Liver CirrhosisUVR-TIPSNCT07253389
Comparison of Underdilated Versus Standard TIPS in Preventing Variceal Rebleeding in Patients With Cirrhosis
A study testing Underdilated TIPS and Standard TIPS in people with Liver Cirrhosis and Gastroesophageal Varices Bleeding, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Transjugular intrahepatic portosystemic shunt (TIPS) is a key therapeutic intervention for complications of portal hypertension. However, the risk of post-procedural hepatic encephalopathy (HE) limits its broader clinical application. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Gastroesophageal Varices Bleeding
- What is being tested?
- Underdilated TIPS and Standard TIPS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2025to 30 Sep 2029
- 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
- 1. Age 18-75 years. 2. Diagnosis of liver cirrhosis according to the 2023 Consensus Opinion on the Clinical Diagnosis and Treatment of Liver Cirrhosis in China (Chinese Society of Gastroenterology). Diagnosis is based on clinical manifestations and imaging findings; histological confirmation is required if the diagnosis remains inconclusive.
- 3. High-risk acute variceal bleeding, defined as any of the following:
- High-risk acute esophageal or type 1 gastroesophageal variceal bleeding, including: Child-Pugh grade B with a score > 7 and endoscopic evidence of active bleeding; Child-Pugh grade C with a score < 14.
- Hepatic venous pressure gradient (HVPG) > 20 mmHg during bleeding.
- Early rebleeding within 5 days.
- Bleeding uncontrolled despite pharmacological and endoscopic therapy. 4. History of esophageal or gastric variceal bleeding with failure of standard first-line treatment [endoscopy combined with non-selective beta-blockers (NSBB)]; or first hemorrhage accompanied by grade 2 ascites and/or portal vein thrombosis; GOV2 or IGV1 gastric variceal bleeding; ectopic variceal bleeding; or bleeding from refractory portal hypertensive gastropathy.
- 5. Planned TIPS procedure. 6. Ability and willingness to provide written informed consent.
Who cannot join
- Budd-Chiari syndrome or other causes of non-cirrhotic portal hypertension.
- Current or prior malignancy, including hepatocellular carcinoma or malignancies of other organs.
- Complete thrombosis of the main portal vein.
- Severe psychiatric or neurologic disorders (e.g., uncontrolled epilepsy, dementia).
- Prior liver resection or liver transplantation.
- Prior TIPS or surgical portosystemic shunt.
Show all 13Show fewer
- Pregnancy or lactation.
- Any contraindication to TIPS, including:
- Congestive heart failure (New York Heart Association class C or D, or left ventricular ejection fraction < 50%).
- Severe pulmonary hypertension (mean pulmonary artery pressure > 45 mmHg as measured invasively).
- Uncontrolled systemic infection. (4) Severe overt hepatic encephalopathy (OHE) with unmodifiable spontaneous portosystemic shunt.
- 9.Acute hemorrhage with a MELD score ≥ 30 and/or arterial lactate > 12 mmol/L, or presence of acute-on-chronic liver failure (ACLF).
- 10. Systemic conditions requiring ongoing glucocorticoid or nonsteroidal anti-inflammatory drug (NSAID) therapy.
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
Fourth Military Medical University
Xi'an, Shaanxi, 710032
Jun Tie, M.D.,Ph.D., +862984771537, tiejun7776@163.com
About this study
Official title: Comparison of Underdilated Versus Standard Transjugular Intrahepatic Portosystemic Shunt in Preventing Rebleeding From Esophagogastric Varices in Patients With Cirrhosis in Chinese Tertiary Hospitals: Protocol for a Multicenter Randomized Controlled Trial
Transjugular intrahepatic portosystemic shunt (TIPS) is a key therapeutic intervention for complications of portal hypertension. However, the risk of post-procedural hepatic encephalopathy (HE) limits its broader clinical application. In the management of gastroesophageal variceal bleeding, the primary goal of TIPS is to reduce the portosystemic pressure gradient (PPG) to less than 12 mmHg (16 cmH₂O), which defines the standard TIPS procedure. The investigators hypothesize that, in patients undergoing TIPS for the prevention of variceal rebleeding, stent underdilation using a 6-mm balloon (underdilated TIPS) will not increase the risk of rebleeding but may reduce the incidence of overt HE and attenuate liver injury. To test this hypothesis, the investigators have designed a prospective, multicenter, randomized controlled trial.
Read the detailed description
Transjugular intrahepatic portosystemic shunt (TIPS) is a pivotal intervention for managing complications of portal hypertension. However, its clinical utility is limited by the risk of post-procedural hepatic encephalopathy (HE).
The pathogenesis of post-TIPS HE involves two principal mechanisms: the diversion of portal venous blood flow away from the liver and a concurrent reduction in hepatic metabolic capacity. Following TIPS placement, portal venous blood is shunted directly into the systemic circulation, resulting in decreased functional hepatic perfusion. This hemodynamic alteration not only increases the risk of HE but may also exacerbate pre-existing hepatic dysfunction. Evidence suggests that stent diameter plays a critical role in determining shunt patency, efficacy of portal pressure reduction, and the incidence of HE. A stent that is too narrow may inadequately lower portal pressure, leading to suboptimal therapeutic outcomes and an increased risk of shunt stenosis. Conversely, an excessively large stent can substantially increase the risk of HE and further impair liver function. Therefore, identifying an optimal stent diameter that effectively reduces portal pressure while minimizing complications-particularly shunt-induced HE-remains a central focus in TIPS research, aiming to balance procedural efficacy with safety to improve patient outcomes.
Early studies demonstrated that the use of stents with larger diameters than conventional calibers for the portal and hepatic veins was associated with a disproportionately increased risk of hepatic encephalopathy (HE) without substantial additional benefit in portal pressure reduction. Consequently, a stent diameter of 10 mm became the standard during the era of bare metal stents. However, the introduction of polytetrafluoroethylene (PTFE)-covered stents has significantly reduced the incidence of shunt dysfunction and improved the durability of portal pressure reduction following transjugular intrahepatic portosystemic shunt (TIPS) placement. Clinical evidence indicates that 8 mm PTFE-covered stents can maintain long-term patency and achieve adequate portal decompression while substantially lowering the risk of HE. Despite these advancements, the overall incidence of post-TIPS HE remains high, approximately 30%. To further optimize clinical outcomes, recent studies have explored a "stent underdilation" strategy, involving dilation of an 8 mm PTFE-covered stent using a 6 mm balloon. Preliminary data suggest that this approach may further reduce the incidence of HE without significantly increasing the risk of recurrent portal hypertensive events. Nevertheless, there is currently a lack of prospective, head-to-head randomized controlled trials comparing the efficacy and safety of underdilated TIPS versus standard-diameter TIPS in the management of complications related to portal hypertension.
In the context of managing gastroesophageal variceal bleeding, the established therapeutic goal of TIPS is to reduce the portosystemic pressure gradient (PPG) to less than 12 mmHg (16 cmH₂O). Building upon this principle, the investigators propose the following hypothesis: in patients with esophagogastric variceal bleeding undergoing TIPS, underdilated TIPS will reduce the incidence of overt HE and attenuate liver function deterioration without increasing the risk of rebleeding. To evaluate this hypothesis, the investigators have designed the present prospective clinical trial.
- Conditions
- Liver Cirrhosis, Gastroesophageal Varices Bleeding
- Being tested
- Underdilated TIPS, Standard TIPS
- Keywords
- Liver Cirrhosis, Esophageal and gastric variceal bleeding, Transjugular intrahepatic portosystemic shunt, Hepatic encephalopathy
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Underdilated TIPSProcedure or surgery
The procedure will be performed via a transjugular approach, involving puncture from the hepatic vein or inferior vena cava into the portal venous system. Upon successful cannulation, direct portography will be performed to visualize varices and determine the optimal shunt tract, followed by targeted variceal embolization. A Novel VIATORR® Controlled Expansion (VCX) stent graft (W. L. Gore \& Associates, Arizona, USA) will then be deployed intrahepatically to establish the shunt. Subsequently, a 6-mm balloon will be used for suboptimal expansion of the TIPS stent, and the immediate portosystemic pressure gradient (PPG) will be measured.
Standard TIPSProcedure or surgery
The procedure will be performed via a transjugular approach, with puncture conducted from the hepatic vein or inferior vena cava into the portal venous system. After successful cannulation, direct portography will be performed to visualize gastroesophageal varices and identify the optimal shunt tract, followed by targeted variceal embolization. A novel VIATORR® Controlled Expansion (VCX) stent graft (W. L. Gore \& Associates, Arizona, USA) will then be deployed intrahepatically to establish the transjugular intrahepatic portosystemic shunt (TIPS). Subsequently, the TIPS stent will be progressively dilated (starting at 8 mm of diameter) to the minimum diameter needed to achieve a portosystemic pressure gradient (PSPG) below 12 mm Hg.
