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