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NCT Number: NCT07381192

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

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.

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Key information

Conditions

Endoscopic Ultrasound (EUS) Solid Pancreatic Lesion

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 status: Recruiting

Location contact

Zhen Li, doctor

CONTACT

[email protected]

18560086106

About this study

This is an observational study with a prospective, cohort design. We have developed an artificial intelligence system named iEUS-SPL for multimodal, multi-class diagnosing solid pancreatic lesions using endoscopic ultrasound images, endoscopic ultrasound features, clinical data and imaging features from retrospectively collected patients who underwent EUS. The lesion detection rate and diagnostic performance of iEUS-SPL in identifying solid pancreatic lesions will be evaluated in real-time EUS scanning videos over prospective enrolled cases.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. The accuracy of iEUS-SPL for solid pancreatic lesions

    Time frame: During procedure

    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).

  2. The sensitivity of iEUS-SPL for solid pancreatic lesions

    Time frame: During procedure

    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).

  3. The specificicy of iEUS-SPL for solid pancreatic lesions

    Time frame: During procedure

    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).

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

    Time frame: During procedure

    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).

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

    Time frame: During procedure

    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).

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

    Time frame: During procedure

    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).

Secondary outcomes

  1. Comparison of the accuracy between iEUS-SPL and endosonographers

    Time frame: During procedure

    The secondary outcome of the study is to comparing the accuracy between iEUS-SPL and different-level endosonographers in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).

  2. Comparison of the sensitivity between iEUS-SPL and endosonographers

    Time frame: During procedure

    The secondary outcome of the study is to comparing the sensitivity between iEUS-SPL and different-level endosonographers in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).

  3. Comparison of the specificity between iEUS-SPL and endosonographers

    Time frame: During procedure

    The secondary outcome of the study is to comparing the specificity between iEUS-SPL and different-level endosonographers in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).

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

    Time frame: During procedure

    The secondary outcome of the study is to comparing the postive predictive value between iEUS-SPL and different-level endosonographers in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).

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

    Time frame: During procedure

    The secondary outcome of the study is to comparing the negative predictive value between iEUS-SPL and different-level endosonographers in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).

Study contacts

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

Zhen Li

CONTACT

[email protected]

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
2025
Primary completion
2028
Study completion
2028
First posted
Feb 2, 2026
Registry last updated
Feb 2, 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.

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