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AI joins the hunt for hidden pancreatic cancer

NCT ID NCT07809841

Diagnosis Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas Source: ClinicalTrials.gov ↗

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This trial is taking on new participants right now.
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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When the status isn't known

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First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing whether a previously validated artificial intelligence model can help identify high-grade dysplasia or pancreatic cancer in real time during a procedure called digital per-oral pancreatoscopy. The study enrolls 60 adults who need this procedure for suspected or known intraductal papillary mucinous neoplasm (IPMN) or other pancreatic duct abnormalities. During the procedure, the endoscopist first records their own visual assessment without AI. Then the AI overlay turns on, and its findings are recorded separately. Researchers compare both assessments against tissue samples or follow-up imaging to see how accurate the AI is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an artificial intelligence model that analyzes pancreatoscopy video in real time
What this could lead to
If it works, the AI could give doctors a second set of eyes during pancreatoscopy, helping them spot high-grade dysplasia or pancreatic cancer that might otherwise be missed.
What could go wrong
This is a small pilot study of 60 people, so it can only suggest whether the AI is accurate, not prove it. The AI may miss cancers or flag harmless tissue, and results may not hold up in larger, more diverse groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Pancreatic Intraductal Neoplasms pancreatic intraductal papillary-mucinous neoplasm pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intraductal papillary mucinous neoplasm of pancreas Pancreatic neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IECED

    Guayaquil, Guayas, 090505, Ecuador

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