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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Temple University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT01208311
First received: September 22, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  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
Normal
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 Temple University:

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
Groups/Cohorts Assigned Interventions
Normal without cirrhosis Other: Ultrasound
Endoscopic ultrasound of the liver
Patients with Alcohilic cirrhosis Other: Ultrasound
Endoscopic ultrasound of the liver
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

Contacts
Contact: Larry S Miller, M.D 215-707-9985 vivi@temple.edu

Locations
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Larry S Miller, M.D    215-707-9985    vivi@temple.edu   
Principal Investigator: Larry S Miller, M.D         
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Larry S Miller, M.D Temple University
  More Information

Publications:

Responsible Party: Dr. Larry Miller, Temple University
ClinicalTrials.gov Identifier: NCT01208311     History of Changes
Other Study ID Numbers: 4539
Study First Received: September 22, 2010
Last Updated: September 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
Alcoholic cirrhosis
hepatitis c cirrhosis

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

ClinicalTrials.gov processed this record on November 27, 2014