Study on Clinical Outcome of Vascular Inflow Occlusion in Open Liver Resection

February 2, 2015 updated by: Cheung Yue Sun, Chinese University of Hong Kong

Open Liver Resection With or Without Vascular Inflow Occlusion: a Randomized Control Trial

This study aims to evaluate whether applying inflow vascular occlusion in modern liver resection is associated with better clinical outcome.

Eligible patients are randomly assigned to the two surgical techniques: with or without the application of inflow vascular occlusion.

Patients outcome including liver function recovery, operative time and blood loss are compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

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
        • 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 years
  • Child-Pugh Class A or B

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, or transarterial internal radiation
  • When portal vein resection is anticipated
  • Emergency hepatectomy
  • Ruptured hepatocellular carcinoma
  • Rehepatectomy (repeated liver resection)
  • Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver
  • When concomitant bowel or bile duct resection is anticipated

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: 1
Intermittent clamp group
Procedure: Intermittent Pringle maneuver
Pringle maneuver is performed by isolation of the hepatoduodenal ligament which is then encircled and occluded with atraumatic vascular clamp. The clamp is applied for 15 minutes followed by unclamping for 5 minutes and repeated till end of liver transection. Limits of clamp cycle: 3 cycles for cirrhotic liver; 4 cycles for non-cirrhotic liver.
No Intervention: 2
No clamp group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Operative blood loss
Time Frame: From skin incision to completion of operation
From skin incision to completion of operation
Operative time
Time Frame: From skin incision to completion of operation
From skin incision to completion of operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Operative morbidity and mortality
Time Frame: From date of operation to 30-day after operation
From date of operation to 30-day after operation
Recovery of liver function
Time Frame: From date of operation to date of discharge
From date of operation to date of discharge

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Kit-fai Lee, MBBS, Departement of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, 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

May 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CT08017
  • CRE-2008.037-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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