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NCT05979935

A Digital Tongue Diagnosis Model for High- and Low-risk Esophagogastroduodenal Varices in Cirrhosis

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

Summary

The aim of this observational study is to establish an AI deep learning model that can dianosie high-risk varices for patients with cirrhosis effeciently. The main question of this study is to esplore: question 1: Developing a digital tongue diagnosis model, specifically a deep learning model to diagnose high-risk esophageal and gastric varices (HRV) associated with cirrhosis using sublingual vein images. Answering the question of whether the new tongue diagnosis method can accurately diagnose. Question 2: Compare the diagnostic efficacy digital tongue diagnosis model with diagnostic models constructed using other biochemical indicators for HRV in cirrhosis, and answer the question of "how to use it optimally." Question 3: Exploring the correlation between sublingual vein characteristics and Hepatic venous pressure gradient (HVPG). Question 4: Compared with endoscopic examination results, validate the diagnostic performance of the model (AUC ≥ 0.90) and screen for key parameters of sublingual vein characteristics (such as sublingual vein varicosity diameter, vein length, color, etc.). Question 5: Follow-up tongue examination images of patients with cirrhosis who underwent treatment (e.g., endoscopy, splenic embolization, TIPS, etc.) at 1, 2, and 3 years post-treatment were evaluated to assess the efficacy of digital tongue examination models in predicting high-risk esophageal and gastric variceal bleeding at 1, 2, and 3 years post-treatment, as well as the efficacy in predicting endoscopic treatment failure rates and patient mortality associated with bleeding.

Official title: A Clinical Study on the Diagnostic Value of Digital Tongue Diagnosis Model for High- and Low-risk Esophagogastroduodenal Varices in Patients With Liver Cirrhosis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

1300

Start Date

2023-07-01

Completion Date

2029-12-31

Last Updated

2025-08-15

Healthy Volunteers

Conditions

Esophageal Varices Liver Cirrhosis Sublingual Varices Portal Hypertension

Interventions

DIAGNOSTIC_TEST

tongue diagnosis

The tongue image of participants will be collected via camera, and tongue images will be used for AI deep model learning analysis.

Inclusion Criteria: 1. Age 18-75 years (including both age limits), no gender restrictions; 2. Diagnosed with cirrhosis based on clinical presentation, laboratory tests, imaging studies, and/or histopathological examination; 3. Undergone upper gastrointestinal endoscopy within the past 3 months prior to enrollment and have complete endoscopic imaging records; 4. Undergone enhanced CT or MRI scan of the upper abdomen within the past month prior to enrollment; 5. Patients who consent to enrollment and have signed an informed consent form. Exclusion Criteria: 1. Patients who have previously undergone endoscopic treatment for esophageal or gastric varices, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, hepatectomy, balloon occlusion of the portal vein, or liver transplantation; 2. Patients with grade 2-3 ascites or overt hepatic encephalopathy; 3. Patients with a history of portal venous system thrombosis (including the portal vein, splenic vein, superior mesenteric vein, etc.) or portal venous cavernous transformation, and who have been diagnosed with thrombosis within the past two weeks; 4. Patients diagnosed with or suspected of having primary liver cancer or other advanced malignant tumors; 5. Patients with chronic obstructive pulmonary disease and right heart failure; 6. Male and female patients with moderate anemia (hemoglobin \<70 g/L); 7. Patients with poorly controlled diabetes or microvascular complications; 8. Patients with poorly controlled hypertension; 9. Patients with hematological disorders such as polycythemia vera; 10. Patients with local oral lesions affecting sublingual venous blood flow, such as Ludwig's angina, Lemierre syndrome, or complications following certain oral surgeries (e.g., scar contracture or hematoma after tongue or floor of mouth surgery); 11. Patients with sublingual venous varicosities; 12. Patients who have experienced other severe systemic infections within the past 2 weeks prior to enrollment; 13. Pregnant women and peripartum women; 14. Patients with mental disorders; 15. Patients with incomplete medical records; 16. Patients unable to cooperate in completing the clinical study; 17. Other reasons deemed unsuitable for participation by the investigator.

Locations (1)

Qilu Hospital of Shdong University

Jinan, Shandong, China