Prediction of Esophageal Varices in Liver Cirrhosis Using Tongue Bioinformatics

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05979935
Collaborator
Jinan Central Hospital (Other), Qianfoshan Hospital (Other)
200
1
7.1
28.3

Study Details

Study Description

Brief Summary

The goal of this observational study is to compare the tongue bioinformatics of high-risk and low-risk patients with esophageal varices due to liver cirrhosis.

The main question of this study is to explore whether there exists a relationship between the degree of esophageal varices and tongue bioinformatics in liver cirrhosis. it aims to answer 2 questions as below:

question 1: If these is a significant difference in tongue bioinformatics between patients in liver cirrhosis with high-risk and low-risk of esophageal varices.

Question 2; If tongue bioinformatics can be used as a diagnostic basic for testing esophageal varices in liver cirrhosis.

Firstly, participants will be divided into two groups according to their degree of esophageal varices from electronic gastroscopy report and CT scan report including high-risk group and low-risk group. Secondly, participants will be asked to show their tongue, including the surface and sublingual veins of tongue, and the tongue images of each participants will be collected by researchers via camera. After finishing tongue image collection, participants will receive a professional tongue diagnosis report in Traditional Chinese Medicine and health suggestion.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: tongue diagnosis

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Study on Predicting Esophageal Varices in Liver Cirrhosis Using Tongue Bioinformatics
Actual Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
patients with high-risk of esophageal varices in liver cirrhosis

The diameter of varices vein is over 0.5cm with red sign in patients with esophageal varices due to liver cirrhosis.

Diagnostic Test: tongue diagnosis
The tongue image of participants will be collected via camera and professional tongue diagnosis report will be provided to pariticipants.

patients with low-risk of esophageal varices in liver cirrhosis

The diameter of varices vein is below 0.5cm with negative red sign in patients with esophageal varices due to liver cirrhosis.

Diagnostic Test: tongue diagnosis
The tongue image of participants will be collected via camera and professional tongue diagnosis report will be provided to pariticipants.

Outcome Measures

Primary Outcome Measures

  1. Esophageal varices is diagnosed by electronic gastroscopy [6 months]

    Electronic gastroscopy is a standard method to diagnosis esophageal varices for patients with cirrhosis. Especially, the electronic gastroscopy can detect the degree of esophageal varices detallly, including the diameter and red sign of varices veins.

  2. Tongue images analysis by artificial intelligence [6 months]

    Tongue images of participants will be analyzed by using artificial intelligence technology. And the result will be used to test If tongue bioinformatics is related to the degree of esophageal varices in liver cirrhosis.

Secondary Outcome Measures

  1. Specific Characteristic in Tongue Bioinformatics [6 months]

    Artificial intelligence technology and statistic analysis will be used to study the specific difference in tongue bioinformatics between high-risk and low-risk group esophageal varices in patients with liver cirrhosis.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. Patients with liver cirrhosis has been diagnosed according to clinical manifestations, blood test and imaging examination.

  2. Patients with abdominal enhanced CT scans and upper gastrointestinal endoscopy,

  3. Patients who have signed informed consent forms.

Exclusion Criteria:
  1. Patient who has previously received endoscopic treatment, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, Hepatectomy, balloon occlusion of retrograde veins or liver transplantation.

  2. Severe ascites or Hepatic encephalopathy is painted.

  3. Patient with concurrent primary liver cancer;

  4. Concurrent severe infection of other systems;

  5. Symptoms of liver cirrhosis subside after antiviral treatment;

  6. Patient who is taking beta receptor blockers;

  7. Paitent with mental disorders;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qilu Hospital of Shdong University Jinan Shandong China

Sponsors and Collaborators

  • Qilu Hospital of Shandong University
  • Jinan Central Hospital
  • Qianfoshan Hospital

Investigators

  • Study Chair: Yanjing Gao, PhD MD, Qilu Hospital of Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT05979935
Other Study ID Numbers:
  • 20230726-QiluH
First Posted:
Aug 7, 2023
Last Update Posted:
Aug 11, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Qilu Hospital of Shandong University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2023