NCT04044248Completed
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
Source: ClinicalTrials.gov · Last updated 19 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 8 (actual)
- First submitted
- 31 Jul 2019
- Start date
- 4 Apr 2019
- Primary completion date
- 18 Jun 2024
- Lead sponsor
- University of Illinois Chicago
- Diseases
- High blood pressure
- NCT number
- NCT04044248
What you commit to
- Study type: Observational
- Participants enrolled: 8
- From 4 Apr 2019 to the primary completion date, 18 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior indwelling TIPS
- Prior endovascular obliteration procedure
Other illness
- Elevated heart pressures (left or right)
- Heart failure or severe valvular insufficiency
- Severe pulmonary hypertension
- Rapidly progressive liver failure
- Uncontrolled systemic infection or sepsis
- Polycystic liver disease
- Extensive primary or metastatic hepatic malignancy
Other
- Severe or uncontrolled hepatic encephalopathy
- Unrelieved biliary obstruction
- Severe uncontrolled coagulopathy
- Pregnancy
Who the study is looking for
- Aged ≥ 18 years
- Ability to provide written consent
- Endoscopically proven acute or recurrent VH from GVs, or high risk GVs
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.