Reversibility of Minimal Hepatic Encephalopathy Following Liver Transplantation

NCT ID: NCT02767622

Last Updated: 2016-05-11

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

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Brief Summary

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This study included 20 patients listed for liver transplantation in addition to 20 age- and sex- matched controls. Neurological, psychiatric, laboratory and radiological examinations were performed for both patients and controls before and 6 months after liver transplantation. Assessment of cognitive functions by Trail Making Test A (TMT A), TMT B, Digit Symbol Test (DST), and Serial Dotting Test (SDT) was done before and after liver transplantation.

Detailed Description

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Conditions

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Minimal Hepatic Encephalopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient Group

Twenty right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation.

Liver transplantation

Intervention Type PROCEDURE

Control Group

Twenty age-matched healthy persons. They were similar to the patient group in respect to the number of education years, sex, and handedness.

No interventions assigned to this group

Interventions

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Liver transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation

Exclusion Criteria

* Overt hepatic encephalopathy.
* Significant cortical atrophy or other structural brain changes revealed by conventional neuro-imaging.
* Regular use of psychotropic drugs, such as benzodiazepines.
* Known major psychiatric disorder.
* Less than 6 months of complete alcohol abstinence.
* Post-transplant toxic levels of immunosuppressive drugs.
* Patients unable to perform the tests (Illiterate or upper limb motor handicaps).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Sara Abdelhakam

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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875

Identifier Type: -

Identifier Source: org_study_id

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