Intralesional Steroid Injection Versus Topical Mitomycin-C Use in Pediatric Benign Recurrent Esophageal Stricture: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Effectiveness measured in terms of improvement in Dysphagia Severity Score (DSS)
研究概览
简要总结
To compare the efficacy of steroid injection versus topical mitomycin-C in the treatment of pediatric benign recurrent esophageal strictures. The rationale for this study is to compare the two therapeutic options in order to measure their effectiveness, in terms of improvement of Dysphagia Severity Score (DSS).
详细描述
After taking approval from the Institutional Review Board of the university; and taking the informed consent from parents, patients fulfilling the inclusion and exclusion criteria will be enrolled in the study. They will be then randomly allocated into two groups; group A and group B. Patients in Group A will be treated with esophageal dilation with a CRE balloon (controlled radial expansion balloon). After adequate dilation of stricture, injection Mitomycin will be applied to the narrowest portion of the stricture. Patients in Group B will be treated with esophageal dilation with a CRE balloon in the same manner. After adequate dilation of stricture, Triamcinolone injection will be injected into the narrowest portion of the stricture, using a sclerotherapy injector. Dysphagia Severity Score will be noted at start of intervention, at 2 weeks after intervention and at 6 weeks post- intervention.
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients up to 16 years of age belonging to both genders
- •Patients with single esophageal stricture
- •Patients with benign recurrent esophageal strictures
- •Patients with any etiology for esophageal stricture including; post-corrosive, congenital, post-anastomotic and eosinophilic.
排除标准
- •Patients unfit for anesthesia and/or hemodynamic instability
- •Patients with hemostatic disorder (platelets <50,000 or international normalized ratio >1.5)
- •Patients who have undergone esophageal surgery in last one month
- •Patients with complications such as; stricture perforation, signs of air leak or mediastinitis
- •Those with hypersensitivity to Mitomycin- C
- •Patients with multiple strictures
结局指标
主要结局
Effectiveness measured in terms of improvement in Dysphagia Severity Score (DSS)
时间窗: 6 weeks
Patients in both groups (group A and group B) will be followed and mean dysphagia severity score will be noted at 0, 2 and 6 weeks of intervention in both the groups. Improvement in dysphagia will be monitored via a validated Dysphagia Severity Score (DSS). It is as follows: 0 Able to eat normal diet/no dysphagia 1. Able to swallow some solid foods 2. Able to swallow only semi solid foods 3. Able to swallow liquids only 4. Unable to swallow anything/total dysphagia
次要结局
未报告次要终点
研究者
Tehreem Fatima
Senior Registrar
King Edward Medical University