NCT05826639已完成不适用
Risks, Safety, and Outcomes of Temperature-sensitive Endobiliary Radiofrequency Ablation in Patients With Malignant Biliary Obstructions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Stent patency
研究概览
简要总结
The purpose of this study is to assess the impact of temperature-sensitive radiofrequency ablation (RFA) immediately before biliary stent placement on duration of biliary stent patency and re-intervention free survival. This is a research study meant to collect information to help other patients with malignant biliary strictures in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Malignant biliary stricture
- •Biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation with placement of biliary stents
- •Patients with life expectancy greater than 3 months
排除标准
- •Patients who are pregnant, have cirrhosis, or significant liver metastasis >30% on radiologic imaging suggestive of poor liver function that will not improve despite endoscopic drainage.
- •Patients who have undergone prior biliary decompression stents or percutaneous drainage that cannot be removed at time of ERCP and thus preclude effective radiofrequency ablation
- •Patients with altered anatomy unable to undergo conventional ERCP
结局指标
主要结局
Stent patency
时间窗: 6 months
Duration of stent patency over the 6 month follow-up period
Re-intervention free survival
时间窗: 6 months
Duration of re-intervention free survival over the 6 month follow-up period
Mortality
时间窗: 6 months
Number of subject deaths following ERCP, over the 6-month follow-up period
次要结局
- Adverse Events(6 months)
- Time until first adverse event(6 months)
研究者
Vinay Chandrasekhara
Principal Investigator
Mayo Clinic
研究点 (1)
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