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Application and clinical evaluation of super-resolution imaging combined with 4K imaging in the diagnosis of early esophageal cancer and precancerous lesions

Application and clinical evaluation of super-resolution imaging combined with 4K imaging in the diagnosis of early esophageal cancer and precancerous lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129135
Enrollment
Unknown
Registered
2026-07-31
Start date
2026-08-07
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early esophageal cancer and precancerous lesions

Interventions

Gold Standard:Taking the pathological test results as the gold standard
Index test:Experimental group (domestic endoscope group): Utilized domestic Keli ultra-resolution imaging technology combined with 4K imaging for the endoscope: Gastroscopy model: EG650, EG650T. Contr

Sponsors

Beijing Friendship Hospital ,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 40–75 years old; 2. Patients receiving endoscopic examination due to gastrointestinal symptoms (e.g., retrosternal discomfort, burning sensation, foreign body sensation during swallowing, etc.) or screening (e.g., endoscopic examination for high-risk populations); 3. Suspected lesions are identified endoscopically, and patients agree to undergo targeted biopsy; 4. Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of esophageal surgery; 2. Advanced malignant tumors of the esophagus; 3. Previous radiotherapy or chemotherapy; 4. Poor image quality (e.g., massive mucus or air bubbles obscuring the view, making the mucosal surface unable to be clearly visualized); 5. Patients with contraindications to endoscopy or anesthesia, including those taking anticoagulants or antiplatelet agents or with contraindications to biopsy; 6. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
sensitivity and specificity for the diagnosis of early esophageal cancer and precancerous lesions;

Secondary

MeasureTime frame
Using pathology as the gold standard, compare the differences in the diagnosis of the nature and boundary judgment of early esophageal cancer and precancerous lesions between the two imaging techniques (sensitivity, specificity, positive predictive value, negative predictive value).;

Countries

China

Contacts

Public ContactLi Peng

Beijing Friendship Hospital ,Capital Medical University

lipeng@ccmu.edu.cn+86 10 63138338

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026