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临床试验/CTRI/2021/10/037410
CTRI/2021/10/037410尚未招募不适用

Efficacy of Intralesional Steroid Injection on Esophageal Stricture Dilatation in Children:A Randomized Controlled Trial

Chacha Nehru Bal Chikitsalaya1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年10月21日最近更新:
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适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
To compare number of dilatations in patients of benign refractory or recurrent esophageal stricture receiving intralesional steroid injection with dilatation or dilatation alone which will be measured as periodic dilatation index.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized controlled trial of role of intralesional steroid in esophageal stricture dilatation. Its  single blinded trial. It will include children with esophageal stricture requiring more than three dilatation to maintain their luminal patency with the age group between 6 months to 12 years.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Participant Blinded

入排标准

年龄范围
6.00 Month(s) 至 12.00 Year(s)（—）
性别
All

入选标准

  • •Children having esophageal stricture and requiring more than three dilatation.

排除标准

  • •Long and Multiple Strictures Post Sclerotherapy Strictures.

结局指标

主要结局

To compare number of dilatations in patients of benign refractory or recurrent esophageal stricture receiving intralesional steroid injection with dilatation or dilatation alone which will be measured as periodic dilatation index.

时间窗: After four sessions dilatation

次要结局

  • -To compare the level of dysphagia and the child’s eating behaviour between the two groups.(-To compare the effect of intralesional steroid injections on the luminal diameter and the stricture length between the two groups.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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