Diagnostic Accuracy of Endocytoscopy for Superficial Esophageal Neoplasia

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

Sponsors & Collaborators

• Ruijin Hospital

  collaborator OTHER

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  collaborator OTHER

• the Tenth People's Hospital affiliated to Tongji University

  collaborator UNKNOWN

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• The Second Hospital of Nanjing Medical University

  collaborator OTHER

• Jiangsu Province Hospital of Traditional Chinese Medicine

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Changhai Hospital

  lead OTHER

Principal Investigators

• Wang Luowei · Changhai hosipital, Shanghai

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-11

Primary Completion

2026-12-01

Completion

2026-12-01

Countries

• China

Study Locations