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NCT04044248 · ClinicalTrials.gov registry record
TIPS Plus Transvenous Obliteration for Gastric Varices
A clinical trial of Cirrhosis, Liver and Encephalopathy, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- 8
- Enrollment target
- 1
- Study location
NCT04044248: Completed study of Cirrhosis, Liver and Encephalopathy, sponsored by University of Illinois at Chicago.
NCT04044248 is a study of Cirrhosis, Liver and Encephalopathy that has completed, run by University of Illinois at Chicago. The registered enrollment target is 8 participants, below the 242-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04044248, a study of Cirrhosis, Liver and Encephalopathy, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Effectiveness outcome
Conditions Studied
Interventions
- DEVICE TIPS-obliteration
Study Locations (1)
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-04-04 |
| Est. Completion | 2024-06-18 |
What the finished NCT04044248 record still lists
NCT04044248 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 242-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 1 intervention - of which TIPS-obliteration is the first listed.
NCT04044248 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04044248 about?
NCT04044248 is a clinical study titled "TIPS Plus Transvenous Obliteration for 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 oblite...
What is the current status of trial NCT04044248?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2019-04-04. Estimated completion is 2024-06-18.
What conditions does trial NCT04044248 study?
This clinical trial studies the following conditions: Cirrhosis, Liver, Encephalopathy, Hypertension, Portal, Esophageal and Gastric Varices, Bleeding Gastric.
What interventions are being tested in trial NCT04044248?
The interventions under investigation include: TIPS-obliteration (DEVICE).
Who is sponsoring clinical trial NCT04044248?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04044248 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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participants (enrollment target), bucketed by value
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