Application of Trans-parenchymal Compressing Suture in Major Liver Resection to Decrease Cutting Surface Related Complication.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 382
- 主要终点
- Cutting surface related complications
研究概览
简要总结
Non-anatomical liver resection with appropriate resection margin was regarded as a potential curative treatment for selected major hepatic carcinoma due to preserving maximal normal liver, especially in cirrhotic patients. But occurrence of cutting surface related complications become a main challenge.
详细描述
In order to better manage the cutting surface after liver resection, we further applied trans-parenchymal compressing suture to "not good" cutting surface in hope of decreasing cutting surface related complication. A majority of studies investigating cutting surface management are limited to non-surgical treatments, such as the application of hemostasis agents including fibrin sealants, oxidized cellulose, and absorbable gelatin sponge13-15 . But there is no consensus regarding the necessity of the hemostatic agent application to the liver cutting surface. Up to date, few studies investigate surgical suture management of the cutting surface in liver resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •tumor size more than 5cm
- •non-anatomical liver resection;
排除标准
- •intravascular infiltration with tumor embolus;
- •previous liver surgical treatment (e.g. microwave ablation; preoperative transcatheter arterial chemoembolization (TACE);
- •other concomitant extrahepatic procedures (e.g. splenectomy).
- •exposed Glisson Shealth, main hepatic veins or (and) retro-hepatic inferior vena cava.
研究组 & 干预措施
Trans-parenchymal compressing suture
TCS: After liver transection, check for active hemorrhage and visible sites of bile leakage of cutting surface by stainless gauze which covered up on the raw cutting surface for 5 minutes. For patients with any positive findings including bloodstain and (or) bile staining, the cutting surface was recognized as "not good" cutting surface and further trans-parenchymal compressing sutured, if possible, using a hepatic needle.
干预措施: TCS (Procedure)
Exposed surface (ES)
147 Patients with exposed surface (ES) were matched as control group. No TCS.
结局指标
主要结局
Cutting surface related complications
时间窗: 90 days
After liver resection, some complication related cutting surface may occur, including surgery site infection, bile leakage, bleeding.
次要结局
- Interventions for cutting surface related complications(90 days)
研究者
Lei Dou
Principle Investigator
Tongji Hospital