Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-0782 | Other Identifier | Asan Medical Center Institution Review Board(IRB) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this prospective study was to evaluate the applicability and diagnostic performances of Smart-Shear wave(SSW) imaging, in comparison with Transient elastography(TE) for the staging of liver fibrosis using pathologic results as the reference standard.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| US elastography | Participants who have the plan of liver transplantation or liver biopsy within 4 weeks will be screened from the outpatient clinic. Two types of ultrasonographic elastography(US elastography) techniques including Smart-Shear Wave(SSW) imaging and transient elastography(TE) will be performed as a diagnostic method for hepatic fibrosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart-Shear Wave(SSW) imaging | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of Smart-Shear Wave(SSW) imaging compared to Transient elastography(TE) in diagnosis for hepatic fibrosis. | Applicability rate between Smart-Shear Wave(SSW) and Transient elastography(TE) will be compared to prove non-inferiority. Applicability rate = {[Total cases- (failure cases + non-reliable measurement cases)]/total case} * 100 (%) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of diagnostic accuracy to predict the degree of hepatic fibrosis. | Areas under the receiver operating curve (AUROCs) of the two techniques will be compared to estimate the probability of correctly predicting the degree of hepatic fibrosis. Substantial discordance between US elastography techniques and histologic staging will also be explored. It is defined as a difference in fibrosis stage by at least 2 points. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
A total of 105 participants will be enrolled. Participants are patients with liver disease who are planning to undergo liver surgery, and potential liver donors for living related liver transplantation.
Study population size was calculated by considering a power of 80%(1-sided alpha of 25%), and an expected dropout rate of 10%.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| So Yeon Kim, Dr | Contact | 82-2-3010-5980 | sykim.radiology@gmail.com | |
| So Hyun Park, Dr | Contact | 82-2-3010-1497 | nnoleeter@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| So Yeon Kim, Dr | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
Not provided
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Transient elastography(TE) | Procedure |
|
|
|
| 1 year |
| The correlation between two US elastography techniques | The correlation between the two US elastography techniques will be tested using the Spearman's correlation coefficient. | 1 year |
| Reliability of Smart-Shear Wave(SSW) comparing diagnostic performance according to the reliable measurement index(RMI) results | Reliable measurement index (RMI) is an reliability index that computes the reliability of the calculated stiffness by analyzing the changes in shapes of propagated shear waves. The diagnostic performance of Smart-Shear wave will be assessed by comparing the RMI result. | 1 year |
| Precision of Smart-Shear Wave(SSW) | Precision of Smart-Shear Wave(SSW) will be assessed using the composite factors, including intraclass correlation coefficients (ICCs), within subject SD(wSD), repeatability coefficient(RC), and within subject CV(wCV). | 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |