Hepatic EncephalopathyNCT07799948
Coil-Assisted Small-Diameter Covered-Stent Shunt Reduction for Refractory Hepatic Encephalopathy After TIPS
A study testing Coil-assisted Small-diameter Stent Shunt reduction in people with Hepatic Encephalopathy and Transjugular Intrahepatic Portosystemic Shunt (TIPS), run by Air Force Military Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Encephalopathy, Transjugular Intrahepatic Portosystemic Shunt (TIPS), Portal Hypertension
- What is being tested?
- Coil-assisted Small-diameter Stent Shunt reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Presence of severe extrahepatic organ failure (e.g., cardiac, pulmonary, or renal failure);
- Significant missing data that precludes evaluation in the retrospective cohort.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Air Force Military Medical University
Xi'an, Shaanxi, 710032
Jun Tie, M.D.,Ph.D, +862984771537, tiejun7776@163.com
About this study
Official title: Coil-Assisted Small-Diameter Covered-Stent Shunt Reduction for Refractory Hepatic Encephalopathy After TIPS: An Ambispective Cohort Study
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.
Read the detailed description
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.
- Conditions
- Hepatic Encephalopathy, Transjugular Intrahepatic Portosystemic Shunt (TIPS), Portal Hypertension, Liver Cirrhosis
- Being tested
- Coil-assisted Small-diameter Stent Shunt reduction
- Keywords
- Refractory hepatic encephalopathy, TIPS reduction, Shunt reduction, Coil-assisted small-diameter stent shunt reduction
- Medical subject headings
- Hepatic Encephalopathy, Hypertension, Portal, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coil-assisted Small-diameter Stent Shunt reductionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Coil-assisted Small-diameter Stent Shunt reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From procedure through 6 months post-procedure
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: procedure through 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tie Jun, Air Force Military Medical University, China
- Investigators
- Jun Tie, Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799948
- Sponsor's protocol ID
- KY20262338-F-1
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coil-Assisted Small-Diameter Covered-Stent Shunt Reduction for Refractory Hepatic Encephalopathy After TIPS: An Ambispective Cohort Study
- ClinicalTrials.gov ID
- NCT07799948
- Acronym / sponsor ID
- KY20262338-F-1
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coil-assisted small-diameter stent shunt reduction | Experimental | Procedure: Coil-assisted Small-diameter Stent Shunt reductionPatients with refractory hepatic encephalopathy after transjugular intrahepatic portosystemic shunt (TIPS) will undergo coil-assisted small-diameter stent shunt reduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- Presence of severe extrahepatic organ failure (e.g., cardiac, pulmonary, or renal failure);
- Significant missing data that precludes evaluation in the retrospective cohort.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coil-assisted Small-diameter Stent Shunt reductionCoil-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. | Procedure or surgery | Coil-assisted small-diameter stent shunt reduction |
Primary outcome
Incidence of overt hepatic encephalopathy
Time frame: From procedure through 6 months post-procedure
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.
7 secondary outcomes
Stent occlusion
Time frame: 6 months post-procedure
variceal rebleeding
Time frame: 6 months post-procedure
New or worsening ascites
Time frame: 6 months post-procedure
Portosystemic pressure gradient (PSPG) before and immediately after the procedure
Time frame: Pre-procedure and immediately post-procedure
Liver function
Time frame: 6 months post-procedure
Liver transplant-free survival
Time frame: 6 months post-procedure
Procedure-related complications
Time frame: procedure through 30 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Tie principal investigator
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coil-assisted Small-diameter Stent Shunt reduction in people with Hepatic Encephalopathy and Transjugular Intrahepatic Portosystemic Shunt (TIPS), run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Tie, M.D.,Ph.D (+862984771537, tiejun7776@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of overt hepatic encephalopathy (time frame: From procedure through 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.