Impact of Positive Bile Cultures on Plastic Biliary Stent Exchange
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Comparative analysis of the incidence rates of acute cholangitis in the scheduled stent exchange group, at one month, vs. standard stent exchange at three months
研究概览
简要总结
This prospective, unicenter, randomized controlled trial evaluates whether a positive bile culture at index ERCP with plastic stenting identifies patients who benefit from earlier stent exchange. Patients with no previous history of sphincterotomy and positive bile cultures after an ERCP will be randomized to stent exchange at 1 month versus 3 months to assess whether personalized scheduling reduces early stent occlusion and secondary acute cholangitis.
详细描述
A positive bile culture obtained at the index ERCP in patients with no previous history of sphincterotomy undergoing plastic biliary stenting may represent a key, yet currently largely ignored, predictor of early stent occlusion and subsequent acute cholangitis. Based on the findings of the TEMPEST Study, conducted in the Gastroenterology Department of Colentina Clinical Hospital (currently submitted for publication), which suggested a clinical benefit of earlier scheduled ERCP for stent exchange in this high-risk subgroup, we hypothesize that bile culture-guided scheduling of stent exchange can improve clinical outcomes.
To test this hypothesis, we propose a prospective, unicentric, randomized controlled trial comparing patients with positive bile cultures at index ERCP randomized to early stent exchange at 1 month versus standard exchange at 3 months. The primary objective is to determine whether personalized scheduling based on initial bile culture results reduces the incidence of early acute cholangitis, thereby offering a simple, low-cost strategy to optimize post-ERCP management and prevent further complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •All patients between 18 and 90 years old with native papilla and obstructive jaundice of any etiology requiring plastic biliary stent placement, with a positive bile culture at index ERCP who can provide written informed consent (obtained from the patient or legal caregiver).
排除标准
- •prior ERCP attempts
- •patients with bilio-digestive surgical or endoscopic anastomoses
- •inability to provide informed consent due to cognitive, legal, or medical reasons
- •scheduled surgical resection within one month after ERCP.
研究组 & 干预措施
Control
standard follow up and stent exchange according to institutional norm
干预措施: stent exchange (Other)
rapid exchange
rapid call back in case of positive bile culture
干预措施: Scheduled biliary stent exchange at one month (Other)
结局指标
主要结局
Comparative analysis of the incidence rates of acute cholangitis in the scheduled stent exchange group, at one month, vs. standard stent exchange at three months
时间窗: from enrollment to the end of treatment at three months
The primary endpoint of this study is the incidence of cholangitis in patients with a positive bile culture at index ERCP with plastic stent placement. By comparing the outcomes between the 2 groups, the study aims to demonstrate that earlier stent exchange in this high-risk subgroup improves patient outcome by decreasing procedure-related complications, supporting a personalized management strategy instead of the current standard.
次要结局
未报告次要终点
研究者
Andrei Voiosu
Lecturer Dr.
Clinical Hospital Colentina