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Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)

NCT04483726 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-08-22

No results posted yet for this study

Summary

Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail.

Study design: A pan-European, randomized controlled, multicenter, patient-blinded non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1. Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs ODP). A blinded adjudication committee will assess all endpoints.

Study population: Two groups of 129 patients (258 in total) with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.

Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)

Control: Open distal pancreatectomy

Conditions

Interventions

PROCEDURE

minimally invasive distal pancreatectomy

Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)

PROCEDURE

open distal pancreatectomy

open distal pancreatectomy

Sponsors & Collaborators

  • AIDS Malignancy Consortium

    collaborator NETWORK

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2021-04-29
Completion
2025-07-09

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04483726 on ClinicalTrials.gov