Contribution of the EyeMAX™ 11Fr (Micro-Tech) Digital Single-Operator Cholangioscope With a Wide Working Channel (EyeMAX-CREGG)

Clinique Paris-Bercy

Status: Completed

Conditions: Bile Duct Stones; Biliary Stenosis; Bile Duct Stenosis; Cholangiocarcinoma

Treatments: Device: DSOC EyeMAX 11Fr

Study type: Observational

Funder types: Other

Identifiers

NCT06933576

EyeMAX-CREGG

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

28 participants in 1 patient group

Patients scheduled for cholangioscopy

Description:

All patients who underwent digital single-operator cholangioscopy using the new EyeMAX™ 11Fr (Micro-Tech Endoscopy, Nanjing, China) and were admitted to one of the CREGG centers between February 2024 and January 2025.

Treatment:

Device: DSOC EyeMAX 11Fr