Connection Between Tongue Signs and Bile Reflux Analysed With Artificial Intelligence

June 20, 2022 updated by: Xiuli Zuo, Shandong University

Analysing the Link Between Tongue Signs and Bile Reflux by Artificial Intelligence

By introducing artificial intelligence into Chinese medicine tongue diagnosis, we collated and collected tongue images, anxiety and depression scales and gastroscopy reports, mined and analysed the correlation between tongue images and bile reflux and anxiety and depression and constructed a prediction model to analyse the possibility of predicting bile reflux and anxiety and depression in patients based on tongue images.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Firstly, after the patient signs the informed consent form, the researcher will collect pictures of the patient's tongue and obtain basic information about the patient.

Second, the patients are scored on the Anxiety and Depression Scale.

Thirdly, after the patient undergoes gastroscopy, the patient's gastroscopy report is obtained.

Finally, the patient's tongue image, information and gastroscopy report are matched to construct an artificial intelligence model of tongue image and bile reflux and anxiety and depression, and the quality of the model is assessed.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Shandong
  - Jinan, Shandong, China, 250012
    - Qilu hosipital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients aged 18-80 years who will undergo gastroscopy and who fulfil the inclusion criteria and do not fulfil the exclusion criteria.

Description

Inclusion Criteria:

Patients aged 18 to 80 years who wish to undergo gastroscopy.
Patients have given their informed consent and signed the informed consent form.

Exclusion Criteria:

Serious heart, liver, kidney or other underlying illness, or mental illness.
Patients taking anti-anxiety or depression medication within 3 months.
Current H. pylori infection.
History of surgery on the digestive or biliary tract.
Peptic ulcer, malignant tumour of the digestive tract, etc.
Patients taking bismuth or other staining medications.
Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Bile Reflux Group Gastroscopic reports of enrolled patients will be extracted and patients will be identified as having bile reflux according to Kellosalo J classification. Grade I: small amount of yellowish reflux emerging from the pyloric orifice and/or yellowish staining of the mucus lake, which is pale yellow in colour. Grade II: intermittent gush of reflux from the pyloric opening and/or yellowish staining of the mucus lake, which is dark yellow. Grade III: frequent gush of yellow-green reflux from the pyloric orifice and/or yellow-green mucus covering the stomach.
Non-biliary reflux group Gastroscopic reports will be extracted from patients enrolled in the group that do not meet the Kellosalo J classification as the non-biliary reflux group.

Group / Cohort

Bile Reflux Group

Gastroscopic reports of enrolled patients will be extracted and patients will be identified as having bile reflux according to Kellosalo J classification.

Grade I: small amount of yellowish reflux emerging from the pyloric orifice and/or yellowish staining of the mucus lake, which is pale yellow in colour.

Grade II: intermittent gush of reflux from the pyloric opening and/or yellowish staining of the mucus lake, which is dark yellow.

Grade III: frequent gush of yellow-green reflux from the pyloric orifice and/or yellow-green mucus covering the stomach.

Non-biliary reflux group

Gastroscopic reports will be extracted from patients enrolled in the group that do not meet the Kellosalo J classification as the non-biliary reflux group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity Time Frame: 3 years	Sensitivity of artificial intelligence models Sensitivity = number of true positives / (number of true positives + number of false negatives) * 100%.	3 years
Specificity Time Frame: 3 years	Specificity of Artificial Intelligence Models Specificity = number of true negatives / (number of true negatives + number of false positives)) *100%	3 years
Positive predictive values(PPV) Time Frame: 3 years	Positive predictive values from artificial intelligence models Positive predictive value = true positive / (true positive + false positive) *100%	3 years
Negative predictive values (NPV) Time Frame: 3 years	Negative predictive values for artificial intelligence models Negative Predictive Value = True Negative / (True Negative + False Negative) *100%	3 years
AUC (95% CI) Time Frame: 3 years	area under the receiver operating characteristic curve (AUC),	3 years
Accuracy Time Frame: 3 years	Accuracy for artificial intelligence models Accuracy = (true positives + true negatives) / total number of subjects * 100%	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 30, 2022

Primary Completion (ANTICIPATED)

June 30, 2024

Study Completion (ANTICIPATED)

June 30, 2025

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria