Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy: incidence of patients receiving technical successful stent placement
研究概览
简要总结
A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.
详细描述
Objective
To assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.
Study design: Single center prospective observational non-randomized clinical study.
Study population: A total of 20 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study. Outcome of the study (efficacy and safety) will be compared to our historic esophageal stent database, including over 1000 patients.
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
- •Patients presenting with dysphagia due to a non-curable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;
- •Requiring treatment for dysphagia (Ogilvie score of 2-41);
- •Life expectancy of less than 12 months;
- •Written informed consent;
- •Age ≥ 18 years.
排除标准
- •Stenosis after laryngectomy;
- •Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
- •Tumor length of more than 14 cm;
- •Previous stent placement for the same condition;
- •Coagulopathy (not corrected prior to stent placement);
- •Patients with eosinophilic esophagitis or an esophageal motility disorder;
- •Nickel titanium (Nitinol) allergy.
结局指标
主要结局
Efficacy: incidence of patients receiving technical successful stent placement
时间窗: 1 day, during stent placement
Technical successful stent placement will be measured during stent placement whether the stent is in the correct position (covering the whole stenosis) and is described as yes or no. After all patients are included, the incidence can be described as percentage.
Complication: incidence of perforation
时间窗: 6 months
The complication perforation during stent placement and during follow-up will be measured using patient anamneses and if necessary upper endoscopy and described as present yes or no. After all patients are included, the incidence can be described as percentage.
Complication: incidence of hemorrhage
时间窗: 6 months
The complication hemorrhage will be measured during stent placement and follow-up using patient anamneses and if necessary with an upper endoscopy and described as present yes or no. After all patients are included, the incidence can be described as percentage.
Complication: incidence of fistula formation
时间窗: 6 months
The complication fistula formation will be measured during stent placement and during follow-up using patient anamneses and if necessary with an upper endoscopy and is described as present yes or no. After all patients are included, the incidence can be described as percentage.
Complication: incidence of gastroesophageal reflux
时间窗: 6 months
The complication gastroesophagel reflux will be measured after stent placement with the use of patient anamneses and will be described as present yes or no. After all patients are included, the incidence can be described as percentage.
Complication: incidence of stent migration
时间窗: 6 months
The complication stent migration will be measured using a new upper endoscopy in case there is recurrent dysphagia (measured with the Ogilvie Dysphagia score from 0 = no dysphagia to 4 = inability to swallow food or liquids, so the higher te score, the worse the outcome) and described as present yes or no. After all patients are included, the incidence can be described as percentage.
Efficacy: clinical outcome
时间窗: 6 months
The clinical outcome will be measured using the Ogilvie Dysphagia Score to determine whether recurrent dysphagia is present after stent placement during follow-up or until death. The Ogilvie Dysphagia Score is a score ranging from 0 = no dysphagia to 4 = inability to swallow any food or liquids, so the higher te score, the worse the outcome.
次要结局
- Incidence of recurrent dysphagia(6 months)
- Pain related to esophageal stent (placement)(6 months)
- Overall survival(6 months)
研究者
Peter Siersema
Prof. dr.
Erasmus Medical Center