Endoscopic submucosal dissection (ESD) is an effective and safe procedure associated with a low recurrence rate for patients with select abnormal and early cancerous lesions throughout the gastrointestinal tract, according to a study in Gastroenterology.
Researchers conducted a prospective study in 10 centers throughout the United States and Canada. The study population consisted of consecutive patients aged ≥18 years who underwent ESD between April 2016 and April 2020.
Primary outcomes were cases with en bloc, R0, and curative resection. Adverse events were categorized according to the American Society of Gastrointestinal Endoscopy (ASGE) consensus criteria.
A total of 692 patients (median age, 66 years; 57.8% men) underwent ESD, and the median lesion size was 40 mm (interquartile range, 25-52 mm). The most common ESD site was in the colon (30.5%), followed by the rectum (27.2%), esophagus (26.2%), stomach (14.6%), and duodenum (1.6%).
En bloc was achieved in 91.5% of patients (633/692), and R0 resection was achieved in 84.2% (583/692) of the cohort. Curative resection was attained in 542 cases (78.3%), ranging from 71.3% in the esophagus to 83.9% in the colon.
Adverse events were observed in 70 cases (10.1%), most of which were either mild (50%) or moderate (40%) in severity. Bleeding was reported in 2.3% of patients, and perforation occurred in 2.9% of cases.
Multivariable analysis showed that severe submucosal fibrosis was associated with failed en bloc, R0, and curative resection, as well as a higher risk for adverse events. Overall recurrence was 5.8% (31/532 cases) with a mean follow-up of 13.3 months (range, 1-60 months).
The researchers stated, “The R1 resection rate was relatively low in our study (15.8%). Noteworthy, on further analysis, most of these cases of incomplete resection were due to positive lateral margins (41.3%).”
“These findings have important clinical implications,” the study authors noted. “Our data reiterate the importance of careful lesion assessment and characterization prior to resection in order to improve resection outcomes and provide a target for future educational efforts for North American endoscopists performing ESD.”
Among several study limitations, the investigators noted that a priori criteria for ESD were not defined in this observational prospective study, and thus the results are subject to selection bias. Further, the relatively short follow-up prohibited significant conclusions to be formed based on longer-term outcomes.
“We demonstrated that ESD can be performed safely, effectively, and is associated with a low recurrence rate,” the researchers commented. “The resection outcomes in this study achieved adequate levels of performance based on current established consensus quality parameters and further support the implementation of ESD for the management of select gastrointestinal neoplasms.”
Disclosures: Some authors reported affiliations with pharmaceutical and medical device companies. Please see the original reference for a full list of disclosures.
Draganov PV, Aihara H, Karasik MS, et al. Endoscopic submucosal dissection (ESD) in North America: a large prospective multicenter study. Gastroenterology. Published online February 18, 2021. doi: 10.1053/j.gastro.2021.02.036