Management of Pancreatic Cystic Lesions Using Artificial Intelligence Based on EUS and Multimodal Data

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHuazhong University of Science and Technology

About this trial

The primary objective is to construct a multimodal AI model (Cyst-AI) based on EUS images and clinical data such as imaging features(CT or MRI) and laboratory tests to assist endoscopists in the diagnosis of pancreatic cystic lesions(PCLs), mainly differentiating mucinous from non-mucinous lesions.

The secondary objective is to evaluate the model's effectiveness in risk stratification and clinical management for patients with PCLs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients whose EUS results indicates pancreatic cystic or cystoid lesions;

Mucinous lesions: including mucinous cystic neoplasm (MCN), intraductal papillary mucinous neoplasm (IPMN);

Non-mucinous lesions: including pancreatic pseudocyst, serous cystic neoplasm (SCN), cystic neuroendocrine tumor (cNET).

Disqualifiers

Patients whose age is less than 18 years old;

Patients who have undergone pancreatic surgery before the EUS examination;

Patients who have received chemotherapy and radiotherapy for pancreatic tumors before the EUS examination;

Pathological results indicate that pancreatic lesions are metastatic lesions from other sites;

Trial population

The cohort will be selected from several hospitals in China, including Tongji Hospital, Tongji Medical College, HUST.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Cyst-AI model

    Diagnostic test

    The multi-center collected data will be divided into a training set, a validation set, and a test set for developing and testing the cyst-AI model.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Cyst-EUS1 intervention

Trial outcomes

Primary outcomes

1

The performance of the diagnostic model in differentiating mucinous from non-mucinous PCLs

The performance of the Cyst-AI diagnostic model will be evaluated using the area under the receiver operating characteristic curve (AUC-ROC), with sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) calculated from the model's predictions on the independent validation dataset. PCLs: pancreatic cystic lesions.

Time frame
Within 3 months upon completion of the diagnostic model training.
2

The risk stratification performance of the clinical management model for mucinous PCLs

The performance of the Cyst-AI risk stratification model to correctly classify lesions into "low risk", "intermediate risk" and "high risk", will be evaluated using the area under the receiver operating characteristic curve (AUC-ROC), with sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) calculated from the model's predictions on the independent validation dataset. PCLs: pancreatic cystic lesions.

Time frame
Within 3 months upon completion of the risk stratification model training.

Secondary outcomes

1

The performance of the diagnostic model in differentiating specific types of PCLs

The performance of the Cyst-AI diagnostic model will be evaluated using the area under the receiver operating characteristic curve (AUC-ROC), with sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) calculated from the model's predictions on the independent validation dataset. PCLs: pancreatic cystic lesions.

Time frame
Within 3 months upon completion of the diagnostic model training.
2

The clinical management performance of the clinical management model for mucinous PCLs

The performance of the Cyst-AI clinical management model to provide accurate clinical recommendations, will be evaluated using the area under the receiver operating characteristic curve (AUC-ROC), with sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) calculated from the model's predictions on the independent validation dataset. PCLs: pancreatic cystic lesions.

Time frame
Within 3 months upon completion of the clinical management model training.
3

The performance of the model in assisting endoscopists of different levels in diagnosing and managing PCLs

The performance of the Cyst-AI model in assisting endoscopists will be evaluated using the area under the receiver operating characteristic curve (AUC-ROC), with sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) calculated from the model's predictions on the independent validation dataset. PCLs: pancreatic cystic lesions.

Time frame
Within 1 months upon completion of the human-machine confrontational crossover study
4

The impact of the model on the decision-making process of endoscopists

Questionnaire for endoscopists after assessment will be used to evaluate the degree of impact.

Time frame
Within 1 months upon completion of the human-machine confrontational crossover study.

Other outcomes

Sponsors and contacts

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