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

Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Procedure: minimally invasive distal pancreatectomy; Procedure: 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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clichy, France
    • Hôpital Beaujon - APHP
  • Montpellier, France
    • CHU Saint Eloi - Montpellier
  • Orléans, France
    • Centre Hospitalier Orléans
  • Paris, France
    • Institut Mutualiste Montsouris
  • Villejuif, France
    • Hopital Paul Brousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIDP; minimally invasive distal pancreatectomy	Procedure: minimally invasive distal pancreatectomy; Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)
Sham Comparator: ODP; open distal pancreatectomy	Procedure: open distal pancreatectomy; open distal pancreatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
microscopically radical resection rate	R0, >1mm	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival	Date of death	1 year
survival	Date of death	2 years
survival	Date of death	3 years
lymph node retrieval	Tumor positive lymph nodes retrieved	1 day
Operative time	Operative time from first incision to closure of the abdomen, minutes	1 day
Intraoperative blood loss	Intraoperative blood loss, mL (suction canister and weight of gauzes)	1 day
intraoperative outcomes	Total duration of the procedure, minutes	1 day
postoperative outcomes	Major complications	1 day
specimen size	Tumor size, mm	1 day
Specimen length	Specimen length, mm	1 day
margin	Distance from tumor to transection, anterior and posterior margin, mm	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: AIDS Malignancy Consortium

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): April 29, 2021
• Study Completion (Anticipated): July 9, 2025

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: cancer; surgery; pancreas; laparoscopy; adenocarcinoma; prospective; randomized; pancreatic; minimally-invasive
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: RECHMPL19_0340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No