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Multicenter observational cohort study of endoscopic band ligation without resection of small-sized subepithelial tumours of the digestive tract (Banding-SET): a clinical protocol.

BACKGROUND AND AIMS: Endoscopic band ligation (EBL) without resection combined with a single-incision needle-knife (SINK) biopsy may have a positive impact on small gastrointestinal subepithelial tumor (SET) management, but it needs to be tested. The aim was to evaluate the feasibility of this strategy in small-sized SET.

METHODS: This prospective multicenter observational cohort study in 7 centers included patients with SETs ≤15mm (confirmed by endoscopic ultrasound (EUS)) between March 2017 and March 2020. The primary outcome was 4 weeks clinical success defined as complete SET disappearance at EUS control. Secondary outcomes were long-term (1 year) clinical success, technical difficulty level, clinical impact, yield pathology, and safety.

CLINICALTRIALS: gov, NCT03247231.

RESULTS: Some 273 patients were screened, and 122 (62.3% women, mean age 60.9±13.2) were included with SET (mean size, 9mm±2.8; gastric location 77%, superficial layer-dependence 63%). Primary endpoint was achieved in 73.6% (95%CI 64.8-81.2). At 1-year follow-up, 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%. Related-adverse events rate was 4.1% (95%CI 1.3-9.3; all mild, n=2 bleeding, n=2 abdominal pain). On multivariable analysis, ≤10mm SET group was associated with a greater success rate (1-year, 87%; RR5.07[95%CI 2.63 - 9.8]) and clinical impact rate (92.7%; RR6.15 [95%CI 2.72 - 13.93].

CONCLUSIONS: EBL plus SINK-biopsy seems to be feasible, and safe, and it may offer a favorable clinical impact in small-sized SETs. Concretely, SETs ≤10mm are the best candidates.

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