Coil-Assisted Small-Diameter Covered-Stent Shunt Reduction for Refractory Hepatic Encephalopathy After TIPS
Recruiting · NCT07799948 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Prior transjugular intrahepatic portosystemic shunt (TIPS) placement;
- Confirmation of patent TIPS stent via imaging and/or hemodynamic evaluation;
- 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;
- Treatment with coil-assisted small-diameter stent shunt reduction;
- Signed informed consent provided by the patient or legal representative (for the prospective cohort).
Exclusion criteria
- Presence of severe extrahepatic organ failure (e.g., cardiac, pulmonary, or renal failure);
- Significant missing data that precludes evaluation in the retrospective cohort.
Where it is running
1 location listed.
- Air Force Military Medical University - Xi'an, Shaanxi, China