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出境医 / 临床实验 / ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement

ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement

Study Description
Brief Summary:
ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions.

Condition or disease
Cirrhosis, Liver Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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?

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We expect about 1000 people in the entire study nationally. The study population will consist of patients over the age of 18 undergoing a TIPS procedure.
Criteria

Inclusion Criteria:

  • Subjects over the age of 18 able to provide consent or have a legally authorized consent in the event the subject is unable to consent due to a transient clinical condition
  • Subject scheduled to undergo a TIPS procedure

Exclusion Criteria:

  • Minors under the age of 18 at the time of enrollment
  • Prisoners
  • Pregnant Women
  • Subjects undergoing TIPS placement as part of an investigational study outside of usual clinical care
Contacts and Locations

Contacts
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Contact: Cynthia Padilla, BA 3129264260 cynthia.padilla@northwestern.edu

Locations
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United States, Arizona
University of Arizona Not yet recruiting
Phoenix, Arizona, United States, 85006
Principal Investigator: Michael Fallon, MD         
Sub-Investigator: Anil Seetharam, MD         
United States, California
Stanford Recruiting
Redwood City, California, United States, 94063
Principal Investigator: Aparna Goel, MD         
Sub-Investigator: Paul Kwo, MD         
Scripps Health Recruiting
San Diego, California, United States, 92121
Principal Investigator: Catherine Frenette, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
Principal Investigator: Jennifer Lai, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Principal Investigator: Giuseppe Morelli, MD         
Sub-Investigator: Roberto J. Firpi-Morell, MD         
United States, Illinois
Northwestern Recruiting
Chicago, Illinois, United States, 60611
Contact: Cynthia Padilla, BA    312-926-4260    cynthia.padilla@northwestern.edu   
Contact: Kim Sipich, CCRP    312-694-1293    k-sipich@northwestern.edu   
Principal Investigator: Lisa VanWagner, MD         
Sub-Investigator: Justin Boike, MD         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Sonali Paul, MD         
Sub-Investigator: Thomas Couri, MD         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Douglas Simonetto, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Principal Investigator: Elizabeth Verna, MD         
Sub-Investigator: Jonathan Susman, MD         
Weill Cornell Not yet recruiting
New York, New York, United States, 10065
Principal Investigator: Brett Fortune, MD         
Sub-Investigator: Arun Jesudian, MD         
United States, Texas
Baylor Scott & White Liver Consultants of Texas Recruiting
Dallas, Texas, United States, 75246
Principal Investigator: Sumeet Asrani, MD         
Sub-Investigator: Jamil Alsahhar, MD         
United States, Wisconsin
University of Wisconsin Madison Not yet recruiting
Madison, Wisconsin, United States, 53705
Principal Investigator: Erin Spengler, MD         
Sub-Investigator: Margarita German, MD         
Sponsors and Collaborators
Northwestern University
University of California, San Francisco
Scripps Health
University of Wisconsin, Madison
University of Florida
University of Arizona
Stanford University
Columbia University
Weill Medical College of Cornell University
Baylor Scott and White Health
Mayo Clinic
University of Chicago
Digestive Health Foundation
Gore
Investigators
Layout table for investigator information
Principal Investigator: Lisa VanWagner, MD Northwestern University
Tracking Information
First Submitted Date May 31, 2019
First Posted Date June 4, 2019
Last Update Posted Date September 11, 2020
Actual Study Start Date June 10, 2019
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement
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
Brief Summary ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population We expect about 1000 people in the entire study nationally. The study population will consist of patients over the age of 18 undergoing a TIPS procedure.
Condition
  • Cirrhosis, Liver
  • Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *
  • Burgos AC, Thornburg B. Transjugular Intrahepatic Portosystemic Shunt Placement for Refractory Ascites: Review and Update of the Literature. Semin Intervent Radiol. 2018 Aug;35(3):165-168. doi: 10.1055/s-0038-1661347. Epub 2018 Aug 6. Review.
  • Lerrigo R, Beste LA, Leipertz SL, Green PK, Lok AS, Kogut MJ, Ioannou GN. Characteristics and outcomes of transjugular intrahepatic portosystemic shunt recipients in the VA Healthcare System. Eur J Gastroenterol Hepatol. 2016 Jun;28(6):667-75. doi: 10.1097/MEG.0000000000000604.
  • Guevara M, Ginès P, Bandi JC, Gilabert R, Sort P, Jiménez W, Garcia-Pagan JC, Bosch J, Arroyo V, Rodés J. Transjugular intrahepatic portosystemic shunt in hepatorenal syndrome: effects on renal function and vasoactive systems. Hepatology. 1998 Aug;28(2):416-22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 31, 2019) 		1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects over the age of 18 able to provide consent or have a legally authorized consent in the event the subject is unable to consent due to a transient clinical condition
  • Subject scheduled to undergo a TIPS procedure

Exclusion Criteria:

  • Minors under the age of 18 at the time of enrollment
  • Prisoners
  • Pregnant Women
  • Subjects undergoing TIPS placement as part of an investigational study outside of usual clinical care
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Cynthia Padilla, BA 3129264260 cynthia.padilla@northwestern.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03973372
Other Study ID Numbers STU00208288
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Lisa VanWagner, Northwestern University
Study Sponsor Northwestern University
Collaborators
  • University of California, San Francisco
  • Scripps Health
  • University of Wisconsin, Madison
  • University of Florida
  • University of Arizona
  • Stanford University
  • Columbia University
  • Weill Medical College of Cornell University
  • Baylor Scott and White Health
  • Mayo Clinic
  • University of Chicago
  • Digestive Health Foundation
  • Gore
Investigators
Principal Investigator: Lisa VanWagner, MD Northwestern University
PRS Account Northwestern University
Verification Date September 2020

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