Helicobacter pylori infection
Conditions
Interventions
Gold Standard:Both mucosal biopsy histopathology and rapid urease tests are positive
Sponsors
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Plan to perform CLE examination; 2. Hp infection-related symptoms or diseases; 3. 13C/14C urea breath test has been completed in the last 3 months; 4. At least 18 years old; 5. Agree to participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have received HP-related treatment or used antibiotics in the last 3 months; 2. Known history of allergy to luciferin sodium or severe drug allergy; 3. Have coagulation dysfunction or are using anticoagulant drugs; 4. Acute gastrointestinal bleeding, other malignant tumors and serious systemic diseases; 5. Pregnant and lactating women; 6. Unable to complete the study due to mental illness or other reasons; 7. The researchers considered other factors unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic efficacy of pCLE qualitative diagnostic criteria for Hp infection (sensitivity, specificity, positive predictive value, negative predictive value, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection rate of Hp infection in UBT negative subjects in pCLE real-time qualitative diagnosis and targeted biopsy under pCLE;Difference in detection rate between targeted biopsy under pCLE and conventional biopsy under white light endoscope in UBT negative subjects; | — |
Countries
China
Contacts
Public ContactJie Chen
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Outcome results
None listed