CirrhosisNCT01807013
Evaluating Ultrasound, Elastometry, Minilaparoscopy and Histology for the Diagnosis of Compensated Liver Cirrhosis.
An observational study of Cirrhosis, run by University Hospital Erlangen at 1 site in Germany.
Trial summary
Prospective study to evaluate the dignostic value of b-mode ultrasound, elastometry and mini-laparoscopic guided liver biopsy for the diagnosis of compensated liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- ultrasound, liver elastometry, minilaparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with suspected chronic liver disease
Who may be able to join
- clinical decision to perform minilaparoscopic guided liver biopsy for the staging of liver disease including the assessment of the degree of fibrosis.
Who cannot join
- ascites
- decompensated liver disease
- esophageal varices
- other collateral circulations
- obstructive cholestasis
- severe heart insufficiency (NYHA III-IV)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Erlangen Nürnberg
Erlangen, Bavaria, 91054
Deike Strobel, Prof. Dr., 09131 - 8535261, deike.strobel@uk-erlangen.de
Lukas Pfeifer
About this study
Official title: Prospective Study to Evaluate the Diagnostic Value of B-mode Ultrasound, Elastometry and Minilaparoscopic Guided Liver Biopsy for the Diagnosis of Compensated Liver Cirrhosis.
Prospective study to evaluate the dignostic value of b-mode ultrasound, elastometry and mini-laparoscopic guided liver biopsy for the diagnosis of compensated liver cirrhosis.
Read the detailed description
Up to now the gold standard for the diagnosis of liver cirrhosis is to perform liver biopsy. This invasive methode is not undisputed. Therefore there is constant effort to improve, develop and apply better diagnostic tools. This study is designed to evaluate the in our eyes now a days most promising examinations: (1) high frequency ultrasound, (2) elastometry and (3) minilaparoscopy. Patients for whom the clinical decision to perform mini laparoscopic guided liver biopsy was taken should be recruited. Successive at three time points the examiner has to decide for or against cirrhosis: (1) after conventional and high frequency ultrasound (2) after elastometry and (3) after laparoscopy.
- Conditions
- Cirrhosis
- Being tested
- ultrasound, liver elastometry, minilaparoscopy
- Keywords
- cirrhosis, liver, elastometry, ultrasound, laparoscopy, diagnosis
- Medical subject headings
- Fibrosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound, liver elastometry, minilaparoscopyProcedure or surgery
- conventional high-end ultrasound technique,
- small access laparoscopy with fine laparoscopes
- Acoustic radiation force impulse (ARFI): ARFI technology uses short-duration acoustic radiation forces (approximately 100 microseconds) to generate a localized tissue displacement which results in a lateral shear-wave propagation. ARFI shear wave velocity (SWV) measured in m/sec tracked with ultrasonic correlation-based methods is proportional to the square root of tissue elasticity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective Evaluation of Acoustic Radiation Force Impulse (ARFI) Elastography and High-Frequency B-Mode Ultrasound in Compensated Patients for the Diagnosis of Liver Fibrosis/Cirrhosis in Comparison to Mini-Laparoscopic Biopsy
Histology is obtained at minilaparoscopy. For an Ishak fibrosis stage of 5/6 or a clearly nodular liver surface at minilaparoscopy cirrhosis is confirmed.
Measured: blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours
Secondary outcomes (1)
Can the non invasive tests be combined resulting in a better accuracy for the prediction of liver cirrhosis/fibrosis?
Measured: blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startFeb 2011
- Primary completionAug 2014
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. D. Strobel, University Hospital Erlangen
- Investigators
- Deike Stobel, Prof. Dr., Study director, Universitätsklinikum Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807013
- Sponsor's protocol ID
- LapSon
- Status last verified
- Jan 2016
- First submitted
- 12 Jul 2012
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate the Diagnostic Value of B-mode Ultrasound, Elastometry and Minilaparoscopic Guided Liver Biopsy for the Diagnosis of Compensated Liver Cirrhosis.
- ClinicalTrials.gov ID
- NCT01807013
- Acronym / sponsor ID
- LapSon
- Conditions
- Cirrhosis
- Keywords
- cirrhosis, liver, elastometry, ultrasound, laparoscopy, diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 8 Mar 2013 (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.
Prospective study to evaluate the dignostic value of b-mode ultrasound, elastometry and mini-laparoscopic guided liver biopsy for the diagnosis of compensated liver cirrhosis.
Detailed description
Up to now the gold standard for the diagnosis of liver cirrhosis is to perform liver biopsy. This invasive methode is not undisputed. Therefore there is constant effort to improve, develop and apply better diagnostic tools. This study is designed to evaluate the in our eyes now a days most promising examinations: (1) high frequency ultrasound, (2) elastometry and (3) minilaparoscopy. Patients for whom the clinical decision to perform mini laparoscopic guided liver biopsy was taken should be recruited. Successive at three time points the examiner has to decide for or against cirrhosis: (1) after conventional and high frequency ultrasound (2) after elastometry and (3) after laparoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with suspected chronic liver disease
Key inclusion criteria (1 listed)
- clinical decision to perform minilaparoscopic guided liver biopsy for the staging of liver disease including the assessment of the degree of fibrosis.
Key exclusion criteria (6 listed)
- ascites
- decompensated liver disease
- esophageal varices
- other collateral circulations
- obstructive cholestasis
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 |
|---|---|---|
| ultrasound, liver elastometry, minilaparoscopy* conventional high-end ultrasound technique, * small access laparoscopy with fine laparoscopes * Acoustic radiation force impulse (ARFI): ARFI technology uses short-duration acoustic radiation forces (approximately 100 microseconds) to generate a localized tissue displacement which results in a lateral shear-wave propagation. ARFI shear wave velocity (SWV) measured in m/sec tracked with ultrasonic correlation-based methods is proportional to the square root of tissue elasticity. | Procedure or surgery | – |
Primary outcome
Prospective Evaluation of Acoustic Radiation Force Impulse (ARFI) Elastography and High-Frequency B-Mode Ultrasound in Compensated Patients for the Diagnosis of Liver Fibrosis/Cirrhosis in Comparison to Mini-Laparoscopic Biopsy
Time frame: blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours
Histology is obtained at minilaparoscopy. For an Ishak fibrosis stage of 5/6 or a clearly nodular liver surface at minilaparoscopy cirrhosis is confirmed.
1 secondary outcome
Can the non invasive tests be combined resulting in a better accuracy for the prediction of liver cirrhosis/fibrosis?
Time frame: blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
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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.
Deike Stobel, Prof. Dr. study director
Universitätsklinikum Erlangen-Nürnberg
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 Cirrhosis, run by University Hospital Erlangen at 1 site in Germany.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Jan 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deike Strobel, Prof. Dr. (09131 - 8535261, deike.strobel@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective Evaluation of Acoustic Radiation Force Impulse (ARFI) Elastography and High-Frequency B-Mode Ultrasound in Compensated Patients for the Diagnosis of Liver Fibrosis/Cirrhosis in Comparison to Mini-Laparoscopic Biopsy (time frame: blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2016.