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CompletedNCT05476978Updated Apr 3, 2024

Artificial Intelligence in EUS for Diagnosing Pancreatic Solid Lesions

An observational study in Pancreatic Ductal Adenocarcinoma, Pancreatitis, Chronic and Pancreatic Neuroendocrine Tumor, sponsored by Huazhong University of Science and Technology. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by Huazhong University of Science and Technology · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Pancreatic Ductal Adenocarcinoma
  • Pancreatitis, Chronic
  • Pancreatic Neuroendocrine Tumor
  • Autoimmune Pancreatitis

Keywords

  • artificial intelligence
  • endoscopic ultrasound
03

In context

Neuroendocrine Tumors

676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.

This study's enrollment of 130 is above the median of 115 across 176 observational studies indexed under Neuroendocrine Tumors.

Browse Neuroendocrine Tumors studies →

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 242 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The cohort will be selected from Tongji Hospital, Tongji Medical College, HUST.

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

Exclusion Criteria:

  • The image is of poor quality.
  • The images contain unique marks which can potentially bias the model, such as the biopsy needle.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (actual)
Patient registry
No

Groups and cohorts

  • Pancreas-EUS

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

    Diagnostic Test: EUS-AI model

Interventions

  • Diagnostic testEUS-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.

06

What researchers measure

Primary outcomes

  1. The model's ability to differentiate pancreatic cancer from other pancreatic solid lesion

    Receiver operating characteristic (ROC) analyses, sensitivity, specificity, accuracy, positive predictive value and negative predictive value will be used to evaluate the efficacy of the model.

    Time frame: After the training process of the EUS-AI model is completed

Secondary outcomes

  1. The model's ability to specify the pancreatic solid lesions such as pancreatic cancer, CP, AIP and NET

    Receiver operating characteristic (ROC) analyses, sensitivity, specificity, accuracy, positive predictive value and negative predictive value will be used to evaluate the efficacy of the model.

    Time frame: After the training process of the EUS-AI model is completed

07

Study locations

1 site
  • Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430030, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05476978
Lead sponsor
Huazhong University of Science and Technology
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, LanZhou University
Responsible party
Bin Cheng (professor, Huazhong University of Science and Technology) — Principal investigator
First posted
Jul 27, 2022
Start date
Jul 1, 2022
Primary completion
Jun 30, 2023
Completion
Jan 24, 2024
Last update
Apr 3, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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