Clinical Trial: Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus

Brief 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 Summary:

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 endoscop
Sponsor: Mayo Clinic

Current Primary Outcome: Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment [ Time Frame: Approximately 2 weeks after invitation letter was sent ]

This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening.


Original Primary Outcome: proportion of subjects who undergo esophageal assessment in the three cohorts in response to invitation for screening. [ Time Frame: 2 years ]

Current Secondary Outcome:

  • Rate of Successful Intubation [ Time Frame: Visit 1 ]
    The rate of successful intubation was defined as the ability to traverse the upper esophageal sphincter and visualize the esophageal mucosa and classified as successful or unsuccessful.
  • Rate of Complete Evaluation [ Time Frame: Visit 1 ]
    The rate of complete evaluation was defined as visualization of the whole esophagus and identification of landmarks: squamocolumnar junction, gastroesophageal junction (upper margin of gastric folds with stomach deflated), and the diaphragmatic hiatus. The categories of evaluation were classified as complete (all three landmarks identified), incomplete (some landmarks identified), or unsuccessful.
  • Rate of Acquisition of Biopsies From the Esophagus [ Time Frame: Visit 1 ]
  • Mean Duration of Procedure [ Time Frame: Visit 1 ]
    Duration of the procedure was defined as time from the beginning of the procedure (initiation of sedation or local anesthesia) to extubation.
  • Mean Time From Extubation to Discharge [ Time Frame: Visit 1 ]
    This outcome measures the recovery time after the procedure.
  • Mean Tolerability Scores [ Time Frame: Day 1 after the procedure ]
    Validated pain scales (where 0 is none and 10 is severe) were used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure. Overall tolerance was rated on a scale from 0 to 10, where 0 is good, and 10 is poor tolerance.
  • Acceptability [ Time Frame: Day 1 after the procedure ]
    Acceptability was defined as the proportion of subjects willing to undergo the procedure again in the future.


Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: January 28, 2011
Date Started: February 2011
Date Completion:
Last Updated: December 23, 2014
Last Verified: December 2014