GastrOesophageal Varices After Sustained Virological Response

NCT04191018 | Unknown

• 1 other identifier: 10320319.6.0000.5262
• Study Type: observational
• Target: 322
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic hepatitis C remains a public health issue because up to 70 million people are chronically infected by hepatitis C virus (HCV) worldwide. Presence of advanced fibrosis/cirrhosis might be associated with liver-related complications, such as hepatocellular carcinoma and oesophageal varices bleeding. Oesophageal varices (OV) might be present in up to 40% of patients with liver cirrhosis have and the mortality rates from bleeding might be up to 20% per episode. Early diagnosis of advanced fibrosis/cirrhosis associated with hepatitis C treatment are key features for preventive and therapeutic measures to reduce liver-related mortality in HCV-infected patients. 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

Conditions

Liver Diseases; Hepatitis C

Keywords

sustained virological response; portal hypertension; cirrhosis; gastrointestinal endoscopy

Outcome Measures

Primary Outcomes (2)

• Incidence of esophageal varices (portal hypertension) after SVR

  Evaluation of presence/absence of esophageal varices after SVR in patients with advanced fibrosis or cirrhosis compared to before treatment

  up to 48 months after SVR

• Validation of the Baveno's criteria to avoid gastrointestinal endoscopy for screening of esophageal varices after SVR

  Validation of the diagnostic performance of non-invasive tests (liver and splenic stiffness or biological markers) to screen esophageal varices in patients with advanced fibrosis/cirrhosis after SVR by DAA treatment for HCV

  up to 48 months after SVR

Secondary Outcomes (1)

• Incidence of regression of esophageal varices after SVR

  up to 48 months after SVR

Interventions

Liver elastography DIAGNOSTIC_TEST

Liver stiffness measurement

Also known as: transient elastography (Fibroscan), 2D-shear wave (GE Healthcare), point-shear wave (Phillips)

Splenic elastography DIAGNOSTIC_TEST

Splenic stiffness measurement

Also known as: transient elastography (Fibroscan), 2D-shear wave (GE Healthcare), point-shear wave (Phllips)

Gastrointestinal endoscopy DIAGNOSTIC_TEST

Gastrointestinal endoscopy

Also known as: esophagogastroduodenoscopy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced fibrosis or cirrhosis with sustained virologic response by direct-acting agents for HCV treatment

You may qualify if:

• Age ≥ 18 years
• 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

You may not qualify if:

• Autoimmune hepatitis, hepatosplenic schistosomiasis or cholestasis diseases
• 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

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead

Study Sites (2)

Evandro Chagas National Institute of Infectious Diseases

Rio de Janeiro, Rio de Janeiro/RJ, 21040-360, Brazil

RECRUITING

Bonsucesso Federal Hospital

Rio de Janeiro, 21041-030, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Liver Diseases; Hepatitis C; Hypertension, Portal; Fibrosis

Interventions

Endoscopy, Gastrointestinal; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Hugo Perazzo, PhD

  Oswaldo Cruz Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo Perazzo, PhD

CONTACT

+5521 3865-9587; hugo.perazzo@ini.fiocruz.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 9, 2019
• Study Start: November 26, 2019
• Primary Completion: August 14, 2022
• Study Completion: February 28, 2024
• Last Updated: December 9, 2019

Record last verified: 2019-12

Locations

BR (2)