Diagnostic Accuracy of Endocytoscopy for Superficial Esophageal Neoplasia

NCT06984055 | Enrolling By Invitation

• 1 other identifier: DAESEN
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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 visualization of living cells in the digestive mucosal layer through methylene blue staining via the endoscopic instrument channel. This technology provides ultra-magnified endocytoscopic images, allowing for identification of key cellular features including epithelial cell morphology and the shape of methylene blue-stained epithelial nuclei, thereby facilitating clear in vivo observation of microstructural characteristics in mucosal tissues - a technique commonly referred to as "optical biopsy". However, current clinical application of EC in China remains limited due to insufficient practical experience and the absence of standardized diagnostic criteria for image interpretation. This study aims to comprehensively evaluate the diagnostic accuracy of domestically developed high-magnification electronic upper gastrointestinal endoscopy for esophageal carcinoma and precancerous lesions, using histopathology as the gold standard. The research objectives include establishing standardized diagnostic evaluation protocols and clarifying the clinical value of this technology through systematic validation.

Conditions

Esophageal Cancer, Squamous Cell

Keywords

Endocytoscopy; Esophageal Neoplasia; Precancerous Lesions; Deep Learning

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  sensitivity and specificity

  10 minutes

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population who underwent endocytoscopy due to related symptoms from April 2025 to December 2026

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• Ruijin Hospital: collaborator
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator
• the Tenth People's Hospital affiliated to Tongji University: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• The Second Hospital of Nanjing Medical University: collaborator
• Jiangsu Province Hospital of Traditional Chinese Medicine: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator

Study Sites (1)

Changhai hosipital

Shanghai, Shanghai Municipality, 20000, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Wang Luowei

  Changhai hosipital, Shanghai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)