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NCT05627882

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

Completed Results posted Last updated 2 March 2026
What this trial tests

trial testing Forward viewing endoscope in Gastro-Intestinal Disorder in 163 participants. Completed in 1 July 2024.

Timeline
14 October 2022
Primary endpoint
1 May 2024
1 July 2024

Quick facts

Lead sponsorBrigham and Women's Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment163
Start date14 October 2022
Primary completion1 May 2024
Estimated completion1 July 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brigham and Women's Hospital

Who can join

18 and older, any sex, with Gastro-Intestinal Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Clinically Significant Endoscopic Findings Primary · Intra-procedural, up to 2 hours post-procedure

Endoscopic findings that alter medical/procedural management including: erosive disease, Barrett's esophagus, peptic ulcer, gastrointestinal malignancy, other.

GroupValue95% CI
Standard ERCP37
Number of Participants With Non-clinically Significant Endoscopic Findings Secondary · Intra-procedural, up to 2 hours post-procedure

Endoscopic findings that do not alter medical/procedural management including: gastritis, diverticulum, and hiatal hernia

GroupValue95% CI
Standard ERCP32

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Gastro-Intestinal Disorder

Currently open trials in the same condition.

Other Brigham and Women's Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05627882.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing