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Trans-parenchymal Compressing Suture in Major Liver Resection

Sponsor
Tongji Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03215290
Collaborator
(none)
382
Enrollment
2
Arms
4
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: TCS
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
382 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Application of Trans-parenchymal Compressing Suture in Major Liver Resection to Decrease Cutting Surface Related Complication.
Actual Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Feb 1, 2017

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tongji Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lei Dou, Principle Investigator, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT03215290
    Other Study ID Numbers:
    • TJ-201206
    First Posted:
    Jul 12, 2017
    Last Update Posted:
    Jul 12, 2017
    Last Verified:
    Jul 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Jul 12, 2017