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).
Study Type
OBSERVATIONAL
Enrollment
28
digital single-operator cholangioscopy using the new EyeMAX™ 11Fr (Micro-Tech Endoscopy, Nanjing, China)
Clinique Paris-Bercy
Charenton-le-Pont, France
Louis Pasteur Clinic
Essey-lès-Nancy, France
Jean Mermoz Private Hospital
Lyon, France
Jules Verne Clinic
Nantes, France
Arnaud Tzang Institut
Saint-Laurent-du-Var, France
overall satisfaction with the EyeMAX 11Fr DSOC
evaluated using a VAS (ranging from 0 - not at all satisfied - to 10 - extremely satisfied)
Time frame: At the end of the procedure
overall satisfaction with the EyeMAX 11Fr DSOC
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.
Time frame: At the end of the procedure
Satisfaction of introduction of the EyeMAX 11Fr into the duodenoscope's working channel
Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)
Time frame: At the end of the procedure
Satisfaction of the exit of the device from the working channel
Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)
Time frame: At the end of the procedure
Satisfaction of the biliary cannulation through the papilla
Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)
Time frame: At the end of the procedure
Satisfaction of the progression through the bile duct
Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)
Time frame: At the end of the procedure
Satisfaction of the maneuverability
Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)
Time frame: At the end of the procedure
Satisfaction of the ease of introducing the biopsy forceps to the target
Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)
Time frame: At the end of the procedure
Satisfaction of the ease of performing biopsies
Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy)
Time frame: At the end of the procedure
image quality (definition, lens cleaning quality, and brightness)
assessed using a VAS (ranging from 0 - very poor - to 10 - exceptional)
Time frame: At the end of the procedure
Utility of use of the harness model compared with the model fixed directly on the duodenoscope
evaluated by the question: "Does the harness facilitate handling? (Y/N)"
Time frame: At the end of the procedure
total ERCP duration
described in minutes
Time frame: At the end of the procedure
Total cholangioscopy duration
described in minutes
Time frame: At the end of the procedure
Cholangioscopy success rate
Percentage of patients in whom the procedure was performed with effective bile duct visualization
Time frame: At the end of the procedure
Number of biopsies performed
Number of bile duct biopsies performed during DSOC procedure
Time frame: At the end of the procedure
Time required to perform biliary biopsies using DSOC
Described in minutes
Time frame: At the end of the procedure
Malignant or benign status of the biliary stricture
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
Time frame: After more than 6 months of follow-up in cases where specimens were negative for malignancy
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