Detection of Early Esophageal Squamous Neoplasia

NCT ID: NCT01909518

Last Updated: 2013-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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).

Conditions

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Esophageal Squamous Intraepithelial Neoplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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pCLE examination

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yangqing Li, PhD. MD

Role: CONTACT

86-531-82169236 ext. 82169508

Facility Contacts

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Yanqing Li, MD. PhD.

Role: primary

86-531-82169236 ext. 82169508

Other Identifiers

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2013SDU-QILU-G02

Identifier Type: -

Identifier Source: org_study_id

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