Endoscopic Submucosal Dissection Clinical Trial
— ESDUKOfficial title:
Endoscopic Submucosal Dissection in the Treatment of Early Gastrointestinal Neoplasia: A UK Cohort Study to Assess Effectiveness and Safety
NCT number | NCT03039309 |
Other study ID # | PHT/2016/45 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 5, 2016 |
Est. completion date | August 2024 |
Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of early gastrointestinal neoplasia.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or Female, aged 18 years or above undergoing endoscopic submucosal dissection - Participant is able to give informed consent for participation in the study Exclusion Criteria: - Patients under the age of 18 - Patients unable to give informed consent |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Portsmputh Hospitals NHS Trust | Portsmouth |
Lead Sponsor | Collaborator |
---|---|
Portsmouth Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Curative resection rate | % of successful resections free of disease at follow up endoscopy by the end of the follow up period (2 years) | 2 years | |
Secondary | En bloc resection rate | % of en bloc resections obtained at the time of initial endoscopic submucosal dissection | At the time of procedure | |
Secondary | Complication rates | % of complications noted within 28 days following endoscopic submucosal dissection | 28 days post procedure | |
Secondary | Mortality rates | % of patients alive at the end of the 2 year follow up | 2 years |
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