A Digital Tongue Diagnosis Model for High- and Low-risk Esophagogastroduodenal Varices in Cirrhosis (NCT05979935) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
A Digital Tongue Diagnosis Model for High- and Low-risk Esophagogastroduodenal Varices in Cirrhosis
China1,300 participantsStarted 2023-07-01
Plain-language 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 ā„ 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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Age 18-75 years (including both age limits), no gender restrictions;
ā. Diagnosed with cirrhosis based on clinical presentation, laboratory tests, imaging studies, and/or histopathological examination;
ā. Undergone upper gastrointestinal endoscopy within the past 3 months prior to enrollment and have complete endoscopic imaging records;
ā. Undergone enhanced CT or MRI scan of the upper abdomen within the past month prior to enrollment;
ā. Patients who consent to enrollment and have signed an informed consent form.
Exclusion criteria
ā. 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;
ā. Patients with grade 2-3 ascites or overt hepatic encephalopathy;
ā. 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;
What they're measuring
1
AUC of tongue diagnostic model
Timeframe: through study completion, up to 3 years