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

Primary An Excision of the targeted lesion in a single specimen Secondary Rate of R0 resection Time Frame 3-4 hours when all vertical and horizontal margins are negative Rate of R1 resection Time Frame 3-4 hours complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins Curative resection Time Frame 3-4 hours 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 Rate of Adverse events with ESD Time Frame 1 month Early (<48 hours) and late (>48 hours) adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE) Rate of complete remission of neoplasia Time Frame 1 month 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

Primary An Excision of the targeted lesion in a single specimen Secondary Rate of R0 resection Time Frame 3-4 hours when all vertical and horizontal margins are negative Rate of R1 resection Time Frame 3-4 hours complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins Curative resection Time Frame 3-4 hours 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 Rate of Adverse events with ESD Time Frame 1 month Early (<48 hours) and late (>48 hours) adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE) Rate of complete remission of neoplasia Time Frame 1 month 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