RecruitingNot ApplicableNCT07799948

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

Coil-Assisted Small-Diameter Covered-Stent Shunt Reduction for Refractory Hepatic Encephalopathy After TIPS: An Ambispective Cohort Study


Sponsor

Air Force Military Medical University, China

Enrollment

30 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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. This single-center ambispective cohort study will evaluate the efficacy and safety of this technique in patients with RHE after TIPS by including both retrospective and prospective cohorts. Outcomes will include hepatic encephalopathy severity and recurrence, stent patency, portal hypertension-related complications, changes in portal pressure gradient, liver function parameters, transplant-free survival, and procedure-related adverse events.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Coil-assisted Small-diameter Stent Shunt reduction for people with hepatic encephalopathy, liver cirrhosis, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURECoil-assisted Small-diameter Stent Shunt reduction

Coil-assisted Small-diameter Stent Shunt reduction: 1. Puncture of the right internal jugular vein, followed by catheter introduction into the existing TIPS stent. 2. Performance of portal venography and measurement of baseline portal pressure gradient. 3. Deployment of a 10-mm coil within the existing TIPS stent as an anchoring point. 4. Delivery and deployment of a 6-mm covered stent within the existing TIPS stent to create a narrowed flow channel. 5. Balloon dilation at both ends of the stent to ensure adequate apposition with the original TIPS stent. 6. Post-procedural portal venography to assess stent patency, portal pressure gradient, and hepatic perfusion.


Locations(1)

Air Force Military Medical University

Xi'an, Shaanxi, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07799948


Related Trials