Underdilated stent technique to reduce encephalopathy after TIPS

Underdilated-stent Technique Improves Post-transjugular Intrahepatic Portosystemic Shunt Encephalopathy: a Randomized Controlled Trial

This trial tries to see if using an underdilated stent (smaller balloon dilation before placing a standard covered stent) during TIPS lowers the chance of hepatic encephalopathy for people with cirrhosis who need TIPS for variceal bleeding or refractory ascites.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University (Academic / other)
• Locations: 2 sites (Chongqing, Chongqing Municipality and 1 other locations)
• Trial ID: NCT07349654 on ClinicalTrials.gov

What this trial studies

This interventional trial compares an underdilated-stent strategy with standard dilation in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for variceal bleeding or refractory ascites. Patients receive either a smaller initial balloon dilation (6 mm) prior to deploying a standard 8 mm covered stent or a full 8 mm dilation during stent placement. The study follows participants for incidence of post-TIPS hepatic encephalopathy, shunt patency, and control of portal hypertension. Results will show whether a smaller immediate lumen reduces encephalopathy while preserving clinical benefit.

Who should consider this trial

Good fit: Adults with liver cirrhosis who have a history of esophagogastric variceal bleeding or refractory/recurrent ascites and are planned for TIPS are the intended candidates.

Not a fit: People with non-cirrhotic portal hypertension, prior TIPS or other portal-pressure altering procedures, advanced malignant disease, irreversible multi-organ failure, or prior overt hepatic encephalopathy (West-Haven ≥2) are excluded and unlikely to benefit.

Why it matters

Potential benefit: If successful, this technique could lower the risk of hepatic encephalopathy after TIPS while maintaining effective portal decompression.

How similar studies have performed: Early reports and small-series experiences with the underdilated approach have suggested reduced post-TIPS encephalopathy, but large randomized data are limited.

Eligibility criteria

Inclusion Criteria:

* Liver cirrhosis, defined by clinical manifestations, biochemical indicators, imaging examinations, or liver biopsy;
* History of esophagogastric variceal bleeding, or refractory/recurrent ascites;
* Intended to undergo TIPS treatment.

Exclusion Criteria:

* Non-cirrhotic portal hypertension;
* Previous treatments that may affect portal pressure, such as TIPS or surgical procedures;
* History of overt hepatic encephalopathy (West-Haven classification ≥2);
* Malignant tumors in advanced stages;
* Concomitant irreversible heart, liver, kidney, or respiratory failure;
* Unable or unwilling to sign the informed consent form.

Where this trial is running

Chongqing, Chongqing Municipality and 1 other locations

• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
• Qianjiang Central Hospital — Qianjiang, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yongjun Zhu, Doctor

Conditions Liver Cirrhosis; Variceal Bleeding, Cirrhosis; Ascites Hepatic; Hepatic Encephalopathy