Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT05992857
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Patients requiring a pancreaticoduodenectomy (PD) for any indication
* Open approach
* Affiliation to the French public healthcare insurance
* Fistula risk score (FRS) ≥ 7 confirmed intraoperatively
* Ability to understand and to comply with the study protocol
* Reconstruction with PJ and external pancreatic stent
* Signed written informed consent
* Inclusion is allowed for patients:
* On curative or long-term anticoagulation or aspirin (indicated for previous thromboembolic complications, heart disease, previous history of stroke)
* Undergoing PD with venous resection
Exclusion Criteria:
* Presence of distant tumor deposits (liver and peritoneal metastases, and/or para-aortic lymph nodes metastases) reveals during intraoperative exploration for patient with malignant pancreatic or periampullary tumor.
* Patients with previous abdominal surgery compromising completion of retromesenteric omentoplasty
* PD with arterial resection (i.e. resection of hepatic artery, splenic artery, superior mesenteric artery, or celiac axis)
* Laparoscopic or robotic PD
* Reconstruction wih pancreatico-gastrostomy
* Total pancreatectomy
* Emergency procedure
* Pregnant women
* Patient under guardianship and curatorship
* Participation in another interventional study evaluating complication after pancreaticoduodenectomy or patient still being in the exclusion period at the end of a previous study evaluating drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05992857
Study Brief:
Protocol Section:
NCT05992857