Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPortsmouth Hospitals NHS Trust

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or Female, aged 18 years or above undergoing endoscopic submucosal dissection

Participant is able to give informed consent for participation in the study

Disqualifiers

Patients under the age of 18

Patients unable to give informed consent

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endoscopic Submucosal Dissection

    Procedure/Surgery

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Curative resection rate

% of successful resections free of disease at follow up endoscopy by the end of the follow up period (2 years)

Time frame
2 years

Secondary outcomes

1

En bloc resection rate

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

Time frame
At the time of procedure
2

Complication rates

% of complications noted within 28 days following endoscopic submucosal dissection

Time frame
28 days post procedure
3

Mortality rates

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

Time frame
2 years

Other outcomes

Sponsors and contacts

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