Main goal: In this non-invasive pilot study, we want to investigate whether these techniques can discriminate between healthy livers and livers with cirrhosis. For the new techniques to be applied as an alternative for biopsy, the output values of…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcomes are:
• Reference intervals
• Intra- and interobserver variability
To this end, the following variables will be measured / calculated: strain (for
elastography) and inhomogeneity (for ASQ), their variances, the corresponding
effect size and coefficients of agreement.
Secondary outcome
nvt
Background summary
There is an urgent need for reliable non-invasive methods to evaluate the
degree of liver fibrosis. The current gold standard, liver biopsy, has several
disadvantages such as a high sampling variability and a high morbidity.
Ultrasound offers two techniques that might be sensitive enough to quantify
liver fibrosis. In this pilot study, we want to measure normal and extreme
values in healthy and diseased livers.
Study objective
Main goal: In this non-invasive pilot study, we want to investigate whether
these techniques can discriminate between healthy livers and livers with
cirrhosis. For the new techniques to be applied as an alternative for biopsy,
the output values of patients with livers with cirrhosis should minimally
overlap with those of persons with healthy livers. Moreover, intra- and
interobserver variations should be low.
Study design
All subjects undergo an ultrasound examination which comprises the two new
techniques.
In group 1, each exam consists of four repeated observations by two observers
according to Obs1-Obs2-Obs1-Obs2
Study burden and risks
Ultrasound is a very safe technique that does not use ionizing radiation. The
examinations, which require placing a probe on the skin between ribs under
mild pressure, is rarely experienced as unpleasant
Postbus 30.001
9700 RB Groningen
NL
Postbus 30.001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Group 1: 25 healthy volunteers, age 25-70 years, BMI 20-40
Group 2: 25 patients with histologically confirmed cirrhosis, age > 18 years
Exclusion criteria
Group 1
History of liver disease
Excessive alcohol use (> 25 consumptions per week for men, > 10 consumptions per week for women)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38429.042.11 |