NCT03427164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

3.6 years

First QC Date

February 2, 2018

Last Update Submit

September 27, 2021

Conditions

Portal Hypertension

Keywords

Transjugular Intrahepatic Portosystemic ShuntTIPScirrhosishepatitisportal vein thrombosisBudd-Chiari DiseaseElastography

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from Baseline to 2 weeks post-procedure

Secondary Outcomes (1)

  • Change in spleen stiffness

    Change from Baseline to Month 12

Study Arms (1)

TIPS

EXPERIMENTAL

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

Interventions

Transjugular Intrahepatic Portosystemic ShuntPROCEDURE

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
TIPS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Hypertension, PortalFibrosisHepatitis

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Study Officials

  • Jill Jones, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 9, 2018

Study Start

October 16, 2017

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)