Endoscopic Submucosal Dissection (ESD) in North America: A Large Prospective Multicenter Study.

ABSTRACT Background and Aims Endoscopic submucosal dissection (ESD) in Asia has been shown to be superior to endoscopic mucosal resection (EMR) and surgery for the management of selected early gastrointestinal cancers. We aimed to evaluate technical outcomes of ESD in North America. Methods Multicenter prospective study on ESD across 10 centers in the United States and Canada between April 2016 to April 2020. End points included: rates of en-bloc resection, R0 resection, curative resection, adverse events, factors associated with failed resection, and recurrence post-R0 resection. Results 692 patients (median age 66, 57.8% men) underwent ESD (median lesion size 40 mm, IQR: 25-52 mm) for lesions in the esophagus (n=181), stomach (n=101), duodenum (n=11), colon (n=211) and rectum (n=188). En bloc, R0, and curative resection rates were 91.5%, 84.2%, and 78.3%, respectively. Bleeding and perforation were reported in 2.3% and 2.9% of the cases, respectively. Only 1 patient (0.14%) required surgery for adverse events. On multivariable analysis, severe submucosal fibrosis was associated with failed en-bloc, R0, and curative resection and higher risk for adverse events. Overall recurrence was 5.8% (31/532) at a mean follow-up of 13.3 months (range 1-60 months). Conclusion In this large multicenter prospective North American experience, we demonstrate that ESD can be performed safely, effectively, and is associated with a low recurrence rate. The technical resection outcomes achieved in this study are in line with the current established consensus quality parameters and further support the implementation of ESD for the treatment of select gastrointestinal neoplasms; ClinicalTrials.gov number, NCT02989818.