Trans-parenchymal Compressing Suture in Major Liver Resection

Liver Carcinoma Resectable Clinical Trial

Official title:

Application of Trans-parenchymal Compressing Suture in Major Liver Resection to Decrease Cutting Surface Related Complication.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215290
• Other study ID #: TJ-201206
• Status: Completed
• Phase: N/A
• First received: June 29, 2017
• Last updated: July 10, 2017
• Start date: October 2016
• Est. completion date: February 2017

Study information

• Verified date: July 2017
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Carcinoma Resectable

Intervention

Procedure:
• TCS
The cutting surface recognized as "not good" cutting surface was further trans-parenchymal compressing sutured, if possible, using a hepatic needle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cutting surface related complications	After liver resection, some complication related cutting surface may occur, including surgery site infection, bile leakage, bleeding.	90 days
Secondary	Interventions for cutting surface related complications	Once the cutting surface related complications occur, some interventions need to be performed to treat these complications, such as percutaneous abdominal paracentesis or reoperation.	90 days