Comparison between imaging methods (ultrasound and computed tomography) in non-alcoholic fatty liver disease
| ISRCTN | ISRCTN39448973 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39448973 |
- Submission date
- 03/04/2021
- Registration date
- 08/04/2021
- Last edited
- 04/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Non-alcoholic fatty liver disease (NAFLD) is the term for a range of conditions caused by a build-up of fat in the liver. It's usually seen in people who are overweight or obese. A healthy liver should contain little or no fat. It's estimated up to 1 in every 3 people in the UK has early stages of NAFLD, where there are small amounts of fat in their liver. Early-stage NAFLD does not usually cause any harm, but it can lead to serious liver damage, including cirrhosis, if it gets worse.
NAFLD is often diagnosed after a blood test called a liver function test produces an abnormal result and other liver conditions, such as hepatitis, are ruled out. But blood tests do not always pick up NAFLD. The condition may also be spotted during an ultrasound scan or CT scan. Ultrasound is a type of scan where sound waves are used to create an image of the inside of your body. A CT scan or computed tomography scan (formerly known as a computed axial tomography or CAT scan) is a medical imaging technique used in radiology to get detailed images of the body noninvasively for diagnostic purposes.
The aim of the study is to perform a comparison between ultrasound elastography and non-enhanced computed tomography (NECT) for diffuse fatty liver diseases.
Who can participate?
Non-alcoholic patients who have been referred by the physician to have NECT abdomen and diagnosed to have fatty liver and other patients referred for NECT abdomen for any other reasons who don’t have fatty changes in the liver.
What does the study involve?
Imaging the liver of healthy volunteers and study group population for detection of fatty liver.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Saveetha Medical College and Hospital (India)
When is the study starting and how long is it expected to run for?
November 2018 to November 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Praveen Sharma. K, kpraveensharma.kps@gmail.com
Contact information
Scientific
Old No: 70, New No: 10
South Bazaar
Pattabiram
Chennai
600072
India
 ORCID ID |
0000-0002-4096-140X |
|---|---|
| Phone | +91 9962335288 |
| kpraveensharma.kps@gmail.com |
Study information
| Study design | Single centre prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN39448973_PIS.docx |
| Scientific title | Comparison between ultrasound elastography and non-enhanced computed tomography Hounsfield units for diffuse fatty liver diseases in non-alcoholic individuals |
| Study objectives | Comparison between ultrasound elastography and non-enhanced computed tomography Hounsfield units for diffuse fatty liver diseases in non-alcoholic individuals |
| Ethics approval(s) | Approved 26/11/2018, (Institutional ethical committee, Saveetha Medical College and Hospital, Thandalam - Tamil Nadu, India; +91 44-66726611; dir.res.su@gmail.com), ref: 602105.SMC/IEC/2018/11/234(A) |
| Health condition(s) or problem(s) studied | Detection of fatty liver disease |
| Intervention | This prospective study included 137 samples in the age group of 10-80 years for a period of 12 months. This study was carried out at the Department of Radiology, Saveetha Medical College & Hospital, Saveetha university after approval from the Institutional Ethics Committee (November 26, 2018). Patients were split into two groups based on diagnosis: 1. Disease group: non-alcoholic patients who have been referred by the physician to have NECT abdomen and diagnosed to have fatty liver 2. Control group: Other patients referred for NECT abdomen for any other reasons who don’t have fatty changes in the liver USG Elastography Study All examinations were performed using an (AFFINITY, PHILIPS 70 USG scanner). All patients were first explained about the USG, the requirement of breath-hold during the measurement of liver stiffness values, and then written informed consent was obtained. Protocol Examination included in 2D-SWE: Probe used: Convex probe Frequency range 1.5~6.0 MHz Frequency: 3.0 MHz Parameters Measured in 2D-SWE: Liver stiffness measurements (LSM) of individual segments are taken from the upper left lobe (segment II), lower left lobe (segment III), and right lobe (segment V and VIII). The mean liver stiffness measurement value (mean LSM) of the entire liver is derived by averaging the LSM values of all four segments. Two similar-sized ROIs (~1 cm) are taken from each of the four segments, 2 cm beneath the liver capsule. This is repeated in the upper and lower poles of the spleen. Care was taken to put the ROI at vessel-free liver and splenic parenchyma. CT study All examinations were performed using an (INGENUITY, PHILIPS 128 slice CT scanner), All patients were first explained about the CT, detailed clinical history was taken, previous medical records were checked, and then written informed consent was obtained. Protocol Examination included: Scan type: Helical Patient orientation: Feet first Acquisition: 5 mm Reconstruction: 1 mm Pitch factor: 1.6:1 Parameters measured in unenhanced CT: Absolute HU of the liver (HU liver): Mean value of the absolute HU measurements taken from the upper left lobe (segment II), lower left lobe (segment III), and right lobe (segment V and VIII). Absolute HU of the spleen (HU spleen): Mean value of the absolute HU measurements taken from upper and lower poles of the spleen. Liver attenuation index (CTL-S): Difference in attenuation values between liver (HU liver) and spleen (HU spleen) The grade of fatty liver disease as per the Five-point grading system. Two similar-sized ROIs (~1 cm) are taken from each of the four segments, 2 cm beneath the liver capsule. This is repeated in the upper and lower poles of the spleen. Care was taken to put the ROI at vessel-free liver and splenic parenchyma. Image analysis In the USG 2D-SWE study, the liver stiffness measurement value (LSM value, measured by kPa) is calculated for each patient. In non-enhanced CT, liver attenuation index value and the score of the visual five-point grading system are calculated. At the end of both imaging investigations, we perform the following steps: We compare the kPa value and liver attenuation index values to find whether there is a progressive rise in LSM value with increasing grade of steatosis or a progressive decrease in LSM value with increasing grade of steatosis. We compare the kPa value with the score of the CT five-point grading system to find whether there is a progressive rise in LSM value with an increasing score of the CT five-point grading system or a progressive decrease in LSM value with an increasing score of CT five-point grading system. Further, we calculate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 2D-SWE when compared to the CT LAI grading system. Statistical analysis USG elastography kilo pascal values and CT Hounsfield unit were calculated. Comparison between various parameters was done using kappa agreement, Pearson's Chi-Square and Receiver Operating Characteristic curve, and p-value. Further, we calculate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 2D-SWE compared to the CT LAI grading system. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | ultrasound elastography, non-enhanced computed tomography |
| Primary outcome measure | Measured at a single time point: 1. Quantitative assessment and Grading of fatty liver by Ultrasound Elastography 2. Quantitative assessment and Grading of fatty liver by Non-Enhanced Computed tomography based on Hounsfield units |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 26/11/2018 |
| Completion date | 30/11/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 137 |
| Total final enrolment | 137 |
| Key inclusion criteria | 1. Disease group: non-alcoholic patients who have been referred by the physician to have NECT abdomen and diagnosed to have fatty liver 2. Control group: Other patients referred for NECT abdomen for any other reasons who don’t have fatty changes in the liver 3. Age 11 - 80 years |
| Key exclusion criteria | 1. Alcoholics with cirrhosis 2. Space-occupying lesions of the liver 3. Debilitated and ventilated patients 4. Pregnancy |
| Date of first enrolment | 15/12/2018 |
| Date of final enrolment | 30/09/2019 |
Locations
Countries of recruitment
- India
Study participating centre
Saveetha Nagar
Thandalam
Chennai
602105
India
Sponsor information
University/education
Department of Radio-Diagnosis
Saveetha Medical College and Hospital
Saveetha Nagar
Thandalam
Chennai
602105
India
| Phone | +91 (0)44-66726677 |
|---|---|
| radiology.smc@saveetha.com | |
| Website | http://www.saveetha.com/ |
"ROR" |
https://ror.org/0034me914 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/05/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/05/2021 | No | Yes |
Additional files
- ISRCTN39448973_PIS.docx
- uploaded 04/05/2021
Editorial Notes
04/05/2021: The participant information sheet was uploaded as an additional file.
07/04/2021: Trial's existence confirmed by Saceetha University
