Clinical usefulness of red dichromatic imaging in hemostatic treatment during endoscopic submucosal dissection: First report from a multicenter, open‐label, randomized controlled trial
Objectives To verify the efficacy and safety of red dichromatic imaging (RDI) in hemostatic procedures during endoscopic submucosal dissection (ESD). Methods This is a multicenter randomized controlled trial of 404 patients who underwent ESD of the esophagus, stomach, colorectum. Patients who receiv...
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Veröffentlicht in: | Digestive endoscopy 2022-01, Vol.34 (2), p.379-390 |
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creator | Fujimoto, Ai Saito, Yutaka Abe, Seiichiro Hoteya, Syu Nomura, Kosuke Yasuda, Hiroshi Matsuo, Yasumasa Uraoka, Toshio Kuribayashi, Shiko Tsuji, Yosuke Ohki, Daisuke Maehata, Tadateru Kato, Motohiko Yahagi, Naohisa |
description | Objectives
To verify the efficacy and safety of red dichromatic imaging (RDI) in hemostatic procedures during endoscopic submucosal dissection (ESD).
Methods
This is a multicenter randomized controlled trial of 404 patients who underwent ESD of the esophagus, stomach, colorectum. Patients who received hemostatic treatments by RDI during ESD were defined as the RDI group (n = 204), and those who received hemostatic treatments by white light imaging (WLI) were defined as the WLI group (n = 200). The primary endpoint was a shortening of the hemostasis time. The secondary endpoints were a reduction of the psychological stress experienced by the endoscopist during the hemostatic treatment, a shortened treatment time, and a non‐inferior perforation rate, in RDI versus WLI.
Results
The mean hemostasis time in RDI (n = 860) was not significantly shorter than that in WLI (n = 1049) (62.3 ± 108.1 vs. 56.2 ± 74.6 s; P = 0.921). The median hemostasis time was significantly longer in RDI than in WLI (36.0 [18.0–71.0] vs. 28.0 [14.0–66.0] s; P = 0.001) in a sensitivity analysis. The psychological stress was significantly lower in RDI than in WLI (1.71 ± 0.935 vs. 2.03 ± 1.038; P |
doi_str_mv | 10.1111/den.14191 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2597799453</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2597799453</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4501-c81032c5ae56b22f341e0d1508fe8e21780e941395e7ffb3f49ab0b12e62f5193</originalsourceid><addsrcrecordid>eNp1kUFu1TAQhi1ERR-FBRdAXoLUtJ7ETmJ21WsLlSrYwDpynHFr5NjBdoTKiiP0PByHk-D2tew6G488nz6N5ifkDbAjKHU8oT8CDhKekQ1w3lTQtvCcbJgEUYm2EfvkZUrfGYNacv6C7De860TL-w35s3XWW60cXROa1XlMiQZDI050svo6hlllq6md1ZX1V9R6eo1zSPn-N0dUeUaf6bTGuzH6KSQdljJL6zivOqSinmxKqLMN_gM9tzHlol9CzNQUPVV0Xl2xFQ3GQxoW9H9_3zo1ojukURXjbH-VdXTwOQbnSpujVe4V2TPKJXz98B6Qb-dnX7efqssvHy-2J5eV5oJBpXtgTa2FQtGOdW0aDsgmEKw32GMNXc9QcmikwM6YsTFcqpGNUGNbGwGyOSDvdt4lhh8rpjzMNml0TnkMaxpqIbtOSi6agr7foTqGlCKaYYnlcvFmADbcRTWUqIb7qAr79kFbDoXTf_IxmwIc74Cf1uHN06bh9OzzTvkPsK6jcA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2597799453</pqid></control><display><type>article</type><title>Clinical usefulness of red dichromatic imaging in hemostatic treatment during endoscopic submucosal dissection: First report from a multicenter, open‐label, randomized controlled trial</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Fujimoto, Ai ; Saito, Yutaka ; Abe, Seiichiro ; Hoteya, Syu ; Nomura, Kosuke ; Yasuda, Hiroshi ; Matsuo, Yasumasa ; Uraoka, Toshio ; Kuribayashi, Shiko ; Tsuji, Yosuke ; Ohki, Daisuke ; Maehata, Tadateru ; Kato, Motohiko ; Yahagi, Naohisa</creator><creatorcontrib>Fujimoto, Ai ; Saito, Yutaka ; Abe, Seiichiro ; Hoteya, Syu ; Nomura, Kosuke ; Yasuda, Hiroshi ; Matsuo, Yasumasa ; Uraoka, Toshio ; Kuribayashi, Shiko ; Tsuji, Yosuke ; Ohki, Daisuke ; Maehata, Tadateru ; Kato, Motohiko ; Yahagi, Naohisa</creatorcontrib><description>Objectives
To verify the efficacy and safety of red dichromatic imaging (RDI) in hemostatic procedures during endoscopic submucosal dissection (ESD).
