Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Pancreaticoduodenectomy without retromesenteric omental flap
  Resection of the pancreatic head, duodenum, distal common bile duct and gallbladder followed by reconstruction using pancreaticojejunostomy, hepaticojejunostomy, and gastrojejunostomy performed on the first jejunal loop.
• Процедура Pancreaticoduodenectomy with retromesenteric omental flap
  All exposed peripancratic arteries should be covered with a retromesentric omental flap

Первичные конечные точки

• Rate of postpancreatectomy haemorrhage clinically significant (graded B or C) [Срок оценки: From surgery to post-operative day 90]

Вторичные конечные точки (7)

• Mortality [Срок оценки: From surgery to post-operative day 90]
• Overall Morbidity [Срок оценки: From surgery to post-operative day 90]
• Rate of grade B+C post-operative pancreatic fistula [Срок оценки: From post-operative day 3 to post-operative day 90]
• Rate of grade A post-pancreatectomy haemorrhage [Срок оценки: From surgery to post-operative day 90]
• Hospital readmission [Срок оценки: From end of initial hospital stay to post-operative day 90]
• Total duration of hospital stay [Срок оценки: From surgery to post-operative day 90]
• Rate of arterial pseudoaneurysm [Срок оценки: Performed at post-operative day 90]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Beaujon Hospital — Clichy

Идентификаторы

NCT: NCT05992857 · APHP220823

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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