Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy. Multicenter Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Clear intraoperative identification of the junction between the cystic duct, the common hepatic duct, and the common bile duct
研究概览
简要总结
This is a multicenter, prospective, interventional clinical trial designed to evaluate and compare two intraoperative imaging modalities: laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG), for the identification of biliary anatomy in technically challenging laparoscopic cholecystectomy. All enrolled subjects will undergo both LUS and ICG during the index procedure, following a standardized sequence, in order to allow intra-subject comparison. LUS will be performed first, followed by fluorescence cholangiography prior to Calot's triangle dissection.
The primary endpoint is the successful identification of the critical junction. Secondary endpoints include visualization of individual biliary structures, time to visualization, total operative time, intraoperative and postoperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Age ≥ 18 years.
- •Written informed consent provided.
- •Indication for laparoscopic cholecystectomy with anticipated technical difficulty due to one or more of the following:
- •Acute cholecystitis.
- •Previous cholangitis, pancreatitis, or endoscopic retrograde cholangiopancreatography.
- •Prior upper abdominal surgery.
- •Obesity (Body Mass Index ≥ 30 kg/m²).
排除标准
- •Known allergy to ICG or iodine.
- •Pregnancy or breastfeeding.
- •High risk of choledocholithiasis (ESGE guidelines).
- •Thyroid disease.
- •Suspected gallbladder malignancy.
- •ASA class IV-V.
- •Chronic kidney disease stage > IIIb.
- •Planned open cholecystectomy.
研究组 & 干预措施
Complex laparoscopic cholecystectomy
Laparoscopic cholecystectomy with anticipated technical difficulty
干预措施: Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG) (Diagnostic Test)
结局指标
主要结局
Clear intraoperative identification of the junction between the cystic duct, the common hepatic duct, and the common bile duct
时间窗: Intraoperative
This intraoperative visualization will be assessed separately for laparoscopic ultrasound (LUS) and indocyanine green fluorescence cholangiography (ICG) and recorded as a binary outcome (yes/no) for each technique in each patient using a standardized intraoperative assessment form completed by the operating surgeon. Laparoscopic ultrasound will be performed first, followed by indocyanine green fluorescence cholangiography, according to a predefined and standardized intraoperative sequence. Intraoperative photographic documentation will be obtained for each imaging modality to objectively demonstrate the visualization of the critical biliary junction. Results will be reported as the proportion of patients with successful visualization for each modality and compared using an intra-subject analysis.
次要结局
未报告次要终点