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

Primary Purpose

Portal Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transjugular Intrahepatic Portosystemic Shunt
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Portal Hypertension focused on measuring Transjugular Intrahepatic Portosystemic Shunt, TIPS, cirrhosis, hepatitis, portal vein thrombosis, Budd-Chiari Disease, Elastography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TIPS

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 2, 2018
Last Updated
September 27, 2021
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03427164
Brief Title
Ultrasound Elastography Assessment of Spleen and Liver Stiffness Before and After Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure
Official Title
Ultrasound Elastography Assessment of Spleen and Liver Stiffness Before and After Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension
Keywords
Transjugular Intrahepatic Portosystemic Shunt, TIPS, cirrhosis, hepatitis, portal vein thrombosis, Budd-Chiari Disease, Elastography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIPS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transjugular Intrahepatic Portosystemic Shunt
Other Intervention Name(s)
TIPS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spleen stiffness
Description
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
Secondary Outcome Measure Information:
Title
Change in spleen stiffness
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Jones, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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