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Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

This study has been completed.
Ministry of Health, France
Information provided by:
Assistance Publique - Hôpitaux de Paris Identifier:
First received: September 14, 2005
Last updated: February 24, 2011
Last verified: March 2007
Liver carcinoma is becoming the main complication of cirrhosis. Treatment of symptomatic or large tumors is disappointing. Regular ultrasonographic screening of small (curable) tumors is currently recommended, but the best periodicity is unknown.This randomized trial is aimed to compare 6-month (current recommendation) and 3-month ultrasonographic screenings.

Condition Intervention Phase
Compensated Cirrhosis Procedure: Ultrasonographic screening Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis. A Randomized Trial Comparing Two Periodicities of Ultrasonographic Surveillance: 3-month vs 6-month

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Incidence of small hepatocellular carcinoma (HCC) [ Time Frame: 6 months versus 3 months ]

Secondary Outcome Measures:
  • Survival [ Time Frame: during the study ]
  • Clinical value of serum alfa-fetoprotein assay [ Time Frame: during the study ]

Enrollment: 1200
Study Start Date: July 2000
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Procedure: Ultrasonographic screening
Ultrasonographic screening

Detailed Description:

Patients: All consecutive patients with compensated HBV, HCV, alcohol or hemochromatosis-related cirrhosis (without any previous clinical complication including liver cancer).

Randomization: factorial: ultrasonography (3-month versus 6-month); serum alfa-fetoprotein assay (none versus 6-month).

End points: rate of small tumors (first main criteria); survival (second main criteria).


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Compensated cirrhosis

Exclusion Criteria:

  • Antecedent of osmic acid synoviorthesis or of isotopic synoviorthesis of the studied knee
  • Intra-articular injection of triamcinolone hexacetonide in three months preceding the inclusion or by a different corticoid in the month preceding the inclusion
  • Evolutionary infectious or neoplastic pathology
  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 identifier: NCT00190385

Hopital Jean Verdier
Paris, Ile de France, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Principal Investigator: Jean-Claude Trinchet, Pr, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sylla KHAOUSSOU, Department of Clinical Research of developpement Identifier: NCT00190385     History of Changes
Other Study ID Numbers: AOM03009
Study First Received: September 14, 2005
Last Updated: February 24, 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hepatocellular carcinoma

Additional relevant MeSH terms:
Liver Cirrhosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site processed this record on June 22, 2017