Detection of Early Esophageal Squamous Neoplasia

• Conditions: Esophageal Squamous Intraepithelial Neoplasia

• Registration Number: NCT01909518
• Lead Sponsor: Shandong University

Brief Summary

The aim of the present study：

1. To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia.

2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy

Detailed Description

Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device and has shown its value for diagnosing Barrett's esophagus, colonal polyps and etc. However, none research has focus on early esophageal squamous neoplasia until now. Previous diagnosis of early esophageal neoplasia is based on the lugol staining which is time wasting and have many adverse events.Other researches have suggested virtual chromoendoscopys are beneficial for screening esophageal tumors. Therefore, the aim of the present study is 1.To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia according to the surface maturation scoring(SMS) diagnostic criteria and 2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy(I-SCAN).

Study Timeline

• Status Verified: 2013-07
• Study Start: 2013-07
• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-24
• Last Update Submitted: 2013-07-24
• Study First Posted: 2013-07-26
• Last Update Posted: 2013-07-26
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients aged between 50 and 80 years old
• Patients undergo screening endoscopy or histologically verified esophageal squamous intraepithelial neoplasia before.

Exclusion Criteria

• Advanced esophageal, gastric or duodenal cancer
• History of upper GI tract surgery
• Coagulopathy or acute GI bleeding
• Pregnant or breast-feeding (for females)
• Impaired renal function
• Allergy to fluorescein sodium
• Inability to provide informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The diagnostic accuracy of pCLE on early esophageal squamous neoplasia	6 month	Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of early esophageal squamous neoplasia by using probe-based confocal laser endomicroscopy

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China