Optimal Weight-Based Indocyanine Green Dosage for Fluorescent Cholangiography in Laparoscopic Cholecystectomy Among Chinese Population：Construction and Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Subjective Biliary Tract Visualization Quality Score
研究概览
简要总结
This is a single-center prospective study designed to develop and validate an individualized, low-dose indocyanine green (ICG) protocol for near-infrared fluorescence cholangiography during emergency laparoscopic cholecystectomy in patients with moderate to severe acute cholecystitis.
The main problem we aim to solve is that inflammation in the bile duct wall often makes standard ICG doses ineffective for clear visualization. We will use pre-operative MRI to measure the thickness of the common bile duct (CBD) wall, then calculate a personalized ICG dose using a simple formula. We will first test and refine this formula in a small group of patients, then verify its effectiveness in a second group. The goal is to achieve clear, high-contrast imaging of the bile ducts, which helps surgeons operate more safely and accurately.
All patients will receive a low, personalized dose of ICG given by vein 1 hour before surgery. We will evaluate how well the bile ducts show up on the fluorescence images, as well as safety and effectiveness outcomes. This study will provide a practical, patient-tailored solution for improving bile duct visualization in emergency gallbladder surgery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years undergoing emergency laparoscopic cholecystectomy.
- •Diagnosis of moderate to severe acute cholecystitis according to the 2018 Tokyo Guidelines.
- •Preoperative MRI available for common bile duct wall thickness measurement.
- •Ability to provide informed consent.
排除标准
- •Known allergy or contraindication to indocyanine green (ICG).
- •Severe renal or hepatic dysfunction (eGFR <30 mL/min/1.73m² or Child-Pugh class B/C cirrhosis).
- •Pregnancy or breastfeeding.
- •Previous biliary surgery or known choledocholithiasis requiring preoperative intervention.
- •Unstable hemodynamic status requiring conversion to open surgery before ICG administration.
研究组 & 干预措施
Individualized ICG Fluorescence Cholangiography Arm
All patients with moderate to severe acute cholecystitis undergoing emergency laparoscopic cholecystectomy receive an individualized, low-dose indocyanine green (ICG) injection. The ICG dose is calculated using a formula based on preoperative MRI-measured common bile duct wall thickness (0.012 + 0.0035625 × wall thickness, mg/kg), administered intravenously 1 hour before surgery. Near-infrared fluorescence cholangiography is performed during surgery to visualize the biliary anatomy.
干预措施: Indocyanine Green (ICG) Fluorescence Cholangiography (Drug)
结局指标
主要结局
Subjective Biliary Tract Visualization Quality Score
时间窗: Intraoperatively (during emergency laparoscopic cholecystectomy)
Intraoperative assessment of biliary tract visualization quality using a 4-point subjective scale (1=poor, 2=fair, 3=good, 4=excellent). The score is assigned by the operating surgeon based on the clarity of the cystic duct and common bile duct fluorescence signals, with a primary endpoint of achieving a mean score of ≥3.0 across all enrolled patients.
次要结局
未报告次要终点
研究者
Weibin Wang
Chief Physician
Peking Union Medical College Hospital