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
- 1
- 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
研究组 & 干预措施
Standard Clinical Care Endoscopic Dilation Group
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.
干预措施: Endoscopic therapy with esophageal dilation (Procedure)
Esophageal Self-Dilation Therapy (ESDT) Group
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.
干预措施: Esophageal self-dilation therapy (Device)
Observational Study Group
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
干预措施: Esophageal self-dilation therapy (Device)
Observational Study Group
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
干预措施: Endoscopic therapy with esophageal dilation (Procedure)
Standard Clinical Care Endoscopic Dilation, Then ESDT
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
干预措施: Esophageal self-dilation therapy (Device)
Standard Clinical Care Endoscopic Dilation, Then ESDT
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
干预措施: Endoscopic therapy with esophageal dilation (Procedure)
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