Annals of gastroenterology · 2025
A prospective international multisite randomized controlled trial of water exchange with and without distal cap(s) in adenoma detection.
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Leung Felix W, Cadoni Sergio, Chen Long, Chen Yu, Cheng Chi-Liang, Cheung Ramsey, Dixit Vivek, Elashoff David, Friedland Shai, Gallittu Paolo, Hsieh Yu-Hsi, Cheng Chia Hsin, Jacob Noam, Jamgotchian Nora, Jia Hui, Kuo Yen-Lin, Lee Bai-Ping, Leung Joseph W, Mura Donatella, Pan Jennifer Yi-Jiun, Pan Yanglin, Quan Susan Y, Saha Angshuman, Shaikh Aliya, Sul James, Tseng Chih-Wei, Tsui Yi-Ning, Wilhalme Holly, Wong Robert J, Yen Andrew W, Zhang Linhui
Аннотация
BACKGROUND: Interval cancers are linked to a low adenoma detection rate (ADR), prompting calls for benchmark-guided ADR performance improvement. Although water exchange and a straight cap (CAP) have been reported to independently improve ADR, the effects of Daisycuff™ and Endocuff Vision® remained unknown. We hypothesized that selected cap(s) could increase ADR and related water exchange outcomes.
METHODS: Subjects were randomized to No cap, or CAP, Daisycuff™ and Endocuff Vision® at 7, 5 and 2 sites. The primary outcome was ADR. Outcomes were compared for No cap vs. the above randomized caps.
RESULTS: Demographic and historic data revealed adequate randomization. Despite variations in site-specific pretrial ADR, the aggregated data showed that the ADR of No cap (45.6%) exceeded the latest benchmark (35%). Each added cap increased the ADR, and the difference using Daisycuff™(52.8%) approached statistical significance (P=0.05). In the right colon, CAP and Daisycuff™ significantly increased ADR. In the left colon, Daisycuff™ significantly increased adenoma per colonoscopy. Factors that improved adenoma detection were consistent with published reports. Detection rates based on site, indication, sedation type, polyp size, shape and pathology in the No cap group were consistent with conventional data and were not influenced by the caps.
CONCLUSIONS: The significantly higher right-colon ADRs with CAP and Daisycuff™ suggest potential clinical relevance for reducing interval cancers. Although water exchange with or without caps yields ADRs that surpass the benchmark, the positive findings for selected cap(s) need to be confirmed in order to enhance the options for further improvement of water exchange.
METHODS: Subjects were randomized to No cap, or CAP, Daisycuff™ and Endocuff Vision® at 7, 5 and 2 sites. The primary outcome was ADR. Outcomes were compared for No cap vs. the above randomized caps.
RESULTS: Demographic and historic data revealed adequate randomization. Despite variations in site-specific pretrial ADR, the aggregated data showed that the ADR of No cap (45.6%) exceeded the latest benchmark (35%). Each added cap increased the ADR, and the difference using Daisycuff™(52.8%) approached statistical significance (P=0.05). In the right colon, CAP and Daisycuff™ significantly increased ADR. In the left colon, Daisycuff™ significantly increased adenoma per colonoscopy. Factors that improved adenoma detection were consistent with published reports. Detection rates based on site, indication, sedation type, polyp size, shape and pathology in the No cap group were consistent with conventional data and were not influenced by the caps.
CONCLUSIONS: The significantly higher right-colon ADRs with CAP and Daisycuff™ suggest potential clinical relevance for reducing interval cancers. Although water exchange with or without caps yields ADRs that surpass the benchmark, the positive findings for selected cap(s) need to be confirmed in order to enhance the options for further improvement of water exchange.