Optimal concentration of Lugol's solution for detecting early esophageal carcinoma: A randomized controlled trial

Background and Aim Lugol chromoendoscopy is the standard technique to detect an esophageal squamous cell carcinoma (ESCC). However, a high concentration of Lugol's solution can induce mucosal injury and adverse events. We aimed to investigate the optimal concentration of Lugol's solution t...

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Veröffentlicht in:Journal of gastroenterology and hepatology 2023-06, Vol.38 (6), p.962-969
Hauptverfasser: Qu, Jun‐yan, Li, Yan, Liu, Guan‐qun, Li, Zhen, Zhong, Ning, Zhang, Ming‐ming, Li, Yue‐yue, Yu, Tao, Lu, Xue‐feng, Li, Li‐xiang, Liu, Han, Qi, Qing‐qing, Li, Yan‐qing, Zuo, Xiu‐li
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container_title Journal of gastroenterology and hepatology
container_volume 38
creator Qu, Jun‐yan
Li, Yan
Liu, Guan‐qun
Li, Zhen
Zhong, Ning
Zhang, Ming‐ming
Li, Yue‐yue
Yu, Tao
Lu, Xue‐feng
Li, Li‐xiang
Liu, Han
Qi, Qing‐qing
Li, Yan‐qing
Zuo, Xiu‐li
description Background and Aim Lugol chromoendoscopy is the standard technique to detect an esophageal squamous cell carcinoma (ESCC). However, a high concentration of Lugol's solution can induce mucosal injury and adverse events. We aimed to investigate the optimal concentration of Lugol's solution to reduce mucosal injury and adverse events without degrading image quality. Methods This was a two‐phase double‐blind randomized controlled trial. In phase I, 200 eligible patients underwent esophagogastroduodenoscopy and then were randomly (1:1:1:1:1) sprayed with 1.2%, 1.0%, 0.8%, 0.6%, or 0.4% Lugol's solution. Image quality, gastric mucosal injury, adverse events, and operation satisfaction were compared to investigate the minimal effective concentration. In phase II, 42 cases of endoscopic mucosectomy for early ESCC were included. The patients were randomly assigned (1:1) to the minimal effective (0.6%) or conventional (1.2%) concentration of Lugol's solution for further comparison of the effectiveness. Results In phase I, the gastric mucosal injury was significantly reduced in 0.6% group (P 
doi_str_mv 10.1111/jgh.16190
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However, a high concentration of Lugol's solution can induce mucosal injury and adverse events. We aimed to investigate the optimal concentration of Lugol's solution to reduce mucosal injury and adverse events without degrading image quality. Methods This was a two‐phase double‐blind randomized controlled trial. In phase I, 200 eligible patients underwent esophagogastroduodenoscopy and then were randomly (1:1:1:1:1) sprayed with 1.2%, 1.0%, 0.8%, 0.6%, or 0.4% Lugol's solution. Image quality, gastric mucosal injury, adverse events, and operation satisfaction were compared to investigate the minimal effective concentration. In phase II, 42 cases of endoscopic mucosectomy for early ESCC were included. The patients were randomly assigned (1:1) to the minimal effective (0.6%) or conventional (1.2%) concentration of Lugol's solution for further comparison of the effectiveness. Results In phase I, the gastric mucosal injury was significantly reduced in 0.6% group (P &lt; 0.05). Furthermore, there was no statistical significance in image quality between 0.6% and higher concentrations of Lugol's solution (P &gt; 0.05, respectively). It also showed that the operation satisfaction decreased in 1.2% group compared with the lower concentration groups (P &lt; 0.05). In phase II, the complete resection rate was 100% in both groups, while 0.6% Lugol's solution showed higher operation satisfaction (W = 554.500, P = 0.005). Conclusions The study indicates that 0.6% might be the optimal concentration of Lugol's solution for early detection and delineation of ESCC, considering minimal mucosal injury and satisfied image. The registry of clinical trials: ClinicalTrials.gov (NCT03180944).