Trial Outcomes & Findings for Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness (NCT NCT03352882)
NCT ID: NCT03352882
Last Updated: 2019-10-01
Results Overview
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.
TERMINATED
NA
1 participants
Pre-TIPS and 30 days Post-TIPS creation
2019-10-01
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
|
1
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness
Baseline characteristics by cohort
| Measure |
Open Label
n=1 Participants
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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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
51 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
|
Childs-Pugh Score
|
8 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-TIPS and 30 days Post-TIPS creationPopulation: This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-TIPS and 30 days Post-TIPS creationPopulation: This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted.
Baseline PSG (mm Hg) correlation to baseline liver stiffness by ultrasound ARFI (m/s)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days Post-TIPS and 12 months Post-TIPS creationPopulation: This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted.
Difference in frequency of paracentesis and freedom from recurrence of variceal bleeding at 30 days and 12 months post-TIPS placement
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-TIPS and 30 days Post-TIPS creationPopulation: This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted.
Correlation of hyaluronic acid, a serum marker of liver stiffness, with baseline ARFI measurements, non-invasive radiographic assessment of liver stiffness
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-TIPS and 30 days Post-TIPS creationPopulation: This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted.
Correlation of tissue inhibitor of metalloproteinase-1, a serum marker of liver stiffness, with baseline ARFI measurements, non-invasive radiographic assessment of liver stiffness
Outcome measures
Outcome data not reported
Adverse Events
Open Label
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kimberly A. Forde, MD, PhD - Principal Investigator
University of Pennsylvania
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place