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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Cold Versus Hot Snare Polypectomy for Small Colorectal Polyps : A Pragmatic Randomized Controlled Trial.
- Li-Chun Chang, Chi-Yang Chang, Chi-Yi Chen, Cheng-Hao Tseng, Peng-Jen Chen, Chia-Tung Shun, Wen-Feng Hsu, Yen-Nien Chen, Chieh-Chang Chen, Tien-Yu Huang, Chia-Hung Tu, Mei-Jyh Chen, Chu-Kuang Chou, Ching-Tai Lee, Po-Yueh Chen, Ming-Shiang Wu, and Han-Mo Chiu.
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan (L.C.C., C.C.C., M.J.C., M.S.W., H.M.C.).
- Ann. Intern. Med. 2023 Mar 1; 176 (3): 311319311-319.
BackgroundAlthough cold snare polypectomy (CSP) is considered effective in reducing delayed postpolypectomy bleeding risk, direct evidence supporting its safety in the general population remains lacking.ObjectiveTo clarify whether CSP would reduce delayed bleeding risk after polypectomy compared with hot snare polypectomy (HSP) in the general population.DesignMulticenter randomized controlled study. (ClinicalTrials.gov: NCT03373136).Setting6 sites in Taiwan, July 2018 through July 2020.ParticipantsParticipants aged 40 years or older with polyps of 4 to 10 mm.InterventionCSP or HSP to remove polyps of 4 to 10 mm.MeasurementsThe primary outcome was the delayed bleeding rate within 14 days after polypectomy. Severe bleeding was defined as a decrease in hemoglobin concentration of 20 g/L or more, requiring transfusion or hemostasis. Secondary outcomes included mean polypectomy time, successful tissue retrieval, en bloc resection, complete histologic resection, and emergency service visits.ResultsA total of 4270 participants were randomly assigned (2137 to CSP and 2133 to HSP). Eight patients (0.4%) in the CSP group and 31 (1.5%) in the HSP group had delayed bleeding (risk difference, -1.1% [95% CI, -1.7% to -0.5%]). Severe delayed bleeding was also lower in the CSP group (1 [0.05%] vs. 8 [0.4%] events; risk difference, -0.3% [CI, -0.6% to -0.05%]). Mean polypectomy time (119.0 vs. 162.9 seconds; difference in mean, -44.0 seconds [CI, -53.1 to -34.9 seconds]) was shorter in the CSP group, although successful tissue retrieval, en bloc resection, and complete histologic resection did not differ. The CSP group had fewer emergency service visits than the HSP group (4 [0.2%] vs. 13 [0.6%] visits; risk difference, -0.4% [CI, -0.8% to -0.04%]).LimitationAn open-label, single-blind trial.ConclusionCompared with HSP, CSP for small colorectal polyps significantly reduces the risk for delayed postpolypectomy bleeding, including severe events.Primary Funding SourceBoston Scientific Corporation.
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