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

March 5, 2022 updated by: Cheung Yue Sun, Chinese University of Hong Kong

Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • The Prince of Wales Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative surgical complications
Time Frame: 1 month
30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other post-operative complications
Time Frame: 1 month
post-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay
1 month
Survival
Time Frame: 5 year
Overall and disease-free survival at 1, 3, 5-year
5 year
Recurrence rate of hepatocellular carcinoma
Time Frame: 5 year
Recurrence rate of hepatocellular carcinoma at 1,3,5 year
5 year

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2013

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 1, 2013

First Submitted That Met QC Criteria

January 2, 2013

First Posted (Estimate)

January 3, 2013

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 5, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2012.351-T

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.

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