Refractory Ascites Clinical Trial
Official title:
Evaluation of Hemodynamic Parameters Following Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Verified date | February 2024 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 inserted between the portal vein (vein that carries blood from the intestines into the liver) to a hepatic vein (vein that carries blood away from the liver back to the heart). This means that blood that would usually gets filtered through the liver is now bypassing the liver and going directly to the heart. Because more blood will be flowing to the heart, the heart needs to be strong enough to handle the extra volume. This study is being done to determine the impact of the TIPS procedure on cardiac (heart) function by collecting data (heart pressures) during the TIPS procedure. Immediately after TIPS and at standard follow-up time points, labs and transthoracic echocardiograms (TTE or echo) will also be collected. The device(s) used in this study are neither the intervention studied nor the experimental variable of interest. Devices are commercially available and used, and procedures are performed, in accordance with the institution's standard of care.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Medical College of Wisconsin/Froedtert Hospital | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin | Radiological Society of North America |
United States,
ACR-SIR-SPR Practice Parameter for the Creation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS). :25.
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Correlation of cardiac events with laboratory values | correlations will be made between outcome BNP, TNF-a, eNOS, endothelin-1 | labs will be obtained at baseline and post TIPS at 1-3 days, 2 weeks +/- 3 days, 4-6 weeks, and 4-6 months | |
Primary | Cardiac related events | any cardiac event to include, heart failure, heart attack, pulmonary hypertension | from insertion of TIPS to 2 years post TIPS | |
Secondary | Clinical success | No further need for paracentesis or thoracentesis at 6 months | 6 months after TIPS placement | |
Secondary | Overall survival | evaluation of overall survival from time of TIPS placement to death | all patients will be followed for 2 years after TIPS placement | |
Secondary | Complications | Any peri or post procedural TIPS related events including liver failure, need for re-intervention, etc. | from insertion of TIPS to 2 years post TIPS | |
Secondary | TIPS patency | evaluation of how long the TIPS remains patent without need for further intervention | from insertion of TIPS to 2 years post TIPS |
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