TIPS Plus Transvenous Obliteration for Gastric Varices

November 16, 2024 updated by: Ron Gaba, University of Illinois at Chicago

Single Center Prospective Pilot Study of Combined Transjugular Intrahepatic Portosystemic Shunt Creation Plus Transvenous Obliteration for the Treatment of Gastric Varices

Variceal hemorrhage (VH) from gastric varices (GVs) results in significant morbidity and mortality among patients with liver cirrhosis. In cases of acute bleeding, refractory bleeding, or high risk GVs, the transjugular intrahepatic portosystemic shunt (TIPS) creation and transvenous variceal obliteration procedures have used to treat GVs. While these techniques are effective, each is associated with limitations, including non-trivial rebleeding and hepatic encephalopathy rates for TIPS and aggravation of esophageal varices, development of new or worsening ascites, and formation of difficult to treat ectopic varices for transvenous obliteration. 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. Yet, despite a strong mechanistic basis for their combination, there are few studies investigating the combined effectiveness of TIPS plus transvenous obliteration. Thus, the aim 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, with the overall goal of improving the clinical outcomes of patients with VH related to GVs. The work proposed could lead to important advances in the treatment of bleeding complications due to liver cirrhosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult persons aged ≥ 18 years with liver disease and endoscopically proven acute or recurrent variceal hemorrhage from gastric varices (GVs) or endoscopically proven high risk GVs referred to Interventional Radiology (IR) for minimally invasive variceal therapy.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
TIPS-obliteration
Patients undergoing combined transjugular intrahepatic portosystemic shunt (TIPS) creation plus transvenous obliteration for the treatment of gastric varices (GVs).
Device: TIPS-obliteration
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ron C Gaba, M.D. M.S., University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-0156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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Drug Interventions

Conditions

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Drug Interventions

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