Liver CirrhosisU-TIPSNCT07587671
Underdilated VCX-TIPS Versus EVL Plus NSBB for Secondary Prophylaxis of Variceal Bleeding in Cirrhosis
A study testing Underdilated VCX-TIPS, Endoscopic Variceal Ligation and Nonselective Beta-Blockers in people with Liver Cirrhosis and Portal Hypertension, run by West China Hospital at 3 sites in China.
Trial summary
Variceal bleeding is a major complication of portal hypertension in patients with cirrhosis and is associated with substantial risks of rebleeding and death. Current guidelines recommend endoscopic variceal ligation combined with nonselective beta-blockers as standard secondary prophylaxis for esophageal variceal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension, Gastroesophageal Varices Bleeding
- What is being tested?
- Underdilated VCX-TIPS, Endoscopic Variceal Ligation and Nonselective Beta-Blockers
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesChina
- Study dates
- 1 Aug 2026to 30 Jul 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years, regardless of sex.
- Diagnosis of liver cirrhosis based on previous histology, imaging, laboratory tests, and/or clinical manifestations.
- Hospitalization for acute upper gastrointestinal bleeding, with endoscopic confirmation that the bleeding is related to esophageal varices or type 1 gastroesophageal varices.
- Successful control of acute bleeding after standard acute-phase treatment, with stable vital signs and entry into the secondary prophylaxis phase.
- Child-Pugh score of 5 to 13.
- The investigator judges that both underdilated VCX-TIPS and EVL plus NSBB are clinically feasible and that randomization is appropriate.
- The participant or legally authorized representative understands the study procedures and voluntarily signs written informed consent.
Who cannot join
- Hemodynamic instability, persistent active bleeding, or need for immediate rescue TIPS, surgical hemostasis, or interventional radiologic hemostasis.
- A strong current indication for early or pre-emptive TIPS that makes randomization to EVL plus NSBB clinically inappropriate.
- Child-Pugh score greater than 13.
- Previous TIPS, surgical portosystemic shunt, BRTO, CARTO, PARTO, or other procedures that substantially alter portosystemic blood flow.
- Isolated gastric varices, type 2 gastroesophageal varices, ectopic varices, or a bleeding source other than esophageal varices or type 1 gastroesophageal varices.
- Non-cirrhotic portal hypertension.
Show all 15Show fewer
- Cavernous transformation of the portal vein or portal venous thrombosis that makes standardized TIPS technically infeasible.
- Previous recurrent or refractory overt hepatic encephalopathy, or a history of West Haven grade II to IV overt hepatic encephalopathy unrelated to gastrointestinal bleeding.
- Severe heart failure, severe pulmonary hypertension, severe tricuspid regurgitation, right heart failure, or other contraindications to TIPS.
- Uncontrolled severe infection, sepsis, or multiple organ failure.
- Hepatocellular carcinoma beyond the Milan criteria or other advanced malignancy.
- Severe renal insufficiency requiring long-term renal replacement therapy.
- Pregnancy or breastfeeding.
- Absolute contraindication to EVL, NSBB, or TIPS.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study or unable to complete follow-up.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
West China Hospital, Sichuan University
Chengdu, 610041
Xiaoze Wang, MD, (+86)15208207573, wang_xiaoze@wchscu.cn
Xiaoze Wang, MD
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 610041
Yongjun Zhu, MD, (+86)187343034366, hp545204493@126.com
West China Xiamen Hospital, Sichuan University
Xiamen, 610041
Bingcan Yang, MD, (+86)13534322322, yang_bingcan@wchscu.cn
About this study
Official title: Underdilated VIATORR Controlled Expansion Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Nonselective Beta-Blockers for Secondary Prophylaxis of Variceal Bleeding in Patients With Cirrhosis: A Multicenter, Open-Label, Randomized Controlled Trial
Variceal bleeding is a major complication of portal hypertension in patients with cirrhosis and is associated with substantial risks of rebleeding and death. Current guidelines recommend endoscopic variceal ligation combined with nonselective beta-blockers as standard secondary prophylaxis for esophageal variceal bleeding and type 1 gastroesophageal variceal bleeding. Transjugular intrahepatic portosystemic shunt can markedly reduce portal pressure and prevent recurrent variceal bleeding, but its broader use in secondary prophylaxis is limited by the risk of post-TIPS hepatic encephalopathy and liver function deterioration.