| Study group | Role | What they receive |
|---|---|---|
| Standard TIPS | Active comparator | Standard TIPS Group: In the standard group, the TIPS stent will be progressively dilated (starting at 8 mm of diameter) to the minimum diameter needed to achieve a portosystemic pressure gradient (PSPG) below 12 mm Hg. Receives: Procedure: Standard TIPS |
| Underdilated TIPS | Experimental | Underdilated TIPS Group:In this group, the TIPS stent was underdilated using a 6-mm balloon, and the immediate post-procedure portal pressure gradient (PPG) was measured. Receives: Procedure: Underdilated TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of gastroesophageal 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: Throughout the entire follow-up period（up to 12 months）
Secondary outcomes (6)
All-cause rebleeding
Measured: Throughout the entire follow-up period（up to 12 months）
Stent dysfunction
Diagnosis of TIPS stent dysfunction follows a stepwise approach utilizing Doppler ultrasound, angiography, and measurement of the portosystemic pressure gradient (PPG). Stent dysfunction is diagnosed if either of the following criteria is met: (1) shunt stenosis ≥50% or complete occlusion; (2) an increase in PPG ≥25% compared to the baseline value measured immediately after stent placement. Angiography is indicated under the following circumstances: (1) recurrence of portal hypertension-related complications-TIPS stent dysfunction should be suspected upon recurrence of symptoms such as rebleeding, new-onset ascites, or persistence of ascites beyond 4-8 weeks; (2) color Doppler ultrasound findings-when flow direction is hepatofugal and mean maximum portal vein flow velocity (mVPmax) < 28 cm/s; when flow direction is hepatopetal and mVPmax < 39 cm/s.
Measured: 12 months
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.
Measured: 12 months
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: 12 months
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: 12 months
Liver transplantation-free survival
Defined as the time from the TIPS procedure to the end of follow-up, liver transplantation, or death.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start20 Oct 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This multicenter, single-blind randomized controlled trial (1:1 allocation) evaluates whether underdilated TIPS effectively controls variceal bleeding and reduces overt hepatic encephalopathy in cirrhotic patients. Conducted across 5 Chinese tertiary Grade A hospitals (Xijing Hospital as coordinating center), participants undergo pre-TIPS screening. Stratified block randomization ensures balance: stratified by center, then by sex, age (\<60 vs. ≥60), Child-Pugh class (\<9 vs. ≥9), bleeding indication (acute vs. secondary prophylaxis), variceal type (esophageal/GOV1 vs. GOV2/IGV1), and cirrhosis etiology (hepatitis B vs. non-hepatitis B). 324 patients per group are randomized to underdilated (experimental) or standard-diameter (control) TIPS.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Daping Hospital of Army Medical University, General Hospital of Ningxia Medical University
- 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
- NCT07253389
- Sponsor's protocol ID
- KY20252233-F-2
- Acronym
- UVR-TIPS
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Liu L, Wei B, Zhang F, Liang-Zhi W, Yao W, Yuan X, Gou X, Li K, Wang Z, Zhu Y, Xu J, Niu J, Han N, Gao R, Zhuge Y, Wu H, Tie J; Digestive Vascular Diseases Collaborative Group, Chinese Society of Gastroenterology, Chinese Medical Association (DVDCG). Comparison of underdilated versus standard transjugular intrahepatic portosystemic shunt in preventing rebleeding from oesophagogastric varices in patients with cirrhosis in Chinese tertiary hospitals: protocol for a multicentre randomised controlled trial (UVR-TIPS trial). BMJ Open. 2026 Aug 5;16(8):e115218. doi: 10.1136/bmjopen-2025-115218.
PubMed 42556834
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Underdilated Versus Standard Transjugular Intrahepatic Portosystemic Shunt in Preventing Rebleeding From Esophagogastric Varices in Patients With Cirrhosis in Chinese Tertiary Hospitals: Protocol for a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07253389
- Acronym / sponsor ID
- UVR-TIPS / KY20252233-F-2
- Conditions
- Liver Cirrhosis, Gastroesophageal Varices Bleeding
- Keywords
- Liver Cirrhosis, Esophageal and gastric variceal bleeding, Transjugular intrahepatic portosystemic shunt, Hepatic encephalopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Collaborators
- West China Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Daping Hospital of Army Medical University, General Hospital of Ningxia Medical University
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 28 Nov 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.
Transjugular intrahepatic portosystemic shunt (TIPS) is a key therapeutic intervention for complications of portal hypertension. However, the risk of post-procedural hepatic encephalopathy (HE) limits its broader clinical application. In the management of gastroesophageal variceal bleeding, the primary goal of TIPS is to reduce the portosystemic pressure gradient (PPG) to less than 12 mmHg (16 cmH₂O), which defines the standard TIPS procedure. The investigators hypothesize that, in patients undergoing TIPS for the prevention of variceal rebleeding, stent underdilation using a 6-mm balloon (underdilated TIPS) will not increase the risk of rebleeding but may reduce the incidence of overt HE and attenuate liver injury. To test this hypothesis, the investigators have designed a prospective, multicenter, randomized controlled trial.
