Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom

Endoscopic Submucosal Dissection Clinical Trial

— ESDUK  

Official title:

Endoscopic Submucosal Dissection in the Treatment of Early Gastrointestinal Neoplasia: A UK Cohort Study to Assess Effectiveness and Safety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03039309
• Other study ID #: PHT/2016/45
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Endoscopic Submucosal Dissection
• Neoplasms

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