Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy

Stomach Neoplasms Clinical Trial

— CLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851305
• Other study ID #: 2008SDU-QILU-G01
• Secondary ID: 2006GG3202022200
• Status: Completed
• Phase: N/A
• First received: February 24, 2009
• Last updated: July 16, 2012
• Start date: August 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2012
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1786
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Precancerous Conditions
• Stomach Neoplasms

Intervention

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.
• Gastroscopes (Pentax, Tokyo, Japan)
Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.		one year	No
Secondary	To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs.		one year	No