NCT01208311

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

12 years

First QC Date

September 22, 2010

Last Update Submit

December 28, 2016

Conditions

AlcoholismCirrhosisHepatitis c

Keywords

Alcoholic cirrhosishepatitis c cirrhosiscirrhosis

Outcome Measures

Primary Outcomes (1)

  • Luminosity on ultrasound

    Once at the time of the endoscopic ultrasound

Study Arms (1)

Patients with Hepatitis C Cirrhosis

Patients with Hepatitis C Cirrhosis

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Collect endoscopic ultrasound images form normal subjects, alcoholic liver patients and patients with hepatitis C Cirrhosis.

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LIJ Medical Center- NSLIJ Health System

New Hyde Park, New York, 11040, United States

Location

Related Publications (10)

  • Brown JJ, Naylor MJ, Yagan N. Imaging of hepatic cirrhosis. Radiology. 1997 Jan;202(1):1-16. doi: 10.1148/radiology.202.1.8988182. No abstract available.

    PMID: 8988182BACKGROUND

  • Mergo PJ, Ros PR. Imaging of diffuse liver disease. Radiol Clin North Am. 1998 Mar;36(2):365-75. doi: 10.1016/s0033-8389(05)70028-2.

    PMID: 9520988BACKGROUND

  • Taylor HM, Ros PR. Hepatic imaging. An overview. Radiol Clin North Am. 1998 Mar;36(2):237-45. doi: 10.1016/s0033-8389(05)70019-1.

    PMID: 9520979BACKGROUND

  • Zwiebel WJ. Sonographic diagnosis of diffuse liver disease. Semin Ultrasound CT MR. 1995 Feb;16(1):8-15. doi: 10.1016/0887-2171(95)90011-x.

    PMID: 7718284BACKGROUND

  • Aube C, Oberti F, Korali N, Namour MA, Loisel D, Tanguy JY, Valsesia E, Pilette C, Rousselet MC, Bedossa P, Rifflet H, Maiga MY, Penneau-Fontbonne D, Caron C, Cales P. Ultrasonographic diagnosis of hepatic fibrosis or cirrhosis. J Hepatol. 1999 Mar;30(3):472-8. doi: 10.1016/s0168-8278(99)80107-x.

    PMID: 10190731BACKGROUND

  • 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. doi: 10.1148/radiology.135.2.7367613.

    PMID: 7367613BACKGROUND

  • 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. doi: 10.1046/j.1365-2362.2001.00840.x.

    PMID: 11422403BACKGROUND

  • 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. doi: 10.1111/j.1365-2796.1993.tb00640.x.

    PMID: 8429291BACKGROUND

  • 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. doi: 10.3748/wjg.v9.i11.2484.

    PMID: 14606081BACKGROUND

  • 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. Epub 2008 Feb 13.

    PMID: 18270828RESULT

MeSH Terms

Conditions

AlcoholismFibrosisHepatitis CLiver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesLiver CirrhosisLiver Diseases, AlcoholicAlcohol-Induced Disorders

Study Officials

  • Larry S Miller, M.D

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2010

First Posted

September 23, 2010

Study Start

December 1, 2004

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 29, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)