The VIATORR Controlled Expansion stent is designed to allow controlled expansion between 8 and 10 mm. However, even 8-mm TIPS may still be associated with a substantial risk of overt hepatic encephalopathy. This trial evaluates an underdilated VCX-TIPS strategy, in which a commercially available 8-10 mm VIATORR Controlled Expansion stent is initially dilated only with a 6-mm balloon, aiming to achieve sufficient portal decompression while reducing the risk of excessive shunting.
This is a prospective, multicenter, open-label, parallel-group, randomized superiority trial. Eligible patients with cirrhosis who have recovered from acute esophageal variceal bleeding or type 1 gastroesophageal variceal bleeding and have entered the secondary prophylaxis phase will be randomly assigned in a 1:1 ratio to receive either underdilated VCX-TIPS or endoscopic variceal ligation plus nonselective beta-blockers. The primary outcome is the composite of all-cause death or clinically significant upper gastrointestinal rebleeding within 1 year after randomization.
Read the detailed description
This multicenter randomized controlled trial is designed to compare an underdilated VCX-TIPS strategy with standard secondary prophylaxis using endoscopic variceal ligation plus nonselective beta-blockers in patients with cirrhosis who have experienced esophageal variceal bleeding or type 1 gastroesophageal variceal bleeding.
Patients with cirrhosis aged 18 to 75 years who have achieved successful control of acute variceal bleeding and are clinically stable will be screened. Eligible participants will be randomized after written informed consent has been obtained, generally between 5 and 21 days after successful hemostasis. Patients with ongoing bleeding, hemodynamic instability, a need for immediate rescue TIPS, or a strong indication for early or pre-emptive TIPS that makes randomization to EVL plus NSBB inappropriate will be excluded.
Participants assigned to the experimental group will undergo TIPS using a commercially available 8-10 mm VIATORR Controlled Expansion stent. After stent deployment, the stent will be initially dilated only with a 6-mm balloon to achieve an initial effective shunt diameter of approximately 6 mm. Further dilation to 8 mm will not be performed solely because the portal pressure gradient remains above 12 mmHg. Additional dilation will be allowed only under predefined rescue conditions, such as persistent active bleeding, inadequate reduction of portal pressure gradient with persistent high-risk collateral perfusion despite embolization, or clinically significant rebleeding during follow-up. Selective embolization of responsible variceal inflow vessels may be performed according to standardized local procedures.
Participants assigned to the control group will receive standard secondary prophylaxis with serial endoscopic variceal ligation and nonselective beta-blockers. Endoscopic variceal ligation will be repeated approximately every 4 weeks until variceal eradication or conversion to a low-risk status. Carvedilol will be the preferred nonselective beta-blocker, starting at 6.25 mg once daily and increasing to 12.5 mg once daily after 1 week if tolerated. Propranolol may be used if carvedilol is not tolerated or is clinically inappropriate.
The primary endpoint is the time from randomization to the first occurrence of all-cause death or clinically significant upper gastrointestinal rebleeding within 365 days. Key secondary outcomes include transplant-free survival, overall survival, liver-related mortality, clinically significant rebleeding, variceal-related rebleeding, overt hepatic encephalopathy, severe overt hepatic encephalopathy, acute-on-chronic liver failure, liver function deterioration, TIPS dysfunction, actual stent diameter at 3 months, unplanned rehospitalization, length of hospital stay, transfusion requirement, direct medical costs, and adverse events. Participants will be followed for 12 months for the primary analysis and up to 24 months for extended secondary outcome analyses.
