Trans-parenchymal Compressing Suture in Major Liver Resection

Not Applicable

Completed

• Conditions: Liver Carcinoma Resectable
• Interventions: Procedure: TCS

• Registration Number: NCT03215290
• Lead Sponsor: Tongji Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2017-01
• Study Completion: 2017-02
• Study First Submitted: 2017-06-29
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-10
• Last Update Submitted: 2017-07-10
• Study First Posted: 2017-07-12
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

Inclusion Criteria

1. tumor size more than 5cm
2. non-anatomical liver resection;

Exclusion Criteria

1. intravascular infiltration with tumor embolus;
2. previous liver surgical treatment (e.g. microwave ablation; preoperative transcatheter arterial chemoembolization (TACE);
3. other concomitant extrahepatic procedures (e.g. splenectomy).
4. exposed Glisson Shealth, main hepatic veins or (and) retro-hepatic inferior vena cava.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans-parenchymal compressing suture	TCS	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.

Primary Outcome Measures

Name	Time	Method
Cutting surface related complications	90 days	After liver resection, some complication related cutting surface may occur, including surgery site infection, bile leakage, bleeding.

Secondary Outcome Measures

Name	Time	Method
Interventions for cutting surface related complications	90 days	Once the cutting surface related complications occur, some interventions need to be performed to treat these complications, such as percutaneous abdominal paracentesis or reoperation.