Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Esophageal Dysplasia
- Sponsor
- Tenwek Hospital
- Enrollment
- 305
- Locations
- 1
- Primary Endpoint
- Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Esophageal squamous cell cancer (ESCC) is common in the developing world, and is the leading cancer diagnosis at Tenwek Hospital in southwestern Kenya. The investigators long-term goal is to understand the pathogenesis and risk factors for ESCC in Kenya, and to establish effective screening and prevention programs. The investigators hypothesize that asymptomatic esophageal squamous dysplasia (ESD) is common in their region, and the current protocol is designed to determine the prevalence of ESD in residents of southwestern Kenya.
Detailed Description
The prevalence of esophageal squamous dysplasia will be determined after evaluating pathology reports from unstained lesions and normal biopsies after staining with Lugol's iodine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 20 years
- •No dysphagia (subjects will be asked "do you have trouble swallowing food or water? Do they get stuck inside after you swallow?" in their primary language
Exclusion Criteria
- •Cardiac, respiratory, or metabolic disease that would increase the risk of endoscopy: history of myocardial infarction, arrhythmias, chronic obstructive pulmonary disease, diabetes, allergy to lidocaine.
- •Unable or unwilling to provide informed consent.
Outcomes
Primary Outcomes
Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence
Time Frame: 2 years
Secondary Outcomes
- percentage of subjects with mild esophageal squamous dysplasia calculated as a prevalence(2 years)
- percentage of subjects with severe esophageal squamous dysplasia calculated as a prevalence(2 years)
- percentage of subjects with moderate esophageal squamous dysplasia calculated as a prevalence(2 years)