Detection of Early Esophageal Squamous Neoplasia

Esophageal Squamous Intraepithelial Neoplasia Clinical Trial

Official title:

Detection of Early Esophageal Squamous Neoplasia by Using Virtual Chromoendoscopy and Probe-based Confocal Laser Endomicroscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01909518
• Other study ID #: 2013SDU-QILU-G02
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2013
• Last updated: July 24, 2013
• Start date: July 2013
• Est. completion date: December 2013

Study information

• Verified date: July 2013
• Source: Shandong University
• Contact: Yangqing Li, PhD. MD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma in Situ
• Esophageal Squamous Intraepithelial Neoplasia
• Neoplasms

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic accuracy of pCLE on early esophageal squamous neoplasia	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	6 month	No