Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy : a Phase 2 Trial

Официальное название

Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy: a Phase 2 Trial

Обзор

Design of the study Prospective, single arm, multicentric, phase II open trial Number of participating sites 14 French centers of HPB Surgery departments associated with 14 Radiation Oncology Departments. Implementation of the study A screening of eligible patients will be made locally by the referring surgeon of each centre based on patient medical records. * Inclusion visit at the first surgical consultation (W-3 to D1) (V0) The inclusion visit will be done by the surgeon within 3 weeks before the first radiation oncologist visit * D1 (V1): first radiation oncologist visit * W2 (+/- 3D) and W4 (+/- 3D) (V2 et V3): Preoperative simulation process and treatment delivery * A first visit at W+2 (+/- 3 D) will be mandatory to validate the positioning of the target volume by CBCT with IV constrast or MRI * Then to start of the administration of radiotherapy at W+4 (+/- 3 D): Radiotherapy with 20 Gy, in 2 fraction of 10Gy with a one-day gap, so over a total period of 3 W9 ( +/- 1W) (V4): post-radiotherapy follow-up \- Preoperative visit Day-1 before PD (V5) W10 (+/- 1W) (V6): * Pancreaticoduodenectomy and post operative hospitalisation W14 (+/- 1W) (V7): follow up with surgeon (30 days after pancreaticoduodenectomy) * W22 (+/-1W) (V8): follow up with surgeon (90 days after pancreaticoduodenectomy) * W34 (+/-1W) (V9): Last study visit (radiation oncologist) (6 months after pancreaticoduodenectomy) Medical follow-up by radiation oncologist at 6 months after surgery to assess the occurrence of potential late toxicities due to radiotherapy

Вмешательства

• Другое Stereotactic radiotherapy / pancreaticoduodenectomy
  A dose of 20 Gy delivered in 2 fractions of 10 Gy, 1 day apart, of preoperative stereotactic radiotherapy Surgery : pancreaticoduodenectomy

Первичные конечные точки

• Number of patients at W22 (within 90 days from surgery) without grade B/C postoperative pancreatic fistula (POPF) [Срок оценки: Week 22]

Вторичные конечные точки (12)

• To assess overall surgical complication rate at W22 (90 days after surgery) [Срок оценки: Week 22]
• To assess severe surgical complication rate at W22 (90 days after surgery) [Срок оценки: Week 22]
• To assess, during surgery (W10), the hardness of pancreas texture on the specimen after resection with a durometer [Срок оценки: Week 10]
• To assess, during surgery (W10), the hardness of pancreas texture on the specimen after resection by the surgeon [Срок оценки: Week 10]
• To assess, during surgery (W10), technical difficulties added by radiotherapy, according to the surgeon [Срок оценки: Day of surgery- Week 10]
• To assess on a pathological point of view the resected specimen at W14 [Срок оценки: Day of surgery-week 14]
• To assess on a pathological point of view the resected specimen at W14 [Срок оценки: Day of surgery-week 14]
• Pancreatic functionnal outcomes at W22 (de novo diabetes) [Срок оценки: Week 22]
• Pancreatic functionnal outcomes at W22 (exocrine pancreatic insufficiency) [Срок оценки: Week 22]
• To assess mortality rate at W22 [Срок оценки: Week 22]
• To assess overall length of hospital stay after surgery [Срок оценки: Up to Week 34]
• To assess readmission rate at W22 [Срок оценки: Week 22]

Критерии участия

Критерии включения

• Aged ≥ 45 years old
• Candidate for pancreaticoduodenectomy by laparotomy
• Body mass index (BMI) ≥ 25kg/m2
• Diameter of main pancreatic duct (MPD) < 3 mm on preoperative CT scan or MRI at the isthmus of the pancreas (future pancreatic section area)
• Affiliation to a social security system (AME excepted)
• Signed informed consent

Критерии исключения

• Surgery indication : Chronic pancreatitis
• Surgery indication : Pancreatic ductal adenocarcinoma
• History of syndromic or hereditary pancreatic tumor
• Contraindication to pancreaticoduodenectomy
• Planned multivisceral resection involving organs or parts of organs not normally involved in pancreatico-duodenectomy
• Planned external drainage of the main pancreatic duct at the end of the surgery
• Neoadjuvant treatment planned or performed by chemotherapy or radiotherapy
• History of chronic hepatitis (F3) or cirrhosis (F4)
• Contraindication to radiotherapy
• Previous history of abdominal radiotherapy
• Extended pancreatic resection on the left beyond the radiotherapy area (left of the pancreatic isthmus)
• History of complicated peptic ulcer
• Patient treated for less than 4 weeks for an ulcer
• History of pancreatic surgery
• Ongoing pregnancy (confirmed by a test beta-HCG) or breast feeding or absence of birth control
• Patients with a active pathology or history that may interfere with the study in progress or the interpretation of its results according to the investigator
• Patients with a history or suspicion of non-compliance with medical regimens or will be unable to complete the entire study
• Treatment with systemic corticosteroids (excluding inhaled corticosteroids)
• Participation in another interventional clinical study (RIPH1, clinical investigation or clinical trial) or exclusion period set after the study
• Protected persons under legal guardianship or conservatorship

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Department of HPB Surgery, Hospital Pitié Salpétrière — Paris

Идентификаторы

NCT: NCT07370987 · APHP240932 · IDRCB : 2025-A00206-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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