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

Hepatocellular Carcinoma Clinical Trial

Official title:

Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759901
• Other study ID #: CRE-2012.351-T
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18

• Child's A or B cirrhosis

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Pringle
Vascular clamp is applied across hepatoduodenal ligament intermittently in 15 minutes on / 5 minutes off interval

Locations

Country	Name	City	State
China	The 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	Post-operative surgical complications	30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection	1 month
Secondary	Other post-operative complications	post-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay	1 month
Secondary	Survival	Overall and disease-free survival at 1, 3, 5-year	5 year
Secondary	Recurrence rate of hepatocellular carcinoma	Recurrence rate of hepatocellular carcinoma at 1,3,5 year	5 year