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Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma

NCT ID: NCT01642797

Last Updated: 2012-07-18

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

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-09-30

Brief Summary

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i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol.

ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield.

iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric IM/IN/CA.

Detailed Description

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Gastric cancer remains the world's second leading cause of cancer-related deaths. The prognosis for patients with this cancer clearly depends on stage at diagnosis. At least for the intestinal subtype of gastric adenocarcinoma, a cascade of histopathologic lesions has been defined: chronic gastritis, atrophic chronic gastritis, intestinal metaplasia (IM), and intraepithelial neoplasia (IN). The identification of these lesions and follow-up of patients in whom they are found could lead to diagnosis of gastric cancer at an early stage, thus improving patients' survival. The diagnosis of these lesions, which often appear in flat mucosa, is currently based on histopathologic examination of endoscopic biopsy specimens. However, conventional white-light endoscopy (WLE) for this purpose has high interobserver variability and a poor correlation with histopathologic finding.

Confocal laser endomicroscopy (CLE), producing both conventional WLE and confocal microscopic images, can provide a direct histological observation of the in vivo tissue without the need for biopsy. Recently, CLE has shown its value for diagnosing gastric IM, intraepithelial neoplasia and carcinoma. However, none of those CLE criteria for gastric IM, IN or carcinoma (CA) has been validated in various endoscopic centers, hence reducing the reliability and clinical application of them.

Conditions

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Gastric Intestinal Metaplasia Gastric Intraepithelial Neoplasia Gastric Carcinoma

Keywords

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confocal laser endomicroscopy gastric intestinal metaplasia gastric intraepithelial neoplasia gastric carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CLE-TB

Confocal laser endomicroscopy with Targeted Biopsy

Group Type EXPERIMENTAL

Confocal laser endomicroscopy (Pentax, EG3870K)

Intervention Type DEVICE

Confocal laser endomicroscopy with Targeted Biopsy

WLE-SB

Standard White-light endoscopy with Standard Biopsy

Group Type EXPERIMENTAL

Standard White-light endoscopy (Pentax, 90i)

Intervention Type DEVICE

Standard White-light endoscopy with Standard Biopsy

Interventions

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Confocal laser endomicroscopy (Pentax, EG3870K)

Confocal laser endomicroscopy with Targeted Biopsy

Intervention Type DEVICE

Standard White-light endoscopy (Pentax, 90i)

Standard White-light endoscopy with Standard Biopsy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or Female aged 18-80
* Patients with H. pylori infection, or histologically verified gastric intestinal metaplasia, low-grade intraepithelial neoplasia, and atrophic gastritis

Exclusion Criteria

* Patients with gastrectomy, acute GI bleeding, and advanced gastric cancer
* Patients under conditions unsuitable for performing CLE including coagulopathy, impaired renal function, pregnancy or breastfeeding, and known allergy to fluorescein sodium
* Inability to provide informed consent and other situations that could interfere with the examination protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Wales Hospital, Shatin, Hong Kong

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Chief of the department of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the University of New South Wales, Bankstown-Lidcombe Hospital

Bankstown, , Australia

Site Status

the Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hongkong, China

Site Status

Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

National University Hospital, National University of Singapore

Singapore, , Singapore

Site Status

Countries

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Australia China Singapore

Central Contacts

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Yanqing Li, PhD. MD.

Role: CONTACT

Phone: 86-531-8216923

Email: [email protected]

Facility Contacts

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Rupert W. L. Leong, MD. PhD.

Role: primary

Joseph Jao-Yiu Sung, MD. PhD.

Role: primary

Ho Khek Yu, MD. PhD.

Role: primary

Other Identifiers

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20120621

Identifier Type: -

Identifier Source: org_study_id