Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital

Completed

• Conditions: Esophageal Dysplasia

• Registration Number: NCT01981876
• Lead Sponsor: Tenwek Hospital

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-13
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-26
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage rate of subjects with Esophageal Squamous dysplasia calculated as Prevalence	2 years

Secondary Outcome Measures

Name	Time	Method
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
percentage of subjects with mild esophageal squamous dysplasia calculated as a prevalence	2 years

Trial Locations

Locations (1)

Tenwek Hospital; 🇰🇪 Bomet, Riftvalley, Kenya