GastrOesophageal Varices After Sustained Virological Response
NCT ID: NCT04191018
Last Updated: 2019-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
322 participants
OBSERVATIONAL
2019-11-26
2024-02-28
Brief Summary
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Liver elastography is a high accurate non-invasive test for diagnosis of advanced fibrosis/cirrhosis. Few different methods of liver elastography are currently available: transient elastography by Fibroscan and ultrasound elastography by point-shear wave (p-SWE) and 2D-shear wave (2D-SWE). Gastrointestinal endoscopy (GIE) has been considered the gold standard for screening or surveillance of esophageal varices. More recently, international guidelines have been recommending the use of non-invasive methods to indicate or avoid OV screening: Baveno VI guidelines proposed that compensated cirrhotic patients with a liver stiffness measurement (LSM) by transient elastography \<20kPa and a platelet count \>150,000/μL can avoid screening endoscopy. The use of direct-acting agents (DAAs) has revolutionized the treatment of chronic hepatitis C with high effectiveness shown using all-oral interferon-free regimens. HCV cure, sustained virological response (SVR), has been associated with lower rates of liver-related complications, increase in quality of life and decrease in waiting-list registrations for liver transplantation in patients with chronic hepatitis C. Preliminary studies have been reporting significant regression liver stiffness after SVR. However, it is unclear whether SVR might decrease portal hypertension leading to OV regression and a reduced risk of variceal bleeding. In addition, the use of non-invasive methods to avoid OV screening must be validated in HCV patients after SVR. The aims of this cross-sectional study with prospective inclusion of patients will be: (i) to evaluate the impact of SVR in portal hypertension in HCV patients with advanced fibrosis/liver cirrhosis treated by interferon-free regimens and (ii) to validate non-invasive methods to avoid OV screening by GIE
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Liver elastography
Liver stiffness measurement
Splenic elastography
Splenic stiffness measurement
Gastrointestinal endoscopy
Gastrointestinal endoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of advanced fibrosis or cirrhosis (stage F≥3 METAVIR) based on liver stiffness by transient elastography (≥ 9,5 kPa) or liver biopsy
* Gastrointestinal endoscopy at least 24 months before start of direct-acting agents for HCV treatment
* Liver stiffness measurement at least 18 months after SVR
Exclusion Criteria
* Liver transplantation
* Presence of high volume ascites or hepatocellular carcinoma
* Participation in programs of esophageal band ligation for eradication of esophageal varices
* Presence of signs of acute decompensated liver disease
18 Years
99 Years
ALL
No
Sponsors
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Oswaldo Cruz Foundation
OTHER
Responsible Party
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Principal Investigators
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Hugo Perazzo, PhD
Role: PRINCIPAL_INVESTIGATOR
Oswaldo Cruz Foundation
Locations
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Evandro Chagas National Institute of Infectious Diseases
Rio de Janeiro, Rio de Janeiro/RJ, Brazil
Bonsucesso Federal Hospital
Rio de Janeiro, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Hugo Perazzo, PhD
Role: primary
Gustavo Pereira, PhD
Role: primary
Flavia Fernandes, PhD
Role: backup
Other Identifiers
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10320319.6.0000.5262
Identifier Type: -
Identifier Source: org_study_id