Objective To investigate the success rate of cold snare polypectomy (CSP) for complete resection of 4–9 mm colorectal adenomatous polyps compared with that of hot snare polypectomy (HSP).
Design A prospective, multicentre, randomised controlled, parallel, non-inferiority trial conducted in 12 Japanese endoscopy units. Endoscopically diagnosed sessile adenomatous polyps, 4–9 mm in size, were randomly assigned to the CSP or HSP group. After complete removal of the polyp using the allocated technique, biopsy specimens from the resection margin after polypectomy were obtained. The primary endpoint was the complete resection rate, defined as no evidence of adenomatous tissue in the biopsied specimens, among all pathologically confirmed adenomatous polyps.
Results A total of 796 eligible polyps were detected in 538 of 912 patients screened for eligibility between September 2015 and August 2016. The complete resection rate for CSP was 98.2% compared with 97.4% for HSP. The non-inferiority of CSP for complete resection compared with HSP was confirmed by the +0.8% (90% CI −1.0 to 2.7) complete resection rate (non-inferiority p<0.0001). Postoperative bleeding requiring endoscopic haemostasis occurred only in the HSP group (0.5%, 2 of 402 polyps).
Conclusions The complete resection rate for CSP is not inferior to that for HSP. CSP can be one of the standard techniques for 4–9 mm colorectal polyps. (Study registration: UMIN000018328)
- colorectal neoplasm
- colonic polyps
- colorectal Cancer
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Contributors TK, YT and NU planned the study. IY and ST were statistical advisors. SA, EA, MK, TA, KT, YK, MI, KK, MN, DW, AY, NF, MS, MO, KF, YS, HK, SH and HI had leadership in each institute and collected data. KT organised the study group. TK wrote the manuscript, and all the authors approved the final version of this manuscript.
Funding This study was funded by the Investigator Sponsored Research Program of Boston Scientific (ISREND00006).
Competing interests This study was funded by the Investigator Sponsored Research Program of Boston Scientific. The funder paid for statistical analysis, construction of electronic data collecting system and English proofreading service. However, the funder was not involved in the study design, recruitment, analysis plan or interpretation of data.
Ethics approval Institutional Review Board of each participating centre.
Provenance and peer review Not commissioned; externally peer reviewed.
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