Gastrointestinal Tumors
Conditions
Interventions
Experimental group: Confocal endoscopy combined with fluorescent molecular probe examination:Subjects in the experimental group underwent confocal endoscopy combined with fluorescent molecular probe e
Control group: Conventional white light endoscopy examination:Subjects in the control group underwent conventional white-light endoscopy. Under white-light mode, subtle changes in the color, morpholog
Sponsors
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. High-risk populations include: (1) Gastric cancer high-risk population: Age >=45 years, and meeting any of the following criteria: 1) Residing in a high-incidence area of gastric cancer (defined at the county-level administrative unit, with age-standardized incidence rate >20/100,000 using the 2000 Chinese population structure as standard); 2) Having a family history of gastric cancer among first-degree relatives (parents, children, and siblings); 3) Positive result from any of the following: urea breath test, serum *Helicobacter pylori* (Hp) antibody, or stool Hp antigen test; 4) Having unhealthy lifestyle and dietary habits such as smoking, heavy drinking, high-salt diet, and preserved foods; 5) Having chronic atrophic gastritis, gastric ulcer, gastric polyps, remnant stomach after surgery, hypertrophic gastritis, pernicious anemia, or other such diseases. (2) Colorectal cancer high-risk population: 1) Sporadic colorectal cancer high-risk population: Based on age, sex, family history of colorectal cancer in first-degree relatives, smoking, and body mass index (BMI), a risk score for sporadic colorectal cancer is calculated as follows: - Age: =60 years (2 points); - Sex: female (0 points), male (1 point); - Smoking history: no (0 points), yes (1 point); - BMI: =23 kg/m^2 (1 point); - First-degree relatives (parents, children, and siblings) diagnosed with colorectal cancer: none (0 points), yes (1 point; if one first-degree relative was diagnosed at age =4 points are identified as high-risk. 2) Hereditary colorectal cancer high-risk population: Individuals with Lynch syndrome or familial adenomatous polyposis, etc. 2. Good compliance, able to cooperate with the entire clinical trial (routine endoscopy, imaging, and laboratory examinations) and subsequent follow-up; 3. Able to understand and accept the study protocol, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Not suitable for undergoing endoscopy, including coagulation disorders, renal insufficiency, severe cardiopulmonary diseases, or allergy to fluorescein sodium; 2.Severe infections (e.g., severe hepatitis, tuberculosis, pneumonia, urinary tract infection, etc.) or other life-threatening diseases; 3.Pregnant or breastfeeding women; 4.History of previous gastrointestinal surgery, active gastrointestinal bleeding, or acute phase of inflammatory bowel disease; 5.Concurrent participation in another clinical trial of a drug or device; 6.Inability to assume legal responsibility, or any medical or ethical reasons that would affect the continuation of the study; 7.Any other conditions deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lesion detection rate;Diagnostic sensitivity;Diagnostic specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year survival rate;Tumor recurrence rate; | — |
Countries
China
Contacts
Public ContactRong Lin
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed