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A Study of Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping (AA+IVC)

Primary Purpose

Surgical Approach & Incisions, Blood Loss

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IVC clamping
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Approach & Incisions focused on measuring Anterior approach, infrahepatic inferior vena cava clamping, hepatic resection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Understanding and being willing to sign the informed consent form
  • Aged 18-75 years
  • Diagnosed HCC by clinical findings and radiography,tumor size ≥ 5cm and located in the right lobe, need to perform right hemihepatectomy or major right hepatic resection (three Couinaud's segments)
  • Without any surgery contraindication
  • Child-Pugh grade A

Exclusion Criteria:

  • Refusal to take part in the study
  • With lymph node or extrahepatic metastases
  • History of previous hepatectomy or other abdominal operation
  • Those who can not be follow-up
  • Non-HCC

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    anterior approach+IVC clamping

    anterior approach

    Arm Description

    Use anterior approach combined with infrahepatic Inferior Vena Cava clamping in right hepatectomy for HCC patients.

    Only use anterior approach in right hepatectomy for HCC patients.

    Outcomes

    Primary Outcome Measures

    intraoperative total blood loss

    Secondary Outcome Measures

    operation time
    intraoperative CVP value
    morbidity and mortality
    postoperative hepatorenal function
    postoperative hospital stay
    disease-free survival duration and overall survival duration
    blood loss during parenchymal transection

    Full Information

    First Posted
    May 22, 2012
    Last Updated
    August 5, 2015
    Sponsor
    Eastern Hepatobiliary Surgery Hospital
    Collaborators
    The First Affiliated Hospital of Xiamen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01608386
    Brief Title
    A Study of Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping
    Acronym
    AA+IVC
    Official Title
    Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping Right Hepatic Resection for Large Hepatocellular Carcinoma: A Prospective Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eastern Hepatobiliary Surgery Hospital
    Collaborators
    The First Affiliated Hospital of Xiamen University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Anterior approach results in better operative and survival outcomes compared with the conventional approach in patients with large hepatocellular carcinoma (HCC), but anterior approach has the problem of bleeding from the hepatic vein. Our previous study showed that infrahepatic inferior vena cava (IVC) clamping can reduce blood loss during conventional hepatic resection. The investigators guess infrahepatic IVC clamping may also reduce blood loss in anterior approach right hepatic resection. So the investigators conduct this prospective, randomized, controlled trial to compare anterior approach combined with infrahepatic IVC clamping and anterior approach in major right hepatectomy for large HCC.
    Detailed Description
    Traditionally, mobilisation of the right hemiliver followed by right hepatic vein control before parenchymal transection has been considered the standard approach to a major right hepatectomy. However, this approach is often difficult and hazardous when performing liver resection for large hepatocellular carcinoma (HCC) or for tumors with extrahepatic organ invasion in the right retrohepatic region.In setting of right hepatectomy by an anterior approach,liver mobilisation is performed only at the end of parenchymal transection, when all vascular connections have already been interrupted.The anterior approach was found to be associated with significantly less intraoperative blood loss, less blood transfusions and a lower hospital mortality rate.However,excessive bleeding can occur at the deeper plane of parenchymal transection from the right hepatic vein or middle hepatic vein. Bleeding from the hepatic veins is closely related to the CVP.Our previous retrospective analysisfound that the infrahepatic inferior vena cava (IVC) clamping is efficacious in reducing CVP without the need of systemic fluid restriction and is associated with significantly less intraoperative blood loss during complex hepatectomy. The aim of the present study was therefore to evaluate if the application of the anterior approach combined with infrahepatic IVC clamping during right hepatectomy for large HCC reduces intraoperative blood loss.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Approach & Incisions, Blood Loss
    Keywords
    Anterior approach, infrahepatic inferior vena cava clamping, hepatic resection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    anterior approach+IVC clamping
    Arm Type
    Experimental
    Arm Description
    Use anterior approach combined with infrahepatic Inferior Vena Cava clamping in right hepatectomy for HCC patients.
    Arm Title
    anterior approach
    Arm Type
    No Intervention
    Arm Description
    Only use anterior approach in right hepatectomy for HCC patients.
    Intervention Type
    Procedure
    Intervention Name(s)
    IVC clamping
    Intervention Description
    in right hepatectomy,use anterior approach and infrahepatic Inferior Vena Cava clamping.
    Primary Outcome Measure Information:
    Title
    intraoperative total blood loss
    Time Frame
    participants will be followed for the duration of the entire operation,an expected average of 140 minutes
    Secondary Outcome Measure Information:
    Title
    operation time
    Time Frame
    the duration of the entire operation,an expected average of 140 minutes
    Title
    intraoperative CVP value
    Time Frame
    participants will be followed for the duration of the parenchymal transection,an expected average of 20 minutes
    Title
    morbidity and mortality
    Time Frame
    participants will be followed for the duration of the postoperative hospital stay,an expected average of 15 days
    Title
    postoperative hepatorenal function
    Time Frame
    postoperative day 1,3 and 7
    Title
    postoperative hospital stay
    Time Frame
    the duration of the postoperative hospital stay,an expected average of 15 days
    Title
    disease-free survival duration and overall survival duration
    Time Frame
    the duration from operation to recurrence or death,an expected average of 3 years
    Title
    blood loss during parenchymal transection
    Time Frame
    the duration of the parenchymal transection,an expected average of 20 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Understanding and being willing to sign the informed consent form Aged 18-75 years Diagnosed HCC by clinical findings and radiography,tumor size ≥ 5cm and located in the right lobe, need to perform right hemihepatectomy or major right hepatic resection (three Couinaud's segments) Without any surgery contraindication Child-Pugh grade A Exclusion Criteria: Refusal to take part in the study With lymph node or extrahepatic metastases History of previous hepatectomy or other abdominal operation Those who can not be follow-up Non-HCC
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jiamei Yang, MD
    Organizational Affiliation
    Eastern Hepatobiliary Surgery Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Chengjun Sui, MD
    Organizational Affiliation
    Eastern Hepatobiliary Surgery Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    A Study of Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping

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