Clinical trial NCT06939023: Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)
Official title: Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3): an International Multicenter Patient-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
name: Catharina Ziekenhuis Eindhoven
name: Erasmus Medical Center
name: Medisch Spectrum Twente
name: Maastricht University Medical Center
name: University Medical Center Groningen
name: Onze Lieve Vrouwe Gasthuis
First posted: 2025-04-22
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: COMPOS-panc left score
timeFrame: 90 days
Secondary outcomes:
measure: Total hospital-related costs
timeFrame: 90 days
measure: Spleen-preservation rate and spleen-preservation technique
timeFrame: Surgery
measure: Pancreatic surgery specific complications
timeFrame: 90 days
Other outcomes:
measure: Operative outcomes
timeFrame: Surgery
measure: Length of hospital stay
timeFrame: 90 days postoperatively
measure: Patient-reported outcomes
timeFrame: 1 year postoperative
Locations:
Study officials:
affiliation: University of Jordan
name: Prof. Mohammad Abu Hilal, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC
name: Prof. Marc Besselink, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: