Clinical trial NCT06933576: Contribution of the EyeMAX™ 11Fr (Micro-Tech) Digital Single-Operator Cholangioscope With a Wide Working Channel
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholangiocarcinoma
Biliary Stenosis
Bile Duct Stones
Bile Duct Stenosis
Keywords: cholangioscopy
Digital Single-Operator Cholangioscope
Lead sponsor: Clinique Paris-Bercy
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: overall satisfaction with the EyeMAX 11Fr DSOC
timeFrame: At the end of the procedure
measure: overall satisfaction with the EyeMAX 11Fr DSOC
timeFrame: At the end of the procedure
Secondary outcomes:
measure: Satisfaction of introduction of the EyeMAX 11Fr into the duodenoscope's working channel
timeFrame: At the end of the procedure
measure: Satisfaction of the exit of the device from the working channel
timeFrame: At the end of the procedure
measure: Satisfaction of the biliary cannulation through the papilla
timeFrame: At the end of the procedure
measure: Satisfaction of the progression through the bile duct
timeFrame: At the end of the procedure
measure: Satisfaction of the maneuverability
timeFrame: At the end of the procedure
measure: Satisfaction of the ease of introducing the biopsy forceps to the target
timeFrame: At the end of the procedure
measure: Satisfaction of the ease of performing biopsies
timeFrame: At the end of the procedure
measure: image quality (definition, lens cleaning quality, and brightness)
timeFrame: At the end of the procedure
measure: Utility of use of the harness model compared with the model fixed directly on the duodenoscope
timeFrame: At the end of the procedure
measure: total ERCP duration
timeFrame: At the end of the procedure
measure: Total cholangioscopy duration
timeFrame: At the end of the procedure
measure: Cholangioscopy success rate
timeFrame: At the end of the procedure
measure: Number of biopsies performed
timeFrame: At the end of the procedure
measure: Time required to perform biliary biopsies using DSOC
timeFrame: At the end of the procedure
measure: Malignant or benign status of the biliary stricture
timeFrame: After more than 6 months of follow-up in cases where specimens were negative for malignancy
Other outcomes:
measure: Adverse effects (AEs) and severe AEs due to ERCP
timeFrame: Within one month of the procedure
Locations:
city: Charenton-le-Pont
country: France
facility: Clinique Paris-Bercy
city: Essey-les-Nancy
country: France
facility: Louis Pasteur Clinic
city: Lyon
country: France
facility: Jean Mermoz Private Hospital
city: Nantes
country: France
facility: Jules Verne Clinic
city: Saint Laurent du Var
country: France
facility: Arnaud Tzang Institut
Study officials:
affiliation: Pôle Digestif Paris-Bercy, Clinique Paris-Bercy
name: David Karsenti, MD
role: STUDY_CHAIR
References: