Evaluation of Indocyanine Green Fluorescent Cholangiography Versus Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy: Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- biliary fistula rate
研究概览
简要总结
The aim of the present study is to evaluate whether the use of indocyanine green fluorescent cholangiography is responsible in a decrease of biliary fistula's rate in patients with liver diseases requiring liver resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •benin or malignant liver disease with resection of 2 or more segments
- •liver resection by laparotomy
- •written consent
排除标准
- •previous hepatectomy
- •emergency surgery
- •allergy to indocyanine green
- •allergy to methylene blue
- •pregnancy or breastfeeding
研究组 & 干预措施
indocyanine green fluorescent cholangiography
use of indocyanine green fluorescent cholangiography in the patients of this arm, an indocyanine green fluorescent cholangiography is performed
干预措施: indocyanine green fluorescent cholangiography (Procedure)
methylene blue
injection of methylene blue during the surgery
干预措施: methylene blue (Drug)
结局指标
主要结局
biliary fistula rate
时间窗: postoperative week 4
the biliary fistula is defined as a bilirubin in the drain three times higher than the serum bilirubin. the primary endpoint will be evaluated by a medical committee composed by investigators not involved in the patients enrollment.
次要结局
未报告次要终点