Endoscopic findings that alter medical/procedural management including: erosive disease, Barrett's esophagus, peptic ulcer, gastrointestinal malignancy, other.
| Group | Value | 95% CI |
|---|---|---|
| Standard ERCP | 37 |
Last reviewed · How we verify
Evaluation of the Impact of a Forward Viewing Scope at Time of ERCP
trial testing Forward viewing endoscope in Gastro-Intestinal Disorder in 163 participants. Completed in 1 July 2024.
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 163 |
| Start date | 14 October 2022 |
| Primary completion | 1 May 2024 |
| Estimated completion | 1 July 2024 |
| Sites | 1 location across United States |
Brigham and Women's Hospital
18 and older, any sex, with Gastro-Intestinal Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Endoscopic findings that alter medical/procedural management including: erosive disease, Barrett's esophagus, peptic ulcer, gastrointestinal malignancy, other.
| Group | Value | 95% CI |
|---|---|---|
| Standard ERCP | 37 |
Endoscopic findings that do not alter medical/procedural management including: gastritis, diverticulum, and hiatal hernia
| Group | Value | 95% CI |
|---|---|---|
| Standard ERCP | 32 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing