Artificial Intelligence in EUS for Diagnosing Pancreatic Solid Lesions

NCT ID: NCT05476978

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-01-24

Brief Summary

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We aim to develop an EUS-AI model which can facilitate clinical diagnosis by analyzing EUS pictures and clinical parameters of patients.

Detailed Description

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EUS is considered to be a more sensitive modality than CT in detecting pancreatic solid lesions due to its high spatial resolution. However, the diagnostic performance is largely dependent on the experience and the technical abilities of the practitioners. Therefore, we aim to develop an objective EUS diagnostic model based on the convolutional neural network, an artificial intelligence technique. In addition, clinical parameters such as risk factors, tumor biomarkers and radiology findings are also added to this artificial intelligence model in order to mimic the actual clinical diagnosis procedures and to increase the performance of this model.

Conditions

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Pancreatic Ductal Adenocarcinoma Pancreatitis, Chronic Pancreatic Neuroendocrine Tumor Autoimmune Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pancreas-EUS

Patients since 2014 with EUS pictures of normal pancreas or pancreatic solid lesions have been included in this cohort.

EUS-AI model

Intervention Type DIAGNOSTIC_TEST

The test subset (approximately 20% of total patients) is reserved for the final evaluation of the EUS-AI model. Clinical parameters and EUS pictures of each patient in the test subset will be inputed into the trained EUS-AI model, and the most possible diagnosis will be given by the model.

Interventions

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EUS-AI model

The test subset (approximately 20% of total patients) is reserved for the final evaluation of the EUS-AI model. Clinical parameters and EUS pictures of each patient in the test subset will be inputed into the trained EUS-AI model, and the most possible diagnosis will be given by the model.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent EUS using a curved line array echoendoscope (GF-UCT260; Olympus Medical Systems) since 2014 in our affiliation.
* For each patient, all available native EUS pictures are included.
* Patients' diagnosis are validated by surgical outcomes or fine-needle aspiration (FNA) findings and have a compatible clinical course with a follow-up period of more than 6 months.

Exclusion Criteria

* The image is of poor quality.
* The images contain unique marks which can potentially bias the model, such as the biopsy needle.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Bin Cheng

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

References

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Cui H, Zhao Y, Xiong S, Feng Y, Li P, Lv Y, Chen Q, Wang R, Xie P, Luo Z, Cheng S, Wang W, Li X, Xiong D, Cao X, Bai S, Yang A, Cheng B. Diagnosing Solid Lesions in the Pancreas With Multimodal Artificial Intelligence: A Randomized Crossover Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2422454. doi: 10.1001/jamanetworkopen.2024.22454.

Reference Type DERIVED
PMID: 39028670 (View on PubMed)

Other Identifiers

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EUS-AI 2022

Identifier Type: -

Identifier Source: org_study_id

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