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Multi-center Evaluation of the Clinical Utility of ESD in the Western Population

ConditionEndoscopic Submucosal Dissection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Florida

About this trial

The aim of this multi-center study is to prospectively document the clinical utility of ESD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

a. Age 18 years or older.

b. Scheduled to undergo ESD as part of their standard of care.

Disqualifiers

a. Any contraindication to performing endoscopy.

b. Participation in another research protocol that could interfere or influence the outcome measures of the present study.

c. Patient is unable/unwilling to provide informed consent.

Trial population

Patients scheduled to undergo ESD at the University of Florida and participating centers as medically indicated and part of their standard of care

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endoscopic Submucosal Dissection

    Other intervention

    This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Lesion of the Gastrointestinal tract1 intervention

Trial outcomes

Primary outcomes

1

Rate of en-bloc resection

An Excision of the targeted lesion in a single specimen

Time frame
3-4 hours

Secondary outcomes

1

Rate of R0 resection

when all vertical and horizontal margins are negative

Time frame
3-4 hours
2

Rate of R1 resection

complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins

Time frame
3-4 hours
3

Curative resection

this will have the following: R0 resection, Well to moderately differentiated histology, Absence of Lymphovascular invasion, Absence of budding, Absence of invasion beyond superficial submucosa

Time frame
3-4 hours
4

Rate of Adverse events with ESD

Early (\<48 hours) and late (\>48 hours) adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov
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