An interventional study of Coil-assisted Small-diameter Stent Shunt reduction in Hepatic Encephalopathy, Transjugular Intrahepatic Portosystemic Shunt (TIPS) and Portal Hypertension, sponsored by Air Force Military Medical University, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Treatment
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.
Transjugular intrahepatic portosystemic shunt (TIPS) is a cornerstone minimally invasive therapy for complications of portal hypertension, including gastroesophageal variceal hemorrhage and refractory ascites. By creating a low-resistance intrahepatic conduit between the portal venous system and the hepatic vein or inferior vena cava, TIPS effectively lowers portal pressure. However, hepatic encephalopathy (HE) remains among the most common and clinically consequential adverse events after TIPS. Mechanistically, shunting diverts ammonia and other gut-derived neurotoxins away from hepatic detoxification, increasing systemic exposure and precipitating neuropsychiatric symptoms. The incidence of post-TIPS HE is approximately 30%, and nearly 8% of patients develop refractory hepatic encephalopathy (RHE). RHE is characterized by recurrent or persistent HE despite guideline-based medical therapy, including lactulose, rifaximin, nutritional optimization, and correction of precipitating factors. It is associated with substantial reductions in quality of life, frequent hospitalizations, and adverse outcomes related to falls, infections, and progressive malnutrition.
Management of RHE begins with optimized medical therapy-lactulose, rifaximin, dietary optimization (including appropriate protein intake), and identification and treatment of triggers. Nevertheless, a subset of patients continues to experience recurrent grade II or higher HE, prompting consideration of interventional strategies. TIPS shunt reduction is widely regarded as an effective option, yet current techniques for flow modulation have important limitations.
One approach uses adjunctive embolization: a smaller-diameter bare-metal stent is placed within the original TIPS stent to promote thrombosis between the stents and thereby restrict flow. In practice, the magnitude and durability of flow reduction can be unpredictable because flow may persist through the bare-stent interstices, and thrombus formation may be delayed or inconsistent. A second strategy is the parallel-stent technique, in which a balloon-expandable stent is deployed in parallel within the existing shunt to reduce the effective lumen diameter. This method often requires dual venous access (jugular and femoral), increasing procedural complexity, time, and access-related risk, which limits broader applicability. A third category includes constrained stents, either manually modified or commercially preconstrained. Handmade techniques commonly create a suture-induced "waist" in a covered stent; however, the location and degree of constriction are operator dependent and may change after deployment, raising concerns about excessive restriction and rebound portal hypertension. Commercial constrained stents improve standardization but still offer limited post-deployment adjustability. Collectively, these approaches reflect a persistent trade-off between procedural simplicity and hemodynamic control, underscoring the need for a more standardized, predictable, single-access strategy for shunt flow reduction.
To address these unmet needs, we developed a coil-assisted small-diameter covered-stent shunt-reduction technique for patients with RHE after TIPS. The procedure entails placement of a 10-mm coil within the existing TIPS to serve as an anchoring scaffold, followed by deployment of a 6-mm covered stent to achieve controlled reduction in shunt caliber and flow. We hypothesize that this approach can mitigate post-TIPS HE while maintaining an acceptable safety profile.
To test this hypothesis, we designed a single-center ambispective (bidirectional) cohort study. The retrospective cohort includes patients treated between October 2025 and August 2026, and the prospective cohort will enroll patients receiving the same intervention from September 2026 onward, with standardized follow-up. Efficacy and safety outcomes-including HE 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-will be systematically evaluated.
225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 154 interventional studies indexed under Hepatic Encephalopathy.
Browse Hepatic Encephalopathy studies →Air Force Military Medical University, China is the lead sponsor of 178 studies on the registry; 37 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with refractory hepatic encephalopathy after transjugular intrahepatic portosystemic shunt (TIPS) will undergo coil-assisted small-diameter stent shunt reduction.
Procedure: Coil-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.
Incidence of overt hepatic encephalopathy
Hepatic encephalopathy is classified according to the 2022 European Association for the Study of the Liver (EASL) Clinical Practice Guidelines using the West-Haven criteria. Overt hepatic encephalopathy is defined as grade II or higher.
Time frame: From procedure through 6 months post-procedure
Stent occlusion
Stent occlusion will be evaluated by imaging examinations, including Doppler ultrasound, contrast-enhanced CT, or angiography. Stent occlusion is defined as complete loss of patency of the shunt.
Time frame: 6 months post-procedure
variceal rebleeding
Clinically significant rebleeding is defined in accordance with the Baveno V consensus criteria and is identified by recurrence of melena or hematemesis accompanied by any of the following: a) requirement for hospitalization; b) need for blood transfusion; c) hemoglobin decrease of ≥3 g/dL; or d) death within 6 weeks.
Time frame: 6 months post-procedure
New or worsening ascites
Defined as an increase of at least one grade in ascites severity on ultrasound (grading criteria: Grade 0 = none, Grade 1 = mild, Grade 2 = moderate, Grade 3 = large), or persistent ascites requiring paracentesis.Grade 1: Ascites detected only by ultrasound, without abdominal distension. Shifting dullness is negative. Ultrasound shows ascites in abdominal spaces with a depth of \<3 cm.Grade 2 : Moderate abdominal distension with symmetrical enlargement. Shifting dullness may be negative or positive. Ultrasound shows ascites surrounding the intestines but not extending beyond the mid-abdomen, with a depth of 3-10 cm.Grade 3: Marked abdominal distension, positive shifting dullness, and possible abdominal bulging or umbilical hernia. Ultrasound shows ascites occupying the entire abdominal cavity, with a depth of \>10 cm.
Time frame: 6 months post-procedure
Portosystemic pressure gradient (PSPG) before and immediately after the procedure
Portosystemic pressure gradient (PSPG) will be measured before and immediately after the flow restriction procedure to evaluate hemodynamic changes.
Time frame: Pre-procedure and immediately post-procedure
Liver function
Liver function will be evaluated using the Child-Pugh score (based on bilirubin, albumin, INR, ascites, and hepatic encephalopathy) and the Model for End-Stage Liver Disease (MELD) score. Child-Pugh Score A to C ( scores ranging from 5 to 15), with higher scores indicating more severe liver dysfunction and a worse prognosis. Child-Pugh Score Grading : Class A: 5-6 scores；Class B: 7-9 scores；Class C: 10-15 scores. MELD = 3.78 × Ln\[serum total bilirubin (mg/dL)\] + 11.2 × Ln\[INR\] + 9.57 × Ln\[serum creatinine (mg/dL)\] + 6.4 × (etiology: 0 for cholestatic or alcoholic, 1 for other). Risk Stratification : High Risk: \>18 scores; Intermediate Risk: 15-18 scores; Low Risk: ≤14 scores.
Time frame: 6 months post-procedure
Liver transplant-free survival
Defined as the time from the TIPS procedure to the end of follow-up, liver transplantation, or death.
Time frame: 6 months post-procedure
Procedure-related complications
Procedure-related complications will include any immediate complications associated with the procedure, such as puncture site hematoma, arrhythmia, and contrast agent-related allergic reactions.
Time frame: procedure through 30 days post-procedure
Plan to share: Yes
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