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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT00730743

First received: August 6, 2008

Last updated: July 6, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 6, 2008

Last Updated Date

July 6, 2011

Start Date ^ICMJE

May 2008

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Operative blood loss [ Time Frame: From skin incision to completion of operation ] [ Designated as safety issue: Yes ]
Operative time [ Time Frame: From skin incision to completion of operation ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Operative blood loss [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
Operative time [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00730743 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Operative morbidity and mortality [ Time Frame: From date of operation to 30-day after operation ] [ Designated as safety issue: Yes ]
Recovery of liver function [ Time Frame: From date of operation to date of discharge ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Operative morbidity and mortality [ Time Frame: Intraoperative and postoperative ] [ Designated as safety issue: Yes ]
Recovery of liver function [ Time Frame: Postoperative ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatectomy

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: 1
Intermittent clamp group

Intervention: Procedure: Intermittent Pringle maneuver
No Intervention: 2
No clamp group

Publications *

Lee KF, Cheung YS, Wong J, Chong CC, Wong JS, Lai PB. Randomized clinical trial of open hepatectomy with or without intermittent Pringle manoeuvre. Br J Surg. 2012 Sep;99(9):1203-9. doi: 10.1002/bjs.8863. Epub 2012 Jul 24.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

126

Estimated Completion Date

August 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00730743

Other Study ID Numbers ^ICMJE

CT08017, CRE-2008.037-T

Has Data Monitoring Committee

Responsible Party

Dr Lee Kit Fai, Department of Surgery, The Chinese University of Hong Kong

Study Sponsor ^ICMJE

Chinese University of Hong Kong

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kit-fai Lee, MBBS

Departement of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong

Information Provided By

Chinese University of Hong Kong

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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