NCT05421520

Brief Summary

In the early stage, the investigators successfully constructed an artificial intelligence model-based ultrasonic endoscopy-assisted film reading system and named the modified system biliopancreatic Master. The system can realize real-time ultrasonic station recognition and anatomical mark recognition and provide doctors with corresponding operation techniques. This study aimed to verify the feasibility and effectiveness of the biliopancreatic master system developed by our project team in shortening the training period of ultrasound endoscopists through a single-center clinical study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 21, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 8, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

August 24, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

May 21, 2022

Last Update Submit

August 22, 2023

Conditions

Endoscopic Ultrasound

Keywords

Ultrasound EndoscopyArtificial intelligenceLearning curve

Outcome Measures

Primary Outcomes (1)

  • Learning cycle for ultrasound endoscopists

    The number of guided examinations required by the trainees to achieve the level of stable independent operation of ultrasonic endoscopy

    No more than 1 year

Secondary Outcomes (1)

  • Duration of operation by ultrasound endoscopists

    No more than 1 year

Study Arms (2)

A novice with ai-assisted assistance

EXPERIMENTAL

When patients are randomly assigned to the experimental group, the visiting physician will perform endoscopic ultrasound with the assistance of the ai-assisted system

Device: Artificial intelligence assisted system

A novice without ai-assisted assistance

NO INTERVENTION

When the patients were randomly assigned to the control group, the visiting physician would not perform endoscopic ultrasonography with the assistance of the AI-assisted system

Interventions

Artificial intelligence assisted systemDEVICE

A deep learning-based bile duct scanning system that can prompt endoscopists to scan standard stations, identify bile ducts and stones in real time

A novice with ai-assisted assistance

Eligibility Criteria

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

You may qualify if:

  • Endoscopists with experience in performing more than 300 gastroscopies; Lack of experience in independently operating an endoscopic ultrasound (EUS); No experience in EUS-guided fine-needle aspiration biopsy (FNA).
  • Patient:
  • Patient age ≥18 years; Patients who consecutively undergo sedated EUS procedures; Ability to read, understand, and sign the informed consent; Patients suspected of having biliary (both pancreatic and biliary) lesions based on clinical symptoms and/or radiological findings and/or laboratory test results; High-risk patients for pancreatic cancer: known genetic mutations associated with the risk of pancreatic cancer (BRCA2, BRCA1, PALB2, ATM, CDKNA/p16); familial pancreatic ductal adenocarcinoma with no known lineage mutations; Peutz-Jeghers syndrome (STK11); Lynch syndrome (MLH1/MSH2/MSH6, EPCAM, PMS2); familial adenomatous polyposis (APC) etc. Based on the preoperative cholangiopancreatography report, patients are classified into those with or without radiological findings. Patients with radiological findings are categorized by lesion location, such as the pancreas, PD, CBD, and other lesions (like gallbladder, duodenal papilla suspected of biliary invasion).

You may not qualify if:

  • Patients with absolute contraindications to EUS examination; Previous gastric surgery; Pregnancy; Severe internal medical diseases; History of allergy to anesthesia drugs; Esophageal narrowing or obstruction; Upper gastrointestinal anatomical abnormalities caused by advanced tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Eighth Affiliated Hospital, Sun Yat-sen University

Shenzhen, Guangdong, 518066, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Study Officials

  • Yu Honggang, Doctor

    Renmin Hospital of Wuhan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Honggang, Doctor

CONTACT

13871281899yuhonggang@whu.edu.cn

: Yu Honggang, Doctor

CONTACT

: 13871281899yuhonggang@whu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Experimental: novices with AI-assisted system Control：without AI-assisted system
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2022

First Posted

June 16, 2022

Study Start

October 8, 2023

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

August 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)