NCT01759901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

3.8 years

First QC Date

January 1, 2013

Last Update Submit

March 5, 2022

Conditions

Hepatocellular Carcinoma

Keywords

hepatectomyvascular inflow occlusion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Other post-operative complications

    1 month

  • Survival

    5 year

  • Recurrence rate of hepatocellular carcinoma

    5 year

Study Arms (2)

Pringle

EXPERIMENTAL

Intermittent vascular inflow occlusion applied during liver resection

Procedure: Pringle

Non-Pringle

NO INTERVENTION

No vascular inflow occlusion applied during liver resection

Interventions

PringlePROCEDURE

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

Also known as: Vascular inflow occlusion
Pringle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18
  • Child's A or B cirrhosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (2)

  • 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.

    PMID: 31420724DERIVED

  • 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.

    PMID: 29696328DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Kit Fai Lee, MBBS

    Clinical Associate Professor (honorary)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor (honorary)

Study Record Dates

First Submitted

January 1, 2013

First Posted

January 3, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

CN(1)