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TIPS Plus Transvenous Obliteration for Gastric Varices

NCT04044248 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2024-11-19

No results posted yet for this study

Summary

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.

Conditions

  • Cirrhosis, Liver
  • Hypertension, Portal
  • Esophageal and Gastric Varices
  • Bleeding Gastric
  • Encephalopathy

Interventions

DEVICE

TIPS-obliteration

Transjugular intrahepatic portosystemic shunt (TIPS) decompression of portal hypertension coupled with transvenous obliteration of gastric varices (GVs).

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Ron C Gaba, M.D. M.S. · University of Illinois at Chicago

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2024-06-18
Completion
2024-06-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04044248 on ClinicalTrials.gov