Reversibility of Minimal Hepatic Encephalopathy Following... | NCT02767622

Studies
Reversibility of Minimal Hepatic Encephalopathy Following Liver Transplantation

NCT02767622

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

May 11, 2016Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Minimal Hepatic Encephalopathy

Interventions

Liver transplantation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Apr 2015Actual

Completion Date

Not provided

First Submitted Date

May 7, 2016

First Submission Date that Met QC Criteria

May 7, 2016

First Posted Date

May 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2016

Last Update Posted Date

May 11, 2016Estimated

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient Group		Twenty right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation.	Procedure: Liver transplantation
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liver transplantation	Procedure		Patient Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of Psychometric tests.		6 months following liver transplantation.

Secondary Outcomes

Measure	Description	Time Frame
Improvement of liver functions and MELD score following liver transplantation.		6 months following liver transplantation.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D016031	Liver Transplantation

Ancestor Terms

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics

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Browse Branches

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