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

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

Detailed Description
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Multi-center prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed. All patients scheduled to undergo ESD at the University of Florida and participating centers as medically indicated will be considered for the study. Patients in whom ESD is considered as part of their standard medical care will be offered to participate in this study. The physician performing the procedure will also discuss the study with the subjects. If the patient agrees to participate, he or she will be given the informed consent form and allowed enough time to read it. Opportunity to ask questions will be provided. If the patient agrees to participate, he or she will sign the consent form and a copy will be provided. Data will be prospectively recorded according to the data collection form. ESD will be performed as medically indicated. The investigators from each respective center on this project will also be in charge of the medical care of the patients enrolled in the study. Follow-up will be carried out as medically indicated and no additional studies or clinic visits will be needed specifically for the purpose of this study.

Official Title
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Multi-center Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in the Western Population

Conditions
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Endoscopic Submucosal Dissection

Intervention / Treatment
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* Other: Endoscopic Submucosal Dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a. Age 18 years or older. b. Scheduled to undergo ESD as part of their standard of care. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lesion of the Gastrointestinal tract<br>Investigator will collect prospective data on the Endoscopic Submucosal dissection that is used as part of the subjects standard of care to remove the Gastrointestinal lesion | Other: Endoscopic Submucosal Dissection<br>* This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.<br>* Other names: ESD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of en-bloc resection | An Excision of the targeted lesion in a single specimen | 3-4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of R0 resection | when all vertical and horizontal margins are negative | 3-4 hours | 
| Rate of R1 resection | complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins | 3-4 hours | 
| 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 | 3-4 hours | 
| 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) | 1 month | 
| Rate of complete remission of neoplasia | Absence of a visible lesion and/or absence of the neoplastic lesion on biopsy specimens (histopathology) obtained from the ESD site on follow up evaluations | 1 month |