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

Pancreatic Ductal Adenocarcinoma Clinical Trial

— DIPLOMA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04483726
• Other study ID #: RECHMPL19_0340
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 9, 2020
• Est. completion date: July 9, 2025

Study information

• Verified date: August 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: July 9, 2025
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

Procedure:
• minimally invasive distal pancreatectomy
Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)
• open distal pancreatectomy
open distal pancreatectomy

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	AIDS Malignancy Consortium

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microscopically radical resection rate	R0, >1mm	1 day
Secondary	survival	Date of death	1 year
Secondary	survival	Date of death	2 years
Secondary	survival	Date of death	3 years
Secondary	lymph node retrieval	Tumor positive lymph nodes retrieved	1 day
Secondary	Operative time	Operative time from first incision to closure of the abdomen, minutes	1 day
Secondary	Intraoperative blood loss	Intraoperative blood loss, mL (suction canister and weight of gauzes)	1 day
Secondary	intraoperative outcomes	Total duration of the procedure, minutes	1 day
Secondary	postoperative outcomes	Major complications	1 day
Secondary	specimen size	Tumor size, mm	1 day
Secondary	Specimen length	Specimen length, mm	1 day
Secondary	margin	Distance from tumor to transection, anterior and posterior margin, mm	1 day