Liver Fibrosis Clinical Trial
Official title:
Gastrointestinal, Hepatic and Biliary Sequelae of Frequent Ketamine Use: a Prospective Observational Study
NCT number | NCT02165488 |
Other study ID # | UW14-237 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | December 2019 |
Verified date | March 2020 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
30% of ketamine users complain of abdominal discomfort. Long-term ketamine use is associated with hepatotoxicity and pathologic changes to the biliary tract. Yet the prevalence of gastrointestinal and hepatobiliary pathologies in ketamine users has not been well-described. The investigators plan to recruit a large number of ketamine users based on referrals from different Psychiatry clusters in Hong Kong and to investigate the underlying cause of abdominal discomfort, describe the prevalence of different gastrointestinal and hepatobiliary pathologies and describe their long-term outcome.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Use of ketamine or ketamine mixed with other psychotropic drugs with frequency of at least twice per month over 6 months within the last 2 years. - Recurrent abdominal discomfort over the past 3 months or more. - Han Chinese ethnicity. - Age 18-60 years. Exclusion Criteria: - Mental retardation or unable to give informed consent - Co-existing biliary disorders including recurrent pyogenic cholangitis, primary sclerosing cholangitis, IgG4 sclerosing cholangiopathy and HIV cholangiopathy. - Other significant medical co-morbidities |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of cholangiopathic changes | 3 months | ||
Primary | Incidence of peptic ulcer disease | 3 months | ||
Primary | Incidence of liver fibrosis | 3 months | ||
Secondary | Long-term outcome of peptic ulcer disease in ketamine users | 24 months | ||
Secondary | Long-term outcome of liver fibrosis in ketamine users | up to 24 months | ||
Secondary | Long-term outcomes of cholangiopathic changes in ketamine users | Up to 24 months |
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