Comparison of Underdilated Versus Standard TIPS in Preventing Variceal Rebleeding in Patients With Cirrhosis

NCT07253389 | Recruiting DMC

• 1 other identifier: KY20252233-F-2
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Cirrhosis; Gastroesophageal Varices Bleeding

Keywords

Liver Cirrhosis; Esophageal and gastric variceal bleeding; Transjugular intrahepatic portosystemic shunt; Hepatic encephalopathy

Outcome Measures

Primary Outcomes (1)

• 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.

  Throughout the entire follow-up period（up to 12 months）

Secondary Outcomes (6)

• All-cause rebleeding

  Throughout the entire follow-up period（up to 12 months）

• Stent dysfunction

  12 months

• New or worsening ascites

  12 months

• Incidence of overt hepatic encephalopathy

  12 months

• Liver function

  12 months

Study Arms (2)

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.

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.

Procedure: Underdilated TIPS

Interventions

Underdilated TIPS PROCEDURE

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.

Underdilated TIPS

Standard TIPS PROCEDURE

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.

Standard TIPS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years;
• Diagnosis of liver cirrhosis based on clinical and imaging findings according to the 2023 Consensus Opinion on the Clinical Diagnosis and Treatment of Liver Cirrhosis in China (Chinese Society of Gastroenterology); histological confirmation required if diagnosis is inconclusive;
• High-risk acute variceal bleeding, defined as presence of any of the following: Child-Pugh class C; Child-Pugh class B with active endoscopic evidence of bleeding; early rebleeding within 5 days; or failure of pharmacologic and endoscopic therapy to control bleeding;
• History of esophagogastric variceal bleeding with documented failure of standard first-line therapy (endoscopic intervention plus nonselective beta-blocker, NSBB);
• Scheduled to undergo TIPS;
• Hepatic and renal function meeting all of the following criteria: Child-Pugh score ≤13; AST and ALT \<5× upper limit of normal (ULN); serum creatinine \<1.5× ULN;
• Ability and willingness to provide written informed consent.

You may not qualify if:

• (1) Budd-Chiari syndrome or other causes of non-cirrhotic portal hypertension; (2) current or prior malignancy, including hepatocellular carcinoma or extrahepatic malignancies; (3) complete thrombosis of the main portal vein; (4) severe psychiatric or neurological disorders (e.g., uncontrolled epilepsy, dementia); (5) history of liver resection or liver transplantation; (6) prior TIPS or surgical portosystemic shunt; (7) pregnancy or lactation; (8) any contraindication to TIPS, including severe right or left ventricular dysfunction, moderate-to-severe pulmonary hypertension despite optimal medical therapy, untreated severe valvular heart disease, or uncontrolled systemic infection; (9) acute variceal hemorrhage with MELD score ≥30 and/or arterial lactate \>12 mmol/L, or presentation with acute-on-chronic liver failure (ACLF); (10) severe or refractory overt hepatic encephalopathy in the absence of a correctable spontaneous portosystemic shunt; (11) systemic conditions requiring ongoing systemic treatment with glucocorticoids or nonsteroidal anti-inflammatory drugs (NSAIDs).

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

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

Study Officials

• Jun Tie

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Tie, M.D.,Ph.D.

CONTACT

+862984771537; tiejun7776@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, investigators and procedural nursing staff were aware of group assignments. However, patients, follow-up researchers (responsible for data collection and endpoint assessment), and statisticians were blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of clinical research

Model Details: 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). 85 patients per group are randomized to underdilated (experimental) or standard-diameter (control) TIPS.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 28, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)