TTS Esophageal HILZO Covered Self-expandable Metal Stent for Palliation of Malignant Dysphagia: A Safety and Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Through-the-scope stent placement (feasibility): incidence of device related adverse device events at moment of stent placement
研究概览
简要总结
A multicenter non-randomized prospective clinical study assessing the safety and feasibility of the esophageal through-the-scope HILZO Covered self-expandable metal stent placement for palliation of malignant dysphagia
详细描述
The main objective of this study is to evaluate the safety and efficacy of placement of the esophageal HILZO Covered stent with the TTS method in patients with non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy.
Other (secondary) objects are to assess the effect of the stent on the presence of hyperplastic reaction after implantation, the functional complications and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy. A tumor is considered inoperable if the patient has local tumor infiltration in the surrounding organs, distant metastases or a poor general health due to serious concomitant disease. OR
- •Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal or gastric cardia cancer.
- •Requiring treatment for dysphagia (dysphagia score of ≥ 2, according to Ogilvie2)
- •Written informed consent
- •Age ≥ 18 years
排除标准
- •Inappropriate cultural level and understanding of the study.
- •Simultaneous participation in another clinical study
- •Life expectancy of less than 12 months
- •Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
- •Tumor length of more than 12cm
- •Previous stent placement for the same condition
研究组 & 干预措施
Patients
Patients with malignant dysphagia treated with the HILZO stent
干预措施: HILZO esophageal stent (Device)
结局指标
主要结局
Through-the-scope stent placement (feasibility): incidence of device related adverse device events at moment of stent placement
时间窗: 1 day
Device related adverse events are defined as all adverse events that take place during the through-the-scope stent placement. The incidence of the device related adverse events will be recorded.
Incidence of treatment associated adverse events during follow-up (safety)
时间窗: 1 year
Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux.
Through-the-scope stent placement (feasibility): (1) ease of deployment at intended esophageal location
时间窗: 1 day
Technical success is defined as ease of through-the-scope deployment and placement of the stent at the required esophageal location.
次要结局
- Dysphagia, measured with the Ogilvie Dysphagia score (functional outcome)(6 months)
- Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale (functional outcome)(6 months)