David Karsenti, Adrien Sportes, Sarah Leblanc, Stéphane Béchet, Jonathan Derman, Isaac Fassler, Bertrand Brieau
{"title":"具有宽工作通道的EyeMAX™11Fr （Micro-Tech）数字单操作胆管镜的贡献：法国首次经验的多中心试点研究。","authors":"David Karsenti, Adrien Sportes, Sarah Leblanc, Stéphane Béchet, Jonathan Derman, Isaac Fassler, Bertrand Brieau","doi":"10.1177/17562848251360117","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Digital single-operator cholangioscopy (DSOC) enhances biliary stricture diagnosis, but the collection of quality samples can be difficult due to the small diameter of the working channel.</p><p><strong>Objectives: </strong>A new DSOC system (EyeMAX™ 11Fr; Micro-Tech Endoscopy, Nanjing, China) with a 2.0-mm working channel, accommodating pediatric forceps (1.6 mm), has been introduced in France. This study reports on the first French experience.</p><p><strong>Design: </strong>A retrospective, multicenter observational study.</p><p><strong>Methods: </strong>The study on DSOC was conducted across five endoscopy units within the French Society of Private Hepato-Gastroenterology (SFHGL-CREGG). Satisfaction and procedural evaluations were recorded using a visual analog scale (VAS) and compared with the Spyglass™ DS II (Boston Scientific, Marlborough, MA, USA).</p><p><strong>Results: </strong>Among 28 patients, 71.5% had undergone prior endoscopic sphincterotomy. Indications were biliary strictures in 26 patients and lithiasis in 2. Strictures were located in the bile duct (41%) or hilum (59%). The mean satisfaction score was 8.69 out of 10, with the EyeMAX 11Fr rated as superior to the SpyGlass DS II in 86% of cases. The mean biopsy count was 8.52 in 13.19 min, with 100% procedural success. Pathology specimens were rich (24%), adequate (52%), low (12%), or absent (12%). Sensitivity for cholangiocarcinoma was 73.7% (14/19). Benign strictures regressed in all cases. Procedure-related complications included pain twice (7.1%), fever once (3.6%), infection once (3.6%), and pancreatitis twice (7.1%), all of which were resolved rapidly.</p><p><strong>Conclusion: </strong>This first study on the EyeMAX 11Fr DSOC highlights its ease of use, superior biopsy facilitation, and high user satisfaction, achieving 73.7% sensitivity for cholangiocarcinoma diagnosis.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID: NCT06933576.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251360117"},"PeriodicalIF":3.4000,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12344333/pdf/","citationCount":"0","resultStr":"{\"title\":\"Contribution of the EyeMAX™ 11Fr (Micro-Tech) digital single-operator cholangioscope with a wide working channel: a multicenter pilot study on the first French experiences.\",\"authors\":\"David Karsenti, Adrien Sportes, Sarah Leblanc, Stéphane Béchet, Jonathan Derman, Isaac Fassler, Bertrand Brieau\",\"doi\":\"10.1177/17562848251360117\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Digital single-operator cholangioscopy (DSOC) enhances biliary stricture diagnosis, but the collection of quality samples can be difficult due to the small diameter of the working channel.</p><p><strong>Objectives: </strong>A new DSOC system (EyeMAX™ 11Fr; Micro-Tech Endoscopy, Nanjing, China) with a 2.0-mm working channel, accommodating pediatric forceps (1.6 mm), has been introduced in France. This study reports on the first French experience.</p><p><strong>Design: </strong>A retrospective, multicenter observational study.</p><p><strong>Methods: </strong>The study on DSOC was conducted across five endoscopy units within the French Society of Private Hepato-Gastroenterology (SFHGL-CREGG). Satisfaction and procedural evaluations were recorded using a visual analog scale (VAS) and compared with the Spyglass™ DS II (Boston Scientific, Marlborough, MA, USA).</p><p><strong>Results: </strong>Among 28 patients, 71.5% had undergone prior endoscopic sphincterotomy. Indications were biliary strictures in 26 patients and lithiasis in 2. Strictures were located in the bile duct (41%) or hilum (59%). The mean satisfaction score was 8.69 out of 10, with the EyeMAX 11Fr rated as superior to the SpyGlass DS II in 86% of cases. The mean biopsy count was 8.52 in 13.19 min, with 100% procedural success. Pathology specimens were rich (24%), adequate (52%), low (12%), or absent (12%). Sensitivity for cholangiocarcinoma was 73.7% (14/19). Benign strictures regressed in all cases. 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Contribution of the EyeMAX™ 11Fr (Micro-Tech) digital single-operator cholangioscope with a wide working channel: a multicenter pilot study on the first French experiences.
Background: Digital single-operator cholangioscopy (DSOC) enhances biliary stricture diagnosis, but the collection of quality samples can be difficult due to the small diameter of the working channel.
Objectives: A new DSOC system (EyeMAX™ 11Fr; Micro-Tech Endoscopy, Nanjing, China) with a 2.0-mm working channel, accommodating pediatric forceps (1.6 mm), has been introduced in France. This study reports on the first French experience.
Design: A retrospective, multicenter observational study.
Methods: The study on DSOC was conducted across five endoscopy units within the French Society of Private Hepato-Gastroenterology (SFHGL-CREGG). Satisfaction and procedural evaluations were recorded using a visual analog scale (VAS) and compared with the Spyglass™ DS II (Boston Scientific, Marlborough, MA, USA).
Results: Among 28 patients, 71.5% had undergone prior endoscopic sphincterotomy. Indications were biliary strictures in 26 patients and lithiasis in 2. Strictures were located in the bile duct (41%) or hilum (59%). The mean satisfaction score was 8.69 out of 10, with the EyeMAX 11Fr rated as superior to the SpyGlass DS II in 86% of cases. The mean biopsy count was 8.52 in 13.19 min, with 100% procedural success. Pathology specimens were rich (24%), adequate (52%), low (12%), or absent (12%). Sensitivity for cholangiocarcinoma was 73.7% (14/19). Benign strictures regressed in all cases. Procedure-related complications included pain twice (7.1%), fever once (3.6%), infection once (3.6%), and pancreatitis twice (7.1%), all of which were resolved rapidly.
Conclusion: This first study on the EyeMAX 11Fr DSOC highlights its ease of use, superior biopsy facilitation, and high user satisfaction, achieving 73.7% sensitivity for cholangiocarcinoma diagnosis.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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