Ultrasound Elastography Assessment of Spleen and Liver Stiffness Before and After Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure

Not Applicable

Completed

• Conditions: Portal Hypertension
• Interventions: Procedure: Transjugular Intrahepatic Portosystemic Shunt

• Registration Number: NCT03427164
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2017-10-16
• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-09
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All patients who undergo TIPS placement at the University of Kansas Medical Center (KUMC) are eligible for participation in this study

Exclusion Criteria

• Patients under 18 years of age
• Patients with prior splenectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TIPS	Transjugular Intrahepatic Portosystemic Shunt	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.

Primary Outcome Measures

Name	Time	Method
Spleen stiffness	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.

Secondary Outcome Measures

Name	Time	Method
Change in spleen stiffness	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States