N/A
Completed N=88
Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS
Biliary Tract Disease
Source: ClinicalTrials.gov NCT02524418 ↗
Enrolled (actual)
88
Serious AEs
1.3%
Results posted
Mar 2017
Primary outcomePrimary: Number of Participants With Procedure Technical Success — 70; 3 participants
Summary
This is a prospective evaluation of the clinical utility of the new cholangioscopy platform SpyGlass DS. The aims of this study are to prospectively document the clinical utility and technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and management of pancreatic-biliary disorders.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Procedure Technical Success |
70; 3 | — |
| SECONDARY Time to Set-up the Spyglass DS for the Procedure |
5 | — |
| SECONDARY Measurement of Total Procedure Time Using the Spyglass DS |
64.3 | — |
| SECONDARY Measurement in Minutes for Spyglass DS Diagnostic Maneuvers |
27.5 | — |
| SECONDARY Measurement in Minutes for Spyglass DS Therapeutic Maneuvers |
12.1 | — |
| SECONDARY Number of Cholangioscopic Exams That Detected Ductal Stones |
35; 2 | — |
| SECONDARY Strictures Found During the Procedure Will be Measured |
27 | — |
| SECONDARY Spybite Sampling Attempts Per Procedure |
3.94 | — |
| SECONDARY Number of Participants With Successful Removal of the Biliary or Pancreas Stones |
24 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who have been scheduled to undergo a cholangiopancreatoscopy as routine clinical care
Exclusion Criteria
- failure to provide informed consent
- any contraindications to endoscopy
Data sourced from ClinicalTrials.gov (NCT02524418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.