Prognostic Value of Measuring DsAz by MRI in Cirrhotic Patients on Prophylactic Treatment With β Blocker (AzyMR) (AzyMR)

December 22, 2020 updated by: University Hospital, Angers

Portal hypertension (PHT) that leads to esophageal varices is clinically present, at the time of diagnosis, in 60% of cirrhotic patients (Groszmann NEJM 2005). Variceal bleeding is a life-threatening complication. The yearly incidence of the first variceal bleeding in cirrhotic patients is estimated to 4%. This risk increases to 15% when medium or large varices are initially present, (D'amico Baillieres Clin Gastroenterol 1997); Therefore, for patient with medium or large varices a primary prophylaxis treatment with nonselective beta-blockers must be instituted decreasing risk of bleeding approximately by half (d'amico Hepatology 2005).

The method to evaluate the efficacy of beta blockers treatment is the hepatic venous pressure gradient (HVPG). HVPG < 12 mmHg or a decrease of HVPG of 20% after beta blocker treatment reduce dramatically the risk of bleeding (Feu F. Lancet 1995). But a good response (HVPG < 12 mmHg or reduction > 20%) to beta blockers was observed only in almost 30 % of patients. In non responder patients, the variceal bleeding incidence is estimated to 24 % at 2 years.

In this situation, alternative treatments to beta-blockers have been suggested: endoscopic ligation, which was shown to be as effective as beta blockers in primary prevention, and more recently carvedilol (Reiberger, Gut 2012).

So, HVPG monitoring may provide critical information for patients. However, because of its technical requirement and its invasivity, HVPG measurement is not feasible in clinical practice . So, there is a general consensus to continue indefinitely beta blockers treatment without control of hemodynamic efficiency (merkel J. Hepatology 2009).

Previous studies have suggested the interest of azygos blood flow measurements for evaluating hemodynamic changes in the esophageal collateral vessels of patients with portal hypertension (Bosch J. Hepatology 1985 ). More recently Magnetic Resonance Imaging (MRI) has been reported to be an efficient technique to assess azygos blood flow (Gouya Radiology 2011) in cirrhotic patients. Its feasibility is obviously higher than HVPG measurement.

However, in the same way that HVPG, a large-scale implementation in clinical practice of azygos blood flow measurement by MRI requires to specify minimal absolute threshold, or relative post-therapeutic decrease, related with no variceal bleeding.

Study Overview

Status

Status

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Completed

Conditions

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Study Type

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Interventional

Enrollment (Actual)

Enrollment

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71

Phase

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  • Not Applicable

Contacts and Locations

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Study Locations

  • France
      • Angers, France
        • CHU Angers

Participation Criteria

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Eligibility Criteria

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Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Cirrhotic patients requiring β blocker in primary prophylaxis of bleeding esophageal varices

Exclusion Criteria:

  • Patients under 18 year's old
  • life expectancy of less than one month
  • Patient already has a vasoactive treatment
  • patient with CHC or portal vein thrombosis
  • patient without social security or deprived of freedom
  • contraindication to MRI
  • contraindication to beta-blockers
  • mental state does not allow the signing of an informed consent

Study Plan

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How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

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Intervention / Treatment

Intervention / Treatment

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Other: open-label study
Other: azygos blood flow measurements by MRI

What is the study measuring?

Primary Outcome Measures

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Outcome Measure
Time Frame
Number an severity of adverse events occurring during follow up
Time Frame: during 2 years
during 2 years

Collaborators and Investigators

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Sponsor

Sponsor

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University Hospital, Angers

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

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October 1, 2014

Primary Completion (Actual)

Primary Completion

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April 1, 2018

Study Completion (Actual)

Study Completion

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December 1, 2020

Study Registration Dates

First Submitted

First Submitted

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June 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

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June 17, 2015

First Posted (Estimate)

First Posted

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June 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

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Other Study ID Numbers

Other Study ID Numbers

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  • AOI 2014-02

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