Metabolic Dysfunction-Associated Fatty Liver Disease Impairs Intraoperative Indocyanine Green Fluorescence Cholangiography Quality: Development and Validation of a Predictive Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Common bile duct FI / Liver background FI (C/L)
研究概览
简要总结
Near-infrared fluorescence cholangiography has been shown to improve the clinical outcomes of laparoscopic cholecystectomy (LC). However, it remains unclear whether hepatic steatosis in patients with metabolic dysfunction-associated fatty liver disease (MAFLD) influences the quality of indocyanine green fluorescence imaging (ICG-FI), and whether the quality can be predicted preoperatively. This study aimed to evaluate the impact of MAFLD on intraoperative fluorescence quality and to develop a multiple linear regression model for predicting intraoperative ICG-FI.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years, any sex;
- •Definite surgical indication for cholecystectomy;
- •Underwent LC;
- •No severe contraindications such as significant cardiac, pulmonary, renal, or cerebral dysfunction.
排除标准
- •Known allergy to ICG or iodinated contrast agents;
- •Use of medications affecting biliary excretion within 2 weeks prior to surgery; (3) LC without ICG-FI;
- •(4) Incomplete clinical data.
结局指标
主要结局
Common bile duct FI / Liver background FI (C/L)
时间窗: Perioperative period
The common bile duct-to-liver background fluorescence intensity ratio (C/L) \[Unit: Dimensionless number\] \[Time Frame: Perioperative period\] \[Measurement steps: Three photographs per case were obtained with the following requirements: Calot's triangle centred in the image, liver background positioned superiorly, and the CBD inferiorly, ensuring all measurement sites were visible and unobstructed. Each image was converted to greyscale, and regions of interest (ROI) of \>3000 pixels were selected for each critical structure to calculate FI. The mean FI from the three images was recorded as the final value for each structure.\]
次要结局
- Qualitative assessment of fluorescence visualization(Perioperative period)