Connection Between Tongue Signs and Bile Reflux Analysed With Artificial Intelligence

NCT ID: NCT05369572

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2025-06-30

Brief Summary

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.

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.

Conditions

Artificial Intelligence; Tongue; Bile Reflux

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Xiuli Zuo

doctoral supervisor of Qilu Hospital gastroenterology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiuli Zuo, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Qilu hosipital

Jinan, Shandong, China

Countries

China

Central Contacts

Xiuli Zuo, MD, PhD

Role: CONTACT

zuoxiuli@sdu.edu.cn

86 15588818685 ext. 0531-88369277

Other Identifiers

2022SDU-QILU-G002

Identifier Type: -

Identifier Source: org_study_id