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

Hepatitis c Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208311
• Other study ID #: 4539
• Status: Completed
• Phase: N/A
• First received: September 22, 2010
• Last updated: December 28, 2016
• Start date: December 2004
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• hepatic cirrhosis and hepatitis C and undergoing endoscopy

• Alcoholic liver and undergoing endoscopy

• Normal liver undergoing endoscopy

Exclusion Criteria:

• pregnancy

• Children

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alcoholism
• Cirrhosis
• Fibrosis
• Hepatitis
• Hepatitis C
• Liver Cirrhosis

Locations

Country	Name	City	State
United States	LIJ Medical Center- NSLIJ Health System	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (10)

Andanappa HK, Dai Q, Korimilli A, Panganamamula K, Friedenberg F, Miller L. Acoustic liver biopsy using endoscopic ultrasound. Dig Dis Sci. 2008 Apr;53(4):1078-83. doi: 10.1007/s10620-008-0211-4. — View Citation

Aubé C, Oberti F, Korali N, Namour MA, Loisel D, Tanguy JY, Valsesia E, Pilette C, Rousselet MC, Bedossa P, Rifflet H, Maïga MY, Penneau-Fontbonne D, Caron C, Calès P. Ultrasonographic diagnosis of hepatic fibrosis or cirrhosis. J Hepatol. 1999 Mar;30(3):472-8. — View Citation

Brown JJ, Naylor MJ, Yagan N. Imaging of hepatic cirrhosis. Radiology. 1997 Jan;202(1):1-16. Review. — View Citation

Harbin WP, Robert NJ, Ferrucci JT Jr. Diagnosis of cirrhosis based on regional changes in hepatic morphology: a radiological and pathological analysis. Radiology. 1980 May;135(2):273-83. — View Citation

Hirata M, Akbar SM, Horiike N, Onji M. Noninvasive diagnosis of the degree of hepatic fibrosis using ultrasonography in patients with chronic liver disease due to hepatitis C virus. Eur J Clin Invest. 2001 Jun;31(6):528-35. — View Citation

Hultcrantz R, Gabrielsson N. Patients with persistent elevation of aminotransferases: investigation with ultrasonography, radionuclide imaging and liver biopsy. J Intern Med. 1993 Jan;233(1):7-12. — View Citation

Mergo PJ, Ros PR. Imaging of diffuse liver disease. Radiol Clin North Am. 1998 Mar;36(2):365-75. Review. — View Citation

Taylor HM, Ros PR. Hepatic imaging. An overview. Radiol Clin North Am. 1998 Mar;36(2):237-45. Review. — View Citation

Zheng RQ, Wang QH, Lu MD, Xie SB, Ren J, Su ZZ, Cai YK, Yao JL. Liver fibrosis in chronic viral hepatitis: an ultrasonographic study. World J Gastroenterol. 2003 Nov;9(11):2484-9. — View Citation

Zwiebel WJ. Sonographic diagnosis of diffuse liver disease. Semin Ultrasound CT MR. 1995 Feb;16(1):8-15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Luminosity on ultrasound		Once at the time of the endoscopic ultrasound	No