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

NCT05627882 | Completed Results FDA Device

• 1 other identifier: 2022A002001
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastro-Intestinal Disorder

Keywords

endoscopy; ERCP

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Participants With Non-clinically Significant Endoscopic Findings

  Intra-procedural, up to 2 hours post-procedure

Study Arms (1)

Standard ERCP

Patients undergoing ERCP with standard side viewing scope

Diagnostic Test: Forward viewing endoscope

Interventions

Forward viewing endoscope DIAGNOSTIC_TEST

Additional examination with standard forward viewing endoscope

Standard ERCP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are referred for clinically indicated ERCP procedure

You may qualify if:

• All adult patients referred for clinically-indicated ERCP

You may not qualify if:

• inability to provide consent

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• 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.

  PMID: 30315778 BACKGROUND

• 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.

  PMID: 26878048 BACKGROUND

• 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.

  PMID: 20541625 BACKGROUND

MeSH Terms

Conditions

Digestive System Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Marvin Ryou
• Organization: Brigham and Women's Hospital

mryou@bwh.harvard.edu

617-732-5550

Study Officials

• Marvin Ryou, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopic Innovations

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 28, 2022
• Study Start: October 14, 2022
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 2, 2026
• Results First Posted: March 2, 2026

Record last verified: 2026-02

Locations

US (1)