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

NCT07799948 | Recruiting DMC

• 1 other identifier: KY20262338-F-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Encephalopathy; Transjugular Intrahepatic Portosystemic Shunt (TIPS); Portal Hypertension; Liver Cirrhosis

Keywords

Refractory hepatic encephalopathy; TIPS reduction; Shunt reduction; Coil-assisted small-diameter stent shunt reduction

Outcome Measures

Primary Outcomes (1)

• 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.

  From procedure through 6 months post-procedure

Secondary Outcomes (7)

• Stent occlusion

  6 months post-procedure

• variceal rebleeding

  6 months post-procedure

• New or worsening ascites

  6 months post-procedure

• Portosystemic pressure gradient (PSPG) before and immediately after the procedure

  Pre-procedure and immediately post-procedure

• Liver function

  6 months post-procedure

Study Arms (1)

Coil-assisted small-diameter stent shunt reduction

EXPERIMENTAL

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

Interventions

Coil-assisted Small-diameter Stent Shunt reduction PROCEDURE

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.

Coil-assisted small-diameter stent shunt reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Presence of severe extrahepatic organ failure (e.g., cardiac, pulmonary, or renal failure);
• Significant missing data that precludes evaluation in the retrospective cohort.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy; Hypertension, Portal; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Tie

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Tie, M.D.,Ph.D

CONTACT

+862984771537; tiejun7776@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of clinical research

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)