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| ID | Type | Description | Link |
|---|---|---|---|
| U54CA193417 | U.S. NIH Grant/Contract | View source |
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Lack of enrollment
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Pilot study examining changes in liver stiffness measured by ultrasound before and after TIPS creation
Single arm pilot study of adults ≥18yo investigating changes in liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS. Duration of participation is 30 days from TIPS creation. TIPS creation with Viatorr stent graft will be in accordance with its FDA-approved indication for symptomatic portal hypertension and per the manufacturer's instructions for use. Liver stiffness will be measured on pre-TIPS and post-TIPS ultrasounds using Phillips Epiq Ultrasound systems equipped with ElastPQ ultrasound shear wave elastography. Both ultrasounds will be performed at times which are standard of care before and after TIPS creation. Primary objectives include liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS. Secondary objectives include change in portosystemic gradient, clinical success as measured by difference in frequency of repeat paracentesis post-TIPS or freedom from recurrence of variceal bleeding and rate of hepatic encephalopathy. Exploratory objectives include serum biomarkers of liver stiffness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Other | All enrolled participants will undergo hepatic ultrasound with acoustic radiation force impulse (ARFI) before and 30 days after creation of TIPS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Diagnostic Test | Hepatic ultrasound using gray scale, color Doppler, and spectral Doppler imaging to evaluate hepatic vein and portal vein patency, direction and velocity of flow respectively. ARFI will be performed in the right hepatic lobe. Three measurements of stiffness (m/s) will be performed and the mean value recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Liver Stiffness | The primary study endpoint will be decrease in liver stiffness following TIPS creation as measured by ARFI using mean propagation velocity values in meters per second. Mean normal values and mean values indicating severe fibrosis range about 0.8-1.7 m/s and about 1-3.4 m/s respectively. We hypothesize TIPS creation will reduce the liver stiffness by > 50%. Change in liver stiffness will be correlated to change in PSG. | Pre-TIPS and 30 days Post-TIPS creation |
| Measure | Description | Time Frame |
|---|---|---|
| PSG (mm hg) and ARFI (m/s) Correlation | Baseline PSG (mm Hg) correlation to baseline liver stiffness by ultrasound ARFI (m/s) | Pre-TIPS and 30 days Post-TIPS creation |
| Frequency of Paracentesis and Recurrence of Variceal Bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Forde, MD, MHS | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label | All enrolled participants will undergo hepatic ultrasound with acoustic radiation force impulse (ARFI) before and 30 days after creation of TIPS. Ultrasound: Hepatic ultrasound using gray scale, color Doppler, and spectral Doppler imaging to evaluate hepatic vein and portal vein patency, direction and velocity of flow respectively. ARFI will be performed in the right hepatic lobe. Three measurements of stiffness (m/s) will be performed and the mean value recorded. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label | All enrolled participants will undergo hepatic ultrasound with acoustic radiation force impulse (ARFI) before and 30 days after creation of TIPS. Ultrasound: Hepatic ultrasound using gray scale, color Doppler, and spectral Doppler imaging to evaluate hepatic vein and portal vein patency, direction and velocity of flow respectively. ARFI will be performed in the right hepatic lobe. Three measurements of stiffness (m/s) will be performed and the mean value recorded. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decrease in Liver Stiffness | The primary study endpoint will be decrease in liver stiffness following TIPS creation as measured by ARFI using mean propagation velocity values in meters per second. Mean normal values and mean values indicating severe fibrosis range about 0.8-1.7 m/s and about 1-3.4 m/s respectively. We hypothesize TIPS creation will reduce the liver stiffness by > 50%. Change in liver stiffness will be correlated to change in PSG. | This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted. | Posted | Pre-TIPS and 30 days Post-TIPS creation |
|
1 year, 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label | All enrolled participants will undergo hepatic ultrasound with acoustic radiation force impulse (ARFI) before and 30 days after creation of TIPS. Ultrasound: Hepatic ultrasound using gray scale, color Doppler, and spectral Doppler imaging to evaluate hepatic vein and portal vein patency, direction and velocity of flow respectively. ARFI will be performed in the right hepatic lobe. Three measurements of stiffness (m/s) will be performed and the mean value recorded. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly A. Forde, MD, PhD - Principal Investigator | University of Pennsylvania | (215) 349-8222 | kforde@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2016 | Sep 9, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 5, 2016 | Sep 9, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Difference in frequency of paracentesis and freedom from recurrence of variceal bleeding at 30 days and 12 months post-TIPS placement
| 30 days Post-TIPS and 12 months Post-TIPS creation |
| Hyaluronic Acid and ARFI Correlation | Correlation of hyaluronic acid, a serum marker of liver stiffness, with baseline ARFI measurements, non-invasive radiographic assessment of liver stiffness | Pre-TIPS and 30 days Post-TIPS creation |
| Tissue Inhibitor of Metalloproteinase-1 and ARFI Correlation | Correlation of tissue inhibitor of metalloproteinase-1, a serum marker of liver stiffness, with baseline ARFI measurements, non-invasive radiographic assessment of liver stiffness | Pre-TIPS and 30 days Post-TIPS creation |
| Participants |
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| Age, Continuous | Median | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Childs-Pugh Score | The Child-Pugh score is a system for assessing the prognosis of chronic liver disease, primarily cirrhosis. It provides a forecast of the increasing severity of liver disease and expected survival rate.The score is determined by five clinical measures of liver disease. A score of 1, 2, or 3 is given to each measure, with 3 being the most severe. The five clinical measures are:
The Childs-Pugh score ranges from 5 to 15 and a higher score indicates greater severity of liver disease. | Number | units on a scale |
|
|
| Secondary | PSG (mm hg) and ARFI (m/s) Correlation | Baseline PSG (mm Hg) correlation to baseline liver stiffness by ultrasound ARFI (m/s) | This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted. | Posted | Pre-TIPS and 30 days Post-TIPS creation |
|
|
| Secondary | Frequency of Paracentesis and Recurrence of Variceal Bleeding | Difference in frequency of paracentesis and freedom from recurrence of variceal bleeding at 30 days and 12 months post-TIPS placement | This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted. | Posted | 30 days Post-TIPS and 12 months Post-TIPS creation |
|
|
| Secondary | Hyaluronic Acid and ARFI Correlation | Correlation of hyaluronic acid, a serum marker of liver stiffness, with baseline ARFI measurements, non-invasive radiographic assessment of liver stiffness | This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted. | Posted | Pre-TIPS and 30 days Post-TIPS creation |
|
|
| Secondary | Tissue Inhibitor of Metalloproteinase-1 and ARFI Correlation | Correlation of tissue inhibitor of metalloproteinase-1, a serum marker of liver stiffness, with baseline ARFI measurements, non-invasive radiographic assessment of liver stiffness | This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted. | Posted | Pre-TIPS and 30 days Post-TIPS creation |
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| 1 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |