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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)256 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

256

Conditions

Pancreatectomy Distal Pancreatectomy (DP)Pancreatic Neoplasms Pancreatic Adenoma Pancreatic Cyst

Interventions

Laparoscopic minimally invasive left-sided pancreatecomyPROCEDURE

Laparoscopic minimally invasive left-sided pancreatecomy

Robot-assisted minimally invasive left-sided pancreatecomyPROCEDURE

Robot-assisted minimally invasive left-sided pancreatecomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

COMPOS-panc left score

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.

Time frame: 90 days

Secondary Outcomes

Total hospital-related costs

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

Time frame: 90 days

Spleen-preservation rate and spleen-preservation technique

Compare L-MILP and R-MILP for spleen-preservation rate and spleen-reservation technique (Kimura versus Warshaw technique)

Time frame: Surgery

Pancreatic surgery specific complications

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.

Time frame: 90 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts