TIPS Placement for Liver Cirrhosis

Not currently recruiting at 13 trial locations
CP
BO
DG
Overseen ByDyann Gregory
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather information on patients undergoing a procedure called TIPS, which helps manage portal hypertension (increased blood pressure in the liver). Researchers will track patients over five years to understand how this procedure affects their health and identify important clinical outcomes. Individuals scheduled for the TIPS procedure as part of their regular treatment are well-suited for this trial. As an unphased trial, it offers patients the opportunity to contribute to valuable research that could improve future treatment options.

What prior data suggests that TIPS placement is safe for liver cirrhosis patients?

A previous study showed that TIPS was successful in 96.6% of patients, indicating it can be a reliable procedure. However, some patients experienced major complications. Research has shown that older patients, particularly those aged 70 and above, had higher rates of hospital readmission, often due to hepatic encephalopathy, a brain condition related to liver disease.

Another study found that a small number of patients experienced bleeding from veins in the esophagus or stomach within 30 days after the procedure. Over time, the shunt used in the procedure tended to malfunction more frequently, with about 28.4% experiencing issues at 1 year and over 50% at 5 years.

Overall, TIPS is generally safe and effective, but there are risks, especially for older patients. These risks should be considered alongside the potential benefits when deciding about joining this study.12345

Why are researchers excited about this trial?

Researchers are excited about TIPS (Transjugular Intrahepatic Portosystemic Shunt) placement for patients with portal hypertension because it offers a minimally invasive approach to reducing pressure in the portal vein, which is different from traditional surgical methods like portosystemic shunts. Unlike these surgical options, TIPS creates a pathway within the liver that can alleviate complications such as variceal bleeding and ascites. This technique not only potentially improves survival rates but also enhances the quality of life for patients by providing a quicker recovery time and reducing the need for repeated hospitalizations.

What evidence suggests that TIPS placement is effective for managing portal hypertension in liver cirrhosis?

Research has shown that TIPS placement effectively manages liver cirrhosis complications, such as high blood pressure in the liver. One study found that a month after the procedure, 77.5% of patients improved. The procedure is technically successful, with some studies reporting a 100% success rate. Another study found that specific stents effectively manage severe symptoms, such as bleeding from swollen veins in the esophagus or stomach. Overall, TIPS has helped many patients with these challenging conditions.36789

Who Is on the Research Team?

LV

Lisa VanWagner, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person or virtual)

Pre-TIPS Assessment

Participants complete questionnaires and assessments before TIPS placement

1-2 weeks
1 visit (in-person)

TIPS Procedure

TIPS placement procedure and collection of blood and rectal samples

1 day
1 visit (in-person)

Post-TIPS Follow-up

Participants are monitored for clinical outcomes and complete questionnaires at specified intervals

5 years
Multiple visits (in-person and virtual) at months 1, 3, 6, 12, and yearly thereafter

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Gore

Collaborator

Trials
4
Recruited
5,500+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Scripps Health

Collaborator

Trials
59
Recruited
43,400+

University of Wisconsin, Madison

Collaborator

Trials
1,249
Recruited
3,255,000+

University of Florida

Collaborator

Trials
1,428
Recruited
987,000+

University of Arizona

Collaborator

Trials
545
Recruited
161,000+

Stanford University

Collaborator

Trials
2,527
Recruited
17,430,000+

Columbia University

Collaborator

Trials
1,529
Recruited
2,832,000+

Weill Medical College of Cornell University

Collaborator

Trials
1,103
Recruited
1,157,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40434426/

Outcomes of transjugular intrahepatic portosystemic shunt ...

Results: One month after TIPS, 31 (77.5%) patients had clinical response, and 9 (22.5%) had no response. The technical success rate was 100%.

National Trends and Outcomes of Transjugular Intrahepatic ...

A total of 55,145 TIPS procedures were captured during the study period. Annual procedural volume did not change significantly (5,979 in 2003, 5,880 in 2012).

Outcomes of transjugular intrahepatic portosystemic shunt ...

The data demonstrate that TIPS placement using 12 mm diameter PTFE-covered stents is efficacious in cirrhotic patients with pHTN complicated by variceal ...

Clinical outcomes of transjugular intrahepatic ...

The overall rebleeding rate after TIPS placement was 21.1 and 16.7% in the uncovered and covered stent groups, respectively, but the difference was not ...

Effectiveness of controlled-expansion transjugular ...

Overall, 200 patients underwent interdisciplinary evaluation for CX-TIPS. In 62.5% CX-TIPS was recommended and 82.4% of these patients underwent ...

Outcomes After Transjugular Intrahepatic Portosystemic Shunt ...

TIPS can be performed safely in patients 70 years and older, but the overall readmissions, and specifically for HE, were significantly higher in older patients.

Feasibility, Safety and Efficacy of Transjugular Intrahepatic ...

TIPS was successful in 96.6% of patients. Major complications (2 patients) and shunt-related events after TIPS were similar to those reported in the control ...

Shunt dysfunction and mortality after transjugular intrahepatic ...

1-year, 2-year, and 5-year dysfunction rates were 28.4% (CI 24.6–32.3), 38.9% (CI 34.5–43.3), and 52.4% (CI 47.2–57.6) (see Fig. 1). An example ...

EASL Clinical Practice Guidelines on TIPS

The aim of these EASL guidelines is to comprehensively address all aspects of TIPS in patients with cirrhosis.