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N/A N=163

Evaluation of the Impact of a Forward Viewing Scope at Time of ERCP

Gastro-Intestinal Disorder

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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