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Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT01759901
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
47
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery. However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to post-operative liver dysfunction.

The investigators hypothesize that liver resection without the use of vascular inflow occlusion (Pringle maneuver) is associated with lower postoperative complications rate.

The aim of this study is to evaluate whether elective open liver resection without vascular inflow occlusion (Pringle Maneuvre) would lead to a reduction of post-operative surgical complications in patient with hepatocellular carcinoma.

Eligible patients undergoing liver resection in the Prince of Wales Hospital will be recruited and randomized into 2 study arms comparing the effect of Pringle maneuver.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pringle

Intermittent vascular inflow occlusion applied during liver resection

Procedure: Pringle
Vascular clamp is applied across hepatoduodenal ligament intermittently in 15 minutes on / 5 minutes off interval
Other Names:
  • Vascular inflow occlusion

    		•
    No Intervention: Non-Pringle

    No vascular inflow occlusion applied during liver resection

    Outcome Measures

    Primary Outcome Measures

    1. Post-operative surgical complications [1 month]

      30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection

    Secondary Outcome Measures

    1. Other post-operative complications [1 month]

      post-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay

    2. Survival [5 year]

      Overall and disease-free survival at 1, 3, 5-year

    3. Recurrence rate of hepatocellular carcinoma [5 year]

      Recurrence rate of hepatocellular carcinoma at 1,3,5 year

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age >18

    • Child's A or B cirrhosis

    Exclusion Criteria:

    • Informed consent not available

    • Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal vein embolisation

    • Presence of hepatic artery thrombosis, previous transarterial therapy like TACE, lipiodol-ethanol mixture injection or transarterial internal radiation

    • Anticipation of portal vein resection

    • Emergency hepatectomy

    • Ruptured HCC

    • Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver

    • Anticipation of concomitant bowel or bile duct resection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Prince of Wales Hospital Hong Kong China

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    • Principal Investigator: Kit Fai Lee, MBBS, Clinical Associate Professor (honorary)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cheung Yue Sun, Clinical Assistant Professor (honorary), Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT01759901
    Other Study ID Numbers:
    • CRE-2012.351-T
    First Posted:
    Jan 3, 2013
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022
    Keywords provided by Cheung Yue Sun, Clinical Assistant Professor (honorary), Chinese University of Hong Kong
    hepatectomy
    vascular inflow occlusion
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Mar 18, 2022