An Artificial Intelligence System for Multimodal, Multi-class Diagnosing Solid Pancreatic Lesions Based on Endoscopic Ultrasound

NCT07381192 | Recruiting

• 1 other identifier: 2025-SDU-QILU-6
• Study Type: observational
• Target: 383
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to validate an artificial intelligence system named iEUS-SPL(intelligent endoscopic ultrasound system-solid pancreatic lesion) for detecting and multimodal, multi-class diagnosing solid pancreatic lesions during endoscopic ultrasound(EUS) examination.

Conditions

Endoscopic Ultrasound (EUS); Solid Pancreatic Lesion

Keywords

endoscopic ultrasound; solid pancreatic lesion

Outcome Measures

Primary Outcomes (6)

• The accuracy of iEUS-SPL for solid pancreatic lesions

  The primary outcome of the study is to evaluate the accuracy of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).

  During procedure

• The sensitivity of iEUS-SPL for solid pancreatic lesions

  The primary outcome of the study is to evaluate the sensitivity of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).

  During procedure

• The specificicy of iEUS-SPL for solid pancreatic lesions

  The primary outcome of the study is to evaluate the specificity of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).

  During procedure

• The postive predictive value of iEUS-SPL for solid pancreatic lesions

  The primary outcome of the study is to evaluate the postive predictive value of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).

  During procedure

• The negative predictive value of iEUS-SPL for solid pancreatic lesions

  The primary outcome of the study is to evaluate the negative predictive value of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).

  During procedure

• the lesion detection rate of iEUS-SPL for detecting solid pancreatic lesions

  The primary outcome of the study is to evaluate the lesion detection rate of the iEUS-SPL in identifying the solid pancreatic lesions(defined as the number of detected lesions divided by the total number of lesions).

  During procedure

Secondary Outcomes (5)

• Comparison of the accuracy between iEUS-SPL and endosonographers

  During procedure

• Comparison of the sensitivity between iEUS-SPL and endosonographers

  During procedure

• Comparison of the specificity between iEUS-SPL and endosonographers

  During procedure

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

  During procedure

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

  During procedure

Study Arms (1)

Patients undergoing EUS

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

Device: iEUS-SPL(intelligent endoscopic ultrasound system-pancreatic solid lesion)

Interventions

iEUS-SPL(intelligent endoscopic ultrasound system-pancreatic solid lesion) DEVICE

The iEUS-SPL will automaticly detect solid pancreatic lesions and integrate the patients' endoscopic ultrasound images, endoscopic ultrasound features, clinical data and imaging features to perform a five-category classification for the lesions, categorizing them as pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis and chronic pancreatitis.

Patients undergoing EUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with suspected solid pancreatic lesions undergoing EUS.

You may qualify if:

• Patients aged ≥18 years scheduled for EUS with suspected solid pancreatic lesions based on clinical symptoms, medical history, laboratory tests or radiological examinations agree to participate in the research and be able to sign informed consent.
• Patients with no prior history of treatment for pancreatic lesions.

You may not qualify if:

• Patients with absolute contraindications to EUS examination.
• Pregnancy or lactating.
• Uncorrectable coagulopathy(PTT\>50 seconds or INR\>1.5) and/or uncorrectable thrombocytopenia(platelet count\<50×109/L).
• Upper gastrointestinal obstruction.
• 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.
• Patients who refuse to sign the informed consent.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• The Affiliated Hospital of Qingdao University: collaborator
• 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
• Qianfoshan Hospital: collaborator
• Shengli Oilfield Hospital: collaborator
• Binzhou Medical University: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (18)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Endoscopic ultrasound images, endoscopic ultrasound features, clinical data and imaging features from patients who underwent endoscopic ultrasound.

Central Study Contacts

Zhen Li

CONTACT

18560086106; qilulizhen@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: February 2, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 2, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)