Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05992857 En recrutement IDF

Titre

Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.

Type

Interventional

Pathologie

Phase

N/A

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

octobre 2024

Date de fin

janvier 2027

Dernière mise à jour

02 décembre 2025

Résumé

To assess the efficacy of complete covering using retromesenteric omentoplasty vs. partial covering or no covering of peripancreatic arteries in decreasing incidence of grade B+C post-pancreatectomy hemorrhage (PPH), i.e. treated by transfusion and / or radiological or surgical hemostasis after PD in patients with high risk of POPF.

Détail

Voir le détail Grade B+C postpancreatectomy hemorrhage (PPH) is a severe complication following pancreaticoduodenectomy (PD), more frequently observed in patients with high-risk of postoperative pancreatic fistula (POPF). To date no randomized controlled trial has assessed the impact of an omentoplasty covering all arteries exposed during PD on the prevention of clinically relevant postpancreatectomy hemorrhage (PPH) in patients with high-risk of POPF (fistula risk score between 7 to 10) In the standard technique, no omental flap is used or an omental flap is only interposed between the pancreatic anastomosis and the hepatic artery, and/or the round ligament wraps the hepatic artery only. An orignal approach is proposed using a J-shaped omental flap created by the mobilization of the greater omentum and ascended through the retromesentric route to cover all the peri-pancreatic arteries at risk of bleeding after pancreatic resection. Patient fulfilling eligibility criteria will be enrolled during a selection visit (V0) which may take place 45 days and up to 1 day prior PD surgery. Patient will be randomized intra-operatively either in the experimental arm or the control arm for allocation the omental covering technique. After surgery, the following visits will be planned for the patient follow up: - V2: End of hospitalization visit which can be done up to 1 day prior discharge. - V3: POD 45 (±15) days which will take place at the hospital. - Vai: Additional visit which may take place if the patient is readmitted for postoperative complication. Those visits may take place between V2 and V4 up to 1 day prior discharge. - V4: POD 90 (±15) days is the end of study visit. It will take place at the hospital. During those visits, data will be collected to validate the primary and secondary endpoints of the trial. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CH DE VERSAILLES SITE ANDRE MIGNOT	SAUVANET Alain	En recrutement IDF	13/12/2025 07:38:09	Contacter
INSTITUT MUTUALISTE MONTSOURIS	SAUVANET Alain	En recrutement IDF	13/12/2025 07:38:08	Contacter
AP-HP Assistance publique - Hôpitaux de Paris		En recrutement IDF	13/12/2025 07:38:09	Contacter
	AP-HP - Hôpital Beaujon
	AP-HP - Hôpital Beaujon
	AP-HP - Hôpital Cochin
	AP-HP - Hôpital Henri Mondor-Albert Chenevier
	AP-HP - Hôpital La Pitié-Salpêtrière
	AP-HP - Hôpital Paul Brousse

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

- 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:

Critère de non inclusion

- 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.

NCT05992857 - Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.

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