomy
Robot-assisted minimally invasive left-sided pancreatecomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COMPOS-panc left score
Time Frame: 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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total hospital-related costs
Time Frame: 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
90 days
Spleen-preservation rate and spleen-preservation technique
Time Frame: Surgery
Compare L-MILP and R-MILP for spleen-preservation rate and spleen-reservation technique (Kimura versus Warshaw technique)
Surgery
Pancreatic surgery specific complications
Time Frame: 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.
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative outcomes
Time Frame: Surgery
Total operative time (first skin incision to fully closed skin incisions, min.); Time of reconstruction phase; Estimated intraoperative blood loss (mL); Serious intraoperative complications; Conversion; Reason for conversion; Surgeon's mental strain (measured at the end of surgery).
Surgery
Length of hospital stay
Time Frame: 90 days postoperatively
Days from surgery to discharge; Readmission rates; Total of hospitalized days.
90 days postoperatively
Patient-reported outcomes
Time Frame: 1 year postoperative
(Health-related) Quality of Life measurement using validated EORTC questionnaires: Baseline, 1-, 3-, 6- months and 1 year
1 year postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

University Medical Center Groningen
Maastricht University Medical Center
Erasmus Medical Center
Catharina Ziekenhuis Eindhoven
Leiden University Medical Center
Onze Lieve Vrouwe Gasthuis
Medisch Spectrum Twente

Investigators

  • Principal Investigator: Prof. Mohammad Abu Hilal, MD PhD, University of Jordan
  • Principal Investigator: Prof. Marc Besselink, MD, PhD, Amsterdam UMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL88413.018.24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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