Methods
This is a multicenter randomized controlled trial of 404 patients who underwent ESD of the esophagus, stomach, colorectum. Patients who received hemostatic treatments by RDI during ESD were defined as the RDI group (n = 204), and those who received hemostatic treatments by white light imaging (WLI) were defined as the WLI group (n = 200). The primary endpoint was a shortening of the hemostasis time. The secondary endpoints were a reduction of the psychological stress experienced by the endoscopist during the hemostatic treatment, a shortened treatment time, and a non‐inferior perforation rate, in RDI versus WLI.
Results
The mean hemostasis time in RDI (n = 860) was not significantly shorter than that in WLI (n = 1049) (62.3 ± 108.1 vs. 56.2 ± 74.6 s; P = 0.921). The median hemostasis time was significantly longer in RDI than in WLI (36.0 [18.0–71.0] vs. 28.0 [14.0–66.0] s; P = 0.001) in a sensitivity analysis. The psychological stress was significantly lower in RDI than in WLI (1.71 ± 0.935 vs. 2.03 ± 1.038; P < 0.001). There was no significant difference in the ESD treatment time between RDI (n = 161) and WLI (n = 168) (58.0 [35.0–86.0] vs. 60.0 [38.0–88.5] min; P = 0.855). Four perforations were observed, but none of them took place during the hemostatic treatment.
Conclusions
Hemostatic treatment using RDI does not shorten the hemostasis time. RDI, however, is safe to use for hemostatic procedures and reduces the psychological stress experienced by endoscopists when they perform hemostatic treatment during ESD.
UMIN000025134.</description><identifier>ISSN: 0915-5635</identifier><identifier>EISSN: 1443-1661</identifier><identifier>DOI: 10.1111/den.14191</identifier><identifier>PMID: 34775648</identifier><language>eng</language><publisher>Australia</publisher><subject>Endoscopic Mucosal Resection - adverse effects ; endoscopic submucosal dissection ; Hemostasis ; Hemostatics ; Humans ; multicenter randomized controlled trial ; red dichromatic imaging ; Treatment Outcome</subject><ispartof>Digestive endoscopy, 2022-01, Vol.34 (2), p.379-390</ispartof><rights>2021 Japan Gastroenterological Endoscopy Society</rights><rights>2021 Japan Gastroenterological Endoscopy Society.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4501-c81032c5ae56b22f341e0d1508fe8e21780e941395e7ffb3f49ab0b12e62f5193</citedby><cites>FETCH-LOGICAL-c4501-c81032c5ae56b22f341e0d1508fe8e21780e941395e7ffb3f49ab0b12e62f5193</cites><orcidid>0000-0003-4547-5213 ; 0000-0003-3489-3356 ; 0000-0003-0186-3599 ; 0000-0002-4425-4331 ; 0000-0002-9574-7451 ; 0000-0003-4279-0138 ; 0000-0001-7891-9795 ; 0000-0002-7579-1316 ; 0000-0002-2736-6921 ; 0000-0002-5067-552X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fden.14191$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fden.14191$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34775648$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fujimoto, Ai</creatorcontrib><creatorcontrib>Saito, Yutaka</creatorcontrib><creatorcontrib>Abe, Seiichiro</creatorcontrib><creatorcontrib>Hoteya, Syu</creatorcontrib><creatorcontrib>Nomura, Kosuke</creatorcontrib><creatorcontrib>Yasuda, Hiroshi</creatorcontrib><creatorcontrib>Matsuo, Yasumasa</creatorcontrib><creatorcontrib>Uraoka, Toshio</creatorcontrib><creatorcontrib>Kuribayashi, Shiko</creatorcontrib><creatorcontrib>Tsuji, Yosuke</creatorcontrib><creatorcontrib>Ohki, Daisuke</creatorcontrib><creatorcontrib>Maehata, Tadateru</creatorcontrib><creatorcontrib>Kato, Motohiko</creatorcontrib><creatorcontrib>Yahagi, Naohisa</creatorcontrib><title>Clinical usefulness of red dichromatic imaging in hemostatic treatment during endoscopic submucosal dissection: First report from a multicenter, open‐label, randomized controlled trial</title><title>Digestive endoscopy</title><addtitle>Dig Endosc</addtitle><description>Objectives
To verify the efficacy and safety of red dichromatic imaging (RDI) in hemostatic procedures during endoscopic submucosal dissection (ESD).
