Endoscopy · 2025
A novel colonoscope with 230-degree extra-wide field-of-view optics: a prospective first-in-human pilot study.
СтатьяМногоцентровое исследованиеКлиническое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Neuhaus Horst, Schiemer Moritz, Grossmann Johannes, Schmidt Arthur
Аннотация
BACKGROUND: A model-based trial of a novel colonoscope with extra-wide field-of-view (EFOV) optics previously demonstrated a higher polyp detection rate compared with a standard colonoscope. We report on the first-in-human study assessing its clinical utility.
METHODS: This two-center prospective pilot trial included patients scheduled for colorectal cancer (CRC) screening, evaluation of a positive fecal immunochemical test, or polyp surveillance. The primary end point was the cecal intubation rate with the EFOV colonoscope. Secondary end points included terminal ileum intubation rate, procedure time, detection rates for polyps (PDR), adenomas (ADR), and sessile serrated lesions (SSLDR), adenomas per colonoscopy (APC), therapeutic success, and adverse events.
RESULTS: 64 patients were enrolled. Indications were CRC screening (n = 48) or polyp surveillance (n = 16). The cecum was reached in all patients (100%; 95%CI 94.4%–100%) within a median time of 5 (range 2–20) minutes. The terminal ileum was intubated in 96.9% (95%CI 89.2%–99.6%) of cases. A total of 84 polyps were detected and removed in 43/64 patients (PDR 67%). The ADR, SSLDR, and APC were 43.8%, 17.2%, and 0.81 (95%CI 0.5–1.1), respectively. No adverse events occurred.
CONCLUSIONS: This first-in-human study showed that the EFOV colonoscope can be effectively and safely used in clinical practice. It promises improved detection of hidden polyps.
METHODS: This two-center prospective pilot trial included patients scheduled for colorectal cancer (CRC) screening, evaluation of a positive fecal immunochemical test, or polyp surveillance. The primary end point was the cecal intubation rate with the EFOV colonoscope. Secondary end points included terminal ileum intubation rate, procedure time, detection rates for polyps (PDR), adenomas (ADR), and sessile serrated lesions (SSLDR), adenomas per colonoscopy (APC), therapeutic success, and adverse events.
RESULTS: 64 patients were enrolled. Indications were CRC screening (n = 48) or polyp surveillance (n = 16). The cecum was reached in all patients (100%; 95%CI 94.4%–100%) within a median time of 5 (range 2–20) minutes. The terminal ileum was intubated in 96.9% (95%CI 89.2%–99.6%) of cases. A total of 84 polyps were detected and removed in 43/64 patients (PDR 67%). The ADR, SSLDR, and APC were 43.8%, 17.2%, and 0.81 (95%CI 0.5–1.1), respectively. No adverse events occurred.
CONCLUSIONS: This first-in-human study showed that the EFOV colonoscope can be effectively and safely used in clinical practice. It promises improved detection of hidden polyps.