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

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ClinicalTrials.gov Identifier: NCT04483726
Recruitment Status : Recruiting
First Posted : July 23, 2020
Last Update Posted : October 19, 2021
Sponsor:
Collaborator:
AIDS Malignancy Consortium
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Procedure: minimally invasive distal pancreatectomy Procedure: open distal pancreatectomy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial
Actual Study Start Date : July 9, 2020
Estimated Primary Completion Date : July 9, 2022
Estimated Study Completion Date : July 9, 2025

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




Primary Outcome Measures :
  1. microscopically radical resection rate [ Time Frame: 1 day ]
    R0, >1mm


Secondary Outcome Measures :
  1. survival [ Time Frame: 1 year ]
    Date of death

  2. survival [ Time Frame: 2 years ]
    Date of death

  3. survival [ Time Frame: 3 years ]
    Date of death

  4. lymph node retrieval [ Time Frame: 1 day ]
    Tumor positive lymph nodes retrieved

  5. Operative time [ Time Frame: 1 day ]
    Operative time from first incision to closure of the abdomen, minutes

  6. Intraoperative blood loss [ Time Frame: 1 day ]
    Intraoperative blood loss, mL (suction canister and weight of gauzes)

  7. intraoperative outcomes [ Time Frame: 1 day ]
    Total duration of the procedure, minutes

  8. postoperative outcomes [ Time Frame: 1 day ]
    Major complications

  9. specimen size [ Time Frame: 1 day ]
    Tumor size, mm;

  10. Specimen length [ Time Frame: 1 day ]
    Specimen length, mm

  11. margin [ Time Frame: 1 day ]
    Distance from tumor to transectionanterior and posterior margin mm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • ASA >3 (see appendix 17.3.2);
  • A medical history of chronic pancreatitis (according to the M-ANNHEIM criteria, see Appendix for detailed definition);
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483726


Contacts
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Contact: François Régis SOUCHE +334 67 33 70 72 fr-souche@chu-montpellier.fr
Contact: Guillemette TACONNET +334 67 33 55 73 g-taconnet_decker@chu-montpellier.fr

Locations
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France
Hôpital Beaujon - APHP Not yet recruiting
Clichy, France
Contact: Safi DOKMAK         
CHU Saint Eloi - Montpellier Recruiting
Montpellier, France
Contact: François-Régis SOUCHE         
Centre Hospitalier Orléans Recruiting
Orléans, France
Contact: Olivier SAINT-MARC         
Institut Mutualiste Montsouris Recruiting
Paris, France
Contact: David FUKS         
Hôpital Paul Brousse Not yet recruiting
Villejuif, France
Contact: Antonio SA CUNHA         
Sponsors and Collaborators
University Hospital, Montpellier
AIDS Malignancy Consortium
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04483726    
Other Study ID Numbers: RECHMPL19_0340
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms