Liver FibrosisNCT03342560
Beyond Confounders: Addressing Source of Measurement Variability and Error in Shear Wave Elastography
A study testing Sonographic SWE measurements with 4 different ultrasound systems in people with Liver Fibrosis and Liver Diseases, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Chronic liver disease is a major problem in the general population and there is an unmet need to diagnose(and screen) for liver disease with using noninvasive, cost-effective and sensitive techniques.The investigators hypothesize that variation using ultrasound elastography for the estimation of stage of liver… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis, Liver Diseases
- What is being tested?
- Sonographic SWE measurements with 4 different ultrasound systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2017to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients
- Men or Woman
- Suspected diffuse liver disease and have had a liver biopsy within the last 6 months or are scheduled for a liver biopsy in the next 3 months.
- Consent to participate in the study
Who cannot join
- Pregnancy
- Acute illness/ cognitive impairment resulting in inability to cooperate with ultrasound
- Patients that do not consent to ultrasound examination
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Chronic liver disease is a major problem in the general population and there is an unmet need to diagnose(and screen) for liver disease with using noninvasive, cost-effective and sensitive techniques.The investigators hypothesize that variation using ultrasound elastography for the estimation of stage of liver fibrosis and steatosis in patients with diffuse liver disease exists due to different methods of measurements, and/or different systems. The proposed investigation is a cross-sectional study using ultrasound elastography and fat quantification modalities. The investigators are planning to enroll 30 subjects 18 years old and older in whom diffuse liver disease is suspected, and who have undergone non-focal liver biopsy in the past 6 months or are scheduled to undergo biopsy within 3 months of enrollment, as part of their routine clinical care. The investigators will use 4 different ultrasound devices with their shear wave elastography and speed of sound functions.
Specific aims;
- Compare shear wave elastography(SWE) measurements from different ultrasound systems; using histopathology as reference standards.
- Assess intra-operator and inter-operator reliability by measuring variability in elastography values by two operators on a single system.
- Determine the effect of deviations from guidelines(less number of measurements and measurements during active breath)
Read the detailed description
Liver disease and cirrhosis are important causes of morbidity and mortality in the United States and are a major public health problem with 40,000 deaths and more than 1.4 billion dollars spent on medical services. Hepatic fibrosis is the final common pathway for many different liver insults and is known to be a dynamic process, which is reversible if diagnosed early and treated. If untreated, fibrosis eventually progresses to cirrhosis, which is irreversible. The diagnosis of fibrosis relies on liver biopsy (the gold standard) however, is an invasive procedure with risks and sampling errors. Indirect biomarkers of fibrogenesis can measure some of these components to determine categories of fibrosis, with a sensitivity and specificity of 47% and 90% respectively.It is shown in the literature that, fat content of liver is related with fibrosis development. Biopsy is accepted as the most accurate technique to assess liver fat and fibrosis amount.
Fibrotic livers demonstrate increased stiffness, a property that can be measured using technology named Ultrasound Elastography or sonoelastography (SWE). SWE is performed by insonating the patient with a low energy, amplitude, and frequency shear wave created by a vibrating probe. The propagated wave travels faster with increasing fibrosis: the stiffer the tissue, the faster the shear wave propagates. A pulse-echo ultrasound acquisition allows measurement of the wave velocity and the results are presented as kilopascals (kPa). Prior reports have described sensitivity and specificity for liver fibrosis detection of 80% and 97% respectively for SWE. The benefits of SWE are that it is inexpensive, reproducible, painless, rapid (< 10 min), easy to perform, and can be used for diagnosis, prognosis and monitoring disease progression.
The objective of this study is to compare the variation in elastography values and study the factors that might cause these variations.
The proposed investigation is a cross-sectional study using ultrasound elastography. The investigators are planning to enroll 30 subjects 18 years old and older in whom diffuse liver disease is suspected, and who have undergone non-focal liver biopsy in the past 6 months or are scheduled to undergo biopsy within 3 months of enrollment, as part of their routine clinical care.
All subjects will be required to come to the MGH main campus for 2 study visits within 60 days of each other. In addition, subjects will need to fast for at least 4 hours prior to study visits
There will be two visits in this study and maximum 60 days time frame between the visits is anticipated. Two operators will perform the ultrasound examination. Reproducibility and repeatability of the ultrasound devices will be estimated.
Ultrasound examination including sonoelastography will be performed using four FDA-approved ultrasound units; Both operators will perform;
- Median Elastograpy (10 measurements) on regular and variable map at a depth(in the area between 2cm from capsule and 6.5cm from skin)
- Median SWE value with active/free breath(10measurements)
- Median SWE value with less number of acquisitions(3measurements)
These measurements will be collected in subgroups using specific systems. In second visit, all measurements will be repeated with the same operators.
- Conditions
- Liver Fibrosis, Liver Diseases
- Being tested
- Sonographic SWE measurements with 4 different ultrasound systems
- Keywords
- Liver Fibrosis, Ultrasound Elastography, Shear wave speed, Stiffness, Liver Biopsy
- Medical subject headings
- Liver Cirrhosis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonographic SWE measurements with 4 different ultrasound systemsDevice
Sonographic Shear wave elastography will be performed to quantify liver fibrosis
| Study group | Role | What they receive |
|---|---|---|
| 30 Patients with known liver biopsy results | Experimental | Patients with chronic liver disease with known biopsy results Receives: Device: Sonographic SWE measurements with 4 different ultrasound systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviations From Suggested Guidelines- Any Effect on Agreement
We collected guideline suggested shear wave elastography measurements from 20 patients. Guidelines suggest collecting 1) 10 measurements, 2) Asking patient to hold breath during the measurements. As a deviation from guideline suggestions, we collected measurements during free breath movements without asking patient to hold breath. As a deviation from the guideline suggestions, fewer number of measurements (3 measurements) were collected with asking the patient to hold breath during the measurements. All measurements were collected using one type of ultrasound system. All measurements were collected by 2 operators in 2 visits.
Measured: Visit 1 and Visit 2, an average of 2.5 hours for each visit
Interoperator and Intraoperator Agreement in m/s and kPA Units
In 20 patients we collected 10 shear wave elastography measurements in m/s and kPA units. Using one of the available ultrasound systems, 2 operators collected these measurements in 2 visits. Theoretically, m/s to kPA conversion can be made using an equation. However, some systems provide opportunity to get data in both units. Although algebraically m/s and kPA can be converted to each other, we found some minor differences in terms of inter-operator and intra-operator agreement.
Measured: Visit 1 and Visit 2, an average of 2.5 hours for each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start29 Jun 2017
- Primary completion14 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canon Medical Systems, USA, Siemens Medical Solutions, Radiological Society of North America
- Responsible party
- Principal investigator, Anthony Samir, Massachusetts General Hospital
- Investigators
- Anthony E. Samir, MD, MPH, Principal investigator, Associate Medical Director, Ultrasound Imaging Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342560
- Sponsor's protocol ID
- 2017P000940
- Status last verified
- Oct 2019
- First submitted
- 6 Nov 2017
- Last updated
- 28 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Younossi ZM, Stepanova M, Afendy M, Fang Y, Younossi Y, Mir H, Srishord M. Changes in the prevalence of the most common causes of chronic liver diseases in the United States from 1988 to 2008. Clin Gastroenterol Hepatol. 2011 Jun;9(6):524-530.e1; quiz e60. doi: 10.1016/j.cgh.2011.03.020. Epub 2011 Mar 25.
PubMed 21440669Mokdad AA, Lopez AD, Shahraz S, Lozano R, Mokdad AH, Stanaway J, Murray CJ, Naghavi M. Liver cirrhosis mortality in 187 countries between 1980 and 2010: a systematic analysis. BMC Med. 2014 Sep 18;12:145. doi: 10.1186/s12916-014-0145-y.
PubMed 25242656Pinzani M, Rombouts K. Liver fibrosis: from the bench to clinical targets. Dig Liver Dis. 2004 Apr;36(4):231-42. doi: 10.1016/j.dld.2004.01.003.
PubMed 15115333Scholmerich J, Holstege A. Aetiology and pathophysiology of chronic liver disorders. Drugs. 1990;40 Suppl 3:3-22. doi: 10.2165/00003495-199000403-00003.
PubMed 2081479Pellicoro A, Ramachandran P, Iredale JP, Fallowfield JA. Liver fibrosis and repair: immune regulation of wound healing in a solid organ. Nat Rev Immunol. 2014 Mar;14(3):181-94. doi: 10.1038/nri3623.
PubMed 24566915Actis GC, Olivero A, Lagget M, Pellicano R, Smedile A, Rizzetto M. The practice of percutaneous liver biopsy in a gastrohepatology day hospital: a retrospective study on 835 biopsies. Dig Dis Sci. 2007 Oct;52(10):2576-9. doi: 10.1007/s10620-006-9724-x. Epub 2007 Apr 12.
