Hepatic Encephalopathy (HE)THEUDCANCT07273734
UDCA to Prevent Post-TIPS Hepatic Encephalopathy
A study testing Ursodeoxycholic Acid (UDCA) and Lactulose in people with Hepatic Encephalopathy (HE) and TIPS, run by West China Hospital at 1 site in China.
Trial summary
Hepatic encephalopathy (HE) commonly occurs after transjugular intrahepatic portosystemic shunt (TIPS). Ursodeoxycholic acid (UDCA) has been reported to alleviate neurodegenerative disease recently. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Encephalopathy (HE), TIPS
- What is being tested?
- Ursodeoxycholic Acid (UDCA) and Lactulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Confirmed cirrhosis (biopsy, elastography, or standard radiologic/biochemical criteria).
- Elective TIPS for (a) refractory/recurrent ascites and/or (b) recurrent variceal bleeding not responsive to treatment with endoscopic band ligation and beta-blockers.
- Preemptive TIPS for patients with variceal bleeding and Child-Pugh C (10-13 points), patients with Child-Pugh B and active bleeding during endoscopy, or patients with hepatic venous pressure gradient (HVPG) ≥ 20 mmHg.
- Ability to start study drug within 72 hours before TIPS.
- Signed informed consent.
Who cannot join
- Contraindications to TIPS (e.g., severe heart failure ≥NYHA III, severe pulmonary hypertension, uncontrolled sepsis, advanced HCC at risk with TIPS, unrelieved biliary obstruction, Child-Pugh score >13, main-trunk PVT if not recanalizable, technical infeasibility).
- Prior OHE grade II-IV without precipitating factor; overt neurological disease affecting cognition (e.g., Parkinson's, Alzheimer's).
- Current or planned ursodeoxycholic acid (UDCA) therapy for an approved indication (e.g., primary biliary cholangitis), or UDCA use within the prior 3 months.
- Current/recent rifaximin use (<3 months) or strong UDCA contraindication/hypersensitivity.
- Salvage TIPS.
- Non-cirrhotic portal hypertension.
- Pregnancy/lactation.
- Any condition that, in investigators' judgment, precludes safe participation.
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
West China Hospital, Sichuan University
Chengdu
Xiaoze Wang, MD, (+86)15208207573, wang_xiaoze@wchscu.cn
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Ursodeoxycholic Acid Plus Lactulose vs Lactulose Alone for the Prevention of Overt Hepatic Encephalopathy After TIPS Placement
Hepatic encephalopathy (HE) commonly occurs after transjugular intrahepatic portosystemic shunt (TIPS). Ursodeoxycholic acid (UDCA) has been reported to alleviate neurodegenerative disease recently. This open-label multicenter randomized controlled trial tests whether adding UDCA (13-15 mg/kg/day) to standard lactulose prophylaxis reduces the incidence of overt HE (OHE; West Haven grade II-IV) after TIPS, compared with lactulose alone. The regimen starts within 72 hours before TIPS and continues for 3 months. The trial aims to evaluate the effect of UDCA in reducing the incidence of post-TIPS OHE.
Read the detailed description
Post-TIPS OHE occurs in 35-50% of patients and worsens quality of life and resource use. Existing guidance consistently recommends lactulose as the backbone therapy for HE and for secondary prophylaxis, titrated to 2-3 soft stools/day; however, evidence for primary prophylaxis after TIPS has been limited and heterogeneous, and consensus varies across documents. Hydrophilic bile acids, especially ursodeoxycholic acid (UDCA), have demonstrated important anti-apoptotic and neuroprotective activities in clinical practice. Published experimental and clinical evidence suggests its potential therapeutic use as a disease-modifier in neurodegenerative and metabolic brain diseases. This trial evaluates whether bile-acid modulation with UDCA at standard hepatology dosing (13-15 mg/kg/day) combined with lactulose reduces early post-TIPS OHE. The protocol uses stratified randomization, prespecified outcome adjudication (West Haven), and intention-to-treat analysis. Key secondary endpoints include mortality, transplant-free survival, minimal HE tests (PHES, Stroop test), frailty, quality of life, and bile-acid/metabolomic profiling in optional sub-studies.
