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临床试验/NCT02889471
NCT02889471已完成不适用

Routine Nasobiliary Insertion During ERCP to Prevent, Diagnose and Treat of Biliary Injury in High Risk Patients.

Minia University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
conversion to open

研究概览

简要总结

110 patients with common bile duct (CBD) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy admitted to departement of surgery of Minia university hospital for ERCP then laparoscopic cholecystectomy (LC). the patient divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP after CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done within the same week of ERCP. Tans-nasobiliary Intraoperative cholangiography was done and methylene blue injected at the end of the procedure to detected any leak in NB group

详细描述

110 patients with common bile duct (CBD) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy as , age > 65 , male sex, obesity, acute cholecystitis, previous upper abdominal surgery, and certain ultrasonographic findings i.e. distended gall bladder (GB), thickened GB wall, pericholecystic fluid collection and impacted stone etc. these patients admitted to department of surgery of Minia university hospital for ERCP followed with laparoscopic cholecystectomy (LC). the patient divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP to settle high up in the intrahepatic biliary tree after complete CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done within the same week of ERCP. sequential, multiple, step after step, tans-nasobiliary Intraoperative cholangiography was done during every step in cholecystectomy especially during dissection of calot's triangle and just before clipping of supposed cystic duct (CD) to make sure that the structure supposed to be CD was not the CBD. after the end of procedure methylene blue is injected from the the NB to detected any leak and if present

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with GB stone complicated with CBD stones
  • accept to share in the study
  • the presence of one or more preoperative predictors for high risk for difficult cholecystectomy
  • patient fit for LC

排除标准

  • patients< 18 and >80
  • unfit for surgery
  • didn't accept to share in the study

结局指标

主要结局

conversion to open

时间窗: 6 hours

incidence of conversion to open

biliary injury

时间窗: 2 weeks

the incidence of biliary injury complicating cholecystectomy either discovered intraoperative or postoperative

次要结局

  • mortality(one month)
  • operative time(6 hours)
  • hospital stay(one month)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Mstafa Hassan Sewefy

MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt

Minia University

研究点 (2)

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