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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06939023

Acronym

DIPLOMA-3

Enrollment

256

Registered

2025-04-22

Start date

2025-06-01

Completion date

2028-06-01

Last updated

2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

PROCEDURELaparoscopic minimally invasive left-sided pancreatecomy

Laparoscopic minimally invasive left-sided pancreatecomy

PROCEDURERobot-assisted minimally invasive left-sided pancreatecomy

Robot-assisted minimally invasive left-sided pancreatecomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Patient-blinded up to post-operative day 5. Blinded adjudication committee assessing the primary endpoint.

Intervention model description

1:1 randomization

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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.

Other

Measure	Time frame	Description
Length of hospital stay	90 days postoperatively	Days from surgery to discharge; Readmission rates; Total of hospitalized days.
Patient-reported outcomes	1 year postoperative	(Health-related) Quality of Life measurement using validated EORTC questionnaires: Baseline, 1-, 3-, 6- months and 1 year
Operative outcomes	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).

Countries

Netherlands

Contacts

Primary ContactCharlotte Baggerman van Houweninge, MD

c.e.baggermanvanhouweninge@amsterdamUMC.nl+31618037377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026