- Conditions
- Liver Cirrhosis, Portal Hypertension, Gastroesophageal Varices Bleeding, Esophageal Varices, Hepatic Encephalopathy
- Being tested
- Underdilated VCX-TIPS, Endoscopic Variceal Ligation, Nonselective Beta-Blockers
- Keywords
- Cirrhosis, Portal hypertension, Esophageal variceal bleeding, Secondary prophylaxis, Transjugular intrahepatic portosystemic shunt, Underdilation, Endoscopic variceal ligation, Hepatic encephalopathy
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal, Esophageal and Gastric Varices, Hepatic Encephalopathy, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Underdilated VCX-TIPSProcedure or surgery
Transjugular intrahepatic portosystemic shunt will be created using a VIATORR Controlled Expansion 8-10 mm stent. The stent will initially be dilated only with a 6-mm balloon. Portal pressure gradient will be measured before and after shunt creation. Additional embolization of responsible variceal inflow vessels may be performed if clinically indicated. Further dilation to 8 mm will be reserved for predefined rescue situations.
Endoscopic Variceal LigationProcedure or surgery
Serial endoscopic variceal ligation will be performed according to standardized endoscopic procedures. EVL will be repeated approximately every 4 weeks until variceal eradication or conversion to a low-risk status. For type 1 gastroesophageal varices with substantial gastric extension or high-risk bleeding stigmata, endoscopic tissue adhesive injection may be performed according to local standardized procedures.
Nonselective Beta-BlockersDrug
Carvedilol will be the preferred nonselective beta-blocker, starting at 6.25 mg once daily and increasing to 12.5 mg once daily after 1 week if tolerated. Dose adjustment, temporary discontinuation, or switching to propranolol will be allowed according to heart rate, blood pressure, renal function, infection status, and overall tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Underdilated VCX-TIPS | Experimental | Participants assigned to this group will undergo transjugular intrahepatic portosystemic shunt creation using a commercially available 8-10 mm VIATORR Controlled Expansion stent. After stent deployment, the stent will be initially dilated only with a 6-mm balloon to achieve an initial effective shunt diameter of approximately 6 mm. Further dilation to 8 mm will be allowed only under predefined rescue conditions. Selective embolization of responsible variceal inflow vessels may be performed according to standardized procedures. Receives: Procedure: Underdilated VCX-TIPS |
| EVL Plus NSBB | Active comparator | Participants assigned to this group will receive standard secondary prophylaxis using serial endoscopic variceal ligation combined with nonselective beta-blockers. EVL will be repeated approximately every 4 weeks until variceal eradication or conversion to a low-risk status. Carvedilol will be preferred, with propranolol as an alternative if carvedilol is not tolerated or is clinically inappropriate. Receives: Procedure: Endoscopic Variceal Ligation; Drug: Nonselective Beta-Blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of All-Cause Death or Clinically Significant Upper Gastrointestinal Rebleeding
Time from randomization to the first occurrence of all-cause death or clinically significant upper gastrointestinal rebleeding. Clinically significant upper gastrointestinal rebleeding is defined as hematemesis, melena, fresh blood from a nasogastric tube, or endoscopically documented bleeding resulting in hospitalization, blood transfusion, a decrease in hemoglobin of at least 30 g/L, hemodynamic instability, urgent endoscopic, interventional radiologic, or surgical hemostatic therapy, or bleeding-related death. The rebleeding event does not have to be confirmed as variceal in origin for the primary endpoint.
Measured: From randomization to 1 year
Secondary outcomes (9)
Transplant-Free Survival
Time from randomization to death from any cause or liver transplantation, whichever occurs first.
Measured: From randomization to 12 and 24 months
Liver-Related Mortality
Death attributed to liver-related causes, including variceal bleeding, liver failure, acute-on-chronic liver failure, infection related to cirrhosis decompensation, hepatorenal syndrome, or other cirrhosis-related complications.
Measured: From randomization to 12 and 24 months
Clinically Significant Upper Gastrointestinal Rebleeding
Occurrence of clinically significant upper gastrointestinal rebleeding, regardless of whether the bleeding source is confirmed as variceal.
Measured: From randomization to 42 days, 90 days, 180 days, 365 days, and 24 months
Variceal-Related Rebleeding
Upper gastrointestinal rebleeding adjudicated as related to esophageal varices, type 1 gastroesophageal varices, post-EVL ulceration, portal hypertension-related lesions, or TIPS dysfunction.
