Real-Time AI During Pancreatoscopy for Detection of Pancreatic Neoplasia

September 3, 2026 updated by: Instituto Ecuatoriano de Enfermedades Digestivas

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective pilot diagnostic-accuracy study will evaluate the performance of a previously validated artificial intelligence (AI) model when applied in real time during digital per-oral pancreatoscopy (POPS) for the identification of pancreatic neoplastic lesions and intraductal papillary mucinous neoplasm (IPMN).

Adults undergoing clinically indicated digital POPS at the Instituto Ecuatoriano de Enfermedades Digestivas (IECED) will be prospectively enrolled. Eligible patients will include those undergoing pancreatoscopy for suspected or known main-duct or mixed-type IPMN, branch-duct IPMN with suspected main-duct communication and concerning features, indeterminate pancreatic-duct strictures or filling defects, or preoperative assessment and mapping of IPMN extent.

During each POPS examination, the endoscopist will first perform and record a conventional visual assessment while the AI system remains hidden. The AI system, AIWorks-Cholangioscopy, will subsequently be activated during the same examination. The previously validated model was developed and validated using digital cholangioscopy data and will be applied to digital pancreatoscopy video without modification of its model weights. AI-generated findings will be recorded independently and compared with the endoscopist's initial assessment.

The AI system will provide real-time visual information, including detection and localization of suspected abnormal areas. AI findings will be documented as an index diagnostic test and will not independently determine patient management. Tissue sampling and subsequent clinical management will remain at the discretion of the treating endoscopist and multidisciplinary team according to standard clinical practice. When feasible, findings identified by either the endoscopist or AI may be documented for correlation with subsequent tissue sampling. The study will also record whether AI findings were concordant or discordant with the initial endoscopist assessment and whether the information was considered during the procedure.

The reference standard will consist of surgical histopathology when pancreatic resection is performed. In patients who do not undergo surgery, the reference assessment will be based on available intraductal tissue sampling and/or cytology together with clinical, imaging, and endoscopic follow-up for up to 6 months. Histopathologic assessment will be performed independently of the AI findings and the endoscopist's locked pre-AI assessment whenever feasible.

The primary diagnostic endpoint will be patient-level identification of high-grade dysplasia or invasive carcinoma, classified as a binary outcome of high-grade dysplasia/invasive carcinoma versus all other diagnostic categories. Diagnostic performance of real-time AI will be estimated using sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy, with corresponding 95% confidence intervals.

Secondary analyses will evaluate the diagnostic performance of the endoscopist's initial visual assessment, agreement and discordance between AI and endoscopist assessments, identification of IPMN epithelium, segment-level findings, technical feasibility of real-time AI application, and the relationship between AI findings and subsequent tissue sampling or clinical decision-making. Procedural safety will also be assessed through recording of adverse events occurring within 30 days of pancreatoscopy.

The study is designed as a pilot investigation. The planned evaluable sample is 60 participants, with up to approximately 70 participants potentially screened or enrolled to account for exclusions and non-evaluable examinations. The pilot is intended to generate preliminary patient-level diagnostic-accuracy estimates, evaluate the feasibility of real-time AI application during digital POPS, characterize AI-endoscopist concordance, and provide parameters for the design and sample-size planning of a future confirmatory diagnostic-accuracy study.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Carlos Robles-Medranda, MD, FASGE, AGAF
  • Phone Number: 042109180
  • Email: carlosoakm@yahoo.es

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090505
        • IECED

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  1. Adults aged 18 years or older.
  2. Patients with a clinical indication for digital per-oral pancreatoscopy (POPS) as part of their diagnostic evaluation or preoperative assessment.

  3. 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.

  4. Ability to undergo digital POPS according to the treating team's clinical assessment.
  5. Ability to provide written informed consent.
  6. 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.
  7. Willingness and ability to complete the required 6-month clinical/imaging follow-up when a surgical reference standard is not available.

Exclusion Criteria:

  1. Acute pancreatitis within 2 weeks before the planned pancreatoscopy.
  2. Hemodynamic instability or clinical condition precluding safe pancreatoscopy.
  3. ASA physical status IV or V when the treating team determines that the procedure cannot be safely performed.
  4. Uncorrectable coagulopathy or other contraindication to pancreatoscopy and/or tissue sampling.
  5. Pancreatic or gastrointestinal altered anatomy that prevents technically feasible digital POPS.
  6. Evidence of unsafe pancreatic duct disruption or another anatomical or procedural condition that makes pancreatoscopy inappropriate.
  7. Pregnancy.
  8. Inability or unwillingness to provide informed consent.
  9. Inability or unwillingness to complete the required follow-up when a non-surgical reference standard is necessary.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-level diagnostic accuracy of real-time artificial intelligence for high-grade dysplasia or invasive carcinoma
Time Frame: From baseline to 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopist diagnostic accuracy for high-grade dysplasia or invasive carcinoma
Time Frame: From baseline to 6 months
Diagnostic performance of the endoscopist's initial visual assessment, performed before activation of the AI overlay, for identification of high-grade dysplasia or invasive carcinoma at the patient level. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy will be calculated using the prespecified reference standard.
From baseline to 6 months
Agreement between artificial intelligence and endoscopist assessments
Time Frame: During Index procedure
Concordance and discordance between the AI assessment and the endoscopist's pre-AI visual assessment for identification of suspected neoplastic lesions and high-grade dysplasia or invasive carcinoma. Agreement will be summarized using paired proportions and, when appropriate, Cohen's kappa coefficient.
During Index procedure
Diagnostic accuracy for IPMN epithelium
Time Frame: From baseline to 6 months follow up
Diagnostic performance of the real-time AI model for identification of IPMN epithelium, classified as IPMN epithelium present versus absent, using the prespecified reference standard.
From baseline to 6 months follow up
Segment-level detection of abnormal pancreatic duct areas
Time Frame: During index procedure
Ability of the AI model to identify and localize abnormal pancreatic duct segments during digital per-oral pancreatoscopy. AI-positive segments will be compared with corresponding endoscopist assessments and available tissue or cytologic findings.
During index procedure
AI-endoscopist discordance and additional diagnostic information
Time Frame: From baseline to 6 months follow up
Frequency and characteristics of cases in which the AI assessment differs from the initial endoscopist assessment, including AI-positive/endoscopist-negative and AI-negative/endoscopist-positive findings. The analysis will describe whether discordant AI findings were subsequently correlated with tissue sampling or other reference-standard findings.
From baseline to 6 months follow up
Change in intended clinical management after AI assessment
Time Frame: During Index Procedure
Frequency with which the AI findings are associated with a documented change in the endoscopist's intended sampling strategy or intended surgical assessment after review of the real-time AI findings. Any change will be recorded descriptively and will not be mandated by the study protocol.
During Index Procedure
Procedure-related adverse events
Time Frame: From index procedure through 30 days after the procedure
Incidence and severity of adverse events occurring within 30 days after digital per-oral pancreatoscopy, classified according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon.
From index procedure through 30 days after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

September 3, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 9, 2026

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IECED-AIPOPS-0902026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers. The study is a small, single-center pilot diagnostic-accuracy study, and sharing individual-level data could present a risk of participant re-identification given the limited sample size and the specific clinical and procedural characteristics of the study population. Aggregate study results will be reported in accordance with applicable ethical, regulatory, and institutional requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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