Management of Small Subepithelial Tumors by Endoscopic Banding Without Resection and Single-Incision Needle-Knife-assisted Biopsy Sampling: a Prospective Multicenter Study.

Background and Aims: Endoscopic band ligation (EBL) without resection combined with single-incision needle-knife (SINK) biopsy sampling may have a positive impact on small GI subepithelial tumor (SET) management, but the method needs to be tested. The aim was to evaluate the feasibility of this strategy in small-sized SETs. Methods: This prospective multicenter observational cohort study in 7 centers included patients with SETs <= 15 mm (confirmed by EUS) between March 2017 and March 2020. The primary outcome was clinical success at 4 weeks, defined as complete SET disappearance on EUS. Secondary outcomes were long-term (1-year) clinical success, technical difficulty level, clinical impact, yield pathology, and safety. Results: Of 273 patients screened, 122 (62.3% women; mean age, 60.9 +/- 13.2 years) were included with SETs (mean size, 9 +/- 2.8 mm; gastric location, 77%; superficial layer dependence, 63%). The primary endpoint was achieved in 73.6% of patients (95% confidence interval [CI], 64.8-81.2). At the 1-year follow-up, the success rate was 68.4% (95% CI, 59.1-76.8). A favorable clinical impact was observed in 97 cases (79.5%; 95% CI, 71.3-86.3). Pathology diagnosis was known in 70%. Potentially malignant lesions were present in 24.7%. The related adverse events rate was 4.1% (95% CI, 1.3-9.3; all mild: 2 bleeding, 2 abdominal pain). On multivariable analysis, the <= 10-mm SET group was associated with a greater success rate (1 year, 87%; relative risk, 5.07; 95% CI, 2.63-9.8) and clinical impact rate (92.7%; relative risk, 6.15; 95% CI, 2.72-13.93). Conclusions: EBL plus SINK biopsy sampling seems to be feasible and safe, and it may offer a favorable clinical impact in small-sized SETs. In particular, SETs <= 10 mm are the best candidates.