Diagnostic Accuracy of Endocytoscopy for Superficial Esophageal Neoplasia

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai hosipital

Shanghai, Shanghai Municipality, 20000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.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 criteria

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.

Treatment and study plan

Primary outcomes

Diagnostic accuracy

Time frame: 10 minutes

sensitivity and specificity

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

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

Registry information

Official study title

Diagnostic Accuracy of Deep Learning-Assisted Multimodal Endocytoscopy for Superficial Esophageal Neoplasia and Precancerous Lesions: A Multicenter ，Prospective Study

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 22, 2025
Registry last updated: May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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