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

NCT ID: NCT01759901

Last Updated: 2022-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pringle

Intermittent vascular inflow occlusion applied during liver resection

Group Type EXPERIMENTAL

Pringle

Intervention Type PROCEDURE

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

Non-Pringle

No vascular inflow occlusion applied during liver resection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pringle

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

Intervention Type PROCEDURE

Other Intervention Names

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Vascular inflow occlusion

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Cheung Yue Sun

Clinical Assistant Professor (honorary)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kit Fai Lee, MBBS

Role: PRINCIPAL_INVESTIGATOR

Clinical Associate Professor (honorary)

Locations

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The Prince of Wales Hospital

Hong Kong, , China

Site Status

Countries

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China

References

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Lee KF, Chong CCN, Cheung SYS, Wong J, Fung AKY, Lok HT, Lai PBS. Impact of Intermittent Pringle Maneuver on Long-Term Survival After Hepatectomy for Hepatocellular Carcinoma: Result from Two Combined Randomized Controlled Trials. World J Surg. 2019 Dec;43(12):3101-3109. doi: 10.1007/s00268-019-05130-8.

Reference Type DERIVED
PMID: 31420724 (View on PubMed)

Lee KF, Wong J, Cheung SYS, Chong CCN, Hui JWY, Leung VYF, Yu SCH, Lai PBS. Does Intermittent Pringle Maneuver Increase Postoperative Complications After Hepatectomy for Hepatocellular Carcinoma? A Randomized Controlled Trial. World J Surg. 2018 Oct;42(10):3302-3311. doi: 10.1007/s00268-018-4637-3.

Reference Type DERIVED
PMID: 29696328 (View on PubMed)

Other Identifiers

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CRE-2012.351-T

Identifier Type: -

Identifier Source: org_study_id

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