EUCTR2016-001853-41-NL进行中（未招募）1 期
Intensive endoscopic therapy versus conventional treatment for untreated benign anastomotic strictures after esophagectomy: a pilot and randomized controlled trial - INCA trial
Academic Medical Center0 个研究点目标入组 89 人开始时间: 2016年10月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 89
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Untreated benign esophagogastric anastomotic stricture after esophagectomy.
- •The stricture should be suitable for endoscopic incision:
- •-Diagnosed at least 6 weeks after esophagectomy, and
- •-Stricture length = 1 cm.
- •Dysphagia score = 2 = ability to swallow semi-solid food or worse.
- •Age > 18 years.
- •Written informed consent for study participation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 89
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 89
排除标准
- •Benign esophageal stricture other than an esophagogastric anastomotic stricture.
- •Strictures with a morphology unsuitable for needle-knife incision, such as long (> 1 cm), irregulair or tortuous strictures.
- •Previous endoscopic treatment of the esophageal stricture, such as bougie/balloon dilation, steroid injection, incision therapy or stent placement.
- •Previous stent placement post-esophagectomy for anastomotic leakage.
- •(Suspicion of) recurrent or metastasized esophageal cancer.
- •Persisting postoperative esophageal fistula.
- •Inability to discontinue anticoagulants or high-dose antiplatelet drugs at time of the baseline procedure. Low-dose aspirin (max. 100 mg/day) may be continued.
- •Known clotting disorder.
- •Patients unable to provide written consent for the study.
研究者
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