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NOT YET RECRUITING
NCT07809841

Real-Time AI During Pancreatoscopy for Detection of Pancreatic Neoplasia

Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas

View on ClinicalTrials.gov

Summary

This prospective pilot study will evaluate the diagnostic performance of a previously validated artificial intelligence (AI) model when applied in real time during digital per-oral pancreatoscopy (POPS). The study will include adults undergoing clinically indicated pancreatoscopy for suspected or known intraductal papillary mucinous neoplasm (IPMN), indeterminate pancreatic-duct abnormalities, or preoperative assessment of IPMN extent. During the procedure, the endoscopist will first record a visual assessment while the AI system is hidden. The AI overlay will then be activated during the same pancreatoscopy examination, and its findings will be recorded independently. AI and endoscopist assessments will be compared with a prespecified reference standard based on surgical histopathology when available or tissue sampling and clinical/imaging follow-up when surgery is not performed. The primary objective is to estimate the sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy of real-time AI for identifying high-grade dysplasia or invasive carcinoma. The study is designed as a pilot to assess feasibility and generate preliminary diagnostic-accuracy estimates for future confirmatory research.

Official title: Real-Time Application of a Validated Artificial Intelligence Model During Digital Per-Oral Pancreatoscopy for Identification of Pancreatic Neoplastic Lesions and IPMN: A Prospective Pilot Diagnostic Accuracy Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-09-15

Completion Date

2027-08-30

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

AIWorks-Cholangioscopy Real-Time Artificial Intelligence Model

A previously validated artificial intelligence model developed for digital cholangioscopy will be applied in real time to digital per-oral pancreatoscopy video without modification of its model weights. The system provides real-time visual detection and localization of suspected pancreatic duct abnormalities during pancreatoscopy. The AI assessment will be performed after the endoscopist has completed and locked the initial visual assessment. AI findings will be recorded as an index diagnostic test and will not independently determine tissue sampling, treatment, surgery, or other clinical management.

Locations (1)

IECED

Guayaquil, Guayas, Ecuador