- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04044248
TIPS Plus Transvenous Obliteration for Gastric Varices
Single Center Prospective Pilot Study of Combined Transjugular Intrahepatic Portosystemic Shunt Creation Plus Transvenous Obliteration for the Treatment of Gastric Varices
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Liver cirrhosis-or scarring of the liver-occurs with a worldwide prevalence approximating 4.5-9.5%, affecting hundreds of millions of people. Cirrhosis results in 2% of all global mortality, approximating 1 million deaths per year, and affects more than 600,000 persons in the United States. Variceal hemorrhage (VH) from gastroesophageal varices (GEVs) is a leading cause of mortality in patients with liver cirrhosis. Gastric varices (GVs) occur in 5-33% of patients with cirrhotic liver disease and have a bleeding incidence of 25% within 2-years of development, 36% within 3-years, and 44% within 5-years. GVs are associated with high mortality rates approximating 25% at 2-years. First-line therapy in patients who have not bled includes preventative pharmaceuticals, while acute bleeding is typically treated with vasoconstrictive agents and endoscopic variceal ligation or sclerotherapy. In cases of acute hemorrhage, refractory bleeding, or high risk GVs, Interventional Radiology (IR) guided transjugular intrahepatic portosystemic shunt (TIPS) creation is recommended to decompress varices and divert blood flow through a controlled synthetic conduit. In the modern era, TIPS is associated with initial GV bleeding control in greater than 90% of cases. However, GV rebleeding rates after TIPS are non-trivial, widely ranging between 13-53%. Moreover, GVs are widely thought to remain patent and sustain bleeding at low portosystemic pressure gradients (PSGs), as is the case after TIPS. In addition, TIPS can also contribute to high rates hepatic encephalopathy (HE) due to increased portosystemic shunting. Recently, transvenous obliteration techniques-including balloon-occluded retrograde (BRTO) and antegrade (BATO) transvenous obliteration as well as more recent adaptations including coil- (CARTO) and plug-assisted (PARTO) retrograde transvenous obliteration-have been developed with the intent of directly eradicating GVs. While obliteration techniques are associated with high technical success rates approximating 91-100% and low rebleeding incidence less than 5%, the worsened portal hypertension that follows from GV closure results in adverse side effects, including aggravation of esophageal varices (EVs) in 33% of patients, development of new or worsening of ascites in 10% of patients, and formation of difficult to treat ectopic varices.
Traditionally, TIPS and transvenous obliteration have evolved in relative isolation as different philosophical strategies to address VH. TIPS is more commonly utilized in North America and Europe, where portal decompression with or without adjunctive embolization of varices has been a mainstay of endovascular strategy. Conversely, transvenous obliteration evolved in Asia as a direct treatment of VH by obliterating GEVs (particularly GVs) via sclerosis. These approaches were previously viewed as in conflict with one another as obliteration closes GVs but aggravates portal hypertension, whereas TIPS is designed to reduce portal hypertension. Increasingly, however, TIPS and transvenous obliteration are viewed as complimentary procedures that can be combined to reduce bleeding risk and ameliorate sequelae of portal hypertension. Performed together, TIPS and transvenous obliteration result in the elimination of high flow GVs that are at risk for life threatening hemorrhage, with replacement by a man-made endovascular created portosystemic shunt that is not at risk for rupture as well as reduction the risk for post-obliteration EV aggravation, ascites formation, or development of ectopic varices.
Yet, despite a strong mechanistic basis for their combination, there are few studies investigating the effectiveness of combined TIPS plus transvenous obliteration. Thus, the overarching goal of this single center prospective pilot study is to assess the effectiveness and safety of combined TIPS creation plus transvenous obliteration for the treatment of GVs.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ron C Gaba, M.D. M.S.
- Phone Number: 312-996-0242
- Email: rgaba@uic.edu
Study Contact Backup
- Name: Andrew J Lipnik, M.D.
- Phone Number: 312-996-0242
- Email: alipnik@uic.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois at Chicago
-
Contact:
- Ron C Gaba, M.D. M.S.
- Phone Number: 312-996-0242
- Email: rgaba@uic.edu
-
Contact:
- Andrew J Lipnik, M.D.
- Phone Number: 312-996-0242
- Email: alipnik@uic.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged ≥ 18 years
- Ability to provide written consent
- Endoscopically proven acute or recurrent VH from GVs, or high risk GVs
Exclusion Criteria:
- Prior indwelling TIPS
- Prior endovascular obliteration procedure
- Elevated heart pressures (left or right)
- Heart failure or severe valvular insufficiency
- Severe pulmonary hypertension
- Rapidly progressive liver failure
- Severe or uncontrolled hepatic encephalopathy
- Uncontrolled systemic infection or sepsis
- Unrelieved biliary obstruction
- Polycystic liver disease
- Extensive primary or metastatic hepatic malignancy
- Severe uncontrolled coagulopathy
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TIPS-obliteration
Patients undergoing combined transjugular intrahepatic portosystemic shunt (TIPS) creation plus transvenous obliteration for the treatment of gastric varices (GVs).
|
Transjugular intrahepatic portosystemic shunt (TIPS) decompression of portal hypertension coupled with transvenous obliteration of gastric varices (GVs).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endoscopic gastric varices eradication rate
Time Frame: 6-months
|
Effectiveness outcome
|
6-months
|
Endoscopic esophageal varices aggravation/resolution rate
Time Frame: 6-months
|
Effectiveness outcome
|
6-months
|
Imaging gastric variceseradication rate
Time Frame: 1-year
|
Effectiveness outcome
|
1-year
|
Gastric varices rebleeding rate
Time Frame: 1-year
|
Effectiveness outcome
|
1-year
|
Ascites incidence/improvement rate
Time Frame: 1-year
|
Effectiveness outcome
|
1-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TIPS + transvenous obliteration combined technical success rate
Time Frame: 2-weeks
|
Effectiveness outcome
|
2-weeks
|
TIPS + transvenous obliteration combined hemodynamic success rate
Time Frame: 2-weeks
|
Effectiveness outcome
|
2-weeks
|
Procedure related adverse event rate
Time Frame: 30-days
|
Safety outcome
|
30-days
|
Hepatic encephalopathy rate
Time Frame: 1-year
|
Safety outcome
|
1-year
|
Post-TIPS liver failure incidence and degree
Time Frame: 1-year
|
Safety outcome
|
1-year
|
Transplant free survival
Time Frame: 1-year
|
Effectiveness outcome
|
1-year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ron C Gaba, M.D. M.S., University of Illinois at Chicago
Publications and helpful links
General Publications
- Saad WE, Wagner CC, Lippert A, Al-Osaimi A, Davies MG, Matsumoto AH, Angle JF, Caldwell S. Protective value of TIPS against the development of hydrothorax/ascites and upper gastrointestinal bleeding after balloon-occluded retrograde transvenous obliteration (BRTO). Am J Gastroenterol. 2013 Oct;108(10):1612-9. doi: 10.1038/ajg.2013.232. Epub 2013 Aug 13.
- Gaba RC. Retrograde-Antegrade Accelerated Trap Obliteration: A Modified Approach to Transvenous Eradication of Gastric Varices. J Vasc Interv Radiol. 2017 Feb;28(2):291-294. doi: 10.1016/j.jvir.2016.10.004.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Gastrointestinal Diseases
- Liver Diseases
- Esophageal Diseases
- Fibrosis
- Hypertension
- Hemorrhage
- Liver Cirrhosis
- Brain Diseases
- Esophageal and Gastric Varices
- Hypertension, Portal
- Varicose Veins
Other Study ID Numbers
- 2019-0156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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