Endoscopic Submucosal Dissection 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: 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.

Keywords: EMR; Endoscopic Mucosal Resection; Endoscopic Submucosal Dissection; Gastrointestinal Neoplasms; Polyps.

Figure 1.

An 84-year-old patient with a 12-mm protruding lesion (Paris Is) in the background of Barrett’s esophagus is referred for endoscopy (A). The lesion is resected with EMR (B), with pathology confirming this to be a well-differentiated invasive adenocarcinoma with positive deep margins. The patient is deemed not a surgical candidate. He undergoes 4 sessions of cryotherapy and a second EMR due to recurrence of the nodule (C), with pathology demonstrating at least intramucosal adenocarcinoma with no lymphovascular invasion. The patient is subsequently referred for ESD. Two adjacent 10- to 15-mm nodules (Paris Is) were identified at the gastroesophageal junction on retroflexion (D). Successful circumferential ESD (E) with en bloc resection of a 60 × 30 mm tubular specimen (F). Pathology: Focal intramucosal adenocarcinoma with negative lateral and deep resection margins.