- Conditions
- Hepatic Encephalopathy (HE), TIPS
- Being tested
- Ursodeoxycholic Acid (UDCA), Lactulose
- Keywords
- TIPS, UDCA, Hepatic Encephalopathy (HE), Ursodeoxycholic acid
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic Acid (UDCA)Drug
13-15 mg/kg/day orally, in divided doses (BID), starting ≤72 hours before TIPS and continued for 3 months.
LactuloseDrug
Syrup 25 mL BID, initiated after TIPS procedure, titrated to 1-2 soft stools/day, with dose reduction if diarrhea occurs.
| Study group | Role | What they receive |
|---|---|---|
| UDCA + Lactulose | Experimental | Ursodeoxycholic acid (UDCA) 13-15 mg/kg/day orally, in divided doses (BID), starting ≤72 hours before TIPS and continued for 3 months. Lactulose syrup (25 mL BID) is initiated after TIPS procedure, titrated to achieve 1-2 soft stools per day, with stepwise dose reduction if diarrhea occurs. Receives: Drug: Ursodeoxycholic Acid (UDCA); Drug: Lactulose |
| Lactulose Alone | Active comparator | Lactulose syrup (25 mL BID) is initiated after TIPS procedure, titrated to achieve 1-2 soft stools per day, with dose reduction as needed if diarrhea develops. Receives: Drug: Lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Overt Hepatic Encephalopathy (OHE) within 3 Months After TIPS
OHE defined as first occurrence of West Haven grade II-IV hepatic encephalopathy within 3 months after covered TIPS, adjudicated by investigator assessment according to West Haven criteria.
Measured: From TIPS procedure (Day 0) to 3 months post-TIPS (Day 90).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 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.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hepatic Encephalopathy (HE)Studies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Kunming Medical University, Qianjiang Central Hospital of Chongqing, The Third People's Hospital of Kunming City
- Responsible party
- Principal investigator, Xiaoze Wang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273734
- Sponsor's protocol ID
- THE001
- Acronym
- THEUDCA
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maharshi S, Sharma BC. Prophylaxis of hepatic encephalopathy: current and future drug targets. Hepatol Int. 2024 Aug;18(4):1096-1109. doi: 10.1007/s12072-024-10647-9. Epub 2024 Mar 16.
PubMed 38492132Kronsten VT, Paintsil EK, Rodrigues S, Seager MJ, Bernal W, Shawcross DL. Hepatic Encephalopathy: When Lactulose and Rifaximin Are Not Working. Gastroenterology. 2025 Jun;168(6):1076-1084.e1. doi: 10.1053/j.gastro.2025.01.010. Epub 2025 Jan 24. No abstract available.
PubMed 39864468Djernes L, Vilstrup H, Ott P, Eriksen PL. Blood ammonia concentration measurement - effects of sampling site and cirrhosis during induced hyperammonaemia. Metab Brain Dis. 2024 Nov 20;40(1):21. doi: 10.1007/s11011-024-01442-4.
PubMed 39565434Shawcross DL, Thabut D, Amodio P. Ammonia - an enduring foe - What evaluating whole body ammonia metabolism can teach us about cirrhosis and therapies treating hepatic encephalopathy. J Hepatol. 2023 Aug;79(2):266-268. doi: 10.1016/j.jhep.2023.04.039. Epub 2023 May 12. No abstract available.
PubMed 37178732Wang X, Luo X, Yang L. Achieving an effective pressure reduction after TIPS: The need for a new target. J Hepatol. 2021 Jul;75(1):246-248. doi: 10.1016/j.jhep.2021.02.010. Epub 2021 Feb 20. No abstract available.
PubMed 33621635Wang X, Liu G, Wu J, Xiao X, Yan Y, Guo Y, Yang J, Li X, He Y, Yang L, Luo X. Small-Diameter Transjugular Intrahepatic Portosystemic Shunt versus Endoscopic Variceal Ligation Plus Propranolol for Variceal Rebleeding in Advanced Cirrhosis. Radiology. 2023 Aug;308(2):e223201. doi: 10.1148/radiol.223201.
