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RECRUITING

NCT07253389

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

Sponsor: Air Force Military Medical University, China

View on ClinicalTrials.gov

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.

Official title: A Multicenter Randomized Controlled Trial: Comparison of Underdilated Versus Standard Transjugular Intrahepatic Portosystemic Shunt in Preventing Rebleeding From Esophagogastric Varices in Patients With Cirrhosis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2025-10-21

Completion Date

2028-03-31

Last Updated

2025-11-28

Healthy Volunteers

Conditions

Liver Cirrhosis Gastroesophageal Varices Bleeding

Interventions

PROCEDURE

Underdilated TIPS

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.

PROCEDURE

Standard TIPS

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.

Inclusion Criteria: 1. Age 18-75 years; 2. 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; 3. 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; 4. History of esophagogastric variceal bleeding with documented failure of standard first-line therapy (endoscopic intervention plus nonselective beta-blocker, NSBB); 5. Scheduled to undergo TIPS; 6. 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; 7. Ability and willingness to provide written informed consent. Exclusion Criteria: (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).

Locations (1)

Fourth Military Medical University

Xi'an, Shaanxi, China