Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Pringle

• Registration Number: NCT01759901
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery. However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to post-operative liver dysfunction.

The investigators hypothesize that liver resection without the use of vascular inflow occlusion (Pringle maneuver) is associated with lower postoperative complications rate.

The aim of this study is to evaluate whether elective open liver resection without vascular inflow occlusion (Pringle Maneuvre) would lead to a reduction of post-operative surgical complications in patient with hepatocellular carcinoma.

Eligible patients undergoing liver resection in the Prince of Wales Hospital will be recruited and randomized into 2 study arms comparing the effect of Pringle maneuver.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-01
• Study First Submitted QC: 2013-01-02
• Study First Posted: 2013-01-03
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-05
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age >18
• Child's A or B cirrhosis

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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, lipiodol-ethanol mixture injection or transarterial internal radiation
• Anticipation of portal vein resection
• Emergency hepatectomy
• Ruptured HCC
• Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver
• Anticipation of concomitant bowel or bile duct resection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pringle	Pringle	Intermittent vascular inflow occlusion applied during liver resection

Primary Outcome Measures

Name	Time	Method
Post-operative surgical complications	1 month	30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection

Secondary Outcome Measures

Name	Time	Method
Other post-operative complications	1 month	post-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay
Survival	5 year	Overall and disease-free survival at 1, 3, 5-year
Recurrence rate of hepatocellular carcinoma	5 year	Recurrence rate of hepatocellular carcinoma at 1,3,5 year

Trial Locations

Locations (1)

The Prince of Wales Hospital; 🇨🇳 Hong Kong, China