N/A
N=163
Evaluation of the Impact of a Forward Viewing Scope at Time of ERCP
Gastro-Intestinal Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05627882 ↗Enrolled (actual)
163
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Number of Participants With Clinically Significant Endoscopic Findings — 37 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Forward viewing endoscope (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Endoscopic Findings |
37 | — |
| SECONDARY Number of Participants With Non-clinically Significant Endoscopic Findings |
32 | — |
Summary
This study will be a prospective, tandem-designed study to determine the proportion of clinically significant missed lesions when using a side- or oblique-viewing endoscope as compared to the standard forward-viewing endoscope. Utilizing standard endoscopy protocols in current practice at Brigham and Women's Hospital, consecutive adult patients undergoing ERCP for traditional reasons will undergo back-to-back tandem EGD and ERCP examinations. This process entails an EGD performed by an attending gastroenterologist first. Next, a second blinded attending gastroenterologist will perform ERCP immediately after index EGD. Both endoscopists will note any clinically significant findings, independent of the other providers procedural findings. Clinically significant findings defined as endoscopic findings that alter patient management (i.e., esophageal varices, peptic ulcer disease, hemorrhage, mass, etc.) during EGD and ERCP will be recorded. As previously stated, some institutions already routinely perform EGD with every ERCP.
Eligibility Criteria
Inclusion Criteria
- All adult patients referred for clinically-indicated ERCP
Exclusion Criteria
- inability to provide consent
Data sourced from ClinicalTrials.gov (NCT05627882). 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.