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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02258048
• Other study ID #: 10-02236
• Status: Withdrawn
• Phase: N/A
• First received: October 2, 2014
• Last updated: March 9, 2016
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

This study will attempt to determine if serial measurements of liver stiffness with transient elastography in patients with early cirrhosis can identify patients at risk of morbidity or mortality associated with hepatic decompensation.

For the Screening Visit, the following procedures will be performed:

1. Patient will read and sign informed consent. Subjects will be given sufficient time to consider, ask questions, and sign the consent forms.

2. Patient will be assigned a subject number

3. Patient will be asked to provide demographic information

4. Patient will be asked to provide a complete medical history and laboratory evaluation

5. Physical examination including blood pressure, heart rate, height, and weight.

6. The following assessments will also be performed:

• Calculation of modified Child Pugh Score: Using the following biochemical variables: Serum Albumin, Total Bilirubin, Serum Creatinine, and INR.

• MELD Score: Based on a continuous function of Bilirubin, INR, and Creatinine, which uses a continuous variable ranging from 6-40.

7. 30cc of blood will be obtained, and serum frozen at -80C (freezer located in Dr. Sigal's office) for up to 5 years. The blood will only be accessible to Dr. Sigal and his research team. This blood may be analysed for known markers of liver disease, markers that may be discovered in the future, and/or to identify new markers of liver disease.

For the Follow-Up Visits the following procedures will be performed every 3 months for up to 2 years:

1. An interim medical history will be obtained, with particular attention to the development of clinical decompensation (ascites, variceal bleeding hepatorenal syndrome, overt hepatic encephalopathy).

2. Physical examination.

3. Measurement of liver stiffness using hepatic elastography.

4. 30cc of blood will be obtained, and serum frozen for future analyses as above.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• History of variceal bleeding, ascites, hepatorenal syndrome, or overt hepatic encephalopathy

• Inability to provide informed consent

• Body mass index (BMI)>35

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver Stiffness	Liver stiffness will be measured using hepatic elastography.	2 years	Yes
Secondary	Evidence of Portal Hypertension	Presence of significant portal hypertension will be determined by the presence of ascites or thrombocytopenia.	2 years	Yes