NCT05246657招募中不适用
EUS-guided Entero-biliary Anastomosis as Fistulas for Therapeutic Access in Benign Biliary Obstructions Not Accessible by ERCP
Hospital del Rio Hortega1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical success
研究概览
简要总结
Background: Transpapillary EUS-BD (rendezvous/antegrade) is gaining acceptance in BBO. The potential of transmural EUS-BD (hepaticogastrostomy/choledochoduodenostomy) in complex BBO warrants study.
Aims: To assess feasibility and efficacy of TEA using transmural covered self-expandable metal-stents (cSEMS) to provide interval biliary drainage and create TAF for biliary endotherapy under cholangioscopy or fluoroscopy in BBO not amenable to ERCP.
详细描述
3.1 Design
Prospective multicenter case series
3.1 Design
Prospective multicenter case series
3.2 Study population
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •• Consecutive patients ≥ 18 years old.
- •Benign biliary obstruction.
- •ERCP failed or where ERCP could not be performed due to surgically-altered anatomy
排除标准
- •• Refusal to sign the informed consent.
- •Malignant biliary obstruction
- •Coagulopathy (INR>1.5) or trombocytopenia (<50,000 platelets/mm3) uncorrectable.
- •Inability to tolerate the sedation necessary for the examination.
- •Pregnancy or lactation.
- •Unable to follow-up
结局指标
主要结局
Clinical success
时间窗: 1 year
Change major or equal than 2 mg/dl of total bilirrubine
次要结局
未报告次要终点
研究者
Marina de Benito Sanz
Principal Investigator
Hospital del Rio Hortega
研究点 (1)
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