NCT05627882|CompletedResultsFDA Device
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Sponsor study identifier
observational
163
1 country
1
Study Start
October 14, 2022
Actual (reported)Primary Completion
May 1, 2024
Actual (reported)Study Completion
July 1, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 14, 2022
Actual (reported)November 2, 2022
Actual (reported)November 28, 2022
Actual (reported)May 1, 2024
Actual (reported)July 1, 2024
Actual (reported)March 2, 2026
Actual (reported)Number of Participants With Clinically Significant Endoscopic Findings
Endoscopic findings that alter medical/procedural management including: erosive disease, Barrett's esophagus, peptic ulcer, gastrointestinal malignancy, other.
Intra-procedural, up to 2 hours post-procedure
Number of Participants With Non-clinically Significant Endoscopic Findings
Intra-procedural, up to 2 hours post-procedure
Patients undergoing ERCP with standard side viewing scope
Additional examination with standard forward viewing endoscope
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients who are referred for clinically indicated ERCP procedure
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Peery AF, Crockett SD, Murphy CC, Lund JL, Dellon ES, Williams JL, Jensen ET, Shaheen NJ, Barritt AS, Lieber SR, Kochar B, Barnes EL, Fan YC, Pate V, Galanko J, Baron TH, Sandler RS. Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2018. Gastroenterology. 2019 Jan;156(1):254-272.e11. doi: 10.1053/j.gastro.2018.08.063. Epub 2018 Oct 10.
Thomas A, Vamadevan AS, Slattery E, Sejpal DV, Trindade AJ. Performing forward-viewing endoscopy at time of pancreaticobiliary EUS and ERCP may detect additional upper gastrointestinal lesions. Endosc Int Open. 2016 Feb;4(2):E193-7. doi: 10.1055/s-0041-109084. Epub 2016 Jan 11.
This study was single center and not a multi-center. Although the knowledge of an ongoing study was present to the endoscopists, it was not possible to adjust for an endoscopist looking extra carefully with a side-viewing exam or less carefully when aware a forward viewing exam would be performed. Additionally, the study was not a randomized controlled trial. Data was collected prospectively and outcome assessors blinded, the risk of bias is markedly decreased compared to a retrospective design
Marvin Ryou, MD
Brigham and Women's Hospital
163 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2022
First Posted
November 28, 2022
Study Start
October 14, 2022
Actual (reported)Can the SurgInfoBot Improve the Consent Process for Endoscopy? A Randomised Controlled Trial
Contact the study team to confirm eligibility.
Ford AC, Marwaha A, Lim A, Moayyedi P. What is the prevalence of clinically significant endoscopic findings in subjects with dyspepsia? Systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2010 Oct;8(10):830-7, 837.e1-2. doi: 10.1016/j.cgh.2010.05.031. Epub 2010 Jun 10.
Shah R, Jajoo K, Steinway SN, Wang T, McCarty TR, Mathews TJ, Trasolini R, Jirapinyo P, Grover A, Lee LS, Thompson CC, Ryou M. Forward-Viewing Endoscopy at the Time of ERCP: A Blinded Tandem Prospective Trial. Endosc Int Open. 2026 Aug 21;14:a29320440. doi: 10.1055/a-2932-0440. eCollection 2026.
Primary Completion
May 1, 2024
Actual (reported)Study Completion
July 1, 2024
Actual (reported)Last Updated
March 2, 2026
Results First Posted
March 2, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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