Underdilated stent technique to reduce encephalopathy after TIPS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: hp545204493@126.com
• Phone: 86-13281121937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Coil-assisted small-diameter stent shunt reduction for refractory HE after TIPS

  A coil-assisted, small-diameter covered-stent technique is being tested to see if it can safely and effectively reduce shunt flow and lessen recurrent hepatic encephalopathy in people with a prior TIPS.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.