</description><identifier>ISSN: 0815-9319</identifier><identifier>EISSN: 1440-1746</identifier><identifier>DOI: 10.1111/jgh.16190</identifier><identifier>PMID: 37094943</identifier><language>eng</language><publisher>Australia: Wiley Subscription Services, Inc</publisher><subject>Adverse events ; Clinical trials ; Coloring Agents ; Esophageal cancer ; Esophageal carcinoma ; Esophageal Neoplasms - pathology ; Esophageal squamous cell cancer ; Esophageal Squamous Cell Carcinoma ; Esophagoscopy - methods ; Gastric mucosa ; Humans ; Image quality ; Lugol's solution ; Mucosa injury ; Squamous cell carcinoma</subject><ispartof>Journal of gastroenterology and hepatology, 2023-06, Vol.38 (6), p.962-969</ispartof><rights>2023 Journal of Gastroenterology and Hepatology Foundation and John Wiley &amp; Sons Australia, Ltd.</rights><rights>2023 Journal of Gastroenterology and Hepatology Foundation and John Wiley &amp; Sons Australia, Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3530-1ce6401e3dc4b4094f7c9a459d23d9c48d805481ebed7d54676b7afcc86e11203</citedby><cites>FETCH-LOGICAL-c3530-1ce6401e3dc4b4094f7c9a459d23d9c48d805481ebed7d54676b7afcc86e11203</cites><orcidid>0000-0003-0575-0399 ; 0000-0001-9556-8771 ; 0000-0001-7042-9695</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%2Fjgh.16190$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjgh.16190$$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/37094943$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Qu, Jun‐yan</creatorcontrib><creatorcontrib>Li, Yan</creatorcontrib><creatorcontrib>Liu, Guan‐qun</creatorcontrib><creatorcontrib>Li, Zhen</creatorcontrib><creatorcontrib>Zhong, Ning</creatorcontrib><creatorcontrib>Zhang, Ming‐ming</creatorcontrib><creatorcontrib>Li, Yue‐yue</creatorcontrib><creatorcontrib>Yu, Tao</creatorcontrib><creatorcontrib>Lu, Xue‐feng</creatorcontrib><creatorcontrib>Li, Li‐xiang</creatorcontrib><creatorcontrib>Liu, Han</creatorcontrib><creatorcontrib>Qi, Qing‐qing</creatorcontrib><creatorcontrib>Li, Yan‐qing</creatorcontrib><creatorcontrib>Zuo, Xiu‐li</creatorcontrib><title>Optimal concentration of Lugol's solution for detecting early esophageal carcinoma: A randomized controlled trial</title><title>Journal of gastroenterology and hepatology</title><addtitle>J Gastroenterol Hepatol</addtitle><description>Background and Aim Lugol chromoendoscopy is the standard technique to detect an esophageal squamous cell carcinoma (ESCC). However, a high concentration of Lugol's solution can induce mucosal injury and adverse events. We aimed to investigate the optimal concentration of Lugol's solution to reduce mucosal injury and adverse events without degrading image quality. Methods This was a two‐phase double‐blind randomized controlled trial. In phase I, 200 eligible patients underwent esophagogastroduodenoscopy and then were randomly (1:1:1:1:1) sprayed with 1.2%, 1.0%, 0.8%, 0.6%, or 0.4% Lugol's solution. Image quality, gastric mucosal injury, adverse events, and operation satisfaction were compared to investigate the minimal effective concentration. In phase II, 42 cases of endoscopic mucosectomy for early ESCC were included. The patients were randomly assigned (1:1) to the minimal effective (0.6%) or conventional (1.2%) concentration of Lugol's solution for further comparison of the effectiveness. Results In phase I, the gastric mucosal injury was significantly reduced in 0.6% group (P &lt; 0.05). Furthermore, there was no statistical significance in image quality between 0.6% and higher concentrations of Lugol's solution (P &gt; 0.05, respectively). It also showed that the operation satisfaction decreased in 1.2% group compared with the lower concentration groups (P &lt; 0.05). In phase II, the complete resection rate was 100% in both groups, while 0.6% Lugol's solution showed higher operation satisfaction (W = 554.500, P = 0.005). Conclusions The study indicates that 0.6% might be the optimal concentration of Lugol's solution for early detection and delineation of ESCC, considering minimal mucosal injury and satisfied image. The registry of clinical trials: ClinicalTrials.gov (NCT03180944).