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

Not Applicable

Active, not recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Procedure: open distal pancreatectomy; Procedure: minimally invasive distal pancreatectomy

• Registration Number: NCT04483726
• Lead Sponsor: University Hospital, Montpellier

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

Study Timeline

• Study First Submitted: 2020-06-23
• Study Start: 2020-07-09
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-23
• Primary Completion: 2021-04-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-22
• Study Completion: 2025-07-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ODP	open distal pancreatectomy	open distal pancreatectomy
MIDP	minimally invasive distal pancreatectomy	minimally invasive distal pancreatectomy

Primary Outcome Measures

Name	Time	Method
microscopically radical resection rate	1 day	R0, \>1mm

Secondary Outcome Measures

Name	Time	Method
postoperative outcomes	1 day	Major complications
margin	1 day	Distance from tumor to transection, anterior and posterior margin, mm
survival	3 years	Date of death
Operative time	1 day	Operative time from first incision to closure of the abdomen, minutes
Intraoperative blood loss	1 day	Intraoperative blood loss, mL (suction canister and weight of gauzes)
lymph node retrieval	1 day	Tumor positive lymph nodes retrieved
intraoperative outcomes	1 day	Total duration of the procedure, minutes
specimen size	1 day	Tumor size, mm
Specimen length	1 day	Specimen length, mm

Trial Locations

Locations (5)

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

CHU Saint Eloi - Montpellier; 🇫🇷 Montpellier, France

Centre Hospitalier Orléans; 🇫🇷 Orléans, France

Hôpital Beaujon - APHP; 🇫🇷 Clichy, France

Hôpital Paul Brousse; 🇫🇷 Villejuif, France