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Connection Between Tongue Signs and Bile Reflux Analysed With Artificial Intelligence

S

Shandong University

Status

Not yet enrolling

Conditions

Artificial Intelligence
Bile Reflux
Tongue

Study type

Observational

Funder types

Other

Identifiers

NCT05369572
2022SDU-QILU-G002

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

1,500 participants in 2 patient groups

Bile Reflux Group
Description:
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
Description:
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.

Trial contacts and locations

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Central trial contact

Xiuli Zuo, MD, PhD

Data sourced from clinicaltrials.gov

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