Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers
45 Years
80 Years
Both
Stomach Neoplasms, Precancerous Conditions
Trial Information
Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.
Outcome Time Frame:
one year
Safety Issue:
No
Principal Investigator
Yanqing Li, PhD. MD.
Investigator Role:
Study Director
Investigator Affiliation:
Department of Gastroenterology, Qilu Hospital, Shandong University
Authority:
China: Ministry of Health
Study ID:
2008SDU-QILU-G01
NCT ID:
NCT00851305
Start Date:
August 2008
Completion Date:
July 2009
Related Keywords:
- Stomach Neoplasms
- Precancerous Conditions
- Stomach
- endoscopy
- neoplasms
- Neoplasms
- Stomach Neoplasms
- Precancerous Conditions
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