Status:
ENROLLING_BY_INVITATION
Diagnostic Accuracy of Endocytoscopy for Superficial Esophageal Neoplasia
Lead Sponsor:
Changhai Hospital
Collaborating Sponsors:
Ruijin Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Conditions:
Esophageal Cancer, Squamous Cell
Eligibility:
All Genders
18-85 years
Brief Summary
In recent years, endocytoscopy (EC) has undergone rapid development as an advanced endoscopic technique. Characterized by real-time histological imaging and detection capabilities, EC enables visualiz...
Eligibility Criteria
Inclusion
- Patients diagnosed with superficial esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia (HGIN) through endoscopic and pathological biopsy examinations, scheduled for endoscopic submucosal dissection (ESD); 2.Patients with esophageal squamous low-grade intraepithelial neoplasia (LGIN) confirmed by endoscopic and biopsy histopathological examinations within the preceding six months; 3. Patients exhibiting esophageal focal lesions detected during painless upper gastrointestinal endoscopy requiring pathological biopsy.
Exclusion
- Patients aged \<18 years or \>80 years;
- Lesions located at the gastroesophageal junction with clinical suspicion of adenocarcinoma or precancerous lesions;
- Patients with contraindications to sedated/anesthetized upper gastrointestinal endoscopy;
- Patients with coagulation disorders;
- Patients with a history of hypersensitivity to relevant medications (including anesthetics or methylene blue);
- Patients presenting dysphagia or gastrointestinal obstructive symptoms, or those with suspected/confirmed digestive tract obstruction, stenosis, or fistulae;
- Patients declining to provide informed consent for study participation, or any other circumstances deemed by investigators to preclude eligibility.
Key Trial Info
Start Date :
March 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06984055
Start Date
March 11 2025
End Date
December 1 2026
Last Update
May 22 2025
Active Locations (1)
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1
Changhai hosipital
Shanghai, Shanghai Municipality, China, 20000