Clinical trial NCT01759901: Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma
Official title: Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatectomy
vascular inflow occlusion
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Post-operative surgical complications
timeFrame: 1 month
Secondary outcomes:
measure: Other post-operative complications
timeFrame: 1 month
measure: Survival
timeFrame: 5 year
measure: Recurrence rate of hepatocellular carcinoma
timeFrame: 5 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Prince of Wales Hospital
Study officials:
affiliation: Clinical Associate Professor (honorary)
name: Kit Fai Lee, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.