An interventional study of Transjugular Intrahepatic Portosystemic Shunt in Portal Hypertension, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention
The primary purpose of this project is to determine if acute monitoring of shunt patency via ultrasound elastography measurements of splenic stiffness before and after TIPS placement results in reduced morbidity and mortality from shunt failure.
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.
375 studies on the registry are indexed under Hypertension, Portal; 114 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 231 interventional studies indexed under Hypertension, Portal.
Browse Hypertension, Portal studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
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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.
Also known as: TIPS
Spleen stiffness
The spleen stiffness will be measured before and after TIPS placement. Spleen stiffness is measured using US elastography and is reported in m/sec.
Time frame: Change from Baseline to 2 weeks post-procedure
Change in spleen stiffness
The spleen stiffness will be measured before and after TIPS placement. Spleen stiffness is measured using US elastography and is reported in m/sec.
Time frame: Change from Baseline to Month 12
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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