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

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

Status: Enrolling

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

Treatments: Procedure: Robot-assisted minimally invasive left-sided pancreatecomy; Procedure: Laparoscopic minimally invasive left-sided pancreatecomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06939023

NL88413.018.24

Details and patient eligibility

About

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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups

Laparoscopic minimally invasive left-sided pancreatecomy

Active Comparator group

Description:

Laparoscopic minimally invasive left-sided pancreatecomy

Treatment:

Procedure: Laparoscopic minimally invasive left-sided pancreatecomy

Robot-assisted minimally invasive left-sided pancreatecomy

Experimental group

Description:

Robot-assisted minimally invasive left-sided pancreatecomy

Treatment:

Procedure: Robot-assisted minimally invasive left-sided pancreatecomy