PubMed 37606572Xiang Y, Tie J, Wang G, Zhuge Y, Wu H, Zhu X, Xue H, Liu S, Yang L, Xu J, Zhang F, Zhang M, Wei B, Li P, Wang Z, Wu W, Chen C, Yang S, Han Y, Tang C, Qi X, Zhang C. Post-TIPS Overt Hepatic Encephalopathy Increases Long-Term but Not Short-Term Mortality in Cirrhotic Patients With Variceal Bleeding: A Large-Scale, Multicenter Real-World Study. Aliment Pharmacol Ther. 2025 Apr;61(7):1183-1196. doi: 10.1111/apt.18509. Epub 2025 Feb 17.
PubMed 39962750Liu J, Ma J, Yang C, Chen M, Shi Q, Zhou C, Huang S, Chen Y, Wang Y, Li T, Xiong B. Sarcopenia in Patients with Cirrhosis after Transjugular Intrahepatic Portosystemic Shunt Placement. Radiology. 2022 Jun;303(3):711-719. doi: 10.1148/radiol.211172. Epub 2022 Mar 15.
PubMed 35289658Lv Y, Wang Q, Luo B, Bai W, Li M, Li K, Wang Z, Xia D, Guo W, Li X, Yuan J, Zhang N, Wang X, Xie H, Pan Y, Nie Y, Yin Z, Fan D, Han G. Identifying the optimal measurement timing and hemodynamic targets of portal pressure gradient after TIPS in patients with cirrhosis and variceal bleeding. J Hepatol. 2025 Feb;82(2):245-257. doi: 10.1016/j.jhep.2024.08.007. Epub 2024 Aug 22.
PubMed 39181214Ehrenbauer AF, Egge JFM, Gabriel MM, Tiede A, Dirks M, Witt J, Wedemeyer H, Maasoumy B, Weissenborn K. Comparison of 6 tests for diagnosing minimal hepatic encephalopathy and predicting clinical outcome: A prospective, observational study. Hepatology. 2024 Aug 1;80(2):389-402. doi: 10.1097/HEP.0000000000000770. Epub 2024 Feb 13.
PubMed 38349709Casadaban LC, Parvinian A, Minocha J, Lakhoo J, Grant CW, Ray CE Jr, Knuttinen MG, Bui JT, Gaba RC. Clearing the Confusion over Hepatic Encephalopathy After TIPS Creation: Incidence, Prognostic Factors, and Clinical Outcomes. Dig Dis Sci. 2015 Apr;60(4):1059-66. doi: 10.1007/s10620-014-3391-0. Epub 2014 Oct 15.
PubMed 25316553
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Ursodeoxycholic Acid Plus Lactulose vs Lactulose Alone for the Prevention of Overt Hepatic Encephalopathy After TIPS Placement
- ClinicalTrials.gov ID
- NCT07273734
- Acronym / sponsor ID
- THEUDCA / THE001
- Conditions
- Hepatic Encephalopathy (HE), TIPS
- Keywords
- TIPS, UDCA, Hepatic Encephalopathy (HE), Ursodeoxycholic acid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Kunming Medical University, Qianjiang Central Hospital of Chongqing, The Third People's Hospital of Kunming City
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Dec 2025 (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.
Hepatic encephalopathy (HE) commonly occurs after transjugular intrahepatic portosystemic shunt (TIPS). Ursodeoxycholic acid (UDCA) has been reported to alleviate neurodegenerative disease recently. This open-label multicenter randomized controlled trial tests whether adding UDCA (13-15 mg/kg/day) to standard lactulose prophylaxis reduces the incidence of overt HE (OHE; West Haven grade II-IV) after TIPS, compared with lactulose alone. The regimen starts within 72 hours before TIPS and continues for 3 months. The trial aims to evaluate the effect of UDCA in reducing the incidence of post-TIPS OHE.
