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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Portal Hypertension Procedure: Transjugular Intrahepatic Portosystemic Shunt Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TIPS
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Jill Jones, MD University of Kansas Medical Center
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03427164    
Other Study ID Numbers: STUDY00004361
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
Transjugular Intrahepatic Portosystemic Shunt
TIPS
cirrhosis
hepatitis
portal vein thrombosis
Budd-Chiari Disease
Elastography
Additional relevant MeSH terms:
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Hypertension, Portal
Liver Diseases
Digestive System Diseases