Use of the French Healthcare Insurance Database (SAMHEPAT)

Use of the French Healthcare Insurance Database to Evaluate How Early Diagnosis of Hepatocellular Carcinomas is Implemented in France: SAMHEPAT Study

Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths).

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Other: Description of the cirrhosis management

Detailed Description

Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths). This cancer is closely associated with the presence of chronic liver underlying disease and early diagnosis following a systematic surveillance of cirrhotic patients could improve disease-free survival in patients declaring HCC. However, the risk-benefit ratio of such monitoring is discussed. Nevertheless, it is recommended in patients with liver cirrhosis, from which the prevalence is estimated between 0.3% and 0.6% in the French population. This debate can lead to a failure to comply with recommendations and promote a large variability in the management of the surveillance of HCC in patients with cirrhosis in practice. Data acquisition regarding the current situation in France is required.

The objective of this project is to use this database to document current practices concerning monitoring of incidents HCC in cirrhotic patients in France. A retrospective cohort study will be conducted on data from SNIIRAM recorded between 2007 and 2015. The primary analysis will focus on multivariate modelling of the deviation rate from the recommendations (advising the realisation of at least two echodoppler ultrasonographies yearly) with a competitive risk model, taking into account gender, social status, Charlson index, age at baseline, the alcoholic etiology of cirrhosis, type of facility and the yearly number of visits to a hepatologist during follow-up. It is estimated that more than 86,000 patients with a minimum follow-up of 3 years will be included in the analysis

• Study Type: Observational
• Enrollment (Actual): 75868

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80084
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cirrhotic patients aged between 18 and 75 years

Description

Inclusion Criteria:

- Cirrhotic patients aged between 18 and 75 years.

(A cirrhotic patient will be defined as a presenting a first occurrence of a codes used in hospitalisation for cirrhosis or as a motive for granting an ALD 6 (cirrhosis motivated) financial support )

Exclusion Criteria:

- None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of deviation from the guidelines	01/01/2007 - 01/01/2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated with deviation from the guidelines	A multivariate regression analysis will be performed to objectivate factors associated with the deviation among sex, poor social status, Charlson index, age at inclusion and the alcoholic aetiology of the cirrhosis, type facility where hospitalisation occurred, number of hepatologist visits and living area	01/01/2007 - 01/01/2018

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Olivier GANRY, MD, PhD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2016
• Primary Completion (Actual): April 9, 2019
• Study Completion (Actual): April 9, 2019

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimated): December 6, 2016

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Oncology; Public Health; Liver; Hepatology
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms; Fibrosis
• Other Study ID Numbers: RNI2015-43 Pr Ganry