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

NCT ID: NCT04483726

Last Updated: 2022-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-09
• Study Completion Date: 2025-07-09

Brief 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

Detailed Description

Rationale: Several systematic reviews have suggested superior short term outcomes after minimally invasive distal pancreatectomy (MIDP) as compared to open distal pancreatectomy (ODP) for benign and pre-malignant disease. In the literature and in a recent pan-European survey, about one third of pancreatic surgeons expressed concerns regarding the oncologic safety (i.e. radical resection, lymph node retrieval and survival) of MIDP in pancreatic cancer. Most surgeons stated that a randomized trial assessing oncologic safety in MIDP vs ODP for pancreatic cancer is needed.

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

Main study parameters/endpoints: Primary outcome is the microscopically radical (R0, >1mm) resection rate. Main secondary outcomes are survival, lymph node retrieval, intraoperative outcomes (such as blood loss, operative time and conversion), postoperative outcomes (such as complications, time to functional recovery and hospital stay) and quality of life

Conditions

Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

MIDP

minimally invasive distal pancreatectomy

Group Type: EXPERIMENTAL

minimally invasive distal pancreatectomy

Intervention Type: PROCEDURE

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

ODP

open distal pancreatectomy

Group Type: SHAM_COMPARATOR

open distal pancreatectomy

Intervention Type: PROCEDURE

open distal pancreatectomy

Interventions

minimally invasive distal pancreatectomy

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

Intervention Type: PROCEDURE

open distal pancreatectomy

open distal pancreatectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years;
• Elective indication for distal pancreatectomy for proven or suspected PDAC;
• Upfront (without induction / down-sizing radio- and/or chemotherapy) resectable PDAC in the pancreatic body or tail;
• The tumor can be radically resected via both minimally invasive or open surgery according to the local treating team;
• The patient is fit to undergo both open and minimally invasive distal pancreatectomy

Exclusion Criteria

• score of American society of anaesthesiologists (ASA) >3;
• A medical history of chronic pancreatitis (according to the M-ANNHEIM criteria);
• Second malignancy necessitating resection during the same procedure;
• Distant metastases (M1) including involved distant lymph nodes;
• Tumor involvement or abutment of major vessels (celiac trunk*, mesenteric artery or portomesenteric vein);
• Pregnancy;
• Participation in another study with interference of study outcomes.
• Cystic lesion having undergone malignant transformation

• the celiac trunk should be 5mm clear from tumor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AIDS Malignancy Consortium

NETWORK

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Beaujon - APHP

Clichy, , France

CHU Saint Eloi - Montpellier

Montpellier, , France

Centre Hospitalier Orléans

Orléans, , France

Institut Mutualiste Montsouris

Paris, , France

Hôpital Paul Brousse

Villejuif, , France

Countries

France

Other Identifiers

RECHMPL19_0340

Identifier Type: -

Identifier Source: org_study_id