Trans-parenchymal Compressing Suture in Major Liver Resection

July 10, 2017 updated by: Lei Dou, Tongji Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

382

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: TCS
The cutting surface recognized as "not good" cutting surface was further trans-parenchymal compressing sutured, if possible, using a hepatic needle.
Other Names:
  • trans-parenchymal compressing suture
No Intervention: Exposed surface (ES)
147 Patients with exposed surface (ES) were matched as control group. No TCS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutting surface related complications
Time Frame: 90 days
After liver resection, some complication related cutting surface may occur, including surgery site infection, bile leakage, bleeding.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interventions for cutting surface related complications
Time Frame: 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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 12, 2017

Study Record Updates

Last Update Posted (Actual)

July 12, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-201206

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Carcinoma Resectable

Clinical Trials on TCS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe