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Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound

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ClinicalTrials.gov Identifier: NCT01208311
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
Larry Miller, Northwell Health

Brief Summary:
The purpose of this study is to determine the amount of fibrosis in the liver of hepatitis C patients with advanced fibrosis, using endoscopic ultrasound.

Condition or disease
Alcoholism Cirrhosis Hepatitis c

Detailed Description:

Background: Transabdominal ultrasound cannot be used to quantitate fibrosis in patients with cirrhosis due to variability in the abdominal wall thickness and composition. This variability can be eliminated by using endoscopic ultrasound.

Aim: To determine the amount of fibrosis in the liver of hepatitis C patients with advanced fibrosis, using endoscopic ultrasound.


Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound.
Study Start Date : December 2004
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Group/Cohort
Patients with Hepatitis C Cirrhosis
Patients with Hepatitis C Cirrhosis



Primary Outcome Measures :
  1. Luminosity on ultrasound [ Time Frame: Once at the time of the endoscopic ultrasound ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Collect endoscopic ultrasound images form normal subjects, alcoholic liver patients and patients with hepatitis C Cirrhosis.
Criteria

Inclusion Criteria:

  • hepatic cirrhosis and hepatitis C and undergoing endoscopy
  • Alcoholic liver and undergoing endoscopy
  • Normal liver undergoing endoscopy

Exclusion Criteria:

  • pregnancy
  • Children

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208311


Locations
United States, New York
LIJ Medical Center- NSLIJ Health System
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Larry S Miller, M.D The Feinstein Institute for Medical Research

Publications of Results:
Other Publications:
Responsible Party: Larry Miller, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT01208311     History of Changes
Other Study ID Numbers: 4539
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Larry Miller, Northwell Health:
Alcoholic cirrhosis
hepatitis c cirrhosis
cirrhosis

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Fibrosis
Liver Cirrhosis
Alcoholism
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders