Gastric Carcinoma Clinical Trial
Official title:
Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma: A Multicenter, Randomized, Controlled Trial
i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted
mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations
compared to WLE with standard biopsy protocol.
ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE
with standard biopsy, can reduce the number of biopsies needed per patient for detection of
gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield.
iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric
IM/IN/CA.
Status | Not yet recruiting |
Enrollment | 242 |
Est. completion date | September 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Male or Female aged 18-80 - Patients with H. pylori infection, or histologically verified gastric intestinal metaplasia, low-grade intraepithelial neoplasia, and atrophic gastritis Exclusion Criteria: - Patients with gastrectomy, acute GI bleeding, and advanced gastric cancer - Patients under conditions unsuitable for performing CLE including coagulopathy, impaired renal function, pregnancy or breastfeeding, and known allergy to fluorescein sodium - Inability to provide informed consent and other situations that could interfere with the examination protocol |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Australia | the University of New South Wales, Bankstown-Lidcombe Hospital | Bankstown | |
China | the Prince of Wales Hospital, Chinese University of Hong Kong | Hongkong | Hongkong |
China | Qilu Hospital, Shandong University | Jinan | Shandong |
Singapore | National University Hospital, National University of Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
Shandong University | National University Hospital, Singapore, Prince of Wales Hospital, Shatin, Hong Kong, The University of New South Wales |
Australia, China, Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of participant with gastric IM/IN/CA | To determine whether CLE with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol. | 1 year | No |
Secondary | number of biopsies needed per patient | To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/CA without the loss of corresponding diagnostic yield. | 1 year | No |
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