CLE: Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy

Sponsor

Shandong University (Other)

Overall Status

Completed

CT.gov ID

NCT00851305

Collaborator

(none)

1,786

Enrollment

Location

Arms

Duration (Months)

162.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms Precancerous Conditions	Device: Endomicroscope (Pentax, Tokyo, Japan) Device: Gastroscopes (Pentax, Tokyo, Japan)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1786 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 confocal laser endomicroscopy Targeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy.	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 Names: Pentax EC3870K endomicroscope
Active Comparator: 2 Conventional endoscopy Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy.	Device: Gastroscopes (Pentax, Tokyo, Japan) Conventional white light gastroscopes (Pentax EG-2940 gastroscopes) Other Names: Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan)

Arm

Intervention/Treatment

Experimental: 1 confocal laser endomicroscopy

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

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 Names:

Pentax EC3870K endomicroscope

Active Comparator: 2 Conventional endoscopy

Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy.

Device: Gastroscopes (Pentax, Tokyo, Japan)

Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)

Other Names:

Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan)

Outcome Measures

Primary Outcome Measures

To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy. [one year]

Secondary Outcome Measures

To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs. [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong	China	250012

Sponsors and Collaborators

Shandong University

Investigators

Study Director: Yanqing Li, PhD. MD., Department of Gastroenterology, Qilu Hospital, Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yanqing Li, Chief of the Department of Gastroenterology, Shandong University

ClinicalTrials.gov Identifier:

NCT00851305

Other Study ID Numbers:

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

First Posted:

Feb 25, 2009

Last Update Posted:

Jul 17, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Yanqing Li, Chief of the Department of Gastroenterology, Shandong University

Stomach

endoscopy

neoplasms

Additional relevant MeSH terms:

Stomach Neoplasms

Precancerous Conditions

Study Results

No Results Posted as of Jul 17, 2012