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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Cheung Yue Sun, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01759901
First received: January 1, 2013
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Procedure: Pringle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Post-operative surgical complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection


Secondary Outcome Measures:
  • Other post-operative complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    post-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay

  • Survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Overall and disease-free survival at 1, 3, 5-year

  • Recurrence rate of hepatocellular carcinoma [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Recurrence rate of hepatocellular carcinoma at 1,3,5 year


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pringle
Intermittent vascular inflow occlusion applied during liver resection
Procedure: Pringle
Vascular clamp is applied across hepatoduodenal ligament intermittently in 15 minutes on / 5 minutes off interval
Other Name: Vascular inflow occlusion
No Intervention: Non-Pringle
No vascular inflow occlusion applied during liver resection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759901

Contacts
Contact: Kit Fai Lee, MBBS 852-26321577 leekf@surgery.cuhk.edu.hk

Locations
China
The Prince of Wales Hospital Recruiting
Hong Kong SAR, China
Contact: Kit Fai Lee, MBBS    852-26321577    leekf@surgery.cuhk.edu.hk   
Principal Investigator: Kit Fai Lee, MBBS         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Kit Fai Lee, MBBS Clinical Associate Professor (honorary)
  More Information

No publications provided

Responsible Party: Cheung Yue Sun, Clinical Assistant Professor (honorary), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01759901     History of Changes
Other Study ID Numbers: CRE-2012.351-T
Study First Received: January 1, 2013
Last Updated: January 2, 2013
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
hepatectomy
vascular inflow occlusion

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2014