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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2028-06-01

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

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Laparoscopic minimally invasive left-sided pancreatecomy

Group Type ACTIVE_COMPARATOR

Laparoscopic minimally invasive left-sided pancreatecomy

Intervention Type PROCEDURE

Laparoscopic minimally invasive left-sided pancreatecomy

Robot-assisted minimally invasive left-sided pancreatecomy

Group Type EXPERIMENTAL

Robot-assisted minimally invasive left-sided pancreatecomy

Intervention Type PROCEDURE

Robot-assisted minimally invasive left-sided pancreatecomy

Interventions

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Laparoscopic minimally invasive left-sided pancreatecomy

Intervention Type PROCEDURE

Robot-assisted minimally invasive left-sided pancreatecomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No