Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Number of Endoscopic Interventions
研究概览
简要总结
This study is being done to see which treatment is more effective in improving the difficulty of swallowing. Researchers are comparing self-dilation to endoscopic dilation.
详细描述
Benign esophageal strictures can be challenging condition to treat. The mainstay of treatment is endoscopic dilations. However, 30 to 40% of these strictures recur despite rigorous dilations. Although a consensus definition does not exist, a stricture is typically termed as a refractory benign esophageal stricture (RBES), when there is a failure to maintain luminal patency after at least 5 endoscopic dilations.
Patients with RBES are extremely difficult to manage and the current armamentarium includes repeated endoscopic dilations, corticosteroid or mitomycin C injections, incisional therapy, and/ or temporary stent placement. These procedures are costly, their efficacy can be short-lived, and are associated with great burden both for the patient and clinician.
Esophageal self -dilation therapy (ESDT) is where the patient learns to pass a polyvinyl dilator orally on a routine basis. In past, smaller studies, ESDT appears to be effective for RBES, reducing the number of endoscopic dilations from an average of 21.7 to an average of 1.
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
- •Refractory benign esophageal stricture defined as an esophageal stricture with persistent dysphagia despite undergoing 5 endoscopic dilations within a 1 year period. Persistent dysphagia will be considered if patients has solid food dysphagia at least once a week
排除标准
- •Patient with malignant esophageal stricture
- •Angulated stricture which prevents safe passage of Maloney dilator in office setting
- •In ability to achieve an esophageal diameter of 10 mm with endoscopic dilation
- •Known significant esophageal motor disorder (i.e. achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)*
- •The presence of esophageal stent
- •Inability to learn self-dilation secondary to blindness or cognitive dysfunction
- •Use of chronic anticoagulants
结局指标
主要结局
Number of Endoscopic Interventions
时间窗: 6 months following serial dilation
Number of endoscopies required in a 6 month interval in subjects who achieved at least a 10-12 mm esophageal diameter during serial dilation for refractory benign esophageal stricture (RBES) and were subsequently treated with ESDT versus standard clinical care
次要结局
- Mayo Dysphagia Questionnaire (MDQ-30) at Baseline(Baseline)
- Length of Days Intervention Free(6 months)
- Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months(12 months)
- Clinically Significant Adverse Events(12 months)
研究者
Jeffrey A Alexander
Principal Investigator
Mayo Clinic