Methods
This is a multicenter randomized controlled trial of 404 patients who underwent ESD of the esophagus, stomach, colorectum. Patients who received hemostatic treatments by RDI during ESD were defined as the RDI group (n = 204), and those who received hemostatic treatments by white light imaging (WLI) were defined as the WLI group (n = 200). The primary endpoint was a shortening of the hemostasis time. The secondary endpoints were a reduction of the psychological stress experienced by the endoscopist during the hemostatic treatment, a shortened treatment time, and a non‐inferior perforation rate, in RDI versus WLI.
Results
The mean hemostasis time in RDI (n = 860) was not significantly shorter than that in WLI (n = 1049) (62.3 ± 108.1 vs. 56.2 ± 74.6 s; P = 0.921). The median hemostasis time was significantly longer in RDI than in WLI (36.0 [18.0–71.0] vs. 28.0 [14.0–66.0] s; P = 0.001) in a sensitivity analysis. The psychological stress was significantly lower in RDI than in WLI (1.71 ± 0.935 vs. 2.03 ± 1.038; P < 0.001). There was no significant difference in the ESD treatment time between RDI (n = 161) and WLI (n = 168) (58.0 [35.0–86.0] vs. 60.0 [38.0–88.5] min; P = 0.855). Four perforations were observed, but none of them took place during the hemostatic treatment.
Conclusions
Hemostatic treatment using RDI does not shorten the hemostasis time. RDI, however, is safe to use for hemostatic procedures and reduces the psychological stress experienced by endoscopists when they perform hemostatic treatment during ESD.
UMIN000025134.</description><subject>Endoscopic Mucosal Resection - adverse effects</subject><subject>endoscopic submucosal dissection</subject><subject>Hemostasis</subject><subject>Hemostatics</subject><subject>Humans</subject><subject>multicenter randomized controlled trial</subject><subject>red dichromatic imaging</subject><subject>Treatment Outcome</subject><issn>0915-5635</issn><issn>1443-1661</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUFu1TAQhi1ERR-FBRdAXoLUtJ7ETmJ21WsLlSrYwDpynHFr5NjBdoTKiiP0PByHk-D2tew6G488nz6N5ifkDbAjKHU8oT8CDhKekQ1w3lTQtvCcbJgEUYm2EfvkZUrfGYNacv6C7De860TL-w35s3XWW60cXROa1XlMiQZDI050svo6hlllq6md1ZX1V9R6eo1zSPn-N0dUeUaf6bTGuzH6KSQdljJL6zivOqSinmxKqLMN_gM9tzHlol9CzNQUPVV0Xl2xFQ3GQxoW9H9_3zo1ojukURXjbH-VdXTwOQbnSpujVe4V2TPKJXz98B6Qb-dnX7efqssvHy-2J5eV5oJBpXtgTa2FQtGOdW0aDsgmEKw32GMNXc9QcmikwM6YsTFcqpGNUGNbGwGyOSDvdt4lhh8rpjzMNml0TnkMaxpqIbtOSi6agr7foTqGlCKaYYnlcvFmADbcRTWUqIb7qAr79kFbDoXTf_IxmwIc74Cf1uHN06bh9OzzTvkPsK6jcA</recordid><startdate>202201</startdate><enddate>202201</enddate><creator>Fujimoto, Ai</creator><creator>Saito, Yutaka</creator><creator>Abe, Seiichiro</creator><creator>Hoteya, Syu</creator><creator>Nomura, Kosuke</creator><creator>Yasuda, Hiroshi</creator><creator>Matsuo, Yasumasa</creator><creator>Uraoka, Toshio</creator><creator>Kuribayashi, Shiko</creator><creator>Tsuji, Yosuke</creator><creator>Ohki, Daisuke</creator><creator>Maehata, Tadateru</creator><creator>Kato, Motohiko</creator><creator>Yahagi, Naohisa</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-4547-5213</orcidid><orcidid>https://orcid.org/0000-0003-3489-3356</orcidid><orcidid>https://orcid.org/0000-0003-0186-3599</orcidid><orcidid>https://orcid.org/0000-0002-4425-4331</orcidid><orcidid>https://orcid.org/0000-0002-9574-7451</orcidid><orcidid>https://orcid.org/0000-0003-4279-0138</orcidid><orcidid>https://orcid.org/0000-0001-7891-9795</orcidid><orcidid>https://orcid.org/0000-0002-7579-1316</orcidid><orcidid>https://orcid.org/0000-0002-2736-6921</orcidid><orcidid>https://orcid.org/0000-0002-5067-552X</orcidid></search><sort><creationdate>202201</creationdate><title>Clinical usefulness of red dichromatic imaging in hemostatic treatment during endoscopic submucosal dissection: First report from a multicenter, open‐label, randomized controlled trial</title><author>Fujimoto, Ai ; Saito, Yutaka ; Abe, Seiichiro ; Hoteya, Syu ; Nomura, Kosuke ; Yasuda, Hiroshi ; Matsuo, Yasumasa ; Uraoka, Toshio ; Kuribayashi, Shiko ; Tsuji, Yosuke ; Ohki, Daisuke ; Maehata, Tadateru ; Kato, Motohiko ; Yahagi, Naohisa</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4501-c81032c5ae56b22f341e0d1508fe8e21780e941395e7ffb3f49ab0b12e62f5193</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Endoscopic