Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma
NCT ID: NCT01759901
Last Updated: 2022-03-18
Study Results
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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COMPLETED
NA
100 participants
INTERVENTIONAL
2013-01-31
2016-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pringle
Intermittent vascular inflow occlusion applied during liver resection
Pringle
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Child's A or B cirrhosis
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Cheung Yue Sun
Clinical Assistant Professor (honorary)
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
Countries
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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.
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.
Other Identifiers
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CRE-2012.351-T
Identifier Type: -
Identifier Source: org_study_id
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