Hemopatch as a Tool to Prevent Biliary Fistula in Liver Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- The rate of biliary fistula
研究概览
简要总结
The aim of the study is to investigate the use of Hemopatch to prevent biliary fistula in patients submitted to surgery for malignancy.
详细描述
Background: Biliary fistula (BF) is one of the most common sources of post hepatectomy morbidity. International Study Group of Liver Surgery (ISGLS) define BF as increased bilirubin concentration in the drain at least 3 times greater than the serum bilirubin concentration on or after postoperative day (POD) 3. BF is graded into grade A, B and C, based on the clinical impact on the postoperative course. Considering ISGLS definition, the incidence of BF ranges from 4,4% to 27,2%. The definition developed in Humanitas Research Hospital (HRH), defines BF as bilirubin concentration in the drain fluid greater than 10 mg/dL on or after POD 3. In this case, the incidence is around 8%. Various topical haemostatic agents have been developed for liver resection area management their usefulness in preventing BF by using a sealing product on the resection surface still remains unclear and needs to be assessed.
Objective
this study aimed to assess the clinical validation of Hemopatch to prevent post-operative biliary fistula. Secondarily, it is aimed to evaluate the clinical validity of the two proposed definition of biliary fistula.
Methods: According to the incidence of BF in our previous series (considering ISGLS definition), we designed a randomized controlled study on 220 patients, who underwent hepatic resection from 2018 to 2020. Patients were randomized to treatment group A (Hemopatch) and standard group B (Tisseal and Tabotamp). Both ISGLS and HRH definitions of BF were considered. All patients were systematically drained. Drains were maintained at least 5 days, and bilirubin was measured on PODs 3, 5, and 7. Drains were removed if the bilirubin concentration in the drain fluid was less than 10 mg/dL on POD 7. A statistical analysis to compare perioperative variables between two groups was performed. Then, a multivariate analysis was performed to identify potential risk factors for BF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •all patients submitted to liver surgery for malignancies.
- •>18 years of age.
排除标准
- •biliary reconstruction
- •other associated visceral resections
结局指标
主要结局
The rate of biliary fistula
时间窗: 12 months
Use a Hemopatch to prevent biliary fistula
次要结局
未报告次要终点
研究者
Prof. Guido Torzilli
Director of the Department of Surgery Head of the General and Hepatobiliary surgery unit, Clinical Professor and Principal investigator
University of Milan