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NCT Number: NCT03039309

Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom

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

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Key information

Conditions

Endoscopic Submucosal Dissection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic submucosal dissection

Procedure

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. En bloc resection rate

    Time frame: At the time of procedure

    % of en bloc resections obtained at the time of initial endoscopic submucosal dissection

  2. Complication rates

    Time frame: 28 days post procedure

    % of complications noted within 28 days following endoscopic submucosal dissection

  3. Mortality rates

    Time frame: 2 years

    % of patients alive at the end of the 2 year follow up

Study contacts

Contact information is provided by the study sponsor or research team.

Prof Pradeep Bhandari, MBBS, MD

CONTACT

[email protected]

02392286000 ext. 5852

Sharmila Subramaniam, MBBS

CONTACT

[email protected]

02392286000 ext. 5852

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Registry information

Official study title

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

Acronym: ESDUK

Important dates

Study start
2016
Primary completion
2026
Study completion
2028
First posted
Feb 1, 2017
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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