Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom (ESDUK)

May 27, 2025 updated by: Portsmouth Hospitals NHS Trust

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing endoscopic submucosal dissection for early gastrointestinal neoplasia (e.g colorectal/gastric/oesophageal) in tertiary referral centres in the UK

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Curative resection rate
Time Frame: 2 years
% of successful resections free of disease at follow up endoscopy by the end of the follow up period (2 years)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
En bloc resection rate
Time Frame: At the time of procedure
% of en bloc resections obtained at the time of initial endoscopic submucosal dissection
At the time of procedure
Complication rates
Time Frame: 28 days post procedure
% of complications noted within 28 days following endoscopic submucosal dissection
28 days post procedure
Mortality rates
Time Frame: 2 years
% of patients alive at the end of the 2 year follow up
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portsmouth Hospitals NHS Trust

Investigators

  • Principal Investigator: Prof Pradeep Bhandari, MBBS, MD, Portsmouth Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2016

Primary Completion (Estimated)

August 4, 2026

Study Completion (Estimated)

August 4, 2028

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (Estimated)

February 1, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHT/2016/45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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