NCT04719117

Brief Summary

In this study, the investigators proposed a prospective study about the effectiveness of artificial intelligence system for Retrograde cholangiopancreatography. The subjects would be include in an analyses groups. The AI-assisted system helps endoscopic physicians estimate the difficulty of Endoscopic retrograde cholangiopancreatography for choledocholithiasis and make recommendations based on guidelines and difficulty scores. The investigators used the stone removal times, success rate of stone extraction and Operating time to reflect the difficulty of the operation, and evaluated whether the results of the AI system were correct.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

3 active sites

Status
unknown

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

September 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

January 15, 2021

Last Update Submit

January 20, 2021

Conditions

Gastrointestinal DiseaseEndoscopyArtificial IntelligenceCholangiopancreatography, Endoscopic Retrograde

Keywords

Deep Learning

Outcome Measures

Primary Outcomes (1)

  • Number of stone removal operations

    The number of times that the stoning balloon and the stoning net were pulled out of the lumen during the stoning process.

    A year

Secondary Outcomes (5)

  • the accuracy of the measurement

    A year

  • Stone clearance success rate

    A year

  • the sensitivity of the prediction of the stone

    A year

  • the operate time

    During surgery

  • the removal stone time

    During surgery

Eligibility Criteria

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

Patients who meet the admission criteria for endoscopic examination.

You may qualify if:

  • Who needs ERCP and its related tests are needed to further define the characteristics of digestive tract diseases
  • Able to read, understand and sign informed consent
  • The investigator believes that the subject can understand the process of the clinical study, is willing and able to complete all the study procedures and follow-up visits, and cooperate with the study procedures
  • Patients with a natural duodenal papilla

You may not qualify if:

  • Has participated in other clinical trials, signed informed consent and is in the follow-up period of other clinical trials
  • Has drug or alcohol abuse or mental disorder in the last 5 years
  • Women who are pregnant or lactating
  • Subjects with previous biliary sphincterotomy
  • The investigator determined that subjects were not suitable for ERCP and related tests
  • A high-risk disease or other special condition that the investigator considers inappropriate for the subject to participate in a clinical trial
  • Patients with known more severe pancreatic head carcinoma
  • Patients with acute pancreatitis within 3 days
  • Biliary stent replacement or removal did not occur after pancreatic angiography as expected
  • Acute cardiovascular and cerebrovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Renmin hospital

Wuhan, Hubei, 430000, China

Location

People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

  • Huang L, Xu Y, Chen J, Liu F, Wu D, Zhou W, Wu L, Pang T, Huang X, Zhang K, Yu H. An artificial intelligence difficulty scoring system for stone removal during ERCP: a prospective validation. Endoscopy. 2023 Jan;55(1):4-11. doi: 10.1055/a-1850-6717. Epub 2022 May 12.

    PMID: 35554877DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Honggang Yu, Doctor

    Wuhan University Renmin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 22, 2021

Study Start

September 1, 2020

Primary Completion

July 1, 2021

Study Completion

December 31, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

CN(3)