Detection of Early Esophageal Squamous Neoplasia

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01909518

Enrollment

200

Registered

2013-07-26

Start date

2013-07-31

Completion date

2013-12-31

Last updated

2013-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Intraepithelial Neoplasia

Keywords

Esophageal Squamous Intraepithelial Neoplasia, surface maturation scoring, probe-based confocal laser endomicroscopy, virtual chromoendoscopy

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactYangqing Li, PhD. MD

liyanqing@sdu.edu.cn86-531-82169236

Outcome results