Coil-assisted small-diameter stent shunt reduction for refractory HE after TIPS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center ambispective study evaluating a coil-anchored, small-diameter covered-stent approach to reduce shunt flow after TIPS in patients with refractory hepatic encephalopathy. The method uses coils as an anchor inside the TIPS tract, followed by placement of a 6-mm covered stent to achieve controlled flow reduction. The study aims to assess both safety and efficacy, comparing outcomes in patients who receive the intervention to historical controls or retrospective data. Standard medical therapies remain the baseline for all participants, with the intervention added for those with persistent HE. Results will inform whether this technique can provide more precise shunt flow control and improve HE-related outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Air Force Military Medical University
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Principal investigator: Jun Tie — Air Force Military Medical University, China
• Study coordinator: Jun Tie, M.D.,Ph.D
• Email: tiejun7776@163.com
• Phone: +862984771537

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.