Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy (CLE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yanqing Li, Shandong University

ClinicalTrials.gov Identifier:

NCT00851305

First received: February 24, 2009

Last updated: July 16, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 24, 2009

Last Updated Date

July 16, 2012

Start Date ^ICMJE

August 2008

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy. [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00851305 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs. [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy

Official Title ^ICMJE

Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers

Brief Summary

The purpose of this study is to determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC).

Detailed Description

Endoscopy is proved to be the best method to achieve early diagnosis of gastric cancer (GC). Confocal laser endomicroscopy (CLE), a new diagnostic modality, has been shown to be valuable in increasing the diagnostic yield of colorectal neoplasias, but it is not clear whether CLE is helpful to find out early gastric cancer (EGC).The aim of the study is to investigate the value of CLE in improving the detection of EGCs.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Stomach Neoplasms
Precancerous Conditions

Intervention ^ICMJE

Device: Endomicroscope (Pentax, Tokyo, Japan)
A Pentax EC3870K endomicroscope which can produce conventional white light endoscopic images and confocal images at the same time with a optical slice thickness of 7 μm, a lateral resolution of 0.7 μm, a scanning depth of 0 to 250 μm, a pixel density of 1024×512 pixels (at an image acquisition rate of 1.6 frames/second)，and a field of view of 475 μm×475 μm.

Other Name: Pentax EC3870K endomicroscope
Device: Gastroscopes (Pentax, Tokyo, Japan)
Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)

Other Name: Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan)

Study Arm (s)

Experimental: 1 confocal laser endomicroscopy
Targeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy.

Intervention: Device: Endomicroscope (Pentax, Tokyo, Japan)
Active Comparator: 2 Conventional endoscopy
Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy.

Intervention: Device: Gastroscopes (Pentax, Tokyo, Japan)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1786

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

45 years old ≤ age < 80 years old
Patients with dyspeptic symptoms or with gastric premalignant conditions for surveillance gastroscopy

Exclusion Criteria:

Known cancers or gastrectomy
Scheduled for endoscopic treatment
Alarm symptoms such as dysphagia, anaemia, gastrointestinal bleeding or obstruction, marked weight loss
Under conditions such as:
- ascites
- jaundice
- liver cirrhosis
- impaired renal function
- coagulopathy
- fever
- pregnancy
- breastfeeding
Inability to provide informed consent
Known allergy to fluorescein sodium

Gender

Both

Ages

45 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00851305

Other Study ID Numbers ^ICMJE

2008SDU-QILU-G01, 2006GG3202022, 2007(Ministry of Health)

Has Data Monitoring Committee

Yes

Responsible Party

Yanqing Li, Shandong University

Study Sponsor ^ICMJE

Shandong University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Yanqing Li, PhD. MD.

Department of Gastroenterology, Qilu Hospital, Shandong University

Information Provided By

Shandong University

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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