The Clinical Efficacy of Endoscopic Postdilation Intralesional Injection of Mitomycin-C in Adults With Refractory Benign Esophageal Stricture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Overall clinical success of mitomycin C injection therapy
研究概览
简要总结
Intralesional Mitomycin-C (MMC) injection has recently been introduced to resolve refractory benign esophageal stricture mostly in children. The investigators aimed to evaluate the clinical efficacy of endoscopic postdilation intralesional injection of MMC in adults with refractory benign esophageal stricture.
详细描述
The participnts who have refractory benign esophageal stricture even after five or more sessions of bougination are prospectively enrolled. A submucosal needle injection of 4mL of a MMC preparation (0.5mg/mL) is endoscopically done with a 0.5mL of eight each injection mainly into the tearing esophageal wall, after esophageal bougie dilation is done upto 14mm in diameter. And then, repeated bouginations combined with MMC injection are done with the interval of eight weeks upto 3 times, if dysphagia symptoms recurr with dysphagis score 3 or more. Initial and overall clinical success rates are evaluated with drug and procedure-related complication rates during the follow-up period of at least 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 29 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged more than 29 year and less than 75 year
- •refractory benign esophageal stricture who had the symptoms of dysphagia score suggested by Mellow et al greater than 3 (0: able to eat a normal diet, 1: able to eat some solid food, 2: able to eat some semi-solids only, 3: able to swallow liquids only, 4: complete dysphagia)
排除标准
- •Patients who have at least one of following conditions were excluded from our study
- •malignant esophageal stricture
- •multiple sites of esophageal stricture
- •pregnant or breast feeding status
- •clinical deterioration not tolerated to endoscopic procedures
- •esophageal motility disorders
- •esophageal leakage or fistula
- •hypersensitivity to mitomycin C
- •bleeding tendency due to thrombocytopenia or clotting disorders
结局指标
主要结局
Overall clinical success of mitomycin C injection therapy
时间窗: 12 months after mitomycin C injection
The improvement of dysphagia score more than one point after once or even after over twice mitomycin C injection therapy during follow up period
Initial clinical success of mitomycin C injection therapy
时间窗: 12 months after mitomycin C injection
the improvement of dysphagia score more than one point after a single mitomycin C injection therapy during overall follow up period
次要结局
- Technical success of mitomycin C injection therapy(through study completion, an average of 1 year)
- complications(through study completion, an average of 1 year)
研究者
Jin Hong Kim
Professor
Ajou University School of Medicine