Karsenti David, Sportes Adrien, Leblanc Sarah, Béchet Stéphane, Derman Jonathan, Fassler Isaac, Brieau Bertrand
Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique Paris-Bercy, 9 Quai de Bercy, Charenton-le-Pont 94220, France.
Digestive Endoscopy Unit, Arnault Tzanck Institute, Saint Laurent du Var, France.
Therap Adv Gastroenterol. 2025 Aug 12;18:17562848251360117. doi: 10.1177/17562848251360117. eCollection 2025.
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.
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.
A retrospective, multicenter observational study.
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).
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.
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.
ClinicalTrials.gov ID: NCT06933576.
数字单操作者胆管镜检查（DSOC）可提高胆管狭窄的诊断率，但由于工作通道直径小，获取高质量样本可能会很困难。
一种新型的DSOC系统（EyeMAX™ 11Fr；中国南京微创医疗器械有限公司）已在法国投入使用，其工作通道直径为2.0毫米，可容纳儿科钳（1.6毫米）。本研究报告了法国的首次使用经验。
一项回顾性、多中心观察性研究。
在法国私立肝胃肠病学会（SFHGL-CREGG）的五个内镜检查单位开展了关于DSOC的研究。使用视觉模拟量表（VAS）记录满意度和操作评估结果，并与Spyglass™ DS II（美国马萨诸塞州马尔伯勒市波士顿科学公司）进行比较。
28例患者中，71.5%曾接受过内镜括约肌切开术。适应症包括26例胆管狭窄和2例结石。狭窄位于胆管（41%）或肝门（59%）。平均满意度评分为8.69分（满分10分），在86%的病例中，EyeMAX 11Fr被评为优于SpyGlass DS II。平均活检次数为8.52次，用时13.19分钟，操作成功率为100%。病理标本丰富（24%）、充足（52%）、较少（12%）或无（12%）。胆管癌的敏感性为73.7%（14/19）。所有病例中的良性狭窄均有所缓解。与操作相关的并发症包括疼痛2次（7.1%）、发热1次（3.6%）、感染1次（3.6%）和胰腺炎2次（7.1%），所有这些并发症均迅速得到解决。
这项关于EyeMAX 11Fr DSOC的首次研究突出了其易用性、活检便利性以及高用户满意度，胆管癌诊断敏感性达到73.7%。
ClinicalTrials.gov标识符：NCT06933576。
