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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Chinese University of Hong Kong.
Recruitment status was  Active, not recruiting
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
  Purpose

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 Intervention
Hepatectomy
Procedure: Intermittent Pringle maneuver

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Liver Resection With or Without Vascular Inflow Occlusion: a Randomized Control Trial

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 126
Study Start Date: May 2008
Estimated Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730743

Locations
China
Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
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
  More Information

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Lee Kit Fai, Department of Surgery, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00730743     History of Changes
Other Study ID Numbers: CT08017, CRE-2008.037-T
Study First Received: August 6, 2008
Last Updated: July 6, 2011
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

ClinicalTrials.gov processed this record on November 25, 2014