ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement
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|ClinicalTrials.gov Identifier: NCT03973372|
Recruitment Status : Enrolling by invitation
First Posted : June 4, 2019
Last Update Posted : August 13, 2019
|Condition or disease|
|Cirrhosis, Liver Transjugular Intrahepatic Portosystemic Shunt (TIPS)|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Advancing Liver Therapeutic Approaches (ALTA). The ALTA Consortium Study Group for the Management of Portal Hypertension - A 5-year Longitudinal Observational Study of Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt (TIPS) Placement|
|Actual Study Start Date :||June 10, 2019|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||July 2024|
- To prospectively collect clinical information on the use and outcomes associated with contemporary real-world practice of Transjugular Intrahepatic Portosystemic Shunts (TIPS) [ Time Frame: up to 5 years ]Transjugular Intrahepatic Portosystemic Shunt (TIPS) was first developed as a salvage tool for life threatening variceal bleeding or for the management of severe ascites refractory to medical therapy. Over the past decade there have been improvements in TIPS stent technology resulting in reduction in stent occlusions as well as increased experience of TIPS use. This increase in TIPS use has been paralleled by the expansion of indications for TIPS placement. As TIPS use has increased, so have the clinical questions surrounding the ideal conditions in which to successfully manage the indication for the procedure, while minimizing the unintended consequences of TIPS.
- The goals of the ALTA consortium are to answer key clinical questions related to contemporary patterns of TIPS usage as well as clinical outcomes. [ Time Frame: up to 5 years ]Recent data supports the use of TIPS for the early treatment of variceal bleeding, treatment of portal vein thrombus to permit successful liver transplantation and decompression of portal hypertension before planned abdominal surgery. Questions on TIPS use still remain. For example, what is the ideal stent diameter and degree of portal gradient pressure reduction required to optimally manage ascites or varices while minimizing hepatic decompensation and hepatic encephalopathy?
- Create a database that will serve to inform and answer clinically related questions about the optimization of TIPS and management. [ Time Frame: up to 5 years ]Currently, the major short-term complications related to TIPS are exacerbation of underlying cardiopulmonary issues andhepatic decompensation. The long-term complication, however, is hepatic encephalopathy which can often have a significant burden on quality of life and may result in additional procedures for constrainment or complete occlusion of the TIPS in severe cases. Although clinical outcomes of TIPS have been published, many of these reports are limited to single center sites with small sample sizes.
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): NCT03973372
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Lisa VanWagner, MD||Northwestern University|