The Accuracy of Probe-based Confocal Endomicroscopy Versus Conventional Biopsies for the Diagnosis of Superficial Gastric Neoplasias
N/A
18 Years
85 Years
18 Years
85 Years
Not Enrolling
Both
Early Gastric Cancer, Gastric Dysplasia
Both
Early Gastric Cancer, Gastric Dysplasia
Trial Information
The Accuracy of Probe-based Confocal Endomicroscopy Versus Conventional Biopsies for the Diagnosis of Superficial Gastric Neoplasias
Inclusion Criteria:
- Patients with biospy proven superficial gastric neoplasia, suitable for endoscopic
resection.
Exclusion Criteria:
- Patients with uncorrectable coagulopathy,
- liver cirrhosis,
- acute gastrointestinal bleeding,
- pregnancy,
- breast feeding,
- documented allergy to fluorescein,
- patients with lesions that were deemed unsuitable for endoscopic resection, and
- patients without documented conventional biopsy results.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
The accuracy of pCLE compared to conventional forceps biopsy
Outcome Description:
The accuracy of pCLE compared to conventional forceps biopsy was assessed using histopathology results following endoscopic resection as a reference
Outcome Time Frame:
in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection.
Safety Issue:
No
Authority:
Republic of Korea: Ministry of Health and Welfare
Study ID:
MD-2012-01
NCT ID:
NCT01688687
Start Date:
February 2012
Completion Date:
Related Keywords:
- Early Gastric Cancer
- Gastric Dysplasia
- Neoplasms
- Stomach Neoplasms
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