2020-07-09
2021-04-29
2025-07-09
9
NCT04483726
University Hospital, Montpellier
University Hospital, Montpellier
INTERVENTIONAL
Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)
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
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-06-23 | N/A | 2022-08-18 |
2020-07-21 | N/A | 2022-08-22 |
2020-07-23 | N/A | 2022-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: MIDP minimally invasive distal pancreatectomy | PROCEDURE: minimally invasive distal pancreatectomy
|
| SHAM_COMPARATOR: ODP open distal pancreatectomy | PROCEDURE: open distal pancreatectomy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| microscopically radical resection rate | R0, >1mm | 1 day |
| Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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