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NCT Number: NCT07543263

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

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.

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Key information

Conditions

Pancreatic Cystic Lesion (PCL)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location contact

Zhen Li, doctor

CONTACT

[email protected]

86+18560086106

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen Li

CONTACT

[email protected]

86+18560086106

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 21, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.