Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom
- Conditions
- Endoscopic Submucosal Dissection
- Registration Number
- NCT03039309
- Lead Sponsor
- Portsmouth Hospitals NHS Trust
- Brief Summary
Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of early gastrointestinal neoplasia.
- Detailed Description
Data will be collected from participating centres on en bloc resection, curative resection, R0 resection and complications/adverse events over a 2 year follow up period.
Demographic details on the patients included in the study will be captured alongside details on the size and location of their early gastrointestinal dysplastic/neoplastic lesions.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Male or Female, aged 18 years or above undergoing endoscopic submucosal dissection
- Participant is able to give informed consent for participation in the study
- Patients under the age of 18
- Patients unable to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Curative resection rate 2 years % of successful resections free of disease at follow up endoscopy by the end of the follow up period (2 years)
- Secondary Outcome Measures
Name Time Method Mortality rates 2 years % of patients alive at the end of the 2 year follow up
En bloc resection rate At the time of procedure % of en bloc resections obtained at the time of initial endoscopic submucosal dissection
Complication rates 28 days post procedure % of complications noted within 28 days following endoscopic submucosal dissection
Trial Locations
- Locations (1)
Portsmputh Hospitals NHS Trust
🇬🇧Portsmouth, United Kingdom