Stomach Neoplasms Clinical Trial
— CLEOfficial title:
Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers
Verified date | July 2012 |
Source | Shandong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
The purpose of this study is to determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC).
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
China | Department of Gastroenterology, Qilu Hospital, Shandong University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong University |
China,
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 |
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