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

NCT06939023 | Recruiting DMC

• 1 other identifier: NL88413.018.24
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pancreas surgery; left-sided pancreatectomy; distal pancreatectomy; minimally invasive surgery; robot-assisted pancreatectomy; left pancreatectomy; robotic pancreatectomy; laparoscopic pancreatectomy

Outcome Measures

Primary Outcomes (1)

• COMPOS-panc left score

  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 Outcomes (3)

• Total hospital-related costs

  90 days

• Spleen-preservation rate and spleen-preservation technique

  Surgery

• Pancreatic surgery specific complications

  90 days

Other Outcomes (3)

• Operative outcomes

  Surgery

• Length of hospital stay

  90 days postoperatively

• Patient-reported outcomes

  1 year postoperative

Study Arms (2)

Laparoscopic minimally invasive left-sided pancreatecomy

ACTIVE COMPARATOR

Laparoscopic minimally invasive left-sided pancreatecomy

Procedure: Laparoscopic minimally invasive left-sided pancreatecomy

Robot-assisted minimally invasive left-sided pancreatecomy

EXPERIMENTAL

Robot-assisted minimally invasive left-sided pancreatecomy

Procedure: Robot-assisted minimally invasive left-sided pancreatecomy

Interventions

Laparoscopic minimally invasive left-sided pancreatecomy PROCEDURE

Laparoscopic minimally invasive left-sided pancreatecomy

Laparoscopic minimally invasive left-sided pancreatecomy

Robot-assisted minimally invasive left-sided pancreatecomy PROCEDURE

Robot-assisted minimally invasive left-sided pancreatecomy

Robot-assisted minimally invasive left-sided pancreatecomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Leiden University Medical Center: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Erasmus Medical Center: collaborator
• Medisch Spectrum Twente: collaborator
• Maastricht University Medical Center: collaborator
• University Medical Center Groningen: collaborator
• Onze Lieve Vrouwe Gasthuis: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic adenoma; Pancreatic Cyst

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Cysts

Study Officials

• Prof. Mohammad Abu Hilal, MD PhD

  University of Jordan

  PRINCIPAL INVESTIGATOR

• Prof. Marc Besselink, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Baggerman van Houweninge, MD

CONTACT

+31618037377; c.e.baggermanvanhouweninge@amsterdamUMC.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient-blinded up to post-operative day 5. Blinded adjudication committee assessing the primary endpoint.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. M.G. Besselink

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

NL (1)