Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 主要终点
- Postoperative complications
研究概览
简要总结
Postoperative pancreatic fistula(POPF) is the most common complication of pancreaticoduodenectomy (PD). Sometimes POPF is associated with biliary fistula(BF), or "mixed" fistula. The purpose of this study is to assess whether the severity of the fistulae, when present, is decreased with an external biliary stent in place.
详细描述
n this single-center study we analyze patients who underwent elective PD from January_2014 to December_2017. Patients are divided into two groups: standard PD (ST-PD)vs PD with external biliary stent(PD-BS). Demographic, preoperative, intraoperative, and postoperative variables will be analyze, including complications according to the Clavien-Dindo classification, and those specific to pancreatic surgeries, and mortality rates within 90 days of operation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Provision of informed consent
- •Patient age > 18 years old;
- •Elective pancreaticoduodenectomy performed for primary pancreatic disease.
排除标准
- •Pancreaticoduodenectomy with multivisceral resection (organ other than duodenum, pancreas, gallbladder, and bile duct);
- •Patients with peritoneal or liver metastases found during surgery.
结局指标
主要结局
Postoperative complications
时间窗: 90 days
Any postoperative complications
次要结局
未报告次要终点
研究者
Gerardo Blanco-Fernández
Chief of Department
Universidad de Extremadura