Portal Hypertension and Liver Resection in Patients With Hepatocellular Carcinoma

February 8, 2018 updated by: Chetana LIM, Henri Mondor University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94000
        • Henri Mondor University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with hepatocellular carcinoma

Description

Patients with hepatocellular carcinoma who undergo surgical resection (intention to treat analysis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Portal hypertension
Hepatectomy
Procedure: Liver resection
Hepatectomy by either open, laparoscopic or robotic procedures
No portal hypertension
Hepatectomy
Procedure: Liver resection
Hepatectomy by either open, laparoscopic or robotic procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 day
In-hospital or 90-day mortality
90 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 day
Survival outcomes
Time Frame: 1,3 and 5 years
Including Overall survival and disease free survival
1,3 and 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: within 90 days after surgery
As defined by the KDIGIO criteria
within 90 days after surgery
Sarcopenia
Time Frame: Before liver resection
using computed tomography
Before liver resection
Time from diagnosis to liver resection
Time Frame: from the date of diagnosis until the date of first referral and from the date of first referral to date of hepatectomy, assessed up to 3 months
from the date of diagnosis until the date of first referral and from the date of first referral to date of hepatectomy, assessed up to 3 months
Impact of PET CT on overall survival following liver resection
Time Frame: Before liver resection
quantitative assessment of metabolic uptake (FDG and choline)
Before liver resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henri Mondor University Hospital

Investigators

  • Principal Investigator: Daniel Azoulay, MD PhD, Henri Mondor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Anticipated)

May 30, 2018

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIM Chetana

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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