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NCT Number: NCT06939023

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

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.

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Key information

Conditions

Pancreatectomy Cysts Digestive System Diseases Digestive System Neoplasms Distal Pancreatectomy (DP) Endocrine Gland Neoplasms Endocrine System Diseases Minimally Invasive Distal Pancreatectomy Minimally Invasive Surgery Minimally Invasive Surgical Technique Neoplasms Neoplasms by Site Pancreatic Adenoma Pancreatic Cyst Pancreatic Cystadenoma Pancreatic Diseases Pancreatic Neoplasms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic minimally invasive left-sided pancreatecomy

Procedure

Laparoscopic minimally invasive left-sided pancreatecomy

Robot-assisted minimally invasive left-sided pancreatecomy

Procedure

Robot-assisted minimally invasive left-sided pancreatecomy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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:

    • Direct cost of the operation
    • Direct cost of the post-operative hospital stay
    • Direct cost of follow-up period, including readmission, outpatient visits, emergency room visits and reintervention

  2. 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)

  3. 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.

Other outcomes

  1. 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).

  2. Length of hospital stay

    Time frame: 90 days postoperatively

    Days from surgery to discharge; Readmission rates; Total of hospitalized days.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Baggerman van Houweninge, MD

CONTACT

[email protected]

+31618037377

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DIPLOMA-3

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 22, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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