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| Name | Class |
|---|---|
| Geisinger Clinic | OTHER |
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The study objective is to demonstrate the clinical performance of ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS) when compared to FibroScan for evaluation of liver fibrosis.
This study has been designed as prospective, single center, single arm, consecutive, blinded, pilot study conducted in a post-market setting using commercially available devices to evaluate the effectiveness of Endoscopic Ultrasound with ShearWave Elastography to estimate hepatic fibrosis in patients with chronic liver disease. It is anticipated that the data from this study will support the need for additional clinical trials. All consenting, eligible patients reporting for an ultrasound and/or liver biopsy for evaluation of fibrosis meeting the inclusion criteria will be consecutively enrolled into the study and assigned a unique study identification number. A total of 52 subjects will be enrolled and treated at a single study site in the US. Enrollment is expected to be completed within 6 months. Each subject will undergo both procedures (FibroScan and EUS with SW Elastography), End of study will be reached after pathology results have been obtained (within a week of the initial procedure).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Consecutive, eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. Each subject will undergo both procedures (FibroScan and EUS with SW Elastography). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS) | Device | ShearWave Measurement is a software option available on the ARIETTA 850 that uses transient pulses to generate shear waves in the body. The tissue's elasticity is directly deduced by measuring the speed of wave propagation. |
| Measure | Description | Time Frame |
|---|---|---|
| Analyze the correlation between SWE of liver and FibroScan of liver with histologic fibrosis stage using Spearman Correlation Coefficient. | Use ANOVA with Tukey Range test to evaluate the level of significance of difference in SWE results across fibrosis stages. | 6 months |
| Analyze the correlation between SWE of liver and FibroScan of liver with histologic fibrosis stage using Spearman Correlation Coefficient. | Construct receiver operating characteristic curves (ROC) to determine which liver section (left or right) had best accuracy of prediction of fibrosis stage and compared overall accuracy between SWE and TE. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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All consenting, eligible patients reporting for an ultrasound and/or liver biopsy for evaluation of fibrosis.
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| Name | Affiliation | Role |
|---|---|---|
| David Diehl, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17822-3069 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39601324 | Derived | Termite F, Borrelli de Andreis F, Liguori A, Gasbarrini A, Attili F, Spada C, Miele L. The Role of Endoscopic Ultrasound in Assessing Portal Hypertension: A State-of-the-Art Literature Review and Evolving Perspectives. Liver Int. 2025 Apr;45(4):e16176. doi: 10.1111/liv.16176. Epub 2024 Nov 27. |
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All IPD that underlie results in a publication will be shared.
Data will be accessible starting 6 months after publication
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| FibroScan | Device | manufactured by Echosens |
|
| ALOKA ARIETTA 850 - | Device | manufactured by Hitachi Healthcare - included on the system is the ShearWave measurement software |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |