Personalized Acute Upper GI Bleeding Diagnostics for Patients at Highest Risk for Endoscopy: Real-World Experience of a Novel, Binary, Bedside Gastric Blood Detection Device.

Background

Upper gastrointestinal bleeding (UGIB) is a common medical emergency associated with significant morbidity, mortality, and healthcare costs. Many patients undergo early endoscopy despite the absence of active bleeding. PillSense is a novel Food and Drug Administration (FDA)-cleared ingestible capsule that rapidly detects the presence of blood in the upper GI tract and may optimize triage decisions.

Methods

We conducted a retrospective study evaluating the impact of PillSense on the management of suspected UGIB in an academic center. The primary outcome was the association between capsule results and clinical decision-making, including endoscopy deferral, prioritization, outpatient scheduling, and airway protection. Secondary outcomes included transfusion requirements, time-to-endoscopy, endoscopic intervention, and 30-day adverse events.

Results

A total of 28 patients (mean age 64.4 ± 17.9 years, 82.7% male) were included. Compared with negative results, positive results were associated with higher transfusion requirements (median 3 (IQR 3-6) vs. 2 (IQR 1-3.25) units; p = 0.041) and shorter time-to-endoscopy (median 0.2 (IQR 0.01-1) vs. 2 (IQR 1-15.5) days; p = 0.017). In high-risk for sedated endoscopy patients, negative results were associated with EGD deferral in 53.8%, with no subsequent adverse events within 30 days. Endoscopic intervention was performed in 62.5% of positive-result patients versus 9.5% of negative-result patients.

Conclusions

The PillSense results were associated with differences in triage and management of high-risk patients with suspected UGIB. Its rapid, accurate, and non-invasive results may reduce unnecessary urgent endoscopy procedures, improve resource utilization, and enhance patient safety, particularly in the highest-risk populations.