Measured: From randomization to 42 days, 90 days, 180 days, 365 days, and 24 months
Overt Hepatic Encephalopathy
Occurrence of overt hepatic encephalopathy, defined as West Haven grade II to IV hepatic encephalopathy.
Measured: From randomization to 12 and 24 months
Acute-on-Chronic Liver Failure
Occurrence of acute-on-chronic liver failure, defined according to the EASL-CLIF criteria.
Measured: From randomization to 12 and 24 months
TIPS Dysfunction
For participants in the TIPS group, TIPS dysfunction is defined as TIPS occlusion, significant stenosis, abnormal TIPS flow velocity associated with clinical recurrence, or the need for balloon dilation, stent revision, TIPS reduction, TIPS occlusion, or parallel TIPS placement.
Measured: From TIPS placement to 3 months, 12 months, and 24 months
Actual Stent Diameter at 3 Months
For participants in the TIPS group, actual stent diameter will be assessed by contrast-enhanced CT at 3 months. The imaging core laboratory will measure the minimum and mean diameters of the controlled expansion segment using centerline reconstruction and cross-sectional measurements perpendicular to the stent axis.
Measured: 3 months after TIPS placement
Adverse Events
Incidence, severity, relationship to study intervention, management, and outcome of adverse events and serious adverse events.
Measured: From randomization to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Xiamen Hospital, West China Tianfu Hospital, Southwest Hospital, China, The Second Affiliated Hospital of Chongqing Medical University, The Second Affiliated Hospital of Kunming Medical University, Chongqing Qianjiang Central Hospital, Chengdu Shangjin Nanfu Hospital
- Responsible party
- Principal investigator, Xiaoze Wang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587671
- Sponsor's protocol ID
- THE002
- Acronym
- U-TIPS
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Underdilated VIATORR Controlled Expansion Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Nonselective Beta-Blockers for Secondary Prophylaxis of Variceal Bleeding in Patients With Cirrhosis: A Multicenter, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07587671
- Acronym / sponsor ID
- U-TIPS / THE002
- Conditions
- Liver Cirrhosis, Portal Hypertension, Gastroesophageal Varices Bleeding, Esophageal Varices, Hepatic Encephalopathy
- Keywords
- Cirrhosis, Portal hypertension, Esophageal variceal bleeding, Secondary prophylaxis, Transjugular intrahepatic portosystemic shunt, Underdilation, Endoscopic variceal ligation, Hepatic encephalopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- West China Xiamen Hospital, West China Tianfu Hospital, Southwest Hospital, China, The Second Affiliated Hospital of Chongqing Medical University, The Second Affiliated Hospital of Kunming Medical University, Chongqing Qianjiang Central Hospital, Chengdu Shangjin Nanfu Hospital
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 14 May 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.
Variceal bleeding is a major complication of portal hypertension in patients with cirrhosis and is associated with substantial risks of rebleeding and death. Current guidelines recommend endoscopic variceal ligation combined with nonselective beta-blockers as standard secondary prophylaxis for esophageal variceal bleeding and type 1 gastroesophageal variceal bleeding. Transjugular intrahepatic portosystemic shunt can markedly reduce portal pressure and prevent recurrent variceal bleeding, but its broader use in secondary prophylaxis is limited by the risk of post-TIPS hepatic encephalopathy and liver function deterioration.
The VIATORR Controlled Expansion stent is designed to allow controlled expansion between 8 and 10 mm. However, even 8-mm TIPS may still be associated with a substantial risk of overt hepatic encephalopathy. This trial evaluates an underdilated VCX-TIPS strategy, in which a commercially available 8-10 mm VIATORR Controlled Expansion stent is initially dilated only with a 6-mm balloon, aiming to achieve sufficient portal decompression while reducing the risk of excessive shunting.
This is a prospective, multicenter, open-label, parallel-group, randomized superiority trial. Eligible patients with cirrhosis who have recovered from acute esophageal variceal bleeding or type 1 gastroesophageal variceal bleeding and have entered the secondary prophylaxis phase will be randomly assigned in a 1:1 ratio to receive either underdilated VCX-TIPS or endoscopic variceal ligation plus nonselective beta-blockers. The primary outcome is the composite of all-cause death or clinically significant upper gastrointestinal rebleeding within 1 year after randomization.
