Prognostic Value of Measuring DsAz by MRI in Cirrhotic Patients on Prophylactic Treatment With β Blocker (AzyMR) (AzyMR)
Primary Purpose
Bleeding Esophageal Varices, Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
azygos blood flow measurements by MRI
Sponsored by
About this trial
This is an interventional other trial for Bleeding Esophageal Varices focused on measuring Measurement of azygos blood flow
Eligibility Criteria
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
Sites / Locations
- CHU Angers
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
open-label study
Arm Description
open-label study
Outcomes
Primary Outcome Measures
Number an severity of adverse events occurring during follow up
Secondary Outcome Measures
Full Information
NCT ID
NCT02475122
First Posted
June 15, 2015
Last Updated
December 22, 2020
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT02475122
Brief Title
Prognostic Value of Measuring DsAz by MRI in Cirrhotic Patients on Prophylactic Treatment With β Blocker (AzyMR)
Acronym
AzyMR
Official Title
Prognostic Value of Measuring DsAz by MRI in Cirrhotic Patients on Prophylactic Treatment With β Blocker (AzyMR)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Esophageal Varices, Cirrhosis
Keywords
Measurement of azygos blood flow
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open-label study
Arm Type
Other
Arm Description
open-label study
Intervention Type
Other
Intervention Name(s)
azygos blood flow measurements by MRI
Primary Outcome Measure Information:
Title
Number an severity of adverse events occurring during follow up
Time Frame
during 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
12. IPD Sharing Statement
Learn more about this trial
Prognostic Value of Measuring DsAz by MRI in Cirrhotic Patients on Prophylactic Treatment With β Blocker (AzyMR)
We'll reach out to this number within 24 hrs