Abstract
Background and Aims
This randomized controlled trial (RCT) was designed to evaluate the short-term outcomes of underwater endoscopic mucosal resection (UEMR) and endoscopic submucosal dissection (ESD) of 21–30 mm colonic polyps.
Method
We conducted a single-center RCT. Patients diagnosed with suspected colorectal intramucosal carcinoma (21–30 mm and adaptable for both UEMR and ESD) were randomly assigned to the UEMR and ESD groups at a 1:1 ratio. The primary endpoint was the R0 resection rate. We independently performed one-sample tests against the set threshold for each treatment. The significance level was set at p = 0.224.
Result
Eleven polyps each in the UEMR and ESD groups, respectively, were analyzed. The R0 resection rate (%) was 36 (95% confidence interval 11–69) and 100 (72–100) for UEMR and ESD, respectively, with a significant difference between the two groups (p = 0.002). The p-value against the set threshold for UEMR was 0.743, whereas that for ESD was < 0.001 (one-sample binomial test). The en bloc resection rates (%) were 82 (48–97) and 100 (72–100) for UEMR and ESD, respectively; however, no significant difference was observed (p = 0.167). The mean treatment time (min) was significantly shorter in the UEMR group (8 ± 6) than in the ESD group (48 ± 29) (p = 0.001).
Conclusion
ESD could achieve a high R0 resection rate, while the en bloc resection rate was comparable between the two treatment techniques with less burden on patients undergoing UEMR for 21–30-mm colorectal polyps.
Clinical Trial Registration
The study was registered at the Japan Registry of Clinical Trial as jRCT1030210015 and jRCT1030210177.
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Acknowledgments
The authors thank the staff of the Endoscopy Center of Chiba University Hospital for providing technical assistance and for helping in the documentation and Hideki Hanaoka, Yoko Hattori, and Park Inkyung at the Clinical Research Data Center of Chiba University Hospital for their data administration. The authors also thank Enago (https://www.enago.jp/) for English language editing.
Funding
The author received the Japanese Foundation for Research and Promotion of Endoscopy Grant (No 1008).
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Contributions
Wrote manuscript: K.O., K.M, and Y.I. Performed endoscopic procedure. K.O., T.M., T.I., and N.A. Interpretation of the data: K.O., T.M., T.I., N.A., T.K., Y.O., T.T., K.S., S.O., and D.M. Statistical analysis: Y.I. Pathological diagnosis: K.M. Supervised manuscript: M.O., J.K., JI.I., and N.K. Generated the random allocation sequence: Y.I. Enrolled participants and who assigned participants to interventions: K.O., T.M., T.I., and N.A.
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All authors were involved in the final approval of the version of the manuscript submitted and have agreed to be accountable for all aspects of the work. There is no relevant conflict of interest or disclosures, including financial and material support for the research and work in this manuscript.
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This study was conducted in accordance with the Helsinki Declaration. Patients’ data were coded, and the anonymity of patients was guaranteed. The study protocol was reviewed and approved by the Ethics Review Committee of Chiba University Graduate School of Medicine (registration no. G2020032 on January 21, 2021 and 4211 on June 17 (in relation to recurrence evaluation)). The study protocol was unchanged after the initiation of this trial.
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Okimoto, K., Matsumura, T., Matsusaka, K. et al. Outcomes for Underwater Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection of 21–30-mm Colorectal Polyps: A Feasible Study. Dig Dis Sci 68, 3963–3973 (2023). https://doi.org/10.1007/s10620-023-08093-y
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DOI: https://doi.org/10.1007/s10620-023-08093-y