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Recruiting NCT03039309

Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom

Observational Endoscopic Submucosal Dissection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic Submucosal Dissection.
Who it may be relevant to
Registry conditions: Endoscopic Submucosal Dissection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Curative resection rate [Time frame: 2 years]
Secondary outcome measures (3)
  • En bloc resection rate [Time frame: At the time of procedure]
  • Complication rates [Time frame: 28 days post procedure]
  • Mortality rates [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Portsmputh Hospitals NHS Trust — Portsmouth

Identifiers

NCT: NCT03039309 · PHT/2016/45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