Pragmatic Approach To Esophageal Dilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.
研究概览
简要总结
The purpose of this study is to better understand the role of a technique called esophageal dilation in patients who complain of trouble swallowing. In patients with esophageal stricture we want to determine if the size of the esophageal dilator makes a difference in symptoms and outcomes. In patients who do not have an obvious esophageal stricture we want to determine if esophageal dilation is an effective therapy in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 with esophageal dysphagia who are 18 years old or older.
- •Patients with dysphagia undergoing Esophagogastroduodenoscopy (EGD).
- •Patients who are able to provide consent for the study.
- •Patients with known esophageal stricture that may have or may not have been dilated before.
排除标准
- •Patients with malignant stricture.
- •Pregnant women.
- •Patients with a personal history of esophageal perforation.
- •Patients with achalasia, or globus sensation.
- •Any accessory procedures, like esophageal stenting, excision, steroid injection, or dysphagia treatment currently being done at outside facility.
结局指标
主要结局
Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.
时间窗: Baseline, every 8 weeks for 12 months
Evaluate the change in dysphagia (the dysphagia score is used to assess for severity of dysphagia, score ranges from 0 to 5 with the higher score indicates greater degree of severity) in patients without strictures undergoing empiric dilation.
Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.
时间窗: Baseline, every 8 weeks for 12 months
Evaluate the change in diet score (the diet score is used to assess the ability of the patient to tolerate food, score ranges from 0 to 5 with the higher score indicates inability to eat) in patients without strictures undergoing empiric dilation.
Change in subjective symptoms of dysphagia in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture. As measured by dysphagia score.
时间窗: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Evaluate the change in dysphagia (the dysphagia score is used to assess for severity of dysphagia, score ranges from 0 to 5 with the higher score indicates greater degree of severity) in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture.
Change in ability to tolerate diet in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture. As measured by diet score.
时间窗: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Evaluate the change in diet score (the diet score is used to assess the ability of the patient to tolerate food, score ranges from 0 to 5 with the higher score indicates inability to eat) in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture.
Achievement of complete relief of dysphagia
时间窗: End of study (12 months)
Evaluate the number of patients in each study arm that achieve complete relief of dysphagia for the remainder of the study.
次要结局
- Dilation sessions required to achieved sustainable change in dysphagia and diet score(End of study (12 months))
- Duration of sustained change between sessions(Every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months)
- Reduction of more than 3 sizes dilators in subsequent dilation sessions to achieve the goal dilation(Every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year)
研究者
Stephen McClave
MD, Professor
University of Louisville