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

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT00730743
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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 1, 2008
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Operative blood loss [From skin incision to completion of operation]

2. Operative time [From skin incision to completion of operation]

Secondary Outcome Measures

1. Operative morbidity and mortality [From date of operation to 30-day after operation]

2. Recovery of liver function [From date of operation to date of discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cheung Yue Sun, Associate Consultant, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT00730743
• Other Study ID Numbers: CT08017; CRE-2008.037-T
• First Posted: Aug 8, 2008
• Last Update Posted: Feb 4, 2015
• Last Verified: Feb 1, 2015

Study Results

No Results Posted as of Feb 4, 2015