CompletedNot Applicable

Pre-emptive Transjugular Intrahepatic Portosystemic Shunt (TIPS) in Cystic Fibrosis Related Liver Disease

5 participantsStarted 2007-06

Plain-language summary

Portal hypertension (PHT) and its sequelae are the most clinically important manifestation in cystic fibrosis related liver disease (CFLD), with end-stage liver failure as a late and rare manifestation. The aim is to evaluate the safety and efficacy of a pre-emptive Transjugular Intrahepatic Portosystemic Shunt (TIPS) for the prophylaxis of variceal bleeding in pediatric CFLD patients with subclinical non-cirrhotic portal hypertension (NCPH)

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Cystic fibrosis * Liver disease detected by an abnormal physical examination (hepatomegaly or splenomegaly, confirmed on US), abnormalities of liver function tests (increase of AST, ALT, GGT levels above the upper normal limits) or ultrasonographic evidence of liver involvement (US liver score ≥ 5). * Indirect signs of portal hypertension on Doppler US * Progressive portal hypertension / liver disease on bi-monthly follow-up, evaluated by physical examination, blood analysis and US Exclusion Criteria: * Cirrhosis on biopsy * Symptomatic portal hypertension (Portosytemic pressure gradient \> 10 mmHg)

What they're measuring

Variceal bleeding

Timeframe: Through study completion, an average of 10 year

Trial details

NCT IDNCT05037643

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Cystic Fibrosis Liver Disease trials