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Clinical Trials/NCT00851305
NCT00851305
Completed
Not Applicable

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

Shandong University1 site in 1 country1,786 target enrollmentAugust 2008
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ConditionsStomach NeoplasmsPrecancerous Conditions

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stomach Neoplasms
Sponsor
Shandong University
Enrollment
1786
Locations
1
Primary Endpoint
To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
July 2009
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shandong University
Responsible Party
Principal Investigator
Principal Investigator

Yanqing Li

Chief of the Department of Gastroenterology

Shandong University

Eligibility Criteria

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:
  • •liver cirrhosis
  • •impaired renal function
  • •coagulopathy
  • •pregnancy
  • •breastfeeding
  • •Inability to provide informed consent

Outcomes

Primary Outcomes

To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.

Time Frame: one year

Secondary Outcomes

  • To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs.(one year)

Study Sites (1)

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