Clinical Trial: Portal Hypertension and Liver Resection in Patients With Hepatocellular Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Assessment and Impact of Portal Hypertension Before and During Liver Resection in Patients With Hepatocellular Carcinoma

Brief Summary:

According to the BCLC guidelines, surgical resection of hepatocellular carcinoma complicating cirrhosis is restricted to patients with preserved liver function, single nodule without vascular invasion and with hepatic venous gradient below 10 mmHg.

However, other guideline treatment, especially from eastern countries demonstrated that surgical resection is safe and feasible and provides better survival than the treatment recommended by the BCLC system for patients with similar stage.

The primary goal of this study is to assess the impact of HVPG on short and long-term outcomes in HCC patients who undergo liver resection.


Detailed Summary: Patients with HCC and candidates for hepatectomy are classified into two groups according to the presence of portal hypertension. Short- and long-term outcomes will be compared.
Sponsor: Henri Mondor University Hospital

Current Primary Outcome: Mortality [ Time Frame: 90 day ]

In-hospital or 90-day mortality


Original Primary Outcome: Mortality [ Time Frame: 90 day ]

Current Secondary Outcome:

  • morbidity [ Time Frame: 90 day ]

    Overall and liver-related complications including liver failure, ascites, biliary fistula, bleeding, pulmonary complications, and renal complications.

    Grading system according to Clavien-Dindo classification

  • Survival outcomes [ Time Frame: 1,3 and 5 years ]
    Including Overall survival and disease free survival


Original Secondary Outcome: morbidity [ Time Frame: 90 day ]

Information By: Henri Mondor University Hospital

Dates:
Date Received: May 20, 2014
Date Started: November 2013
Date Completion: January 2017
Last Updated: February 9, 2016
Last Verified: February 2016