</description><subject>Adverse events</subject><subject>Clinical trials</subject><subject>Coloring Agents</subject><subject>Esophageal cancer</subject><subject>Esophageal carcinoma</subject><subject>Esophageal Neoplasms - pathology</subject><subject>Esophageal squamous cell cancer</subject><subject>Esophageal Squamous Cell Carcinoma</subject><subject>Esophagoscopy - methods</subject><subject>Gastric mucosa</subject><subject>Humans</subject><subject>Image quality</subject><subject>Lugol's solution</subject><subject>Mucosa injury</subject><subject>Squamous cell carcinoma</subject><issn>0815-9319</issn><issn>1440-1746</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kU1LAzEQhoMotlYP_gEJeFAPrckmu9l4K8VPCr3oeUmT2bolu2mTXaT-etNWPQjmMmF4eJiZF6FzSkY0vtvl4n1EMyrJAepTzsmQCp4doj7JaTqUjMoeOglhSQjhRKTHqMcEkVxy1kfr2aqtamWxdo2GpvWqrVyDXYmn3cLZq4CDs92uVzqPDbSg26pZYFDebjAEt3pXC9gKlNdV42p1h8fYq8a4uvoEsxW33lkbv62vlD1FR6WyAc6-6wC9Pdy_Tp6G09nj82Q8HWqWsriChowTCsxoPudx3FJoqXgqTcKM1Dw3OUl5TmEORpiUZyKbC1VqnWdAaULYAF3vvSvv1h2EtqiroMFa1YDrQpHkJCMiSYiI6OUfdOk638TpIpWkkkm5E97sKe1dCB7KYuXj6fymoKTY5lDEHIpdDpG9-DZ28xrML_lz-Ajc7oGPysLmf1Px8vi0V34BkLaSVg</recordid><startdate>202306</startdate><enddate>202306</enddate><creator>Qu, Jun‐yan</creator><creator>Li, Yan</creator><creator>Liu, Guan‐qun</creator><creator>Li, Zhen</creator><creator>Zhong, Ning</creator><creator>Zhang, Ming‐ming</creator><creator>Li, Yue‐yue</creator><creator>Yu, Tao</creator><creator>Lu, Xue‐feng</creator><creator>Li, Li‐xiang</creator><creator>Liu, Han</creator><creator>Qi, Qing‐qing</creator><creator>Li, Yan‐qing</creator><creator>Zuo, Xiu‐li</creator><general>Wiley Subscription Services, Inc</general><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>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-0575-0399</orcidid><orcidid>https://orcid.org/0000-0001-9556-8771</orcidid><orcidid>https://orcid.org/0000-0001-7042-9695</orcidid></search><sort><creationdate>202306</creationdate><title>Optimal concentration of Lugol's solution for detecting early esophageal carcinoma: A randomized controlled trial</title><author>Qu, Jun‐yan ; Li, Yan ; Liu, Guan‐qun ; Li, Zhen ; Zhong, Ning ; Zhang, Ming‐ming ; Li, Yue‐yue ; Yu, Tao ; Lu, Xue‐feng ; Li, Li‐xiang ; Liu, Han ; Qi, Qing‐qing ; Li, Yan‐qing ; Zuo, Xiu‐li</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3530-1ce6401e3dc4b4094f7c9a459d23d9c48d805481ebed7d54676b7afcc86e11203</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adverse events</topic><topic>Clinical trials</topic><topic>Coloring Agents</topic><topic>Esophageal cancer</topic><topic>Esophageal carcinoma</topic><topic>Esophageal Neoplasms - pathology</topic><topic>Esophageal squamous cell cancer</topic><topic>Esophageal Squamous Cell Carcinoma</topic><topic>Esophagoscopy - methods</topic><topic>Gastric mucosa</topic><topic>Humans</topic><topic>Image quality</topic><topic>Lugol's solution</topic><topic>Mucosa injury</topic><topic>Squamous cell carcinoma</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Qu, Jun‐yan</creatorcontrib><creatorcontrib>Li, Yan</creatorcontrib><creatorcontrib>Liu, Guan‐qun</creatorcontrib><creatorcontrib>Li, Zhen</creatorcontrib><creatorcontrib>Zhong, Ning</creatorcontrib><creatorcontrib>Zhang, Ming‐ming</creatorcontrib><creatorcontrib>Li, Yue‐yue</creatorcontrib><creatorcontrib>Yu, Tao</creatorcontrib><creatorcontrib>Lu, Xue‐feng</creatorcontrib><creatorcontrib>Li, Li‐xiang</creatorcontrib><creatorcontrib>Liu, Han</creatorcontrib><creatorcontrib>Qi, Qing‐qing</creatorcontrib><creatorcontrib>Li, Yan‐qing</creatorcontrib><creatorcontrib>Zuo, Xiu‐li</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of