Peter V Draganov1, Hiroyuki Aihara2, Michael S Karasik3, Saowanee Ngamruengphong4, Abdul Aziz Aadam5, Mohamed O Othman6, Neil Sharma7, Ian S Grimm8, Alaa Rostom9, B Joseph Elmunzer10, Salmaan A Jawaid6, Donevan Westerveld11, Yaseen B Perbtani12, Brenda J Hoffman10, Alexander Schlachterman13, Amanda Siegel5, Roxana M Coman14, Andrew Y Wang15, Dennis Yang12. 1. Division of Gastroenterology and Hepatology, University of Florida, Gainesville, Florida. Electronic address: peter.draganov@medicine.ufl.edu. 2. Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. 3. Division of Gastroenterology and Hepatology, Hartford Hospital, Hartford, Connecticut. 4. Division of Gastroenterology and Hepatology, Johns Hopkins Medical Center, Baltimore, Maryland. 5. Division of Gastroenterology and Hepatology, Northwestern Medicine Digestive Health Center, Chicago, Illinois. 6. Gastroenterology and Hepatology Section, Baylor College of Medicine, Houston, Texas. 7. Division of Interventional Endoscopic Oncology and Surgical Endoscopy, Parkview Health, Fort Wayne, Indiana. 8. Division of Gastroenterology and Hepatology, University of North Carolina Hospitals, Chapel Hill, North Carolina. 9. Division of Gastroenterology and Hepatology, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada. 10. Division of Gastroenterology and Hepatology, The Medical University of South Carolina, Charleston, South Carolina. 11. Division of Gastroenterology and Hepatology New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York. 12. Division of Gastroenterology and Hepatology, University of Florida, Gainesville, Florida. 13. Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania. 14. Division of Hospital Gastroenterology, Atrium/Navicent Health, Mercer University, College of Medicine, Macon, Georgia. 15. Division of Gastroenterology and Hepatology, University of Virginia, Charlottesville, Virginia.
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: We conducted a multicenter prospective study on ESD across 10 centers in the United States and Canada between April 2016 and 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: Six hundred and ninety-two patients (median age, 66 years; 57.8% were men) underwent ESD (median lesion size, 40 mm; interquartile range, 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 of 532) at a mean follow-up of 13.3 months (range, 1-60 months). CONCLUSIONS: 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.
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: We conducted a multicenter prospective study on ESD across 10 centers in the United States and Canada between April 2016 and 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: Six hundred and ninety-two patients (median age, 66 years; 57.8% were men) underwent ESD (median lesion size, 40 mm; interquartile range, 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 of 532) at a mean follow-up of 13.3 months (range, 1-60 months). CONCLUSIONS: 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.
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