Detailed description
Post-TIPS OHE occurs in 35-50% of patients and worsens quality of life and resource use. Existing guidance consistently recommends lactulose as the backbone therapy for HE and for secondary prophylaxis, titrated to 2-3 soft stools/day; however, evidence for primary prophylaxis after TIPS has been limited and heterogeneous, and consensus varies across documents. Hydrophilic bile acids, especially ursodeoxycholic acid (UDCA), have demonstrated important anti-apoptotic and neuroprotective activities in clinical practice. Published experimental and clinical evidence suggests its potential therapeutic use as a disease-modifier in neurodegenerative and metabolic brain diseases. This trial evaluates whether bile-acid modulation with UDCA at standard hepatology dosing (13-15 mg/kg/day) combined with lactulose reduces early post-TIPS OHE. The protocol uses stratified randomization, prespecified outcome adjudication (West Haven), and intention-to-treat analysis. Key secondary endpoints include mortality, transplant-free survival, minimal HE tests (PHES, Stroop test), frailty, quality of life, and bile-acid/metabolomic profiling in optional sub-studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UDCA + Lactulose | Experimental | Drug: Ursodeoxycholic Acid (UDCA), Drug: LactuloseUrsodeoxycholic acid (UDCA) 13-15 mg/kg/day orally, in divided doses (BID), starting ≤72 hours before TIPS and continued for 3 months. Lactulose syrup (25 mL BID) is initiated after TIPS procedure, titrated to achieve 1-2 soft stools per day, with stepwise dose reduction if diarrhea occurs. |
| Lactulose Alone | Active comparator | Drug: LactuloseLactulose syrup (25 mL BID) is initiated after TIPS procedure, titrated to achieve 1-2 soft stools per day, with dose reduction as needed if diarrhea develops. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years.
- Confirmed cirrhosis (biopsy, elastography, or standard radiologic/biochemical criteria).
- Elective TIPS for (a) refractory/recurrent ascites and/or (b) recurrent variceal bleeding not responsive to treatment with endoscopic band ligation and beta-blockers.
- Preemptive TIPS for patients with variceal bleeding and Child-Pugh C (10-13 points), patients with Child-Pugh B and active bleeding during endoscopy, or patients with hepatic venous pressure gradient (HVPG) ≥ 20 mmHg.
- Ability to start study drug within 72 hours before TIPS.
Key exclusion criteria (8 listed)
- Contraindications to TIPS (e.g., severe heart failure ≥NYHA III, severe pulmonary hypertension, uncontrolled sepsis, advanced HCC at risk with TIPS, unrelieved biliary obstruction, Child-Pugh score >13, main-trunk PVT if not recanalizable, technical infeasibility).
- Prior OHE grade II-IV without precipitating factor; overt neurological disease affecting cognition (e.g., Parkinson's, Alzheimer's).
- Current or planned ursodeoxycholic acid (UDCA) therapy for an approved indication (e.g., primary biliary cholangitis), or UDCA use within the prior 3 months.
- Current/recent rifaximin use (<3 months) or strong UDCA contraindication/hypersensitivity.
- Salvage TIPS.
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 |
|---|---|---|
| Ursodeoxycholic Acid (UDCA)13-15 mg/kg/day orally, in divided doses (BID), starting ≤72 hours before TIPS and continued for 3 months. | Drug | UDCA + Lactulose |
| LactuloseSyrup 25 mL BID, initiated after TIPS procedure, titrated to 1-2 soft stools/day, with dose reduction if diarrhea occurs. | Drug | Lactulose Alone, UDCA + Lactulose |
Primary outcome
Incidence of Overt Hepatic Encephalopathy (OHE) within 3 Months After TIPS
Time frame: From TIPS procedure (Day 0) to 3 months post-TIPS (Day 90).
OHE defined as first occurrence of West Haven grade II-IV hepatic encephalopathy within 3 months after covered TIPS, adjudicated by investigator assessment according to West Haven criteria.
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 9 Dec 2025.
- Results publication: PubMed 38492132Maharshi S, Sharma BC. Prophylaxis of hepatic encephalopathy: current and future drug targets. Hepatol Int. 2024 Aug;18(4):1096-1109. doi: 10.1007/s12072-024-10647-9. Epub 2024 Mar 16.
- Results publication: PubMed 39864468Kronsten VT, Paintsil EK, Rodrigues S, Seager MJ, Bernal W, Shawcross DL. Hepatic Encephalopathy: When Lactulose and Rifaximin Are Not Working. Gastroenterology. 2025 Jun;168(6):1076-1084.e1. doi: 10.1053/j.gastro.2025.01.010. Epub 2025 Jan 24. No abstract available.
- Results publication: PubMed 39565434Djernes L, Vilstrup H, Ott P, Eriksen PL. Blood ammonia concentration measurement - effects of sampling site and cirrhosis during induced hyperammonaemia. Metab Brain Dis. 2024 Nov 20;40(1):21. doi: 10.1007/s11011-024-01442-4.