PubMed 17436094Cadranel JF, Rufat P, Degos F. Practices of liver biopsy in France: results of a prospective nationwide survey. For the Group of Epidemiology of the French Association for the Study of the Liver (AFEF). Hepatology. 2000 Sep;32(3):477-81. doi: 10.1053/jhep.2000.16602.
PubMed 10960438van der Poorten D, Kwok A, Lam T, Ridley L, Jones DB, Ngu MC, Lee AU. Twenty-year audit of percutaneous liver biopsy in a major Australian teaching hospital. Intern Med J. 2006 Nov;36(11):692-9. doi: 10.1111/j.1445-5994.2006.01216.x.
PubMed 17040353Sparchez Z. Complications after percutaneous liver biopsy in diffuse hepatopathies. Rom J Gastroenterol. 2005 Dec;14(4):379-84.
PubMed 16400355Bravo AA, Sheth SG, Chopra S. Liver biopsy. N Engl J Med. 2001 Feb 15;344(7):495-500. doi: 10.1056/NEJM200102153440706. No abstract available.
PubMed 11172192Rousselet MC, Michalak S, Dupre F, Croue A, Bedossa P, Saint-Andre JP, Cales P; Hepatitis Network 49. Sources of variability in histological scoring of chronic viral hepatitis. Hepatology. 2005 Feb;41(2):257-64. doi: 10.1002/hep.20535.
PubMed 15660389Regev A, Berho M, Jeffers LJ, Milikowski C, Molina EG, Pyrsopoulos NT, Feng ZZ, Reddy KR, Schiff ER. Sampling error and intraobserver variation in liver biopsy in patients with chronic HCV infection. Am J Gastroenterol. 2002 Oct;97(10):2614-8. doi: 10.1111/j.1572-0241.2002.06038.x.
PubMed 12385448Bedossa P, Dargere D, Paradis V. Sampling variability of liver fibrosis in chronic hepatitis C. Hepatology. 2003 Dec;38(6):1449-57. doi: 10.1016/j.hep.2003.09.022.
PubMed 14647056Friedrich-Rust M, Buggisch P, de Knegt RJ, Dries V, Shi Y, Matschenz K, Schneider MD, Herrmann E, Petersen J, Schulze F, Zeuzem S, Sarrazin C. Acoustic radiation force impulse imaging for non-invasive assessment of liver fibrosis in chronic hepatitis B. J Viral Hepat. 2013 Apr;20(4):240-7. doi: 10.1111/j.1365-2893.2012.01646.x. Epub 2012 Jul 31.
PubMed 23490368Fierbinteanu-Braticevici C, Andronescu D, Usvat R, Cretoiu D, Baicus C, Marinoschi G. Acoustic radiation force imaging sonoelastography for noninvasive staging of liver fibrosis. World J Gastroenterol. 2009 Nov 28;15(44):5525-32. doi: 10.3748/wjg.15.5525.
PubMed 19938190
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Confounders: Addressing Source of Measurement Variability and Error in Shear Wave Elastography
- ClinicalTrials.gov ID
- NCT03342560
- Acronym / sponsor ID
- 2017P000940
- Conditions
- Liver Fibrosis, Liver Diseases
- Keywords
- Liver Fibrosis, Ultrasound Elastography, Shear wave speed, Stiffness, Liver Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Canon Medical Systems, USA, Siemens Medical Solutions, Radiological Society of North America
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 28 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic liver disease is a major problem in the general population and there is an unmet need to diagnose(and screen) for liver disease with using noninvasive, cost-effective and sensitive techniques.The investigators hypothesize that variation using ultrasound elastography for the estimation of stage of liver fibrosis and steatosis in patients with diffuse liver disease exists due to different methods of measurements, and/or different systems. The proposed investigation is a cross-sectional study using ultrasound elastography and fat quantification modalities. The investigators are planning to enroll 30 subjects 18 years old and older in whom diffuse liver disease is suspected, and who have undergone non-focal liver biopsy in the past 6 months or are scheduled to undergo biopsy within 3 months of enrollment, as part of their routine clinical care. The investigators will use 4 different ultrasound devices with their shear wave elastography and speed of sound functions.
Specific aims;
- Compare shear wave elastography(SWE) measurements from different ultrasound systems; using histopathology as reference standards.
- Assess intra-operator and inter-operator reliability by measuring variability in elastography values by two operators on a single system.
