NCT07370987招募中2 期
Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy: a Phase 2 Trial
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of patients at W22 (within 90 days from surgery) without grade B/C postoperative pancreatic fistula (POPF)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention group
Other
All patients enrolled in the trial and responding to inclusion/exclusion criteria will receive A dose of 20 Gy delivered in 2 fractions of 10 Gy, 1 day apart, of preoperative stereotactic radiotherapy targeting the isthmus of the pancreas over a 4 cm area that corresponds to the future anastomosis zone
干预措施: Stereotactic radiotherapy / pancreaticoduodenectomy (Other)
结局指标
主要结局
Number of patients at W22 (within 90 days from surgery) without grade B/C postoperative pancreatic fistula (POPF)
时间窗: Week 22
Postoperative fistula grade B and C is defined according to the last ISGPS classification of 2016 and will be adjudicated by independant experts.
次要结局
- To assess overall surgical complication rate at W22 (90 days after surgery)(Week 22)
- To assess severe surgical complication rate at W22 (90 days after surgery)(Week 22)
- To assess, during surgery (W10), the hardness of pancreas texture on the specimen after resection with a durometer(Week 10)
- To assess, during surgery (W10), the hardness of pancreas texture on the specimen after resection by the surgeon(Week 10)
- To assess, during surgery (W10), technical difficulties added by radiotherapy, according to the surgeon(Day of surgery- Week 10)
- To assess on a pathological point of view the resected specimen at W14(Day of surgery-week 14)
- Pancreatic functionnal outcomes at W22 (de novo diabetes)(Week 22)
- Pancreatic functionnal outcomes at W22 (exocrine pancreatic insufficiency)(Week 22)
- To assess mortality rate at W22(Week 22)
- To assess overall length of hospital stay after surgery(Up to Week 34)
- To assess readmission rate at W22(Week 22)
- To assess radiation-induced complications rate, overall and by grade at W9, W10, W14, W22, W34(Week 9, Week 10, Week 14, Week 22 and Week 34)
- To assess safety of radiotherapy at W9, and W34(Week 9 and Week 34)
研究者
研究点 (1)
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