gastroenterology and hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Qu, Jun‐yan</au><au>Li, Yan</au><au>Liu, Guan‐qun</au><au>Li, Zhen</au><au>Zhong, Ning</au><au>Zhang, Ming‐ming</au><au>Li, Yue‐yue</au><au>Yu, Tao</au><au>Lu, Xue‐feng</au><au>Li, Li‐xiang</au><au>Liu, Han</au><au>Qi, Qing‐qing</au><au>Li, Yan‐qing</au><au>Zuo, Xiu‐li</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Optimal concentration of Lugol's solution for detecting early esophageal carcinoma: A randomized controlled trial</atitle><jtitle>Journal of gastroenterology and hepatology</jtitle><addtitle>J Gastroenterol Hepatol</addtitle><date>2023-06</date><risdate>2023</risdate><volume>38</volume><issue>6</issue><spage>962</spage><epage>969</epage><pages>962-969</pages><issn>0815-9319</issn><eissn>1440-1746</eissn><abstract>Background and Aim Lugol chromoendoscopy is the standard technique to detect an esophageal squamous cell carcinoma (ESCC). However, a high concentration of Lugol's solution can induce mucosal injury and adverse events. We aimed to investigate the optimal concentration of Lugol's solution to reduce mucosal injury and adverse events without degrading image quality. Methods This was a two‐phase double‐blind randomized controlled trial. In phase I, 200 eligible patients underwent esophagogastroduodenoscopy and then were randomly (1:1:1:1:1) sprayed with 1.2%, 1.0%, 0.8%, 0.6%, or 0.4% Lugol's solution. Image quality, gastric mucosal injury, adverse events, and operation satisfaction were compared to investigate the minimal effective concentration. In phase II, 42 cases of endoscopic mucosectomy for early ESCC were included. The patients were randomly assigned (1:1) to the minimal effective (0.6%) or conventional (1.2%) concentration of Lugol's solution for further comparison of the effectiveness. Results In phase I, the gastric mucosal injury was significantly reduced in 0.6% group (P &lt; 0.05). Furthermore, there was no statistical significance in image quality between 0.6% and higher concentrations of Lugol's solution (P &gt; 0.05, respectively). It also showed that the operation satisfaction decreased in 1.2% group compared with the lower concentration groups (P &lt; 0.05). In phase II, the complete resection rate was 100% in both groups, while 0.6% Lugol's solution showed higher operation satisfaction (W = 554.500, P = 0.005). Conclusions The study indicates that 0.6% might be the optimal concentration of Lugol's solution for early detection and delineation of ESCC, considering minimal mucosal injury and satisfied image. The registry of clinical trials: ClinicalTrials.gov (NCT03180944).</abstract><cop>Australia</cop><pub>Wiley Subscription Services, Inc</pub><pmid>37094943</pmid><doi>10.1111/jgh.16190</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-0575-0399</orcidid><orcidid>https://orcid.org/0000-0001-9556-8771</orcidid><orcidid>https://orcid.org/0000-0001-7042-9695</orcidid></addata></record>
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subjects Adverse events
Clinical trials
Coloring Agents
Esophageal cancer
Esophageal carcinoma
Esophageal Neoplasms - pathology
Esophageal squamous cell cancer
Esophageal Squamous Cell Carcinoma
Esophagoscopy - methods
Gastric mucosa
Humans
Image quality
Lugol's solution
Mucosa injury
Squamous cell carcinoma
title Optimal concentration of Lugol's solution for detecting early esophageal carcinoma: A randomized controlled trial
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