Usefulness of Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy. Prospective Non-randomized Controlled Clinical Study Comparing Biodegradable vs Non-biodegradable Stents
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- POPF
研究概览
简要总结
Background: postoperative pancreatic fistula (POPF) remains the most important morbidity after pancreaticoduodenectomy (PD). There is no consensual technique for pancreatic reconstruction and many surgeons use a transanastomotic drain. Currently, the stents used are not degradable and they can cause obstruction, stricture and pancreatitis. The use of biodegradable stents that disappear a few months after the intervention could have a role in the prevention of pancreaticojejunostomy complications.
Material and method: A single-center prospective randomized study was planned with patients undergoing PD. A duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis and the stent is placed from the pancreatic duct to the jejunum.
The primary outcome of the study is the evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 undergoing cephalic pancreaticoduodenectomy (Whipple procedure).
排除标准
- •Patients with soft pancreas or chronic pancreatitis.
结局指标
主要结局
POPF
时间窗: 1 week
Evaluation of the presence of POPF (drainage fluid amylase value of \> 5000 U/L on the first day).
次要结局
- Position and degradation of biodegradable stents(3 months)
研究者
David Ferreras
Principal Investigator
Hospital Universitario Virgen de la Arrixaca