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临床试验/CTRI/2023/01/049017
CTRI/2023/01/049017尚未招募不适用

Comparison of biliary gastritis in children with choledochalcyst hepaticoduodenostomy vs hepaticoduodenostomy:A Randomised Trial

AIIMS ,Delhi1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年1月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
Development of biliary gastritis in children with choledochalcyst undergoing hepaticojejunostomy or hepaticoduodonostomy

研究概览

简要总结

Choledochal cyst is the commonest congenital biliary anomaly leading to cystic dilatation of various ducts of biliary tree. Since its recognition, various surgical procedures have been proposed for management of choledochal

cysts. Hepatico-duodenostomy was initially described and commonly performed procedure. It had advantages like more physiological drainage and easier reconstruction. However, long term studies after

hepatico-duodenostomy showed high incidence of duodeno-gastric reflux and biliary gastritis.

PRIMARY OBJECTIVES

Evalaution of biliary gastritis in children with choledochalcyst undergoing hepaticojejunostomy vs. hepaticoduodonostomy by upper gastrointestinal endoscopy and histopathological examination of the antral biopsy

SECONDARY OBJECTIVES

i) Evaluation of symptoms of gastritis

ii) Evaluation of duodenogastric reflux using HIDA scan

iii) To compare episodes of cholangitis following HD and HJ

iv) Duration of surgery and postoperative stay and time to full feeds

v) To compare the postoperative outcomes following HD and HJ in terms of postoperative complications like stricture, intestinal obstruction, leak.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
0.00 Day(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Children undergoing surgical treatment for choledochal cyst at AIIMS ,Delhi.

排除标准

  • Patients who are lost to follow-up during the duration of the study 2)Patients not consenting for the study 3)Patients converted to open surgery.

结局指标

主要结局

Development of biliary gastritis in children with choledochalcyst undergoing hepaticojejunostomy or hepaticoduodonostomy

时间窗: Children will be evaluated in post op period in ward till discharge,at follow up visits at 2 weeks , 1 month, then by HIDA scan at 3 months and upper gastrointestinal endoscopy and biopsy at 6 months respectively

次要结局

  • Patient will also be evaluated for:(1)duodenogastric reflux)

研究者

发起方
AIIMS ,Delhi
申办方类型
Government medical college

研究点 (1)

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