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Coil-Assisted Small-Diameter Covered-Stent Shunt Reduction for Refractory Hepatic Encephalopathy After TIPS

RecruitingNAAges 18 Years - anyAllAir Force Military Medical University, China
NCT07799948 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Refractory hepatic encephalopathy (RHE) after transjugular intrahepatic portosystemic shunt (TIPS) is a serious complication that can markedly impair quality of life and worsen prognosis. Standard medical management-including lactulose, rifaximin, nutritional support, and correction of precipitating factors-is routinely used; however, some patients continue to experience recurrent hepatic encephalopathy despite optimized therapy. TIPS shunt reduction is an established interventional option for RHE, but current techniques may provide limited ability to precisely control the degree of flow reduction while maintaining procedural safety. The investigators developed a coil-assisted, small-diameter covered-stent technique that deploys coils as an anchor within the existing TIPS tract, followed by placement of a 6-mm balloon-dilated covered stent to achieve controlled reduction in shunt flow.

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📋 Eligibility rules (as published)
Inclusion Criteria 1. Prior transjugular intrahepatic portosystemic shunt (TIPS) placement; 2. Confirmation of patent TIPS stent via imaging and/or hemodynamic evaluation; 3. Recurrent episodes of grade II or higher hepatic encephalopathy (by West-Haven criteria) occurring more than twice within a 4-week period, despite standard medical therapy including lactulose, rifaximin, nutritional support, and correction of precipitating factors; 4. Treatment with coil-assisted small-diameter stent shunt reduction; 5. Signed informed consent provided by the patient or legal representative (for the prospective cohort). Exclusion Criteria 1. Presence of severe extrahepatic organ failure (e.g., cardiac, pulmonary, or renal failure); 2. Significant missing data that precludes evaluation in the retrospective cohort.
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What it tests

  • Coil-assisted Small-diameter Stent Shunt reduction
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Where

1 site
Air Force Military Medical University
Xi'an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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