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.
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.
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).
Air Force Military Medical University, China
Lead sponsor
West China Hospital
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
Daping Hospital of Army Medical University
Collaborator
General Hospital of Ningxia Medical University
Collaborator