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

Hepatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730743
• Other study ID #: CT08017
• Secondary ID: CRE-2008.037-T
• Status: Completed
• Phase: N/A
• First received: August 6, 2008
• Last updated: February 2, 2015
• Start date: May 2008
• Est. completion date: August 2011

Study information

• Verified date: February 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hepatectomy

Intervention

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.

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative blood loss		From skin incision to completion of operation	Yes
Primary	Operative time		From skin incision to completion of operation	No
Secondary	Operative morbidity and mortality		From date of operation to 30-day after operation	Yes
Secondary	Recovery of liver function		From date of operation to date of discharge	Yes