NCT05979935Active, not recruiting
A Digital Tongue Diagnosis Model for High- and Low-risk Esophagogastroduodenal Varices in Cirrhosis
A Clinical Study on the Diagnostic Value of Digital Tongue Diagnosis Model for High- and Low-risk Esophagogastroduodenal Varices in Patients With Liver Cirrhosis
Source: ClinicalTrials.gov · Last updated 15 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1300 (estimated)
- First submitted
- 30 Jul 2023
- Start date
- 1 Jul 2023
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- High blood pressure
- NCT number
- NCT05979935
What you commit to
- Study type: Observational
- Planned participants: 1300
- From 1 Jul 2023 to the primary completion date, 31 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 who have experienced other severe systemic infections within the past 2 weeks prior to enrollment;
Other illness
- 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;
- 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 mental disorders;
Lab values
- Male and female patients with moderate anemia (hemoglobin \<70 g/L);
Other
- Patients with grade 2-3 ascites or overt hepatic encephalopathy;
- Patients with sublingual venous varicosities;
- Pregnant women and peripartum women;
- Patients with incomplete medical records;
- Patients unable to cooperate in completing the clinical study;
- Other reasons deemed unsuitable for participation by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shdong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.