NCT04037072撤回2 期
GI-108: Randomized Controlled Double-Blinded Trial Assessing the Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of dysphagia ≥ grade 1 after the dilation procedure
研究概览
简要总结
This study evaluates Mitomycin C as treatment for dysphagia in adult subjects with documented complex esophageal anastomotic strictures. Patients will be randomized in a double-blinded fashion to topical application of normal saline (NS) or Mitomycin C (MMC) at the time of time of index procedure.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Ability to understand and willingness to sign a written informed consent and HIPAA consent document
- •Patients must have symptomatic (dysphagia ≥2), treatment naïve complex esophageal anastomotic stricture (length >2 cm or diameter ≤9mm).
- •Esophago-gastro or esophago-jejunal anastomosis with or without having undergone neoadjuvant or adjuvant radio-chemotherapy
- •Any patient taking antiplatelet agents such as Plavix, Effient, Brilinta, Aggrenox must be able to hold the drugs 5 days prior to dilation and may resume 3 days after the dilation.
- •Any patient on vitamin K antagonists such as warfarin must be able to hold the drugs 5 days prior to dilation and may resume 3 days after the dilation. INR should be checked for such patients at least 24 hours before dilation and it must be < 1.5
- •Patients taking direct thrombin inhibitors such as Pradaxa, Angiomax must be able to hold the drugs 5 days prior to dilation and may resume 3 days after the dilation
- •Patients taking Factor Xa inhibitors must be able to hold the drugs 2 days prior to dilation and may resume 3 days after dilation
- •Patients taking GIIB/IIIA inhibitors must be able to hold the drugs1 day prior to dilation and resume 3 days after the dilation.
- •Patients taking unfractionated heparin must be able to hold the drug 6 hours before dilation and low molecular weight heparin must be held 24 hours before dilation. Unfractionated heparin may resume immediately after the dilation while low molecular weight heparin may resume 3 days after dilation
排除标准
- •Patients with malignant strictures
- •Patients with non-complex benign strictures.
- •Patients with anastomosis creation within ≤ 2 weeks
- •Patients with suspected gastrointestinal perforation or leak that could result in extraluminal extravasation of Mitomycin C
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant or breast feeding. Refer to section 4.4 for further detail.
- •Patients receiving systemic chemotherapy during the treatment of esophageal stricture.
研究组 & 干预措施
Mitomycin C
Experimental
Cotton swab or strip of 2x2 cotton gauze soaked with 0.4mg/mL Mitomycin C
干预措施: Mitomycin C (Drug)
Control
Placebo Comparator
Cotton swab or strip of 2x2 cotton gauze soaked with Normal saline
干预措施: Control (Other)
结局指标
主要结局
Rate of dysphagia ≥ grade 1 after the dilation procedure
时间窗: 6 months
Prevalence of dysphagia grade ≥1 in MMC Vs normal saline treated patients until 6 months after the first follow-up.
次要结局
- Number of procedures needed to reach dilation goal(30 days)
研究者
研究点 (1)
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