Bile Duct Stenosis, Bile Duct Stones, Biliary Stenosis, Cholangiocarcinoma
Conditions
Keywords
cholangioscopy, Digital Single-Operator Cholangioscope
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).
Interventions
DEVICEDSOC EyeMAX 11Fr
digital single-operator cholangioscopy using the new EyeMAX™ 11Fr (Micro-Tech Endoscopy, Nanjing, China)
Sponsors
Clinique Paris-Bercy
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall satisfaction with the EyeMAX 11Fr DSOC | At the end of the procedure | evaluated using a VAS (ranging from 0 - not at all satisfied - to 10 - extremely satisfied) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of introduction of the EyeMAX 11Fr into the duodenoscope's working channel | At the end of the procedure | Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy) |
| Satisfaction of the exit of the device from the working channel | At the end of the procedure | Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy) |
| Satisfaction of the biliary cannulation through the papilla | At the end of the procedure | Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy) |
| Satisfaction of the progression through the bile duct | At the end of the procedure | Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy) |
| Satisfaction of the maneuverability | At the end of the procedure | Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy) |
| Satisfaction of the ease of introducing the biopsy forceps to the target | At the end of the procedure | Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy) |
| Satisfaction of the ease of performing biopsies | At the end of the procedure | Step of the procedure evaluated using a VAS (ranging from 0 - impossible - to 10 - extremely easy) |
| Utility of use of the harness model compared with the model fixed directly on the duodenoscope | At the end of the procedure | evaluated by the question: Does the harness facilitate handling? (Y/N) |
| total ERCP duration | At the end of the procedure | described in minutes |
| Total cholangioscopy duration | At the end of the procedure | described in minutes |
| Cholangioscopy success rate | At the end of the procedure | Percentage of patients in whom the procedure was performed with effective bile duct visualization |
| Number of biopsies performed | At the end of the procedure | Number of bile duct biopsies performed during DSOC procedure |
| Time required to perform biliary biopsies using DSOC | At the end of the procedure | Described in minutes |
| Malignant or benign status of the biliary stricture | 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 |
| image quality (definition, lens cleaning quality, and brightness) | At the end of the procedure | assessed using a VAS (ranging from 0 - very poor - to 10 - exceptional) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects (AEs) and severe AEs due to ERCP | Within one month of the procedure | Defined and graded according to the AGREE classification |
Countries
France
Outcome results
None listed