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NCT Number: NCT05979935

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Esophageal Varices Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Fibrosis Gastrointestinal Diseases Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension Sublingual Varices

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shdong University

Jinan, Shandong, China

About this study

Firstly, participants will be divided into two groups according to their degree of esophageal varices from endoscopic examination and CT report, including high-risk varices (HRV) group and low-risk varices (LRV) 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. Finally, tongue images will be analyzed by AI deep learning model and some specifialized information will be estracted exactly. Besides, 60 patietns will be selected to eplore whtether sublingual vein characteristics is assoicated with HVPG. Finally, patietns will be followed up during 3 years, and gastric variceal bleeding, endoscopic treatment failure rates, and patient mortality risks related to bleeding will be analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years (including both age limits), no gender restrictions;
  • Diagnosed with cirrhosis based on clinical presentation, laboratory tests, imaging studies, and/or histopathological examination;
  • Undergone upper gastrointestinal endoscopy within the past 3 months prior to enrollment and have complete endoscopic imaging records;
  • Undergone enhanced CT or MRI scan of the upper abdomen within the past month prior to enrollment;
  • Patients who consent to enrollment and have signed an informed consent form.

Exclusion criteria

  • 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;
  • Patients with grade 2-3 ascites or overt hepatic encephalopathy;
  • 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;
  • Patients diagnosed with or suspected of having primary liver cancer or other advanced malignant tumors;
  • Patients with chronic obstructive pulmonary disease and right heart failure;
  • Male and female patients with moderate anemia (hemoglobin <70 g/L);
  • Patients with poorly controlled diabetes or microvascular complications;
  • Patients with poorly controlled hypertension;
  • Patients with hematological disorders such as polycythemia vera;
  • 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);
  • Patients with sublingual venous varicosities;
  • Patients who have experienced other severe systemic infections within the past 2 weeks prior to enrollment;
  • Pregnant women and peripartum women;
  • Patients with mental disorders;
  • Patients with incomplete medical records;
  • Patients unable to cooperate in completing the clinical study;
  • Other reasons deemed unsuitable for participation by the investigator.

Treatment and study plan

tongue diagnosis

Diagnostic Test

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

Primary outcomes

  1. AUC of tongue diagnostic model

    Time frame: through study completion, up to 3 years

    Using endoscopic diagnostic criteria as the "gold standard," we calculated the area under the ROC curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value of the VIT-based digital tongue diagnosis model to evaluate its diagnostic performance in diagnosing HRV in cirrhosis.

Secondary outcomes

  1. ROC of biochemical characteristic

    Time frame: through study completion, up to 3 years

    Calculate the AUC valthe digital tongue diagnosis model.ue, sensitivity, specificity, positive predictive value, negative predictive value, and other relevant parameters of the ROC curve for the HRV diagnostic model for cirrhosis constructed based on biochemical indicators, and compare them with

  2. Association between HVPG and sublingual vein

    Time frame: through study completion, up to 3 years

    The association between sublingual vein and HVPG

  3. Characteristic of sublingual vein

    Time frame: through studyy completion, up to 3 years

    Key parameters for screening sublingual vein characteristics (such as sublingual vein varicosity diameter, vein length, color, etc.).

  4. The rate of esophageal variceal bleeding, endoscopic treatment failure, and patient mortality

    Time frame: through study completion, up to 3 years

    The incidence of esophageal variceal bleeding, endoscopic treatment failure rate, and patient mortality related to bleeding in patients with cirrhosis 1, 2, and 3 years after diagnosis.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
  • Army Medical Center of PLA
  • Eighth Affiliated Hospital, Sun Yat-sen University
  • Jinan Central Hospital
  • Jining First People's Hospital
  • Liaocheng People's Hospital
  • Meng Chao Hepatobiliary Hospital of Fujian Medical University
  • Qianfoshan Hospital
  • Shandong Provincial Hospital
  • Shandong Public Health Clinical Center
  • Shanghai Changzheng Hospital
  • Shanghai East Hospital of Tongji University
  • The Second Affiliated Hospital of Shandong First Medical University
  • Tianjin Medical University General Hospital
  • Weifang People's Hospital

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Aug 7, 2023
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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