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THE MULTIVIEW PERSPECTIVE (MVP) STUDY: A BLINDED, TANDEM PROSPECTIVE TRIAL OF FORWARD-VIEW VERSUS SIDE-VIEW EXAMINATION DURING ERCP

Date
May 21, 2024
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Introduction: Most endoscopists perform ERCP with only a side-viewing duodenoscope. We hypothesize significant gastrointestinal findings are missed due to the side-viewing design of the duodenoscope and that at least a subset of patients would benefit from concomitant forward-viewing exam (i.e. standard upper endoscopy) during ERCP. A preliminary analysis found a significant miss rate of 38.63% when patients underwent forward-viewing exam. Here we present the study results having reached target enrollment that may help identify patients who benefit from a forward-viewing exam. Methods: We conducted a blinded, tandem, single-center prospective clinical trial at a tertiary academic center (NCT: NCT05627882). Included patients underwent standard forward-viewing endoscopic exam with one attending followed by ERCP with a second attending that was blinded to the forward-viewing exam. Findings were deemed clinically significant (leading to management change) or classified as non-management altering. Multivariate logistical regression was performed to identify demographics and comorbidities associated with clinically significant findings identified on forward-viewing exam only. These included malignancy, liver, kidney, and cardiovascular comorbidities. Continuous data were compared using two-sample t-test or Wilcoxon rank-sum test and categorical data using Fisher’s exact test. Statistical analysis was performed using SAS 9.4. Results: 145 participants were included. Demographics are shown in Figure 1A. Forward-viewing endoscopic exam noted more endoscopic abnormalities when compared to side-viewing (51.7% (n=75) vs 18.6% (n=27) P<0.001). Clinically significant discrepancies were noted in 28.9% of patients (n=42) on forward viewing exam that were missed on side-viewing exam. The most frequently missed findings are listed (Figure 1B). Malignancy was a statistically significant predictor of missed finding on side-viewing exam by univariate (38.5 vs 19.7%, p=0.018) and multivariate analysis (p=0.041). Surgically altered anatomy was a statistically significant predictor of missed finding on side-viewing exam by univariate (80.0 vs 28.1%, p=0.028) and multivariate analysis (p=0.042). The presence of cardiac, renal, liver comorbidities, anti-coagulation, and gender were not predictors of missed findings on side-viewing exam. (Figure 2). Conclusion: This blinded, tandem prospective trial found clinically significant findings were missed in 28.9% of patients who underwent side-viewing exam alone during ERCP compared to concomitant forward-viewing exam. A significant increase in clinically relevant findings was found in patients with history of malignancy and surgically altered anatomy. These findings suggest that concomitant forward-viewing exam should be considered during ERCP, particularly in patients with history of malignancy and surgically altered anatomy.

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