Mucosal Resection - adverse effects</topic><topic>endoscopic submucosal dissection</topic><topic>Hemostasis</topic><topic>Hemostatics</topic><topic>Humans</topic><topic>multicenter randomized controlled trial</topic><topic>red dichromatic imaging</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fujimoto, Ai</creatorcontrib><creatorcontrib>Saito, Yutaka</creatorcontrib><creatorcontrib>Abe, Seiichiro</creatorcontrib><creatorcontrib>Hoteya, Syu</creatorcontrib><creatorcontrib>Nomura, Kosuke</creatorcontrib><creatorcontrib>Yasuda, Hiroshi</creatorcontrib><creatorcontrib>Matsuo, Yasumasa</creatorcontrib><creatorcontrib>Uraoka, Toshio</creatorcontrib><creatorcontrib>Kuribayashi, Shiko</creatorcontrib><creatorcontrib>Tsuji, Yosuke</creatorcontrib><creatorcontrib>Ohki, Daisuke</creatorcontrib><creatorcontrib>Maehata, Tadateru</creatorcontrib><creatorcontrib>Kato, Motohiko</creatorcontrib><creatorcontrib>Yahagi, Naohisa</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Digestive endoscopy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fujimoto, Ai</au><au>Saito, Yutaka</au><au>Abe, Seiichiro</au><au>Hoteya, Syu</au><au>Nomura, Kosuke</au><au>Yasuda, Hiroshi</au><au>Matsuo, Yasumasa</au><au>Uraoka, Toshio</au><au>Kuribayashi, Shiko</au><au>Tsuji, Yosuke</au><au>Ohki, Daisuke</au><au>Maehata, Tadateru</au><au>Kato, Motohiko</au><au>Yahagi, Naohisa</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical usefulness of red dichromatic imaging in hemostatic treatment during endoscopic submucosal dissection: First report from a multicenter, open‐label, randomized controlled trial</atitle><jtitle>Digestive endoscopy</jtitle><addtitle>Dig Endosc</addtitle><date>2022-01</date><risdate>2022</risdate><volume>34</volume><issue>2</issue><spage>379</spage><epage>390</epage><pages>379-390</pages><issn>0915-5635</issn><eissn>1443-1661</eissn><abstract>Objectives
To verify the efficacy and safety of red dichromatic imaging (RDI) in hemostatic procedures during endoscopic submucosal dissection (ESD).
Methods
This is a multicenter randomized controlled trial of 404 patients who underwent ESD of the esophagus, stomach, colorectum. Patients who received hemostatic treatments by RDI during ESD were defined as the RDI group (n = 204), and those who received hemostatic treatments by white light imaging (WLI) were defined as the WLI group (n = 200). The primary endpoint was a shortening of the hemostasis time. The secondary endpoints were a reduction of the psychological stress experienced by the endoscopist during the hemostatic treatment, a shortened treatment time, and a non‐inferior perforation rate, in RDI versus WLI.
Results
The mean hemostasis time in RDI (n = 860) was not significantly shorter than that in WLI (n = 1049) (62.3 ± 108.1 vs. 56.2 ± 74.6 s; P = 0.921). The median hemostasis time was significantly longer in RDI than in WLI (36.0 [18.0–71.0] vs. 28.0 [14.0–66.0] s; P = 0.001) in a sensitivity analysis. The psychological stress was significantly lower in RDI than in WLI (1.71 ± 0.935 vs. 2.03 ± 1.038; P < 0.001). There was no significant difference in the ESD treatment time between RDI (n = 161) and WLI (n = 168) (58.0 [35.0–86.0] vs. 60.0 [38.0–88.5] min; P = 0.855). Four perforations were observed, but none of them took place during the hemostatic treatment.
Conclusions
Hemostatic treatment using RDI does not shorten the hemostasis time. RDI, however, is safe to use for hemostatic procedures and reduces the psychological stress experienced by endoscopists when they perform hemostatic treatment during ESD.
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source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
subjects | Endoscopic Mucosal Resection - adverse effects endoscopic submucosal dissection Hemostasis Hemostatics Humans multicenter randomized controlled trial red dichromatic imaging Treatment Outcome |
title | Clinical usefulness of red dichromatic imaging in hemostatic treatment during endoscopic submucosal dissection: First report from a multicenter, open‐label, randomized controlled trial |
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