Fluorescence Cholangiography Versus Conventional Intraoperative Cholangiography for Visualization of Biliary Tract Anatomy : a Prospective, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography
研究概览
简要总结
The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may be severe ranging from intraoperative repair to liver transplant or patient's death. Different techniques have been proposed to prevent BDI.
Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages:
- ease of use
- lack of invasiveness
- absence of ionizing radiation to the patient and the operating staff
- performed prior to any dissection (prior to "critical view of safety")
Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI images) to guide biliary tree anatomy visualization will be also evaluated in this study.
The study requires a 2-month patient participation.
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
- •Man or woman > 18 years old
- •Symptomatic gallbladder lithiasis or gallbladder polyps
- •Clinical, biological ou medical imaging history leading to suspicion of gallstones migration
- •Absence of contra-indication to anesthesia and cholecystectomy procedure
- •Ability to understand the study related information and to provide written informed consent
- •Registered with the French social security regime
- •Non inclusion Criteria:
- •Inability to give informed consent
- •Acute Cholecystitis
- •Contraindications to MRI exam (claustrophobia, implantable devices)
- •Potential risk of allergic reactions to iodine-containing contrast agents, to indocyanine green or other fluorescent compounds
- •Pregnancy or breast-feeding
- •Exclusion period from other clinical trial
- •Forfeit freedom from an administrative or legal obligation
- •Under guardianship
排除标准
- 未提供
研究组 & 干预措施
Fluorescence/Virtual cholangiography/IOC
Prior to cholecystectomy, patients will undergo:
- Fluorescence cholangiography (visualization following up to a maximum of 0.5 mg/kg ICG - usually 10 ml of 0,5 mg/ml solution)
- Virtual cholangiography (enhanced-reality) superimposed on fluorescence images
- Conventional IOC (intraoperative cholangiography)
干预措施: Fluorescence cholangiography (da Vinci surgical system) (Device)
Fluorescence/Virtual cholangiography/IOC
Prior to cholecystectomy, patients will undergo:
- Fluorescence cholangiography (visualization following up to a maximum of 0.5 mg/kg ICG - usually 10 ml of 0,5 mg/ml solution)
- Virtual cholangiography (enhanced-reality) superimposed on fluorescence images
- Conventional IOC (intraoperative cholangiography)
干预措施: Virtual cholangiography (Other)
Fluorescence/Virtual cholangiography/IOC
Prior to cholecystectomy, patients will undergo:
- Fluorescence cholangiography (visualization following up to a maximum of 0.5 mg/kg ICG - usually 10 ml of 0,5 mg/ml solution)
- Virtual cholangiography (enhanced-reality) superimposed on fluorescence images
- Conventional IOC (intraoperative cholangiography)
干预措施: Conventional IOC (Procedure)
结局指标
主要结局
To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography
时间窗: Intra-operatively
Percentage of patients for whom fluorescence allows for cysticocholedochal junction with precision at least as good as intraoperative cholangiography (identification of anatomical details and information). Independent aposteriori evaluation performed by a radiologist/surgeon team.
次要结局
- To evaluate time required for the visualization of biliary tree anatomy for each modality : fluorescence, enhanced reality, conventional intraoperative cholangiography(Intra-operatively)
- To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy(Intra-operatively)
- To evaluate the ability of enhanced reality in visualizing the biliary anatomy intra-operatively, especially the cysticocholedochal junction(Intra-operatively)