Distal Pancreatectomy Minimally Invasive or Open for Malignancy (DIPLOMA)

  • STATUS
    Recruiting
  • End date
    Jul 9, 2025
  • participants needed
    15
  • sponsor
    University Hospital, Montpellier
Updated on 28 October 2021
cancer
pdac

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

Details
Condition Pancreatic Ductal Adenocarcinoma
Treatment open distal pancreatectomy, minimally invasive distal pancreatectomy
Clinical Study IdentifierNCT04483726
SponsorUniversity Hospital, Montpellier
Last Modified on28 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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