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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date November 2023
Source Portsmouth Hospitals NHS Trust
Contact Prof Pradeep Bhandari, MBBS, MD
Phone 02392286000
Email pradeep.bhandari@porthosp.nhs.uk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of early gastrointestinal neoplasia.


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Endoscopic Submucosal Dissection
Endoscopic submucosal dissection is an endoscopic resection technique that utilises an endoscopic knife to remove lesions within the gastrointestinal tract in an en bloc fashion.

Locations

Country Name City State
United Kingdom Portsmputh Hospitals NHS Trust Portsmouth

Sponsors (1)

Lead Sponsor Collaborator
Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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