Randomized Controlled Trial of Endoscopic Dilation With or Without Triamcinolone Injection in Patients With Non-malignant Radiation or Anastomotic Esophageal Strictures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Visits to Receive Esophageal Dilation During the 12 Month Follow-up Period
研究概览
简要总结
The purpose of this pilot study is to find out if adding triamcinolone (steroid) injection at the participant's initial esophagogastroduodenoscopy (EGD) procedure will improve the opening of their esophagus and decrease the need for repeat dilations.
详细描述
This is a randomized two-arms cross-over trial. In this study there are two groups, the control group and the triamcinolone treatment group. The cross-over design will apply only in the control group when patients are not responding to EGD dilations alone (defined as no sustained improvement in baseline dysphagia) and they will be allowed to cross-over to the triamcinolone group and undergo 3 successive EGDs with triamcinolone injection.
Typically, triamcinolone (steroid) injection is given as a standard of care after several esophageal dilations are performed and failed to improve the condition. Therefore, researchers want to find out if adding triamcinolone (steroid) injection at the participant's initial EGD procedure will improve the opening of their esophagus and decrease the need for repeat dilations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who present for EGD with dilation for dysphagia symptoms thought secondary to either radiation-induced stricture or anastomotic stricture based on history
排除标准
- •Inability to consent for the procedure
- •Known coagulopathy [International Normalized Ratio (INR) >1.5, Platelets <75 K]
- •Endoscopic finding of a stricture that is not caused by either radiation or anastomotic narrowing
- •Nasopharyngeal strictures
研究组 & 干预措施
EGD with Dilation
Standard of Care: Esophagogastroduodenoscopy (EGD) with dilation alone. If participants are assigned to Arm A and are not showing any clinical improvements as determined by their physician after the first three endoscopic dilation sessions, then they will be crossed over into Arm B.
干预措施: Dilation (Procedure)
EGD with Dilation
Standard of Care: Esophagogastroduodenoscopy (EGD) with dilation alone. If participants are assigned to Arm A and are not showing any clinical improvements as determined by their physician after the first three endoscopic dilation sessions, then they will be crossed over into Arm B.
干预措施: Esophagogastroduodenoscopy (EGD) (Procedure)
EGD with Dilation, plus Triamcinolone
Standard of Care: EGD with dilation and Triamcinolone injection.
干预措施: Dilation (Procedure)
EGD with Dilation, plus Triamcinolone
Standard of Care: EGD with dilation and Triamcinolone injection.
干预措施: Esophagogastroduodenoscopy (EGD) (Procedure)
EGD with Dilation, plus Triamcinolone
Standard of Care: EGD with dilation and Triamcinolone injection.
干预措施: Triamcinolone Injection (Other)
结局指标
主要结局
Number of Visits to Receive Esophageal Dilation During the 12 Month Follow-up Period
时间窗: 12 months
The main outcome measured will be number of visits to receive Esophageal Dilation during the 12-month follow-up period. Successful dilation of the stricture for the procedure will be defined as creation of a mucosal tear confirmed by endoscopic visualization after the last dilation is performed.
次要结局
- Final Dysphagia Score(12 months)