The Use of Transient Elastography to Predict Clinical Decompensation in Patients With Early Cirrhosis

NCT02258048 | Withdrawn

• 1 other identifier: 10-02236
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study designed to examine the role of transient elastography as a predictor of clinical decompensation in patients with early cirrhosis. The study objective is to determine if changes in measurements of liver stiffness with transient elastography can identify patients that will have a more rapid progression of cirrhosis and the development of clinical decompensation. The target population is patients with early stage, well-compensated cirrhosis. Participants of this study will be asked to complete the following procedures: read and sign the informed consent, medical records review (complete medical history, physical examination, laboratory evaluation, endoscopic findings, radiographic findings), undergo transient elastography to measure liver stiffness every three months until the development of clinical decompensation (ascites, variceal bleeding, hepatorenal syndrome, overt hepatic encephalopathy) for up to 2 years.

Conditions

Cirrhosis

Keywords

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Liver Stiffness

  Liver stiffness will be measured using hepatic elastography.

  2 years

Secondary Outcomes (1)

• Evidence of Portal Hypertension

  2 years

Study Arms (1)

Patients with cirrhosis

Eligibility Criteria

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

Study Population

Ambulatory patients with histologic or radiographic evidence of cirrhosis

You may qualify if:

• Ambulatory patients with histologic or radiographic evidence of cirrhosis will be screened for participation in the study.
• Able to provide informed consent
• MELD score \<10
• No history of ascites, variceal bleeding, hepatorenal syndrome, overt hepatic encephalopathy.

You may not qualify if:

• History of variceal bleeding, ascites, hepatorenal syndrome, or overt hepatic encephalopathy
• Inability to provide informed consent
• Body mass index (BMI)\>35

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Sigal, M.D.

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 7, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 10, 2016

Record last verified: 2016-03

Locations

US (1)