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...
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Georg Thieme Verlag KG
2019-08-01
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doaj-e98f324a8479499aa5e798e471c650d72020-11-25T02:55:13ZengGeorg Thieme Verlag KGEndoscopy International Open2364-37222196-97362019-08-010709E1123E112910.1055/a-0854-3561Delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis)Masato Aizawa0Kenichi Utano1Takuya Tsunoda2Osamu Ichii3Takashi Kato4Yasuyuki Miyakura5Mitsuru Saka6Daiki Nemoto7Noriyuki Isohata8Shungo Endo9Yutaka Ejiri10Alan Kawarai Lefor11Kazutomo Togashi12Department of Coloproctology, Aizu Medical Center Fukushima Medical University, Fukushima, JapanDepartment of Coloproctology, Aizu Medical Center Fukushima Medical University, Fukushima, JapanDepartment of Gastroenterology, Takeda General Hospital, Fukushima, JapanDepartment of Gastroenterology, Fukushima Rosai Hospital, Fukushima, JapanDepartment of Gastroenterology, Hokkaido Gastroenterology Hospital, Hokkaido, JapanDepartment of Surgery, Saitama Medical Center Jichi Medical University, Saitama, JapanDepartment of Gastroenterology, Fujita General Hospital, Fukushima, JapanDepartment of Coloproctology, Aizu Medical Center Fukushima Medical University, Fukushima, JapanDepartment of Coloproctology, Aizu Medical Center Fukushima Medical University, Fukushima, JapanDepartment of Coloproctology, Aizu Medical Center Fukushima Medical University, Fukushima, JapanDepartment of Gastroenterology, Fukushima Rosai Hospital, Fukushima, JapanDepartment of Surgery, Jichi Medical University, Shimotsuke, JapanDepartment of Coloproctology, Aizu Medical Center Fukushima Medical University, Fukushima, JapanBackground 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 2017http://www.thieme-connect.de/DOI/DOI?10.1055/a-0854-3561 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Masato Aizawa Kenichi Utano Takuya Tsunoda Osamu Ichii Takashi Kato Yasuyuki Miyakura Mitsuru Saka Daiki Nemoto Noriyuki Isohata Shungo Endo Yutaka Ejiri Alan Kawarai Lefor Kazutomo Togashi |
spellingShingle |
Masato Aizawa Kenichi Utano Takuya Tsunoda Osamu Ichii Takashi Kato Yasuyuki Miyakura Mitsuru Saka Daiki Nemoto Noriyuki Isohata Shungo Endo Yutaka Ejiri Alan Kawarai Lefor Kazutomo Togashi Delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis) Endoscopy International Open |
author_facet |
Masato Aizawa Kenichi Utano Takuya Tsunoda Osamu Ichii Takashi Kato Yasuyuki Miyakura Mitsuru Saka Daiki Nemoto Noriyuki Isohata Shungo Endo Yutaka Ejiri Alan Kawarai Lefor Kazutomo Togashi |
author_sort |
Masato Aizawa |
title |
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_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_sort |
delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis) |
publisher |
Georg Thieme Verlag KG |
series |
Endoscopy International Open |
issn |
2364-3722 2196-9736 |
publishDate |
2019-08-01 |
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 |
url |
http://www.thieme-connect.de/DOI/DOI?10.1055/a-0854-3561 |
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