Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (US)-guided percutaneous cholecystostomy (PC) with the trocar technique by the patient's bedside.
详细描述
This clinical study will include patients who will undergo US-guided PC with the trocar technique. The study will include all cases requiring PC regardless of the underlying cause, while those requiring computed tomography (CT) guidance and those with uncontrolled coagulation disorders will be excluded.
Patient demographics, height, weight, and body mass index (BMI), comorbidities, ASA score, presence or absence of stones, presence or absence of gallbladder perforation at diagnosis, presence or absence of concomitant ascitic effusion, days of preoperative antibiotic treatment, imaging modality used to establish the diagnosis, technical details of the procedure, laboratory values (before and after surgery), and contact information for patient monitoring will be recorded.
The technical success of the method as well as its complications during hospitalization and during a 3-month follow-up period will be calculated. In addition, the anatomical access route during the PC (transhepatic/transperitoneal and intercostal/subcostal), the duration of the operation, the intraoperative and postoperative pain, and the clinical success of the method will be recorded.
After the operation, the patients will be monitored clinically and with laboratory test and, if deemed necessary, US, CT or both imaging will be performed. Before discharge, written instructions will be given regarding the management and care of the catheter.
This study will not burden the hospital financially, as the clinical, laboratory, and imaging tests required for the diagnosis of the underlying etiology that leads to the need to perform the procedure, the technique used to perform the procedure, as well as the monitoring of the patients and the possible complications of the procedure, are part of the hospital's routine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •All patients requiring PC, irrespective of the underlying cause and indication, are suitable for inclusion in the study.
排除标准
- •Patients are going to be excluded from the study if they are younger than 18 years, if they require PC catheter placement under CT guidance (according to the operator's judgement), or if they suffer from severe uncontrollable coagulopathy.
结局指标
主要结局
Technical success
时间窗: Up to 1 hour
Image verification of correct PC catheter placement within the gallbladder lumen with subsequent bile aspiration at the time of initial catheter placement
Procedure-related complications
时间窗: Up to 3 months
Complications attributed to the procedure
次要结局
- duration of the procedure(Up to 1 hour)
- intraprocedural and post-procedural pain(Up to 12 hours)
- clinical success(Up to 72 hours)
研究者
Stavros Spiliopoulos
Associate Professor of Diagnostic and Interventional Radiology
Attikon Hospital
