Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy
详细描述
This is a single-center, randomized, controlled trial (RCT), comparing bedside US-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy (PC). The study will randomize a total of 100 consecutive patients (50 in each group) undergoing PC at one large tertiary university hospital. The primary endpoints will be technical success and procedure-related complication rates. Secondary endpoints will be procedural duration, pain assessment, and clinical success after up to 3 months of follow-up.
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)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients requiring PC, regardless of the underlying cause.
- •Signed informed consent form
排除标准
- •Age <18 years or >100 years
- •The necessity for CT-guided PC catheter placement, according to the judgment of the performing physician
- •Severe uncontrollable coagulopathy
研究组 & 干预措施
Group T
Patients will be randomized to undergo PC catheter placement (8-French) using the trocar method under US guidance while receiving local anesthesia and opioid analgesic, in a bedside setting, either in the US room or in the ICU.
干预措施: Trocar percutaneous cholecystostomy (Procedure)
Group S
Patients will be randomized to undergo PC catheter placement (8-French) using the Sellinger method under US guidance while receiving local anesthesia and opioid analgesic, in a bedside setting, either in the US room or in the ICU.
干预措施: Seldinger percutaneous cholecystostomy (Procedure)
结局指标
主要结局
Technical success
时间窗: At the end of the procedure
Image verified catheter placement within the gallbladder and subsequent bile aspiration
Procedure-related complications
时间窗: 3 months
Minor or major complications attributed to the procedure
次要结局
- Clinical success(72 hours)
- Duration of the procedure(Intraprocedural)
- Intraprocedural pain(End of the procedure)
- Post-procedural pain(12 hours)
研究者
Stavros Spiliopoulos
Assistant Professor in Interventional Radiology
Attikon Hospital