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

NCT07543263 | Not Yet Recruiting

• 1 other identifier: 2026-SDU-QILU-2
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cystic Lesion (PCL)

Keywords

endoscopic ultrasound; pancreatic cystic lesion; machine learning

Outcome Measures

Primary Outcomes (5)

• The accuracy of iEUS-PCL for pancreatic cystic lesions

  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

  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

  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

  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

  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 Outcomes (5)

• Comparison of the accuracy between iEUS-PCL and endosonographers

  During procedure

• Comparison of the sensitivity between iEUS-PCL and endosonographers

  During procedure

• Comparison of the specificity between iEUS-PCL and endosonographers

  During procedure

• Comparison of the postive predictive value between iEUS-PCL and endosonographers

  During procedure

• Comparison of the negative predictive value between iEUS-PCL and endosonographers

  During procedure

Study Arms (1)

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)

Interventions

iEUS-PCL(intelligent endoscopic ultrasound system- pancreatic cystic lesion) DEVICE

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.

Patients undergoing EUS

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

Adult patients with suspected pancreatic cystic lesions undergoing EUS.

You may qualify if:

• \- 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.
• \. Patients with no prior history of treatment for pancreatic lesions.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (20)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

EUS images, EUS features, clinical data and radiological imaging features from patients who underwent EUS.

Central Study Contacts

Zhen Li

CONTACT

86+18560086106; qilulizhen@sdu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 21, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)