Use of the French Healthcare Insurance Database

Cirrhosis Clinical Trial

— SAMHEPAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02983968
• Other study ID #: RNI2015-43 Pr Ganry
• Status: Recruiting
• Start date: September 2016
• Est. completion date: October 2018

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Olivier GANRY, MD, PhD
• Phone: +33 3 66 81 93
• Email: ganry.olivier[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 890
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis

Intervention

Other:
• Description of the cirrhosis management

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of deviation from the guidelines		01/01/2007 - 01/01/2018
Secondary	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