Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID05792267

Clinical Research on Navigation and Quality Control System of Pancreatic Ultrasound Endoscopy Based on Deep Learning

Led by The Third Xiangya Hospital of Central South University · Updated on 2025-02-12

200

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a deep learning-based artificial intelligence (AI) system designed to assist in pancreatic endoscopic ultrasound (EUS) scanning. The study aims to compare the image recognition accuracy of this AI system with that of ultrasound endoscopists and to determine whether the AI system can improve the efficiency of pancreatic scanning. The investigation focuses on the navigation and quality control roles of AI during pancreatic ultrasound endoscopy. Participants will undergo pancreatic EUS examinations either with or without the support of the AI system. The study will collect videos and images from these procedures to establish the AI system's ability to identify pancreatic ultrasound sites and anatomical structures. The AI system's recognition results will be compared to those of experienced endoscopists. Additionally, the study will compare the completeness of standard scanning sites and the scanning duration between AI-assisted and non-assisted procedures. During the trial, participants will have pancreatic EUS performed, and researchers will assess the accuracy of image recognition and the completeness of standard station scanning over a two-year period. Secondary measures include agreement between AI and endoscopist assessments, completeness of anatomical landmarks, and operation time. The study involves randomized allocation into AI-assisted or non-assisted groups, with double masking to reduce bias. Participant involvement includes signing informed consent and undergoing the scheduled procedures and assessments until the study concludes.

CONDITIONS

Brief Title

Clinical Research on a Novel Deep-learning Based System in Pancreatic Endoscopic Ultrasound Scanning

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, but younger than 80 years
  • Patients who require endoscopic ultrasonography of the pancreas
  • Agree to participate and sign the informed consent form
Not Eligible

You will not qualify if you...

  • Poor physical condition such as hemoglobin less than or equal to 8.0 g/dl or severe cardiopulmonary insufficiency
  • Failed anesthesia assessment
  • Pregnancy or breastfeeding
  • Acute stage of chemical and corrosive injury with risk of perforation
  • Recent acute coronary syndrome or unstable ischemic heart attack
  • Heart disease with right-to-left shunt, severe pulmonary hypertension (pulmonary artery pressure over 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome
  • Refusal to participate in the study
  • Previous pancreatic surgery, radiotherapy, or chemotherapy
  • Mental illness, drug addiction, inability to express oneself, or other conditions that may affect follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Single procedure session

Participants undergo pancreatic endoscopic ultrasound scanning either with or without the assistance of an artificial intelligence system.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored for outcomes such as accuracy, completeness of scanning, and operation time over a period of up to 2 years.

Follow-up visits as scheduled during the 2-year period

Trial Site Locations

Total: 1 location

1

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410013

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Research Team

X

Xiaoyan Wang, Doctor

S

Shiqin Huang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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