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

NCT05979935 | Active Not Recruiting

• 1 other identifier: 20230726-QiluH
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Varices; Liver Cirrhosis; Sublingual Varices; Portal Hypertension

Keywords

Esophagogastroduodenal Varices; Liver cirrhosis; Sublingual vein; Portal hypertension

Outcome Measures

Primary Outcomes (1)

• AUC of tongue diagnostic model

  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.

  through study completion, up to 3 years

Secondary Outcomes (4)

• ROC of biochemical characteristic

  through study completion, up to 3 years

• Association between HVPG and sublingual vein

  through study completion, up to 3 years

• Characteristic of sublingual vein

  through studyy completion, up to 3 years

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

  through study completion, up to 3 years

Study Arms (2)

patients with high-risk of esophageal varices in liver cirrhosis

The maximum diameter of varices ≥ 5 mm or maximum diameter of varices \<5mm with positive red sign in patients with liver cirrhosis

Diagnostic Test: tongue diagnosis

patients with low-risk of esophageal varices in liver cirrhosis

the maximum diameter of esophageal varices \< 5 mm without positive red sign in patients with liver cirrhosis.

Diagnostic Test: tongue diagnosis

Interventions

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.

patients with high-risk of esophageal varices in liver cirrhosis; patients with low-risk of esophageal varices in liver cirrhosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects in this study are patients with liver cirrhosis from the Department of Gastroenterology, Qilu Hospital, Shandong University and other 15 hospitaals. According to the 《Prevention and Treatment Plan for Viral Hepatitis》 revised by the Infectious Diseases and Parasitic disease Branch and Hepatology Branch of the Chinese Medical Association in September 2000, Patients with liver cirrhosis and esophageal varices aged 18-75 years will be included in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Qilu Hospital of Shdong University

Jinan, Shandong, China

Location

Related Publications (6)

• 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. Cancer Imaging. 2019 Oct 16;19(1):66. doi: 10.1186/s40644-019-0254-0.

  PMID: 31619297 RESULT

• 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.

  PMID: 32844044 RESULT

• 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.

  PMID: 36085010 RESULT

• 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/s12072-021-10208-4. Epub 2021 Jun 11.

  PMID: 34115257 RESULT

• Gralnek IM, Camus Duboc M, Garcia-Pagan JC, Fuccio L, Karstensen JG, Hucl T, Jovanovic I, Awadie H, Hernandez-Gea V, Tantau M, Ebigbo A, Ibrahim M, Vlachogiannakos J, Burgmans MC, Rosasco R, Triantafyllou K. Endoscopic diagnosis and management of esophagogastric variceal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Nov;54(11):1094-1120. doi: 10.1055/a-1939-4887. Epub 2022 Sep 29.

  PMID: 36174643 RESULT

• de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.

  PMID: 35120736 RESULT

MeSH Terms

Conditions

Esophageal and Gastric Varices; Liver Cirrhosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yanjing Gao, PhD MD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 7, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)