Status:
ACTIVE_NOT_RECRUITING
A Digital Tongue Diagnosis Model for High- and Low-risk Esophagogastroduodenal Varices in Cirrhosis
Lead Sponsor:
Qilu Hospital of Shandong University
Collaborating Sponsors:
Shanghai Changzheng Hospital
Shanghai East Hospital of Tongji University
Conditions:
Esophageal Varices
Liver Cirrhosis
Eligibility:
All Genders
18-75 years
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 esplor...
Detailed Description
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 va...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT05979935
Start Date
July 1 2023
End Date
December 31 2029
Last Update
August 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Qilu Hospital of Shdong University
Jinan, Shandong, China