AlcoholismNCT01208311
Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound
An observational study of Alcoholism and Cirrhosis, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism, Cirrhosis, Hepatitis c
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Collect endoscopic ultrasound images form normal subjects, alcoholic liver patients and patients with hepatitis C Cirrhosis.
Who may be able to join
- hepatic cirrhosis and hepatitis C and undergoing endoscopy
- Alcoholic liver and undergoing endoscopy
- Normal liver undergoing endoscopy
Who cannot join
- pregnancy
- Children
Trial locations and contacts
1 site in 1 country.
United States1 site
LIJ Medical Center- NSLIJ Health System
New Hyde Park, New York, 11040
About this study
Official title: Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound.
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.
Read the 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.
- Conditions
- Alcoholism, Cirrhosis, Hepatitis c
- Keywords
- Alcoholic cirrhosis, hepatitis c cirrhosis, cirrhosis
- Medical subject headings
- Alcoholism, Fibrosis, Hepatitis C, Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Hepatitis C Cirrhosis | Patients with Hepatitis C Cirrhosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Luminosity on ultrasound
Measured: Once at the time of the endoscopic ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startDec 2004
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Miller, Northwell Health
- Investigators
- Larry S Miller, M.D, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208311
- Sponsor's protocol ID
- 4539
- Status last verified
- Dec 2016
- First submitted
- 22 Sep 2010
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 8988182Mergo 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.
PubMed 9520988Taylor 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.
PubMed 9520979Zwiebel 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.
PubMed 7718284Aube 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.
PubMed 10190731Harbin 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.
PubMed 7367613Hirata 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.
PubMed 11422403Hultcrantz 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.
PubMed 8429291Zheng 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.
PubMed 14606081Andanappa 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.
PubMed 18270828
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound.
- ClinicalTrials.gov ID
- NCT01208311
- Acronym / sponsor ID
- 4539
- Conditions
- Alcoholism, Cirrhosis, Hepatitis c
- Keywords
- Alcoholic cirrhosis, hepatitis c cirrhosis, cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Hepatitis C Cirrhosis | – | –Patients with Hepatitis C Cirrhosis |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Collect endoscopic ultrasound images form normal subjects, alcoholic liver patients and patients with hepatitis C Cirrhosis.
Key inclusion criteria (3 listed)
- hepatic cirrhosis and hepatitis C and undergoing endoscopy
- Alcoholic liver and undergoing endoscopy
- Normal liver undergoing endoscopy
Key exclusion criteria (2 listed)
- pregnancy
- Children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Luminosity on ultrasound
Time frame: Once at the time of the endoscopic ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Background: PubMed 8988182Brown 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.
- Background: PubMed 9520988Mergo 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.
- Background: PubMed 9520979Taylor 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.
- Background: PubMed 7718284Zwiebel 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.
- Background: PubMed 10190731Aube 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.
- Background: PubMed 7367613Harbin 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.
- Background: PubMed 11422403Hirata 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.
- Background: PubMed 8429291Hultcrantz 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.
- Background: PubMed 14606081Zheng 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.
- Results publication: PubMed 18270828Andanappa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry S Miller, M.D principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholism and Cirrhosis, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Luminosity on ultrasound (time frame: Once at the time of the endoscopic ultrasound). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01208311, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.