NCT07809841Not yet recruiting
Real-Time AI During Pancreatoscopy for Detection of Pancreatic Neoplasia
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
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 3 Sept 2026
- Start date
- Sept 2026
- Primary completion date
- May 2027
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Diseases
- Pancreatic cancer
- NCT number
- NCT07809841
What you commit to
- Study type: Observational
- Planned participants: 60
- From Sept 2026 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute pancreatitis within 2 weeks before the planned pancreatoscopy.
- Inability or unwillingness to complete the required follow-up when a non-surgical reference standard is necessary.
Other illness
- Hemodynamic instability or clinical condition precluding safe pancreatoscopy.
- Evidence of unsafe pancreatic duct disruption or another anatomical or procedural condition that makes pancreatoscopy inappropriate.
Other
- ASA physical status IV or V when the treating team determines that the procedure cannot be safely performed.
- Uncorrectable coagulopathy or other contraindication to pancreatoscopy and/or tissue sampling.
- Pancreatic or gastrointestinal altered anatomy that prevents technically feasible digital POPS.
- Pregnancy.
- Inability or unwillingness to provide informed consent.
Who the study is looking for
- Adults aged 18 years or older.
- Patients with a clinical indication for digital per-oral pancreatoscopy (POPS) as part of their diagnostic evaluation or preoperative assessment.
- Patients with one or more of the following clinical indications:
- 3.1. Suspected or known main-duct or mixed-type IPMN. 3.2. Branch-duct IPMN with suspected communication with the main pancreatic duct and worrisome features or high-risk stigmata.
- 3.3. Indeterminate main pancreatic duct stricture, filling defect, or intraductal abnormality after cross-sectional imaging and/or EUS.
- 3.4. Need for preoperative assessment or mapping of IPMN extent.
- Ability to undergo digital POPS according to the treating team's clinical assessment.
- Ability to provide written informed consent.
- Availability of an adequate reference-standard assessment, including histopathology when surgery is performed or tissue/cytologic assessment with clinical and imaging follow-up when surgery is not performed.
- Willingness and ability to complete the required 6-month clinical/imaging follow-up when a surgical reference standard is not available.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IECED Coordinator of this site? Confirm its status | Guayaquil | Ecuador | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.