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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


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
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