NCT05792267

Brief Summary

The goal of this clinical trial is to develop and verify the auxiliary role of the artificial intelligence system in pancreatic ultrasound endoscopic scanning.The main questions it aims to answer are as follows: 1.The comparison of the image recognition accuracy between the artificial intelligence system and the ultrasound endoscopist; 2. Whether the artificial intelligence system can improve the efficiency of the pancreatic scanning for the ultrasound endoscopist. Participants will undergo pancreatic EUS with or without the assistance of the artificial intelligence system.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 12, 2025

Status Verified

November 1, 2024

Enrollment Period

3.5 years

First QC Date

March 17, 2023

Last Update Submit

February 7, 2025

Conditions

Pancreatic Disease

Outcome Measures

Primary Outcomes (2)

  • Accuracy

    The number of correctly classified images divided by the total number of images.

    2 year

  • The completeness for standard station scanning

    This was calculated as the number of stations successfully scanned divided by the total number of stations that should have been scanned.

    2 year

Secondary Outcomes (4)

  • Cohen's kappa coefficient.

    2 year

  • The completeness of anatomical landmarks

    2 year

  • The completeness for standard stations and anatomical landmarks per individual

    2 year

  • Operation time

    2 year

Study Arms (2)

AI-assisted group

EXPERIMENTAL

Subjects will undergo EUS examination with the assistance of artificial intelligence(AI) system.

Device: artificial intelligence system

Non-assisted group

NO INTERVENTION

Subjects will undergo EUS examination without the assistance of artificial intelligence(AI) system.

Interventions

artificial intelligence systemDEVICE

Patients will undergo EUS examination with the assistance of artificial intelligence(AI) system.

AI-assisted group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age ≥18 years old, \<80 years old 2.Patients who need endoscopic ultrasonography of pancreas; 3. Agree to participate in this study and sign the informed consent form.

You may not qualify if:

  • Subjects who meet any of the following criteria cannot be selected for this trial:
  • First. The patient's physical condition does not meet the requirements of conventional endoscopic ultrasonography:
  • Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc.
  • Anesthesia assessment failed
  • Pregnancy or breastfeeding
  • In the acute stage of chemical and corrosive injury, it is very easy to cause perforation
  • Recent acute coronary syndrome or clinically unstable ischemic heart attack
  • Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure\> 90mmHg),patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome.
  • Second. Disagree to participate in this study.
  • Third. There are other problems that do not meet the requirements of this research or that affect the results of the research:
  • Pancreatic disease has undergone surgery or radiotherapy and chemotherapy beforehand;
  • Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Xiaoyan Wang, Doctor

    The Third Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Wang, Doctor

CONTACT

+8613974889301wxy20011@163.com

Shiqin Huang, MD

CONTACT

+8618308312098sqhuang0213@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 31, 2023

Study Start

January 1, 2021

Primary Completion

June 30, 2024

Study Completion

June 30, 2025

Last Updated

February 12, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.

Locations

CN(1)