Esophageal cancer is common in Kenya. The precursor of esophageal cancer is esophageal squamous dysplasia (ESD). In this study, persons known to have ESD will undergo endoscopic removal or ablation of ESD in order to prevent development of esophageal cancer.
Esophageal squamous dysplasia (ESD) is the precursor lesion of esophageal squamous cell cancer. ESD causes no symptoms but can be detected by screening. ESD may harbor various grades of dysplasia. Patients with moderate grade or high grade dysplasia (MGD or HGD) have up to a 40-fold increased risk of esophageal squamous cell cancer. In this study, persons known to have ESD with MGD or HGD on the basis of prior screening will be invited to undergo endoscopic treatment with either endoscopic mucosal resection (EMR) and/or radio frequency ablation (RFA) in order to remove or ablate regions of ESD. Participants will undergo a series of endoscopies to treat ESD and monitor success of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Endoscopic removal of regions of ESD.
Endoscopic radiofrequency ablation of regions of ESD
Tenwek Hospital
Bomet, Kenya
Complete resolution of advanced esophageal squamous dysplasia
The percentage of subjects demonstrating complete response defined as complete histological clearance of MGD, HGD and esophageal squamous carcinoma in the treatment areas at 12 months after the initial ablation procedure.
Time frame: 12 months
Safety of endoscopic interventions
Percentage of participants experiencing serious adverse events following EMR or RFA treatment.
Time frame: 12 months
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