CHE in children with liver disease.
Research type
Research Study
Full title
Diagnosis of covert hepatic encephalopathy in children & young people with chronic liver disease.
IRAS ID
234544
Contact name
Marianne Samyn
Contact email
Sponsor organisation
King's College Hospital
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 9 months, 6 days
Research summary
Hepatic encephalopathy (HE) is a serious complication of chronic liver disease (CLD) caused by accumulation of toxic substances in the bloodstream that are normally removed by the liver. It manifests as a wide spectrum of neurological and psychiatric abnormalities, ranging from subclinical alterations to coma. It is associated with poorer quality of life, impaired daily functioning and reduced survival, which does not necessarily normalise post-liver transplantation in those with established HE . Covert HE (CHE), a milder form of HE is difficult to identify in routine clinical practice, as patients tend to be apparently asymptomatic with no particular findings on routine physical examination/investigations. It can be detected by neuropsychological assessment and neurophysiological testing as demonstrated in adults but has not been comprehensively studied in children and young people. The aim of this study is to determine whether the tests used in adults, can be adapted for use in CYP.
Participants will be recruited from the Paediatric Liver service at King’s College Hospital. Clinics are attended by young people with a range of diagnoses of chronic liver diseases, both pre- and post-transplant. Young people with an upcoming clinic appointment at King's College Hospital who meet eligibility criteria for the study will be sent a letter (written and signed by their clinical team) at least a month in advance of their clinic appointment which will explain why the study is taking place, and a Participant Information Sheet, which will described further details of the study. Patients will be telephoned at least 2 weeks prior to their clinic appointment (ensuring they would have received Participant Information Sheet at least 1 week prior to call) to check if they had any questions about the study. For any patients expressing a wish to participate, appointments for he cognitive assessment will take place around their clinic appointment.
Following recruitment, participants will be invited to a private clinic room to take part in the research. The researcher will check that the young person has received an information sheet about the study, outline the limits of confidentiality and give them the opportunity to ask questions before gaining their written consent. Participants will complete the cognitive assessment over approximately 2 ½ - 3 hours, including scheduled comfort breaks. This will involve completing some puzzles (e.g. making shapes out of blocks) and answering some questions (e.g. defining some words). The Critical Flicker Test will be undertaken at the end of testing. The EEG will be scheduled separately, likely in the morning of appointments. Participants will then be debriefed, in order to check they are not experiencing distress following participation.
A full report, detailing their cognitive strengths and weaknesses will be offered to all participants. A follow up ‘feedback’ session will also be offered with the team’s clinical psychologist.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0109
Date of REC Opinion
6 Apr 2018
REC opinion
Favourable Opinion