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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00730743
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : February 4, 2015
Information provided by (Responsible Party):
Cheung Yue Sun, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Hepatectomy Procedure: Intermittent Pringle maneuver Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 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: a Randomized Control Trial
Study Start Date : May 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2011

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

Primary Outcome Measures :
  1. Operative blood loss [ Time Frame: From skin incision to completion of operation ]
  2. Operative time [ Time Frame: From skin incision to completion of operation ]

Secondary Outcome Measures :
  1. Operative morbidity and mortality [ Time Frame: From date of operation to 30-day after operation ]
  2. Recovery of liver function [ Time Frame: From date of operation to date of discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00730743

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cheung Yue Sun, Associate Consultant, Chinese University of Hong Kong Identifier: NCT00730743     History of Changes
Other Study ID Numbers: CT08017
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015