Connection Between Tongue Signs and Bile Reflux Analysed With Artificial Intelligence

NCT05369572 | Unknown DMC

• 1 other identifier: 2022SDU-QILU-G002
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Artificial Intelligence; Tongue; Bile Reflux

Keywords

artificial intelligence; tongue; bile reflux

Outcome Measures

Primary Outcomes (6)

• Sensitivity

  Sensitivity of artificial intelligence models Sensitivity = number of true positives / (number of true positives + number of false negatives) \* 100%.

  3 years

• Specificity

  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)

  Positive predictive values from artificial intelligence models Positive predictive value = true positive / (true positive + false positive) \*100%

  3 years

• Negative predictive values (NPV)

  Negative predictive values for artificial intelligence models Negative Predictive Value = True Negative / (True Negative + False Negative) \*100%

  3 years

• AUC (95% CI)

  area under the receiver operating characteristic curve (AUC),

  3 years

• Accuracy

  Accuracy for artificial intelligence models Accuracy = (true positives + true negatives) / total number of subjects \* 100%

  3 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hosipital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Bile Reflux

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Duodenogastric Reflux; Stomach Diseases; Gastrointestinal Diseases

Study Officials

• Xiuli Zuo, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD, PhD

CONTACT

86 15588818685; zuoxiuli@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctoral supervisor of Qilu Hospital gastroenterology department

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 11, 2022
• Study Start: June 30, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

CN (1)