Background and aims 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 (EyeMAXTM 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 initial French experience.

Methods A retrospective multicenter observational study on DSOC was conducted across five endoscopy units within the CREGG (French Society of Private Hepato-Gastroenterology). Satisfaction and procedural evaluations were recorded using a visual analog scale (VAS) and compared with the SpyglassTM DS II DSOC (Boston Scientific).

Inclusion Criteria:

• all consecutive patients who were referred to one of the participating expert tertiary endoscopy units for an ERCP for a bile duct stenosis

Exclusion Criteria:

• patients with significant tissue mass that could easily be punctured by EUS-FNB were not included.
• non-accessibility to the bile duct due to a history of Billroth II or Roux-en-Y reconstruction,
• coagulation disorders (such as partial thromboplastin time > 42 seconds, prothrombin time [Quick value] < 50%, or platelet count < 50,000/mm³), or treatment with clopidogrel.

The study included all consecutive patients who were referred to one of the participating expert tertiary endoscopy units (5 centers from the CREGG - French Society of Private Hepato-Gastroenterology, in which the EyeMAX DSOC systems were made available), during the first year of availability of this device in France

At this time, no decision has been made regarding the sharing of individual participant data (IPD).

This study is the first French experience with the EyeMAX™ 11Fr digital single-operator cholangioscope and has been designed as an observational study. Accordingly, IPD sharing is not currently planned as part of the initial protocol, but may be considered at a later stage.