NCT05476978

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2024

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

July 25, 2022

Last Update Submit

April 2, 2024

Conditions

Keywords

artificial intelligenceendoscopic ultrasound

Outcome Measures

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.

    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

    After the training process of the EUS-AI model is completed

Study Arms (1)

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

EUS-AI modelDIAGNOSTIC_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.

Pancreas-EUS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pancreatitis, ChronicAdenoma, Islet CellAutoimmune Pancreatitis

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 27, 2022

Study Start

July 1, 2022

Primary Completion

June 30, 2023

Study Completion

January 24, 2024

Last Updated

April 3, 2024

Record last verified: 2024-04

Locations