Detailed description
Transjugular intrahepatic portosystemic shunt (TIPS) is a pivotal intervention for managing complications of portal hypertension. However, its clinical utility is limited by the risk of post-procedural hepatic encephalopathy (HE).
The pathogenesis of post-TIPS HE involves two principal mechanisms: the diversion of portal venous blood flow away from the liver and a concurrent reduction in hepatic metabolic capacity. Following TIPS placement, portal venous blood is shunted directly into the systemic circulation, resulting in decreased functional hepatic perfusion. This hemodynamic alteration not only increases the risk of HE but may also exacerbate pre-existing hepatic dysfunction. Evidence suggests that stent diameter plays a critical role in determining shunt patency, efficacy of portal pressure reduction, and the incidence of HE. A stent that is too narrow may inadequately lower portal pressure, leading to suboptimal therapeutic outcomes and an increased risk of shunt stenosis. Conversely, an excessively large stent can substantially increase the risk of HE and further impair liver function. Therefore, identifying an optimal stent diameter that effectively reduces portal pressure while minimizing complications-particularly shunt-induced HE-remains a central focus in TIPS research, aiming to balance procedural efficacy with safety to improve patient outcomes.
Early studies demonstrated that the use of stents with larger diameters than conventional calibers for the portal and hepatic veins was associated with a disproportionately increased risk of hepatic encephalopathy (HE) without substantial additional benefit in portal pressure reduction. Consequently, a stent diameter of 10 mm became the standard during the era of bare metal stents. However, the introduction of polytetrafluoroethylene (PTFE)-covered stents has significantly reduced the incidence of shunt dysfunction and improved the durability of portal pressure reduction following transjugular intrahepatic portosystemic shunt (TIPS) placement. Clinical evidence indicates that 8 mm PTFE-covered stents can maintain long-term patency and achieve adequate portal decompression while substantially lowering the risk of HE. Despite these advancements, the overall incidence of post-TIPS HE remains high, approximately 30%. To further optimize clinical outcomes, recent studies have explored a "stent underdilation" strategy, involving dilation of an 8 mm PTFE-covered stent using a 6 mm balloon. Preliminary data suggest that this approach may further reduce the incidence of HE without significantly increasing the risk of recurrent portal hypertensive events. Nevertheless, there is currently a lack of prospective, head-to-head randomized controlled trials comparing the efficacy and safety of underdilated TIPS versus standard-diameter TIPS in the management of complications related to portal hypertension.
In the context of managing gastroesophageal variceal bleeding, the established therapeutic goal of TIPS is to reduce the portosystemic pressure gradient (PPG) to less than 12 mmHg (16 cmH₂O). Building upon this principle, the investigators propose the following hypothesis: in patients with esophagogastric variceal bleeding undergoing TIPS, underdilated TIPS will reduce the incidence of overt HE and attenuate liver function deterioration without increasing the risk of rebleeding. To evaluate this hypothesis, the investigators have designed the present prospective clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This multicenter, single-blind randomized controlled trial (1:1 allocation) evaluates whether underdilated TIPS effectively controls variceal bleeding and reduces overt hepatic encephalopathy in cirrhotic patients. Conducted across 5 Chinese tertiary Grade A hospitals (Xijing Hospital as coordinating center), participants undergo pre-TIPS screening. Stratified block randomization ensures balance: stratified by center, then by sex, age (<60 vs. ≥60), Child-Pugh class (<9 vs. ≥9), bleeding indication (acute vs. secondary prophylaxis), variceal type (esophageal/GOV1 vs. GOV2/IGV1), and cirrhosis etiology (hepatitis B vs. non-hepatitis B). 324 patients per group are randomized to underdilated (experimental) or standard-diameter (control) TIPS.
| Arm | Type | Receives |
|---|---|---|
| Standard TIPS | Active comparator | Procedure: Standard TIPSStandard TIPS Group: In the standard group, the TIPS stent will be progressively dilated (starting at 8 mm of diameter) to the minimum diameter needed to achieve a portosystemic pressure gradient (PSPG) below 12 mm Hg. |
| Underdilated TIPS | Experimental | Procedure: Underdilated TIPSUnderdilated TIPS Group:In this group, the TIPS stent was underdilated using a 6-mm balloon, and the immediate post-procedure portal pressure gradient (PPG) was measured. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Age 18-75 years. 2. Diagnosis of liver cirrhosis according to the 2023 Consensus Opinion on the Clinical Diagnosis and Treatment of Liver Cirrhosis in China (Chinese Society of Gastroenterology). Diagnosis is based on clinical manifestations and imaging findings; histological confirmation is required if the diagnosis remains inconclusive.
