NCT04420039已完成不适用
Is Useful a Coaxial Plastic Stent Within a Lumen-Apposing Metal Stent For The Palliative Management Of Malignant Biliary Obstruction?
Hospital Universitari de Bellvitge3 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2015年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 3
- 主要终点
- Potential benefits
研究概览
简要总结
There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided transmural biliary drainage (BD). The aims was to evaluate the safety of LAMS with and without a coaxial DPS in EUS-BD for the palliative management in malignant biliary obstruction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD after failed ERCP cannulation or inaccessible papilla
排除标准
- •Borderline cancer cases
- •Others type of biliary stents
- •Severe coagulopathy or thrombocytopenia.
结局指标
主要结局
Potential benefits
时间窗: 4 weeks
to respond if a coaxial DPS within a biliary LAMS really has a potential benefit in the EUS-BD (less number of adverse events: cholangitis, bleeding, sump syndrome, cholestasis secondary to stent biliary obstruction)
次要结局
- Technical success(24 hours)
- Clinical success(4 weeks)
- Procedure time(2 hours)
- Biliary reintervention(6 months)
研究者
Joan B Gornals
Programme Director, Endoscopy Area, MD, PhD
Hospital Universitari de Bellvitge
研究点 (3)
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