Non-invasive Evaluation Program for TIPS and Follow Up Network 2 (NEPTUN2)

NCT ID: NCT04393519

Last Updated: 2021-10-05

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

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-12

Study Completion Date

2030-12-31

Brief Summary

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Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.

Detailed Description

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NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.

Conditions

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Portal Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective

Prospective cohort that received TIPS from 05/12/2020 onwards

TIPS procedure

Intervention Type DEVICE

Implantation of TIPS for portal hypertension

Interventions

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TIPS procedure

Implantation of TIPS for portal hypertension

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Insertion of TIPS according to guidelines

Exclusion Criteria

* Contraindication for TIPS
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Michael Praktiknjo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Praktiknjo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bonn

Locations

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University Hospital Bonn

Bonn, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Michael Praktiknjo, MD

Role: CONTACT

+49(0)228-287 15770

Johannes Chang, MD

Role: CONTACT

+49(0)228-287 15770

Facility Contacts

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Michael Praktiknjo, MD

Role: primary

+49228 28715770

Johannes Chang, MD

Role: backup

+49228 28715770

Other Identifiers

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NEPTUN2

Identifier Type: -

Identifier Source: org_study_id

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