Status:
UNKNOWN
Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
AIDS Malignancy Consortium
Conditions:
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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, m...
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 p...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04483726
Start Date
July 9 2020
End Date
July 9 2025
Last Update
August 22 2022
Active Locations (5)
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1
Hôpital Beaujon - APHP
Clichy, France
2
CHU Saint Eloi - Montpellier
Montpellier, France
3
Centre Hospitalier Orléans
Orléans, France
4
Institut Mutualiste Montsouris
Paris, France