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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-01-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Cholangiocarcinoma Biliary Stenosis Bile Duct Stones Bile Duct Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients scheduled for cholangioscopy

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.

DSOC EyeMAX 11Fr

Intervention Type DEVICE

digital single-operator cholangioscopy using the new EyeMAX™ 11Fr (Micro-Tech Endoscopy, Nanjing, China)

Interventions

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DSOC EyeMAX 11Fr

digital single-operator cholangioscopy using the new EyeMAX™ 11Fr (Micro-Tech Endoscopy, Nanjing, China)

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No