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Completed

NCT Number: NCT06933576

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

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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Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Bile Duct Stenosis Bile Duct Stones Biliary Stenosis Biliary Tract Diseases Carcinoma Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Paris-Bercy, Charenton-le-Pont, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DSOC EyeMAX 11Fr

Device

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

Primary outcomes

  1. overall satisfaction with the EyeMAX 11Fr DSOC

    Time frame: At the end of the procedure

    evaluated using a VAS (ranging from 0 - not at all satisfied - to 10 - extremely satisfied)

  2. overall satisfaction with the EyeMAX 11Fr DSOC

    Time frame: At the end of the procedure

    Satisfaction with the EyeMAX 11Fr DSOC compared with the device currently available in France, the SpyGlass™ DS II DSOC. Satisfaction was categorized as better, equivalent, or worse relative to the SpyGlass™ DS II.

Secondary outcomes

  1. Satisfaction of introduction of the EyeMAX 11Fr into the duodenoscope's working channel

    Time frame: At the end of the procedure

    Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)

  2. Satisfaction of the exit of the device from the working channel

    Time frame: At the end of the procedure

    Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)

  3. Satisfaction of the biliary cannulation through the papilla

    Time frame: At the end of the procedure

    Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)

  4. Satisfaction of the progression through the bile duct

    Time frame: At the end of the procedure

    Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)

  5. Satisfaction of the maneuverability

    Time frame: At the end of the procedure

    Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)

  6. Satisfaction of the ease of introducing the biopsy forceps to the target

    Time frame: At the end of the procedure

    Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)

  7. Satisfaction of the ease of performing biopsies

    Time frame: At the end of the procedure

    Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)

  8. image quality (definition, lens cleaning quality, and brightness)

    Time frame: At the end of the procedure

    assessed using a VAS (ranging from 0 - very poor - to 10 - exceptional)

  9. Utility of use of the harness model compared with the model fixed directly on the duodenoscope

    Time frame: At the end of the procedure

    evaluated by the question: "Does the harness facilitate handling? (Y/N)"

  10. total ERCP duration

    Time frame: At the end of the procedure

    described in minutes

  11. Total cholangioscopy duration

    Time frame: At the end of the procedure

    described in minutes

  12. Cholangioscopy success rate

    Time frame: At the end of the procedure

    Percentage of patients in whom the procedure was performed with effective bile duct visualization

  13. Number of biopsies performed

    Time frame: At the end of the procedure

    Number of bile duct biopsies performed during DSOC procedure

  14. Time required to perform biliary biopsies using DSOC

    Time frame: At the end of the procedure

    Described in minutes

  15. Malignant or benign status of the biliary stricture

    Time frame: After more than 6 months of follow-up in cases where specimens were negative for malignancy

    The diagnosis of cholangiocarcinoma was established through biliary cytopathological examination of biopsies obtained during DSOC , biliary brushing, EUS-FNB, or surgical resection, and/or based on tumor progression observed after more than 6 months of follow-up in cases where specimens were negative for malignancy

Other outcomes

  1. Adverse effects (AEs) and severe AEs due to ERCP

    Time frame: Within one month of the procedure

    Defined and graded according to the AGREE classification

Sponsors and collaborators

Lead sponsor

Clinique Paris-Bercy

Other

Registry information

Official study 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.

Acronym: EyeMAX-CREGG

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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