- Determine the effect of deviations from guidelines(less number of measurements and measurements during active breath)
Detailed description
Liver disease and cirrhosis are important causes of morbidity and mortality in the United States and are a major public health problem with 40,000 deaths and more than 1.4 billion dollars spent on medical services. Hepatic fibrosis is the final common pathway for many different liver insults and is known to be a dynamic process, which is reversible if diagnosed early and treated. If untreated, fibrosis eventually progresses to cirrhosis, which is irreversible. The diagnosis of fibrosis relies on liver biopsy (the gold standard) however, is an invasive procedure with risks and sampling errors. Indirect biomarkers of fibrogenesis can measure some of these components to determine categories of fibrosis, with a sensitivity and specificity of 47% and 90% respectively.It is shown in the literature that, fat content of liver is related with fibrosis development. Biopsy is accepted as the most accurate technique to assess liver fat and fibrosis amount.
Fibrotic livers demonstrate increased stiffness, a property that can be measured using technology named Ultrasound Elastography or sonoelastography (SWE). SWE is performed by insonating the patient with a low energy, amplitude, and frequency shear wave created by a vibrating probe. The propagated wave travels faster with increasing fibrosis: the stiffer the tissue, the faster the shear wave propagates. A pulse-echo ultrasound acquisition allows measurement of the wave velocity and the results are presented as kilopascals (kPa). Prior reports have described sensitivity and specificity for liver fibrosis detection of 80% and 97% respectively for SWE. The benefits of SWE are that it is inexpensive, reproducible, painless, rapid (< 10 min), easy to perform, and can be used for diagnosis, prognosis and monitoring disease progression.
The objective of this study is to compare the variation in elastography values and study the factors that might cause these variations.
The proposed investigation is a cross-sectional study using ultrasound elastography. The investigators are planning to enroll 30 subjects 18 years old and older in whom diffuse liver disease is suspected, and who have undergone non-focal liver biopsy in the past 6 months or are scheduled to undergo biopsy within 3 months of enrollment, as part of their routine clinical care.
All subjects will be required to come to the MGH main campus for 2 study visits within 60 days of each other. In addition, subjects will need to fast for at least 4 hours prior to study visits
There will be two visits in this study and maximum 60 days time frame between the visits is anticipated. Two operators will perform the ultrasound examination. Reproducibility and repeatability of the ultrasound devices will be estimated.
Ultrasound examination including sonoelastography will be performed using four FDA-approved ultrasound units; Both operators will perform;
- Median Elastograpy (10 measurements) on regular and variable map at a depth(in the area between 2cm from capsule and 6.5cm from skin)
- Median SWE value with active/free breath(10measurements)
- Median SWE value with less number of acquisitions(3measurements)
These measurements will be collected in subgroups using specific systems. In second visit, all measurements will be repeated with the same operators.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 Patients with known liver biopsy results | Experimental | Device: Sonographic SWE measurements with 4 different ultrasound systemsPatients with chronic liver disease with known biopsy results |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult Patients
- Men or Woman
- Suspected diffuse liver disease and have had a liver biopsy within the last 6 months or are scheduled for a liver biopsy in the next 3 months.
- Consent to participate in the study
Key exclusion criteria (3 listed)
- Pregnancy
- Acute illness/ cognitive impairment resulting in inability to cooperate with ultrasound
- Patients that do not consent to ultrasound examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonographic SWE measurements with 4 different ultrasound systemsSonographic Shear wave elastography will be performed to quantify liver fibrosis | Device | 30 Patients with known liver biopsy results |
Primary outcome
Deviations From Suggested Guidelines- Any Effect on Agreement
Time frame: Visit 1 and Visit 2, an average of 2.5 hours for each visit
We collected guideline suggested shear wave elastography measurements from 20 patients. Guidelines suggest collecting 1) 10 measurements, 2) Asking patient to hold breath during the measurements. As a deviation from guideline suggestions, we collected measurements during free breath movements without asking patient to hold breath. As a deviation from the guideline suggestions, fewer number of measurements (3 measurements) were collected with asking the patient to hold breath during the measurements. All measurements were collected using one type of ultrasound system. All measurements were collected by 2 operators in 2 visits.
