An Artificial Intelligence System for Multimodal, Multi-class Diagnosis of Pancreatic Cystic Lesions Based on Endoscopic Ultrasonography

April 23, 2026 updated by: Qilu Hospital of Shandong University
The aim of this study is to develop and validate an artificial intelligence system named iEUS-PCL (intelligent endoscopic ultrasound system-pancreatic cystic lesions） for detecting and multimodal, multi-class diagnosing pancreatic cystic lesions (PCL) during endoscopic ultrasound (EUS) examination.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This multicenter, prospective cohort study aims to develop and validate a multimodal artificial intelligence system named iEUS-PCL for the detection and differential diagnosis of PCL. The model was developed based on retrospectively collected EUS images, EUS features, clinical data and radiological imaging features of patients who underwent EUS examination. The diagnostic performance of iEUS-PCL will be evaluated prospectively in real-time EUS videos and compared with endosonographers' performance.

Study Type

Observational

Enrollment (Estimated)

176

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

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
        • Contact:

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

Adult patients with suspected pancreatic cystic lesions undergoing EUS.

Description

Inclusion Criteria:

- 1. Patients aged ≥18 years scheduled for EUS with suspected pancreatic cystic lesions based on clinical symptoms, medical history, laboratory tests or radiological examinations, and who agree to participate in the research and voluntarily sign the informed consent.

2. Patients with no prior history of treatment for pancreatic lesions.

Exclusion Criteria:

- 1. Patients with absolute contraindications to EUS examination. 2. Pregnancy or lactating. 3. Uncorrectable coagulopathy(PTT>50 seconds or INR>1.5) and/or uncorrectable thrombocytopenia(platelet count<50×109/L). 4. Upper gastrointestinal obstruction. 5. Patients who underwent surgical treatment or anatomical alterations of the pancreas due to lesions in other thoracic and/or abdominal organs, as well as patients with congenital anatomical abnormalities.

6. Patients who have undergone biliary/pancreatic duct stent placement. 7. Patients who refuse to sign the informed consent.

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
Patients undergoing EUS
Patients aged ≥18 years scheduled for EUS with suspected pancreatic cystic lesions based on clinical symptoms, medical history, laboratory tests or radiological examinations are eligible upon agreement to participate in the research and voluntary signing of the informed consent.
Device: iEUS-PCL(intelligent endoscopic ultrasound system- pancreatic cystic lesion)

The iEUS-PCL will automatically detect pancreatic cystic lesions and integrate the patients' EUS images, EUS features, clinical data and radiological imaging features to perform three classification tasks:

  1. binary classification: benign/malignant lesions;
  2. binary classification: mucinous/non-mucinous lesions;
  3. four-category classification: intraductal papillary mucinous neoplasm/ mucinous cystic neoplasm/ serous cyst neoplasm/ pancreatic cyst.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of iEUS-PCL for pancreatic cystic lesions
Time Frame: During procedure
The primary outcome of the study is to evaluate the accuracy of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
During procedure
The sensitivity of iEUS-PCL for pancreatic cystic lesions
Time Frame: During procedure
The primary outcome of the study is to evaluate the sensitivity of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
During procedure
The specificicy of iEUS-PCL for pancreatic cystic lesions
Time Frame: During procedure
The primary outcome of the study is to evaluate the specificity of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
During procedure
The postive predictive value of iEUS-PCL for pancreatic cystic lesions
Time Frame: During procedure
The primary outcome of the study is to evaluate the postive predictive value of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
During procedure
The negative predictive value of iEUS-PCL for pancreatic cystic lesions
Time Frame: During procedure
The primary outcome of the study is to evaluate the negative predictive value of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
During procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the accuracy between iEUS-PCL and endosonographers
Time Frame: During procedure
The secondary outcome of the study is to comparing the accuracy between iEUS-PCL and different-level endosonographers in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
During procedure
Comparison of the sensitivity between iEUS-PCL and endosonographers
Time Frame: During procedure
The secondary outcome of the study is to comparing the sensitivity between iEUS-PCL and different-level endosonographers in identifying in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
During procedure
Comparison of the specificity between iEUS-PCL and endosonographers
Time Frame: During procedure
The secondary outcome of the study is to comparing the specificity between iEUS-PCL and different-level endosonographers in identifying in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
During procedure
Comparison of the postive predictive value between iEUS-PCL and endosonographers
Time Frame: During procedure
The secondary outcome of the study is to comparing the postive predictive value between iEUS-PCL and different level endosonographers in identifying in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
During procedure
Comparison of the negative predictive value between iEUS-PCL and endosonographers
Time Frame: During procedure
The secondary outcome of the study is to comparing the negative predictive value between iEUS-PCL and different-level endosonographers in identifying in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
During procedure

Collaborators and Investigators

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

Sponsor

Qilu Hospital of Shandong University

Collaborators

The Affiliated Hospital of Qingdao University
Shandong Provincial Hospital
Qianfoshan Hospital
Liaocheng People's Hospital
Taian City Central Hospital
Shengli Oilfield Hospital
Binzhou People's Hospital
Qilu Hospital of Shandong University (Qingdao)
Binzhou Medical University

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)

April 20, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026-SDU-QILU-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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