Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus; Gastroesophageal Reflux
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Sedated Endoscopy; Transnasal Endoscopy
Intervention type(s): Device; Device
Intervention description(s): The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.; Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Barrett's Esophagus