Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA) (DIPLOMA)
Primary Purpose
Pancreatic Ductal Adenocarcinoma
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
minimally invasive distal pancreatectomy
open distal pancreatectomy
Sponsored by

About this trial
This is an interventional other trial for Pancreatic Ductal Adenocarcinoma focused on measuring pancreas, pancreatic, surgery, minimally-invasive, cancer, adenocarcinoma, laparoscopy, randomized, prospective
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
Sites / Locations
- Hôpital Beaujon - APHP
- CHU Saint Eloi - Montpellier
- Centre Hospitalier Orléans
- Institut Mutualiste Montsouris
- Hôpital Paul Brousse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
MIDP
ODP
Arm Description
minimally invasive distal pancreatectomy
open distal pancreatectomy
Outcomes
Primary Outcome Measures
microscopically radical resection rate
R0, >1mm
Secondary Outcome Measures
survival
Date of death
survival
Date of death
survival
Date of death
lymph node retrieval
Tumor positive lymph nodes retrieved
Operative time
Operative time from first incision to closure of the abdomen, minutes
Intraoperative blood loss
Intraoperative blood loss, mL (suction canister and weight of gauzes)
intraoperative outcomes
Total duration of the procedure, minutes
postoperative outcomes
Major complications
specimen size
Tumor size, mm
Specimen length
Specimen length, mm
margin
Distance from tumor to transection, anterior and posterior margin, mm
Full Information
NCT ID
NCT04483726
First Posted
June 23, 2020
Last Updated
August 18, 2022
Sponsor
University Hospital, Montpellier
Collaborators
AIDS Malignancy Consortium
1. Study Identification
Unique Protocol Identification Number
NCT04483726
Brief Title
Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)
Acronym
DIPLOMA
Official Title
Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
April 29, 2021 (Actual)
Study Completion Date
July 9, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
AIDS Malignancy Consortium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma
Keywords
pancreas, pancreatic, surgery, minimally-invasive, cancer, adenocarcinoma, laparoscopy, randomized, prospective
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MIDP
Arm Type
Experimental
Arm Description
minimally invasive distal pancreatectomy
Arm Title
ODP
Arm Type
Sham Comparator
Arm Description
open distal pancreatectomy
Intervention Type
Procedure
Intervention Name(s)
minimally invasive distal pancreatectomy
Intervention Description
Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)
Intervention Type
Procedure
Intervention Name(s)
open distal pancreatectomy
Intervention Description
open distal pancreatectomy
Primary Outcome Measure Information:
Title
microscopically radical resection rate
Description
R0, >1mm
Time Frame
1 day
Secondary Outcome Measure Information:
Title
survival
Description
Date of death
Time Frame
1 year
Title
survival
Description
Date of death
Time Frame
2 years
Title
survival
Description
Date of death
Time Frame
3 years
Title
lymph node retrieval
Description
Tumor positive lymph nodes retrieved
Time Frame
1 day
Title
Operative time
Description
Operative time from first incision to closure of the abdomen, minutes
Time Frame
1 day
Title
Intraoperative blood loss
Description
Intraoperative blood loss, mL (suction canister and weight of gauzes)
Time Frame
1 day
Title
intraoperative outcomes
Description
Total duration of the procedure, minutes
Time Frame
1 day
Title
postoperative outcomes
Description
Major complications
Time Frame
1 day
Title
specimen size
Description
Tumor size, mm
Time Frame
1 day
Title
Specimen length
Description
Specimen length, mm
Time Frame
1 day
Title
margin
Description
Distance from tumor to transection, anterior and posterior margin, mm
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hôpital Beaujon - APHP
City
Clichy
Country
France
Facility Name
CHU Saint Eloi - Montpellier
City
Montpellier
Country
France
Facility Name
Centre Hospitalier Orléans
City
Orléans
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
Country
France
Facility Name
Hôpital Paul Brousse
City
Villejuif
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)
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