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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01909518
Other study ID # 2013SDU-QILU-G02
Secondary ID
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


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