Needle-knife inciSion therApy coMpared to Usual caRe of Recurrent Esophagogastric AnastomotIc Strictures: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Dilation free time
研究概览
简要总结
Rationale: The study hypothesizes that NKI followed by endoscopic bougie dilation therapy will result in an increased dysphagia-free period, a reduction of endoscopic procedures and dysphagia-related quality of life, and lower costs, when compared with the standard endoscopic bougie dilation (EBD) in recurrent esophagogastric anastomotic strictures.
Objective: To evaluate the efficacy and cost-effectiveness of needle-knife incision (NKI) followed by EBD compared to standard EBD in patients with recurrent esophagogastric anastomotic strictures.
Study design: This multicenter study is an randomized controlled trial in which NKI followed by EBD will be compared with standard EBD.
Study population: Patients with recurrent dysphagia (at least 1 and a maximum of 5 previous dilations) due to an anastomotic esophagogastric stricture that requires treatment with repeated endoscopic bougie dilations.
Intervention : The intervention to be investigated is the addition of NKI therapy to EBD to 18 mm esophageal diameter.
Main study parameters/endpoints: The primary outcome of this study will be EBD-free time during follow-up of 6 months. Secondary outcome parameters will be the number of endoscopic procedures for treatment of dysphagia, quality of life (QoL), cost-reduction and cost-effectiveness.
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
- Double (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
- •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)).
- •No patency for a standard endoscope (diameter < 10 mm)
- •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 ≤10 mm).
排除标准
- •Benign esophageal stricture other than an esophagogastric anastomotic stricture.
- •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 continued.
- •Known clotting disorder that cannot pre-procedural be corrected.
结局指标
主要结局
Dilation free time
时间窗: 6 months
EBD-free time
次要结局
- Endoscopic procedures(6 months)
- QoL(6 months)
- Cost-reduction(6 months)
- Cost-effectiveness(6 months)