- Results publication: PubMed 37178732Shawcross DL, Thabut D, Amodio P. Ammonia - an enduring foe - What evaluating whole body ammonia metabolism can teach us about cirrhosis and therapies treating hepatic encephalopathy. J Hepatol. 2023 Aug;79(2):266-268. doi: 10.1016/j.jhep.2023.04.039. Epub 2023 May 12. No abstract available.
- Results publication: PubMed 33621635Wang X, Luo X, Yang L. Achieving an effective pressure reduction after TIPS: The need for a new target. J Hepatol. 2021 Jul;75(1):246-248. doi: 10.1016/j.jhep.2021.02.010. Epub 2021 Feb 20. No abstract available.
- Results publication: PubMed 37606572Wang X, Liu G, Wu J, Xiao X, Yan Y, Guo Y, Yang J, Li X, He Y, Yang L, Luo X. Small-Diameter Transjugular Intrahepatic Portosystemic Shunt versus Endoscopic Variceal Ligation Plus Propranolol for Variceal Rebleeding in Advanced Cirrhosis. Radiology. 2023 Aug;308(2):e223201. doi: 10.1148/radiol.223201.
- Results publication: PubMed 39962750Xiang Y, Tie J, Wang G, Zhuge Y, Wu H, Zhu X, Xue H, Liu S, Yang L, Xu J, Zhang F, Zhang M, Wei B, Li P, Wang Z, Wu W, Chen C, Yang S, Han Y, Tang C, Qi X, Zhang C. Post-TIPS Overt Hepatic Encephalopathy Increases Long-Term but Not Short-Term Mortality in Cirrhotic Patients With Variceal Bleeding: A Large-Scale, Multicenter Real-World Study. Aliment Pharmacol Ther. 2025 Apr;61(7):1183-1196. doi: 10.1111/apt.18509. Epub 2025 Feb 17.
- Results publication: PubMed 35289658Liu J, Ma J, Yang C, Chen M, Shi Q, Zhou C, Huang S, Chen Y, Wang Y, Li T, Xiong B. Sarcopenia in Patients with Cirrhosis after Transjugular Intrahepatic Portosystemic Shunt Placement. Radiology. 2022 Jun;303(3):711-719. doi: 10.1148/radiol.211172. Epub 2022 Mar 15.
- Results publication: PubMed 39181214Lv Y, Wang Q, Luo B, Bai W, Li M, Li K, Wang Z, Xia D, Guo W, Li X, Yuan J, Zhang N, Wang X, Xie H, Pan Y, Nie Y, Yin Z, Fan D, Han G. Identifying the optimal measurement timing and hemodynamic targets of portal pressure gradient after TIPS in patients with cirrhosis and variceal bleeding. J Hepatol. 2025 Feb;82(2):245-257. doi: 10.1016/j.jhep.2024.08.007. Epub 2024 Aug 22.
- Results publication: PubMed 38349709Ehrenbauer AF, Egge JFM, Gabriel MM, Tiede A, Dirks M, Witt J, Wedemeyer H, Maasoumy B, Weissenborn K. Comparison of 6 tests for diagnosing minimal hepatic encephalopathy and predicting clinical outcome: A prospective, observational study. Hepatology. 2024 Aug 1;80(2):389-402. doi: 10.1097/HEP.0000000000000770. Epub 2024 Feb 13.
- Results publication: PubMed 25316553Casadaban LC, Parvinian A, Minocha J, Lakhoo J, Grant CW, Ray CE Jr, Knuttinen MG, Bui JT, Gaba RC. Clearing the Confusion over Hepatic Encephalopathy After TIPS Creation: Incidence, Prognostic Factors, and Clinical Outcomes. Dig Dis Sci. 2015 Apr;60(4):1059-66. doi: 10.1007/s10620-014-3391-0. Epub 2014 Oct 15.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ursodeoxycholic Acid (UDCA) and Lactulose in people with Hepatic Encephalopathy (HE) and TIPS, run by West China Hospital 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 9 Dec 2025. 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 Xiaoze Wang, MD ((+86)15208207573, wang_xiaoze@wchscu.cn), 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 (OHE) within 3 Months After TIPS (time frame: From TIPS procedure (Day 0) to 3 months post-TIPS (Day 90).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07273734, which also lists 11 linked publications.
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 9 Dec 2025.