Prediction of Esophageal Varices in Liver Cirrhosis Using Tongue Bioinformatics

Esophageal and Gastric Varices Clinical Trial

Official title:

A Study on Predicting Esophageal Varices in Liver Cirrhosis Using Tongue Bioinformatics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05979935
• Other study ID #: 20230726-QiluH
• Status: Active, not recruiting
• Start date: July 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: July 2023
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: April 2024
• Est. primary completion date: December 29, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patient with liver cirrhosis has been diagnosed according to clinical manifestations, blood test and imaging examination.

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

3. Patient who has 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. Patient with severe ascites or Hepatic encephalopathy is painted.

3. Patient with concurrent primary liver cancer;

4. Patient with concurrent severe infection of other systems;

5. Patient with symptoms of liver cirrhosis subside after antiviral treatment;

6. Patient who is taking beta receptor blockers;

7. Paitent with mental disorders;

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Liver Cirrhosis
• Varicose Veins

Intervention

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

Locations

Country	Name	City	State
China	Qilu Hospital of Shdong University	Jinan	Shandong

Sponsors (5)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	960th Hospital of PLA, Jinan Central Hospital, Qianfoshan Hospital, Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

He C, Liao Q, Fu P, Li J, Zhao X, Zhang Q, Gui Q. Microbiological characteristics of different tongue coatings in adults. BMC Microbiol. 2022 Sep 9;22(1):214. doi: 10.1186/s12866-022-02626-7. — View Citation

Lin Y, Li L, Yu D, Liu Z, Zhang S, Wang Q, Li Y, Cheng B, Qiao J, Gao Y. A novel radiomics-platelet nomogram for the prediction of gastroesophageal varices needing treatment in cirrhotic patients. Hepatol Int. 2021 Aug;15(4):995-1005. doi: 10.1007/s12072- — View Citation

Ou J, Li R, Zeng R, Wu CQ, Chen Y, Chen TW, Zhang XM, Wu L, Jiang Y, Yang JQ, Cao JM, Tang S, Tang MJ, Hu J. CT radiomic features for predicting resectability of oesophageal squamous cell carcinoma as given by feature analysis: a case control study. Cance — View Citation

Tandon M, Singh H, Singla N, Jain P, Pandey CK. Tongue thickness in health vs cirrhosis of the liver: Prospective observational study. World J Gastrointest Pharmacol Ther. 2020 Aug 8;11(3):59-68. doi: 10.4292/wjgpt.v11.i3.59. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal varices is diagnosed by electronic gastroscopy	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.	6 months
Primary	Tongue images analysis by artificial intelligence	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.	6 months
Secondary	Specific Characteristic in Tongue Bioinformatics	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.	6 months