Progressive Versus Conservative Dilation Strategy for Benign Esophageal Strictures: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Total number of dilation procedures within 6 months of follow-up
研究概览
简要总结
A randomized controlled prospective clinical trial assessing the efficacy and safety of progressive esophageal dilation compared to conservative esophageal dilation in patients with severe benign esophageal strictures.
详细描述
A randomized controlled prospective clinical trial assessing the efficacy and safety of progressive esophageal dilation (up to 6mm) compared to esophageal dilation according to the rule-of-3 in patients with severe benign esophageal strictures. Patients will be followed up for 6 months. When recurrent dysphagia occurs within 6 months the patients will be dilated according to the previously allocated strategy.
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)
盲法说明
Participant will be blinded for dilation strategy.
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
- •Dysphagia due to benign esophageal stricture (e.g. surgery, radiation therapy, caustic ingestion, peptic injury, photodynamic therapy) requiring esophageal dilation
- •Requiring first esophageal dilation for dysphagia due to a severe benign esophageal stricture with no patency for standard upper endoscope (9-10mm diameter)
- •No history of esophageal endoscopic dilations for benign strictures the past 6 months
- •Dysphagia for solid, semisolid or liquid food (dysphagia score ≥ 2 [Ogilvie]16, and dysphagia score ≤ 21 [Dakkak and Bennett]19, see appendix)
- •Written informed consent
排除标准
- •Patient < 18 years old
- •Patient is unwilling or unable to sign and date the informed consent
- •Patient is unwilling or unable to comply with the follow-up schedule
- •Patient is unable to understand informed consent and fill in the questionnaires due to a language barrier
- •Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 month
- •Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study
- •Previous esophageal dilation for benign stricture within the past 6 months
- •Patient with a life expectancy < 12 months
- •Patient with a known eosinophilic esophagitis or motility disorder (such as achalasia)
- •Patients with a known malignant esophageal stricture
- •Patients with a benign stricture due to a previous performed laryngectomy
- •Endoscopic exclusion criteria:
- •Benign strictures in the upper part of the esophagus too close to the cricopharyngeal muscle (for the purpose of this protocol, within 1½ cm of the upper esophageal sphincter)
- •Patients with stricture ≥ 10 cm in length
- •Patients with an active esophageal perforation, leak, fistula, or varices
- •Stricture within necrotic chronically bleeding tumors
- •Highly suspected esophageal malignancy
- •Stricture within polypoid lesions
- •Known or strongly suspected dysmotility esophageal disorder
- •Patient with high suspicion for an esophageal web, Schatzki ring, eosinophilic esophagitis, or motility disorder (such as achalasia)
结局指标
主要结局
Total number of dilation procedures within 6 months of follow-up
时间窗: 6 months
Total number of dilation procedures within 6 months of follow-up
Total number of dilation procedures during first dilation session to 16-18mm
时间窗: 1 month
Total number of dilation procedures during first dilation session to 16-18mm
次要结局
- Dysphagia free patients(6 months)
- Timeframe first dilation session(1 month)
- Dysphagia free time period(6 months)
- Incidence of treatment-related mortality (serious) adverse events (safety)(7 months)
- Quality of Life(6 months)
- Medical costs(7 months)