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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Larry Miller, Northwell Health
ClinicalTrials.gov Identifier:
NCT01208311
First received: September 22, 2010
Last updated: December 28, 2016
Last verified: December 2016
  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
Alcoholism
Cirrhosis
Hepatitis c

Study Type: Observational
Study Design: Observational Model: Cohort
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 Northwell Health:

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

Enrollment: 7
Study Start Date: December 2004
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Hepatitis C Cirrhosis
Patients with Hepatitis C Cirrhosis

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   (Adult, Senior)
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
  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
Northwell Health
Investigators
Principal Investigator: Larry S Miller, M.D The Feinstein Institute for Medical Research
  More Information

Publications:

Responsible Party: Larry Miller, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT01208311     History of Changes
Other Study ID Numbers: 4539 
Study First Received: September 22, 2010
Last Updated: December 28, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Northwell Health:
Alcoholic cirrhosis
hepatitis c cirrhosis
cirrhosis

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

ClinicalTrials.gov processed this record on February 20, 2017