Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy: a Multicenter Phase II Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Safety - CTCAE grade 3-4-5 complications related to the intervention
研究概览
简要总结
The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo pancreatoduodenectomy for another indication than pancreatic ductal adenocarcinoma.
- •Pancreatic duct diameter ≤ 3 millimetres, measured on the diagnostic CT scan (at the level of the portomesenteric vein, at the pancreatic neck, the future anastomotic site).
- •WHO-ECOG performance status 0,1 or
- •Ability to undergo stereotactic radiotherapy and surgery.
- •Age ≥ 18 years.
- •Good understanding of the oral and written patient information provided.
- •Written informed consent.
排除标准
- •Patients undergoing pancreatoduodenectomy for (suspected) pancreatic cancer, chronic pancreatitis, or benign neoplasms (e.g. serous cyst) in the periampullary region.
- •Patients with (a history of) chronic pancreatitis
结局指标
主要结局
Safety - CTCAE grade 3-4-5 complications related to the intervention
时间窗: Up to 30 days after surgery
Hardness of pancreas texture, determined by Durometer measurement
时间窗: Histopathological assesment of tissue after surgery
Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO
次要结局
- Overall complications(Up to 30 days after surgery)
- Readmission rate(Postoperative period)
- Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon(Assesment during surgery)
- Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C(Up to 30 days after operation)
- Length of hospital stay(Up to 30 days after surgery)
- 30-day mortality and in-hospital mortality(Up to 30 days after surgery)
- Macroscopic tissue assessment, determined by the pathologist(Histopathological assesment after surgery)
- Surgery related postoperative complications defined according to the Clavien-Dindo classification(Up to 30 days after surgery)
研究者
Casper H.J. van Eijck
prof. dr. Casper H.J. van Eijck
Erasmus Medical Center