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Trans-parenchymal Compressing Suture in Major Liver Resection

Primary Purpose

Liver Carcinoma Resectable

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TCS
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Carcinoma Resectable

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Trans-parenchymal compressing suture

    Exposed surface (ES)

    Arm Description

    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.

    147 Patients with exposed surface (ES) were matched as control group. No TCS.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    June 29, 2017
    Last Updated
    July 10, 2017
    Sponsor
    Tongji Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03215290
    Brief Title
    Trans-parenchymal Compressing Suture in Major Liver Resection
    Official Title
    Application of Trans-parenchymal Compressing Suture in Major Liver Resection to Decrease Cutting Surface Related Complication.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    February 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tongji Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Carcinoma Resectable

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    382 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Trans-parenchymal compressing suture
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Exposed surface (ES)
    Arm Type
    No Intervention
    Arm Description
    147 Patients with exposed surface (ES) were matched as control group. No TCS.
    Intervention Type
    Procedure
    Intervention Name(s)
    TCS
    Other Intervention Name(s)
    trans-parenchymal compressing suture
    Intervention Description
    The cutting surface recognized as "not good" cutting surface was further trans-parenchymal compressing sutured, if possible, using a hepatic needle.
    Primary Outcome Measure Information:
    Title
    Cutting surface related complications
    Description
    After liver resection, some complication related cutting surface may occur, including surgery site infection, bile leakage, bleeding.
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Interventions for cutting surface related complications
    Description
    Once the cutting surface related complications occur, some interventions need to be performed to treat these complications, such as percutaneous abdominal paracentesis or reoperation.
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: tumor size more than 5cm non-anatomical liver resection; Exclusion Criteria: 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.

    12. IPD Sharing Statement

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    Trans-parenchymal Compressing Suture in Major Liver Resection

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