Interoperator and Intraoperator Agreement in m/s and kPA Units
Time frame: Visit 1 and Visit 2, an average of 2.5 hours for each visit
In 20 patients we collected 10 shear wave elastography measurements in m/s and kPA units. Using one of the available ultrasound systems, 2 operators collected these measurements in 2 visits. Theoretically, m/s to kPA conversion can be made using an equation. However, some systems provide opportunity to get data in both units. Although algebraically m/s and kPA can be converted to each other, we found some minor differences in terms of inter-operator and intra-operator agreement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21440669Younossi ZM, Stepanova M, Afendy M, Fang Y, Younossi Y, Mir H, Srishord M. Changes in the prevalence of the most common causes of chronic liver diseases in the United States from 1988 to 2008. Clin Gastroenterol Hepatol. 2011 Jun;9(6):524-530.e1; quiz e60. doi: 10.1016/j.cgh.2011.03.020. Epub 2011 Mar 25.
- Background: PubMed 25242656Mokdad AA, Lopez AD, Shahraz S, Lozano R, Mokdad AH, Stanaway J, Murray CJ, Naghavi M. Liver cirrhosis mortality in 187 countries between 1980 and 2010: a systematic analysis. BMC Med. 2014 Sep 18;12:145. doi: 10.1186/s12916-014-0145-y.
- Background: PubMed 15115333Pinzani M, Rombouts K. Liver fibrosis: from the bench to clinical targets. Dig Liver Dis. 2004 Apr;36(4):231-42. doi: 10.1016/j.dld.2004.01.003.
- Background: PubMed 2081479Scholmerich J, Holstege A. Aetiology and pathophysiology of chronic liver disorders. Drugs. 1990;40 Suppl 3:3-22. doi: 10.2165/00003495-199000403-00003.
- Background: PubMed 24566915Pellicoro A, Ramachandran P, Iredale JP, Fallowfield JA. Liver fibrosis and repair: immune regulation of wound healing in a solid organ. Nat Rev Immunol. 2014 Mar;14(3):181-94. doi: 10.1038/nri3623.
- Background: PubMed 17436094Actis GC, Olivero A, Lagget M, Pellicano R, Smedile A, Rizzetto M. The practice of percutaneous liver biopsy in a gastrohepatology day hospital: a retrospective study on 835 biopsies. Dig Dis Sci. 2007 Oct;52(10):2576-9. doi: 10.1007/s10620-006-9724-x. Epub 2007 Apr 12.
- Background: PubMed 10960438Cadranel JF, Rufat P, Degos F. Practices of liver biopsy in France: results of a prospective nationwide survey. For the Group of Epidemiology of the French Association for the Study of the Liver (AFEF). Hepatology. 2000 Sep;32(3):477-81. doi: 10.1053/jhep.2000.16602.
- Background: PubMed 17040353van der Poorten D, Kwok A, Lam T, Ridley L, Jones DB, Ngu MC, Lee AU. Twenty-year audit of percutaneous liver biopsy in a major Australian teaching hospital. Intern Med J. 2006 Nov;36(11):692-9. doi: 10.1111/j.1445-5994.2006.01216.x.
- Background: PubMed 16400355Sparchez Z. Complications after percutaneous liver biopsy in diffuse hepatopathies. Rom J Gastroenterol. 2005 Dec;14(4):379-84.
- Background: PubMed 11172192Bravo AA, Sheth SG, Chopra S. Liver biopsy. N Engl J Med. 2001 Feb 15;344(7):495-500. doi: 10.1056/NEJM200102153440706. No abstract available.
- Background: PubMed 15660389Rousselet MC, Michalak S, Dupre F, Croue A, Bedossa P, Saint-Andre JP, Cales P; Hepatitis Network 49. Sources of variability in histological scoring of chronic viral hepatitis. Hepatology. 2005 Feb;41(2):257-64. doi: 10.1002/hep.20535.
- Background: PubMed 12385448Regev A, Berho M, Jeffers LJ, Milikowski C, Molina EG, Pyrsopoulos NT, Feng ZZ, Reddy KR, Schiff ER. Sampling error and intraobserver variation in liver biopsy in patients with chronic HCV infection. Am J Gastroenterol. 2002 Oct;97(10):2614-8. doi: 10.1111/j.1572-0241.2002.06038.x.
- 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.
Anthony E. Samir, MD, MPH principal investigator
Associate Medical Director, Ultrasound Imaging Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonographic SWE measurements with 4 different ultrasound systems in people with Liver Fibrosis and Liver Diseases, run by Massachusetts General Hospital 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 4 inclusion and 3 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 28 Oct 2019. 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?
Yes. Results are posted in the registry (first posted 28 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Deviations From Suggested Guidelines- Any Effect on Agreement (time frame: Visit 1 and Visit 2, an average of 2.5 hours for each visit). The study lists 2 primary outcomes in all. 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 NCT03342560, which also lists 30 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 28 Oct 2019.