Detection of Early Esophageal Squamous Neoplasia

Shandong University

Status: Unknown

Conditions: Esophageal Squamous Intraepithelial Neoplasia

Study type: Observational

Funder types: Other

Identifiers

NCT01909518

2013SDU-QILU-G02

Details and patient eligibility

About

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

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

pCLE examination

Description:

pCLE is used to distinguish the suspected lesions detected by I-SCAN in esophagus