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Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis

J

Johannes Gutenberg University (JGU)

Status

Enrolling

Conditions

Hepatic Encephalopathy
Liver Cirrhosis

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

Prediction of hepatic encephalopathy after insertion of a transjugular intrahepatic portosystemic stent shunt (post-TIPS HE) are critical for patient selection prior to TIPS insertion, and a currently unmet, clinically highly relevant need. In this prospective multicenter observational cohort study, the investigators aim to evaluate the ability of Stroop EncephalApp and the simplified Animal Naming Test (S-ANT1) in comparison to the goldstandard PHES to predict the occurence of post-TIPS HE in patients with decompensated liver cirrhosis. Moreover, secondary aims of this study include the detection of potential blood based biomarkers for prediction of post-TIPS HE and the predictive value of frailty and quality of life/sleep prior to TIPS insertion.

Enrollment

83 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Liver cirrhosis (clinical, sonographic, CT-morphological, laparoscopic or histological)
  • TIPS indication: refractory ascites or secondary prophylaxis after variceal bleeding
  • Age ≥ 18 years
  • Ability to give consent
  • Consent to the study after comprehensive information

Exclusion criteria

  • Contraindication against TIPS insertion
  • Lack of consent
  • History of liver transplantation
  • Preemptive TIPS
  • Emergency TIPS
  • Severe neurological comorbidities

Trial contacts and locations

2

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Central trial contact

Christian Labenz, MD; Simon Johannes Gairing, MD

Data sourced from clinicaltrials.gov

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