Status:
COMPLETED
Evaluation of Hemodynamic Parameters Following Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
Radiological Society of North America
Conditions:
Refractory Ascites
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
During a TIPS procedure, a shunt or stent (mesh tube) is passed down the jugular vein (the vein above the collarbone in the neck) using fluoroscopy (real time x-rays) guidance. Then, a stent is insert...
Detailed Description
The long-term goal of this proposal is to improve survival in patients with end stage liver disease following TIPS placement. Given that the most common indications for TIPS placement are also definin...
Eligibility Criteria
Inclusion
- OVERALL INCLUSION
- ≥ 18 years
- Patients with indications as established by the ACR-SIR-SPR practice parameters::
- prophylaxis against recurrent variceal bleed in high-risk patients
- portal hypertensive gastropathy or intestine-opathy
- refractory ascites
- hepatic hydrothorax
- hepatopulmonary syndrome
- hepatorenal syndrome
- decompression of portosystemic collaterals prior to abdominal surgical procedures
- Technically successful creation of a TIPS shunt, defined as creation of a portosystemic shunt with post TIPS creation portosystemic gradient of ≤ 12 mmHg
- STUDY ARM INCLUSION:
- • All patients undergoing elective TIPS who meet at least one of the criteria:
- Right atrial pressure (RAP) ≥ 15mm Hg; OR
- Change in RAP ≥ 10mm Hg; OR
- Peak systolic velocity ratio (PSRV) pressure ≥ 46mm Hg
- CONTROL ARM INCLUSION:
- • Patients undergoing elective TIPS for control of refractory ascites who do not meet at least one of the criteria outlined above for the study arm.
- Historical controls: we will use data collected form our own recent institutional review.
- EXCLUSION All patients who do not exhibit alterations in invasive RAP or PRVS measurements as listed in Inclusion Criteria and do not meet criteria for participation as a control subject (i.e. are not undergoing elective TIPS for control of refractory ascites).
- Admitted for GI bleed.
- Budd-Chiari syndrome.
- TIPS in setting of mesenteric vein thrombosis.
Exclusion
Key Trial Info
Start Date :
September 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04050683
Start Date
September 25 2019
End Date
December 9 2024
Last Update
December 13 2024
Active Locations (1)
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1
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226