Postoperative Biliary Fistula Prevention After Hepatectomy by External Biliary Duct Stent:Prospective Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 22
- 主要终点
- Postoperative biliary fistula
研究概览
简要总结
Aim : Effect of external biliary duct stent after hepatectomy on the occurence of postoperative biliary fistula.
Methods : French prospective multicenter randomized trial. Population study: Adult patients who underwent hepatectomy (> 2 segments) on non-cirrhotic liver.
Hypothesis: decreased postoperative biliary fistula from 15% to 5% with the presence of a external biliary duct stent. With this hypothesis, the number of patients required to be equal to 152 per group for a total of 304 patients.
Outcome measure: Primary : Postoperative biliary complications (biliary fistula, biloma, biliary peritonitis) Secondary : All morbidity, mortality, additional manoeuvres to treat biliary fistula, during of hospital stay and biliary fistula.
Follow up: A follow-up of patients 3 months after surgery for all patients. The planned total duration of the study is 3 years and 3 months.
详细描述
After performing the hepatectomy and verification of hemostasis, patients were randomized (external biliary duct stent or not) by sealed envelopes. Systematic intraoperative test with methylene blue or air by the external biliary duct stent (EBDS) will necessary for all patients. Intra-abdominal drainage or not and type will be at the discretion of the surgeon. The EBDS will be left open for the first 7 postoperative days and then clamped. The EBDS will be removed during a consultation 5 weeks after surgery. Both groups of patients will be reviewed at 3 months after surgery, it will be noted at this point the possible complications related to the presence of EBDS (leakage from the drain, drop..). If patients are hospitalized more than five weeks, the study will stop at their consultation three months or the day of the consultation where the DTC is removed if it is still present at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subject has given his informed consent and signed consent
- •Hepatectomy at least 2 segments of liver parenchyma for a benign or malignant disease by laparotomy
- •Not cirrhotic liver
排除标准
- •Surgery made in emergency
- •Surgery by laparoscopy
- •Need to draw up a bilic-digestive anastomosis
- •Liver cirrhosis
- •History of cholecystectomy
- •Resection of less than 2 segments
- •Preoperative jaundice (total bilirubin> 30 micromol / l)
- •Presence of preoperative biliary drainage
- •Patients requiring the installation of a drain transcystic during the operation
研究组 & 干预措施
external biliary duct stent
'External Biliary duct stent in the bile duct by cystic way'
干预措施: External Biliary duct stent in the bile duct by cystic way (Procedure)
without external biliary duct stent
结局指标
主要结局
Postoperative biliary fistula
时间窗: 3 months after surgey
3 forms of diagnosis : bile in the intra-abdominal drainage; presence of an intra-abdominal collection of bile liquid (biloma); presence of an effusion of bile in the abdominal space (biliary peritonitis).
次要结局
- Morbidity(3 months after surgey)
- Mortality(3 months after surgery)