Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus (challenge)
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About
The hypothesis of this study was that the comparative effectiveness of unsedated transnasal endoscopy (uTNE) will be greater than sedated endoscopy (sEGD) in population screening for BE.
Full description
Barrett's esophagus (BE), a well-known complication of Gastroesophageal Reflux (GER), is the strongest known precursor of esophageal adenocarcinoma. Thus, identifying effective screening approaches for the early detection of BE are highly desired. Current impediments to BE screening include 1) the inability to utilize sedated endoscopy (sEGD) effectively in populations and 2) current GER-based paradigms for detecting BE. Referral center studies demonstrate comparable accuracy between unsedated transnasal endoscopy (uTNE) and sEGD. However, patient acceptability and diagnostic yield with uTNE in general populations remain unknown.
Using the Rochester, Minnesota Epidemiology Project resources, random samples of Olmsted County residents were drawn, and those subjects were mailed validated gastrointestinal symptom questionnaires. These surveys allowed identification of a cohort of community subjects well characterized by the frequency of reflux symptoms. Eligible subjects who were greater than or equal to 50 years old, and who had no previous history of endoscopic evaluation and who were not known to have BE were randomized, stratified by age, sex, and reflux symptoms, and assigned to one of the 3 arms of the study. Subjects in each arm who met the eligibility criteria were initially sent generic invitation letters asking if they agreed to be contacted by phone in two weeks' time to inform them about a research study. If potential subjects explicitly declined to be contacted they were excluded from the study. Eligible subjects were contacted by telephone and only offered the endoscopy technique they had been randomized to. Subjects who accepted and signed an informed consent document were treated according to their randomized assignment and all 3 groups were followed up in the same manner.
Biopsies were taken from any endoscopically suspected BE and from the gastroesophageal junction and squamous mucosa in all subjects. The length of BE segment was defined using Prague criteria. All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete validated tolerability scales and adverse events questionnaires.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Olmsted county, Minnesota resident
- Age 50 or older
- Able to give informed consent
Exclusion criteria
- History of known Barretts Esophagus (BE) or endoscopy within the last 10 years
- History of progressive dysphagia
- Known Zenkers or epiphrenic diverticulum
- History of recurrent epistaxis
- Illnesses that impair ability to complete questionnaires (e.g. metastatic cancer, stroke, dementia)
- Contraindication to esophageal biopsy (such as anticoagulation using warfarin or clopidogrel).
Trial design
Primary purpose
Allocation
Interventional model
Masking
459 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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