Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Stent Intragastric migration rate at M1
研究概览
简要总结
The aim of this prospective, controlled, randomized, multicentre, single-blind study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.
详细描述
In order to reduce the rate of spontaneous intragastric migration of esophageal stent placed for gastroesophageal junction tumor, anti-migration device has been developed. Pilot studies suggest the absence of morbidity of this device, but no comparative study has been conducted to confirm the interest of this anti-migration device.
The aim of this study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.
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Main objective: To evaluate the rate of intragastric migration of 2 types of esophageal stents (one with and the second without anti-migration device) placed for malignant stenosis of the gastroesophageal junction.
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Secondary objective(s):
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Degraded migration rate (M3 and M6) if patient alive, and duration of survival without dysphagia
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Comparison of the morbidity of these two stents
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Comparison of the effectiveness of these two stents on dysphagia and reflux
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Clinical and technical failure rate of these two stents
This is a prospective, controlled, randomized, multicentre, single-blind study.
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
- Single (Participant)
盲法说明
The stent is placed under endoscopy during general anesthesia. The type of stent is not specified in the endoscopy report. The patient is not informed of the type of esophageal stent placed.
入排标准
- 年龄范围
- 18 Years 至 91 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of both sexes aged 18 or over.
- •Patient admitted to one of the investigation centers for dysphagia due to tumoral stenosis of the gastroesophageal junction, locally advanced or metastatic.
- •Patient ASA 1, ASA 2, ASA 3
- •Absence of participation in another clinical study
- •Signed Informed Consent
- •Patients benefiting from the social security system.
排除标准
- •Patient referred for stenosis by extrinsic compression by an extra digestive mass
- •Patients with contraindications relating to the procedures essential for the introduction of a stent
- •Mediastinal radiotherapy or esophageal surgery history
- •Patient under 18 or over 90
- •Patient ASA 4, ASA 5
- •Pregnant Woman
- •Patient unable to give personal consent
- •Absence of signed informed consent
结局指标
主要结局
Stent Intragastric migration rate at M1
时间窗: 1 month
Stent Intragastric migration rate at M1 confirmed on radiography or CT
次要结局
- Gastroesophageal reflux disease (GERD) after stent placement(1 month)
- Stent placement complication : hemorrhage(7 days)
- Dysphagia recurrence at M3(3 months)
- Clinical success rate of stent placement on dysphagia(3 days)
- Stent Intragastric migration rate at M3(3 months)
- Dysphagia-free survival time(3 years)
- Dysphagia recurrence at M6(6 months)
- Stent Intragastric migration rate at M6(6 months)
- Technical success rate of stent placement(1 day)
- Stent placement complication : pain(7 days)
- Stent placement complication : pneumoperitoneum(1 day)
- Dysphagia recurrence at M1(1 month)
研究者
KARSENTI
Principal Investigator
Société Française d'Endoscopie Digestive