Real-Time AI During Pancreatoscopy for Detection of Pancreatic Neoplasia

NCT07809841 | Not Yet Recruiting DMC

• 1 other identifier: IECED-AIPOPS-0902026
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraductal Papillary Mucinous Neoplasm of Pancreas; Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Patient-level diagnostic accuracy of real-time artificial intelligence for high-grade dysplasia or invasive carcinoma

  Diagnostic accuracy of the real-time AI model for identifying high-grade dysplasia or invasive carcinoma at the patient level during digital per-oral pancreatoscopy. AI findings will be classified as positive or negative according to the prespecified diagnostic threshold and compared with the reference standard. The primary analysis will report sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy, each with corresponding 95% confidence intervals.

  From baseline to 6 months

Secondary Outcomes (7)

• Endoscopist diagnostic accuracy for high-grade dysplasia or invasive carcinoma

  From baseline to 6 months

• Agreement between artificial intelligence and endoscopist assessments

  During Index procedure

• Diagnostic accuracy for IPMN epithelium

  From baseline to 6 months follow up

• Segment-level detection of abnormal pancreatic duct areas

  During index procedure

• AI-endoscopist discordance and additional diagnostic information

  From baseline to 6 months follow up

Study Arms (1)

Digital POPS

Adults undergoing clinically indicated digital per-oral pancreatoscopy who receive both the prespecified endoscopist visual assessment and real-time AI assessment during the same procedure.

Diagnostic Test: AIWorks-Cholangioscopy Real-Time Artificial Intelligence Model

Interventions

AIWorks-Cholangioscopy Real-Time Artificial Intelligence Model DIAGNOSTIC_TEST

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.

Digital POPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults aged 18 years or older undergoing clinically indicated digital per-oral pancreatoscopy (POPS) at the Instituto Ecuatoriano de Enfermedades Digestivas (IECED). Participants will be patients evaluated for suspected or known intraductal papillary mucinous neoplasm (IPMN), indeterminate pancreatic duct abnormalities, including strictures or filling defects, or for preoperative assessment and mapping of IPMN extent. Approximately 60 evaluable participants will be included. All participants will undergo the same prospective diagnostic assessment sequence, consisting of an initial endoscopist visual assessment followed by real-time application of the AIWorks-Cholangioscopy artificial intelligence model during the same pancreatoscopy examination. Participants will subsequently be evaluated against the prespecified reference standard based on surgical histopathology when available or tissue sampling and clinical/imaging follow-up.

You may qualify if:

• 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:
• 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.
• Indeterminate main pancreatic duct stricture, filling defect, or intraductal abnormality after cross-sectional imaging and/or EUS.
• 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.

You may not qualify if:

• Acute pancreatitis within 2 weeks before the planned pancreatoscopy.
• Hemodynamic instability or clinical condition precluding safe pancreatoscopy.
• 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.
• Evidence of unsafe pancreatic duct disruption or another anatomical or procedural condition that makes pancreatoscopy inappropriate.
• Pregnancy.
• Inability or unwillingness to provide informed consent.
• Inability or unwillingness to complete the required follow-up when a non-surgical reference standard is necessary.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

IECED

Guayaquil, Guayas, 090505, Ecuador

Location

Related Publications (5)

• Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.

  PMID: 26511519 BACKGROUND

• de Jong DM, Stassen PMC, Groot Koerkamp B, Ellrichmann M, Karagyozov PI, Anderloni A, Kylanpaa L, Webster GJM, van Driel LMJW, Bruno MJ, de Jonge PJF; European Cholangioscopy study group. The role of pancreatoscopy in the diagnostic work-up of intraductal papillary mucinous neoplasms: a systematic review and meta-analysis. Endoscopy. 2023 Jan;55(1):25-35. doi: 10.1055/a-1869-0180. Epub 2022 Jun 3.

  PMID: 35668651 BACKGROUND

• Kahaleh M, Gaidhane M, Shahid HM, Tyberg A, Sarkar A, Ardengh JC, Kedia P, Andalib I, Gress F, Sethi A, Gan SI, Suresh S, Makar M, Bareket R, Slivka A, Widmer JL, Jamidar PA, Alkhiari R, Oleas R, Kim D, Robles-Medranda CA, Raijman I. Digital single-operator cholangioscopy interobserver study using a new classification: the Mendoza Classification (with video). Gastrointest Endosc. 2022 Feb;95(2):319-326. doi: 10.1016/j.gie.2021.08.015. Epub 2021 Aug 31.

  PMID: 34478737 BACKGROUND

• Robles-Medranda C, Valero M, Soria-Alcivar M, Puga-Tejada M, Oleas R, Ospina-Arboleda J, Alvarado-Escobar H, Baquerizo-Burgos J, Robles-Jara C, Pitanga-Lukashok H. Reliability and accuracy of a novel classification system using peroral cholangioscopy for the diagnosis of bile duct lesions. Endoscopy. 2018 Nov;50(11):1059-1070. doi: 10.1055/a-0607-2534. Epub 2018 Jun 28.

  PMID: 29954008 BACKGROUND

• Robles-Medranda C, Baquerizo-Burgos J, Alcivar-Vasquez J, Kahaleh M, Raijman I, Kunda R, Puga-Tejada M, Egas-Izquierdo M, Arevalo-Mora M, Mendez JC, Tyberg A, Sarkar A, Shahid H, Del Valle-Zavala R, Rodriguez J, Merfea RC, Barreto-Perez J, Saldana-Pazmino G, Calle-Loffredo D, Alvarado H, Lukashok HP. Artificial intelligence for diagnosing neoplasia on digital cholangioscopy: development and multicenter validation of a convolutional neural network model. Endoscopy. 2023 Aug;55(8):719-727. doi: 10.1055/a-2034-3803. Epub 2023 Feb 13.

  PMID: 36781156 BACKGROUND

MeSH Terms

Conditions

Pancreatic Intraductal Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Carlos Robles-Medranda, MD, FASGE, AGAF

CONTACT

042109180; carlosoakm@yahoo.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)