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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Larry Miller, Feinstein Institute for Medical Research
ClinicalTrials.gov Identifier:
NCT01208311
First received: September 22, 2010
Last updated: June 23, 2015
Last verified: June 2015
  Purpose

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 Intervention
Alcoholism
Cirrhosis
Hepatitis c
Other: Ultrasound

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound.

Resource links provided by NLM:


Further study details as provided by Feinstein Institute for Medical Research:

Primary Outcome Measures:
  • Luminosity on ultrasound [ Time Frame: Once at the time of the endoscopic ultrasound ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2004
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Normal without cirrhosis
Study volunteers without cirrhosis
Other: Ultrasound
Endoscopic ultrasound of the liver
Patients with Alcoholic cirrhosis
Patients with Alcoholic cirrhosis
Other: Ultrasound
Endoscopic ultrasound of the liver
Patients with Hepatitis C Cirrhosis
Patients with Hepatitis C Cirrhosis
Other: Ultrasound
Endoscopic ultrasound of the liver

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208311

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

Publications:

Responsible Party: Larry Miller, Principal Investigator, Feinstein Institute for Medical Research
ClinicalTrials.gov Identifier: NCT01208311     History of Changes
Other Study ID Numbers: 4539
Study First Received: September 22, 2010
Last Updated: June 23, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Feinstein Institute for Medical Research:
Alcoholic cirrhosis
hepatitis c cirrhosis
cirrhosis

Additional relevant MeSH terms:
Hepatitis C
Liver Cirrhosis
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 27, 2015