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Delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis)
Background and study aims Delayed bleeding is believed to occur less frequently after cold snare polypectomy (CSP), but this has not been validated in clinical trials. This study aimed to compare rates of delayed bleeding after CSP and hot snare polypectomy (HSP). Patients and methods We conducted...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
© Georg Thieme Verlag KG
2019
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6715428/ https://www.ncbi.nlm.nih.gov/pubmed/31475229 http://dx.doi.org/10.1055/a-0854-3561 |
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author | Aizawa, Masato Utano, Kenichi Tsunoda, Takuya Ichii, Osamu Kato, Takashi Miyakura, Yasuyuki Saka, Mitsuru Nemoto, Daiki Isohata, Noriyuki Endo, Shungo Ejiri, Yutaka Lefor, Alan Kawarai Togashi, Kazutomo |
author_facet | Aizawa, Masato Utano, Kenichi Tsunoda, Takuya Ichii, Osamu Kato, Takashi Miyakura, Yasuyuki Saka, Mitsuru Nemoto, Daiki Isohata, Noriyuki Endo, Shungo Ejiri, Yutaka Lefor, Alan Kawarai Togashi, Kazutomo |
author_sort | Aizawa, Masato |
collection | PubMed |
description | Background and study aims Delayed bleeding is believed to occur less frequently after cold snare polypectomy (CSP), but this has not been validated in clinical trials. This study aimed to compare rates of delayed bleeding after CSP and hot snare polypectomy (HSP). Patients and methods We conducted a multicenter, randomized controlled trial. Participants scheduled to undergo endoscopic resection of colorectal polyps ≤ 10 mm were enrolled and randomly assigned to CSP or HSP. Prophylactic clipping was performed at the endoscopists’ discretion. The primary outcome was delayed bleeding rate. Secondary outcomes included immediate bleeding rate and clipping rate. Sample size calculation showed that 451 patients were required in each arm. Results At the end of the study period decided in advance, 308 participants were recruited and an interim analysis was performed. A total of 273 patients (mean age 62.2 ± 8.8 years; 188 males) were analyzed, with 139 patients allocated to CSP and 134 to HSP. In total, 367 polyps were resected with CSP and 360 polyps with HSP. There were no significant differences in patient demographics or polyp characteristics. In per-patient-based analysis, delayed bleeding rates were 0.7 % after CSP and 0.7 % after HSP. Per-polyp analysis showed similar results (CSP: 0.3 % vs. HSP: 0.6 %). The immediate bleeding rate was significantly higher with CSP vs. HSP (54 % vs.14 %, P < 0.0001), while clipping rates were 18 % and 19 %, respectively. Conclusion This interim analysis did not demonstrate that delayed bleeding after CSP is less frequent than after HSP. The delayed bleeding rate after HSP was lower than expected. Meeting presentations: Digestive Disease Week 2017 |
format | Online Article Text |
id | pubmed-6715428 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | © Georg Thieme Verlag KG |
record_format | MEDLINE/PubMed |
spelling | pubmed-67154282019-09-01 Delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis) Aizawa, Masato Utano, Kenichi Tsunoda, Takuya Ichii, Osamu Kato, Takashi Miyakura, Yasuyuki Saka, Mitsuru Nemoto, Daiki Isohata, Noriyuki Endo, Shungo Ejiri, Yutaka Lefor, Alan Kawarai Togashi, Kazutomo Endosc Int Open Background and study aims Delayed bleeding is believed to occur less frequently after cold snare polypectomy (CSP), but this has not been validated in clinical trials. This study aimed to compare rates of delayed bleeding after CSP and hot snare polypectomy (HSP). Patients and methods We conducted a multicenter, randomized controlled trial. Participants scheduled to undergo endoscopic resection of colorectal polyps ≤ 10 mm were enrolled and randomly assigned to CSP or HSP. Prophylactic clipping was performed at the endoscopists’ discretion. The primary outcome was delayed bleeding rate. Secondary outcomes included immediate bleeding rate and clipping rate. Sample size calculation showed that 451 patients were required in each arm. Results At the end of the study period decided in advance, 308 participants were recruited and an interim analysis was performed. A total of 273 patients (mean age 62.2 ± 8.8 years; 188 males) were analyzed, with 139 patients allocated to CSP and 134 to HSP. In total, 367 polyps were resected with CSP and 360 polyps with HSP. There were no significant differences in patient demographics or polyp characteristics. In per-patient-based analysis, delayed bleeding rates were 0.7 % after CSP and 0.7 % after HSP. Per-polyp analysis showed similar results (CSP: 0.3 % vs. HSP: 0.6 %). The immediate bleeding rate was significantly higher with CSP vs. HSP (54 % vs.14 %, P < 0.0001), while clipping rates were 18 % and 19 %, respectively. Conclusion This interim analysis did not demonstrate that delayed bleeding after CSP is less frequent than after HSP. The delayed bleeding rate after HSP was lower than expected. Meeting presentations: Digestive Disease Week 2017 © Georg Thieme Verlag KG 2019-09 2019-08-29 /pmc/articles/PMC6715428/ /pubmed/31475229 http://dx.doi.org/10.1055/a-0854-3561 Text en https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited. |
spellingShingle | Aizawa, Masato Utano, Kenichi Tsunoda, Takuya Ichii, Osamu Kato, Takashi Miyakura, Yasuyuki Saka, Mitsuru Nemoto, Daiki Isohata, Noriyuki Endo, Shungo Ejiri, Yutaka Lefor, Alan Kawarai Togashi, Kazutomo Delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis) |
title | Delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis) |
title_full | Delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis) |
title_fullStr | Delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis) |
title_full_unstemmed | Delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis) |
title_short | Delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis) |
title_sort | delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis) |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6715428/ https://www.ncbi.nlm.nih.gov/pubmed/31475229 http://dx.doi.org/10.1055/a-0854-3561 |
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