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

NCT ID: NCT05466669

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-09

Study Completion Date

2025-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatic Encephalopathy Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Christian Labenz

Priv.-Doz. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Labenz, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz

Locations

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Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status RECRUITING

Department of Medicine I, University Hospital Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christian Labenz, MD

Role: CONTACT

+496131172830

Simon Johannes Gairing, MD

Role: CONTACT

+496131176077

Facility Contacts

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Christian Labenz, MD

Role: primary

+496131172830

Simon Johannes Gairing, MD

Role: backup

+496131176077

Jens Uwe Marquardt, Professor

Role: primary

+4945150044101

References

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Kabelitz MA, Gairing SJ, Tiede A, Schleicher EM, Ahl LG, Wagner L, Zucker-Reimann F, Rieland H, Mauz JB, Weinmann-Menke J, Meyer BC, Pitton MB, Wedemeyer H, Galle PR, Sandmann L, Maasoumy B, Labenz C. Impact of Frailty on the Prognosis of Patients With Liver Cirrhosis Undergoing Insertion of a TIPS. Aliment Pharmacol Ther. 2025 Aug 1. doi: 10.1111/apt.70315. Online ahead of print.

Reference Type DERIVED
PMID: 40751304 (View on PubMed)

Other Identifiers

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20221

Identifier Type: -

Identifier Source: org_study_id

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