Ultrasound Elastography Assessment of Spleen and Liver Stiffness Before and After Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure
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|ClinicalTrials.gov Identifier: NCT03427164|
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : September 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Portal Hypertension||Procedure: Transjugular Intrahepatic Portosystemic Shunt||Not Applicable|
Portal hypertension is a condition that is caused by various disorders of the liver, including cirrhosis, hepatitis, portal vein thrombosis, or Budd-Chiari Disease. Portal hypertension can lead to the accumulation of fluid in the abdomen, called ascites, or put patients at risk for bleeding of the esophagus, stomach, and bowel. In certain patients, portal hypertension is treated by placement of a Transjugular Intrahepatic Portosystemic Shunt (TIPS).
Elastography is a newer exam which measures the consistency, or softness/stiffness, of various organs in the body. It is performed with ultrasound by sliding a transducer across the abdomen. Elastography is most commonly used to evaluate the liver, as disorders that cause damage to the liver result in stiffer liver tissue. The spleen has also been shown to get stiffer in the setting of portal hypertension.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ultrasound Elastography Assessment of Spleen and Liver Stiffness Before and After Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure|
|Actual Study Start Date :||October 16, 2017|
|Actual Primary Completion Date :||May 31, 2021|
|Actual Study Completion Date :||May 31, 2021|
Participants will have measurements taken of spleen stiffness before and after TIPS. Participation will last about 12 months, with visits at 1-2 weeks post-TIPS, 3 months, 6 months, and 12 months.
Procedure: Transjugular Intrahepatic Portosystemic Shunt
The TIPS procedures creates an artificial shunt from the portal vein to the hepatic vein. TIPS allows blood from the congested portal circulation to bypass the fibrotic liver and directly enter the systemic circulation.
Other Name: TIPS
- Spleen stiffness [ Time Frame: Change from Baseline to 2 weeks post-procedure ]The spleen stiffness will be measured before and after TIPS placement. Spleen stiffness is measured using US elastography and is reported in m/sec.
- Change in spleen stiffness [ Time Frame: Change from Baseline to Month 12 ]The spleen stiffness will be measured before and after TIPS placement. Spleen stiffness is measured using US elastography and is reported in m/sec.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427164
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Jill Jones, MD||University of Kansas Medical Center|