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Recruiting
NCT05627882
Evaluation of the Impact of a Forward Viewing Scope at Time of ERCP
Conditions: Gastro-Intestinal Disorder
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 500
Sponsor: Brigham and Women's Hospital
Location: United States
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 ERCPExclusion Criteria:inability to provide consent
Source: ClinicalTrials.gov (NCT05627882). StuddyBuddy aggregates publicly available trial information.