NL-OMON55878招募中不适用
eedle-knife incision therapy compared to usual care of recurrent gastroesophageal anastomotic strictures: a multicenter randomized controlled trial (SAMURAI-study) - SAMURAI study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Recurrent intra- or extrathoracic benign esophagogastric anastomotic
- •stricture after esophagectomy. The definition of a stricture is based on the
- •Ogilvie Dysphagia score (severity of dysphagia), i.e. Ogilvie score * 2 (<=
- •ability to swallow semi-solid food or worse (Appendix table 1)).
- •- The recurrent stricture has been previously treated with at least 1 to a
- •maximum of 5 EBD sessions that reached an esophageal diameter of *16 mm.
- •- The stricture should be suitable for endoscopic incision (stricture length
- •- Age *18 years.
- •- Written informed consent for study participation.
排除标准
- •* Benign esophageal stricture other than an esophagogastric anastomotic
- •* Strictures with a morphology unsuitable for NKI, such as long (> 1 cm),
- •irregulair or tortuous strictures.
- •* Previous endoscopic treatment of the esophageal stricture with steroid
- •injection, incision therapy or stent placement within the past 3 months.
- •* Previous stent placement post-esophagectomy for anastomotic leakage.
- •* (Suspicion of) locally 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
- •* Known clotting disorder that cannot pre-procedural be corrected.
研究者
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