Detailed description
This multicenter randomized controlled trial is designed to compare an underdilated VCX-TIPS strategy with standard secondary prophylaxis using endoscopic variceal ligation plus nonselective beta-blockers in patients with cirrhosis who have experienced esophageal variceal bleeding or type 1 gastroesophageal variceal bleeding.
Patients with cirrhosis aged 18 to 75 years who have achieved successful control of acute variceal bleeding and are clinically stable will be screened. Eligible participants will be randomized after written informed consent has been obtained, generally between 5 and 21 days after successful hemostasis. Patients with ongoing bleeding, hemodynamic instability, a need for immediate rescue TIPS, or a strong indication for early or pre-emptive TIPS that makes randomization to EVL plus NSBB inappropriate will be excluded.
Participants assigned to the experimental group will undergo TIPS using a commercially available 8-10 mm VIATORR Controlled Expansion stent. After stent deployment, the stent will be initially dilated only with a 6-mm balloon to achieve an initial effective shunt diameter of approximately 6 mm. Further dilation to 8 mm will not be performed solely because the portal pressure gradient remains above 12 mmHg. Additional dilation will be allowed only under predefined rescue conditions, such as persistent active bleeding, inadequate reduction of portal pressure gradient with persistent high-risk collateral perfusion despite embolization, or clinically significant rebleeding during follow-up. Selective embolization of responsible variceal inflow vessels may be performed according to standardized local procedures.
Participants assigned to the control group will receive standard secondary prophylaxis with serial endoscopic variceal ligation and nonselective beta-blockers. Endoscopic variceal ligation will be repeated approximately every 4 weeks until variceal eradication or conversion to a low-risk status. Carvedilol will be the preferred nonselective beta-blocker, starting at 6.25 mg once daily and increasing to 12.5 mg once daily after 1 week if tolerated. Propranolol may be used if carvedilol is not tolerated or is clinically inappropriate.
The primary endpoint is the time from randomization to the first occurrence of all-cause death or clinically significant upper gastrointestinal rebleeding within 365 days. Key secondary outcomes include transplant-free survival, overall survival, liver-related mortality, clinically significant rebleeding, variceal-related rebleeding, overt hepatic encephalopathy, severe overt hepatic encephalopathy, acute-on-chronic liver failure, liver function deterioration, TIPS dysfunction, actual stent diameter at 3 months, unplanned rehospitalization, length of hospital stay, transfusion requirement, direct medical costs, and adverse events. Participants will be followed for 12 months for the primary analysis and up to 24 months for extended secondary outcome analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Underdilated VCX-TIPS | Experimental | Procedure: Underdilated VCX-TIPSParticipants assigned to this group will undergo transjugular intrahepatic portosystemic shunt creation using a commercially available 8-10 mm VIATORR Controlled Expansion stent. After stent deployment, the stent will be initially dilated only with a 6-mm balloon to achieve an initial effective shunt diameter of approximately 6 mm. Further dilation to 8 mm will be allowed only under predefined rescue conditions. Selective embolization of responsible variceal inflow vessels may be performed according to standardized procedures. |
| EVL Plus NSBB | Active comparator | Procedure: Endoscopic Variceal Ligation, Drug: Nonselective Beta-BlockersParticipants assigned to this group will receive standard secondary prophylaxis using serial endoscopic variceal ligation combined with nonselective beta-blockers. EVL will be repeated approximately every 4 weeks until variceal eradication or conversion to a low-risk status. Carvedilol will be preferred, with propranolol as an alternative if carvedilol is not tolerated or is clinically inappropriate. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 75 years, regardless of sex.
- Diagnosis of liver cirrhosis based on previous histology, imaging, laboratory tests, and/or clinical manifestations.
- Hospitalization for acute upper gastrointestinal bleeding, with endoscopic confirmation that the bleeding is related to esophageal varices or type 1 gastroesophageal varices.