- High-risk acute esophageal or type 1 gastroesophageal variceal bleeding, including: Child-Pugh grade B with a score > 7 and endoscopic evidence of active bleeding; Child-Pugh grade C with a score < 14.
- Hepatic venous pressure gradient (HVPG) > 20 mmHg during bleeding.
- Early rebleeding within 5 days.
- Bleeding uncontrolled despite pharmacological and endoscopic therapy. 4. History of esophageal or gastric variceal bleeding with failure of standard first-line treatment [endoscopy combined with non-selective beta-blockers (NSBB)]; or first hemorrhage accompanied by grade 2 ascites and/or portal vein thrombosis; GOV2 or IGV1 gastric variceal bleeding; ectopic variceal bleeding; or bleeding from refractory portal hypertensive gastropathy.
Key exclusion criteria (13 listed)
- Budd-Chiari syndrome or other causes of non-cirrhotic portal hypertension.
- Current or prior malignancy, including hepatocellular carcinoma or malignancies of other organs.
- Complete thrombosis of the main portal vein.
- Severe psychiatric or neurologic disorders (e.g., uncontrolled epilepsy, dementia).
- Prior liver resection or liver transplantation.
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 TIPSThe procedure will be performed via a transjugular approach, involving puncture from the hepatic vein or inferior vena cava into the portal venous system. Upon successful cannulation, direct portography will be performed to visualize varices and determine the optimal shunt tract, followed by targeted variceal embolization. A Novel VIATORR® Controlled Expansion (VCX) stent graft (W. L. Gore \& Associates, Arizona, USA) will then be deployed intrahepatically to establish the shunt. Subsequently, a 6-mm balloon will be used for suboptimal expansion of the TIPS stent, and the immediate portosystemic pressure gradient (PPG) will be measured. | Procedure or surgery | Underdilated TIPS |
| Standard TIPSThe procedure will be performed via a transjugular approach, with puncture conducted from the hepatic vein or inferior vena cava into the portal venous system. After successful cannulation, direct portography will be performed to visualize gastroesophageal varices and identify the optimal shunt tract, followed by targeted variceal embolization. A novel VIATORR® Controlled Expansion (VCX) stent graft (W. L. Gore \& Associates, Arizona, USA) will then be deployed intrahepatically to establish the transjugular intrahepatic portosystemic shunt (TIPS). Subsequently, the TIPS stent will be progressively dilated (starting at 8 mm of diameter) to the minimum diameter needed to achieve a portosystemic pressure gradient (PSPG) below 12 mm Hg. | Procedure or surgery | Standard TIPS |
Primary outcome
Cumulative incidence of gastroesophageal variceal rebleeding.
Time frame: Throughout the entire follow-up period（up to 12 months）
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.
6 secondary outcomes
All-cause rebleeding
Time frame: Throughout the entire follow-up period（up to 12 months）
Stent dysfunction
Time frame: 12 months
New or worsening ascites
Time frame: 12 months
Incidence of overt hepatic encephalopathy
Time frame: 12 months
Liver function
Time frame: 12 months
Liver transplantation-free survival
Time frame: 12 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 9 Jun 2026.
- Derived from this study: PubMed 42556834Liu L, Wei B, Zhang F, Liang-Zhi W, Yao W, Yuan X, Gou X, Li K, Wang Z, Zhu Y, Xu J, Niu J, Han N, Gao R, Zhuge Y, Wu H, Tie J; Digestive Vascular Diseases Collaborative Group, Chinese Society of Gastroenterology, Chinese Medical Association (DVDCG). Comparison of underdilated versus standard transjugular intrahepatic portosystemic shunt in preventing rebleeding from oesophagogastric varices in patients with cirrhosis in Chinese tertiary hospitals: protocol for a multicentre randomised controlled trial (UVR-TIPS trial). BMJ Open. 2026 Aug 5;16(8):e115218. doi: 10.1136/bmjopen-2025-115218.
- 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 Underdilated TIPS and Standard TIPS in people with Liver Cirrhosis and Gastroesophageal Varices Bleeding, 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 7 inclusion and 13 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 9 Jun 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?
Cumulative incidence of gastroesophageal variceal rebleeding. (time frame: Throughout the entire follow-up period（up to 12 months）). 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 NCT07253389, which also lists 1 linked publication.
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 Jun 2026.