跳至主要内容
临床试验/NCT06601387
NCT06601387尚未招募不适用

Evaluation of Choledochoduodonostomy Vs Hepaticojejunostomy in Patients with Choledocholithiasis Indicated for Shunt .

Mohamed Ahmed Hassan Aly1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
primary outcome measure

研究概览

简要总结

A biliary-enteric anastomosis can be needed for a number of indications, including malignant or pre-malignant biliary diseases, benign biliary stenosis, bile duct injury, and complex choledocholithiasis. Choledochoduodenostomy is the most simple form of biliary-digestive anastomosis, with only minimal alteration to the normal anatomy. Due to the reported specific complications of choledochoduodenostomy, such as sump syndrome and gastritis caused by biliary reflux, creation of a HJ was preferred in the past decades . A Roux-en-Y hepaticojejunostomy (HJ) does not cause sump syndrome and only rarely reflux gastritis, but the procedure is more extensive, requiring an additional jejuno-jejunostomy .Especially for patients with extensive intra-abdominal adhesions or with a history of small bowel resections, the creation of a Roux-en-Y limb might pose a problem. Some recent publications have concluded that CD leads to acceptable surgical outcome, with low reported incidences of sump syndrome and reflux gastritis. However, these studies do not make a direct comparison between CD and HJ. Especially comparisons of long-term outcomes between CD and HJ are lacking.

详细描述

There are 2 options are available: Choledochoduodonostomy or Roux-en-Y choledochojejunostomy. Both can be accomplished via a laparoscopic approach; however, thereis no consensus to which is best due to a paucity of data comparing the techniques.

Choice of operation is largely left up to the individual surgeon. Athough performed infrequently for benign biliary disease, biliary bypass operations are fundamental for any surgeon and are considered a core operation by the American College of Surgeons for any general surgery resident. In our study we are going to describe in detail our technique and outcomes when used for choledocholethiasis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • residual stones. recurrent stones, failed ERCP due to imacted large stone, Multiple CBD calculi with distal narrowing (Funnel syndrome), Papillary stenosis; impacted calculi, Biliary sludge-symptomatic, Sphincter of Oddi dysfunction/stenosis, Primary CBD stones; previous choledochotomy and Marked CBD dilatation.

排除标准

  • surgically unfit patients, malignancy, infections e.g, cholangitis and coagulation disorders.

结局指标

主要结局

primary outcome measure

时间窗: one year

Abd pain according to pain score from 1 to 10. total billirubin more than 1.2 mg/dl. Fever (temperature more than 38° c)

次要结局

未报告次要终点

研究者

发起方
Mohamed Ahmed Hassan Aly
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Ahmed Hassan Aly

Assistant lecturer general surgery department

Assiut University

研究点 (1)

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