- Successful control of acute bleeding after standard acute-phase treatment, with stable vital signs and entry into the secondary prophylaxis phase.
- Child-Pugh score of 5 to 13.
Key exclusion criteria (15 listed)
- Hemodynamic instability, persistent active bleeding, or need for immediate rescue TIPS, surgical hemostasis, or interventional radiologic hemostasis.
- A strong current indication for early or pre-emptive TIPS that makes randomization to EVL plus NSBB clinically inappropriate.
- Child-Pugh score greater than 13.
- Previous TIPS, surgical portosystemic shunt, BRTO, CARTO, PARTO, or other procedures that substantially alter portosystemic blood flow.
- Isolated gastric varices, type 2 gastroesophageal varices, ectopic varices, or a bleeding source other than esophageal varices or type 1 gastroesophageal varices.
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 |
|---|---|---|
| Underdilated VCX-TIPSTransjugular intrahepatic portosystemic shunt will be created using a VIATORR Controlled Expansion 8-10 mm stent. The stent will initially be dilated only with a 6-mm balloon. Portal pressure gradient will be measured before and after shunt creation. Additional embolization of responsible variceal inflow vessels may be performed if clinically indicated. Further dilation to 8 mm will be reserved for predefined rescue situations. | Procedure or surgery | Underdilated VCX-TIPS |
| Endoscopic Variceal LigationSerial endoscopic variceal ligation will be performed according to standardized endoscopic procedures. EVL will be repeated approximately every 4 weeks until variceal eradication or conversion to a low-risk status. For type 1 gastroesophageal varices with substantial gastric extension or high-risk bleeding stigmata, endoscopic tissue adhesive injection may be performed according to local standardized procedures. | Procedure or surgery | EVL Plus NSBB |
| Nonselective Beta-BlockersCarvedilol will be the preferred nonselective beta-blocker, starting at 6.25 mg once daily and increasing to 12.5 mg once daily after 1 week if tolerated. Dose adjustment, temporary discontinuation, or switching to propranolol will be allowed according to heart rate, blood pressure, renal function, infection status, and overall tolerability. | Drug | EVL Plus NSBB |
Primary outcome
Composite of All-Cause Death or Clinically Significant Upper Gastrointestinal Rebleeding
Time frame: From randomization to 1 year
Time from randomization to the first occurrence of all-cause death or clinically significant upper gastrointestinal rebleeding. Clinically significant upper gastrointestinal rebleeding is defined as hematemesis, melena, fresh blood from a nasogastric tube, or endoscopically documented bleeding resulting in hospitalization, blood transfusion, a decrease in hemoglobin of at least 30 g/L, hemodynamic instability, urgent endoscopic, interventional radiologic, or surgical hemostatic therapy, or bleeding-related death. The rebleeding event does not have to be confirmed as variceal in origin for the primary endpoint.
9 secondary outcomes
Transplant-Free Survival
Time frame: From randomization to 12 and 24 months
Liver-Related Mortality
Time frame: From randomization to 12 and 24 months
Clinically Significant Upper Gastrointestinal Rebleeding
Time frame: From randomization to 42 days, 90 days, 180 days, 365 days, and 24 months
Variceal-Related Rebleeding
Time frame: From randomization to 42 days, 90 days, 180 days, 365 days, and 24 months
Overt Hepatic Encephalopathy
Time frame: From randomization to 12 and 24 months
Acute-on-Chronic Liver Failure
Time frame: From randomization to 12 and 24 months
TIPS Dysfunction
Time frame: From TIPS placement to 3 months, 12 months, and 24 months
Actual Stent Diameter at 3 Months
Time frame: 3 months after TIPS placement
Adverse Events
Time frame: From randomization to 24 months
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 14 May 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Underdilated VCX-TIPS, Endoscopic Variceal Ligation and Nonselective Beta-Blockers in people with Liver Cirrhosis and Portal Hypertension, run by West China Hospital at 3 sites 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 7 inclusion and 15 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Composite of All-Cause Death or Clinically Significant Upper Gastrointestinal Rebleeding (time frame: From randomization to 1 year). 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 14 May 2026.