Clinical trial NCT01288612: Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus
Official title: Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Keywords: Barrett's Esophagus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Center for Advancing Translational Sciences (NCATS)
name: American College of Gastroenterology
First posted: 2011-02-02
Enrollment: 459
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment
timeFrame: Approximately 2 weeks after invitation letter was sent
Secondary outcomes:
measure: Rate of Successful Intubation
timeFrame: Visit 1
measure: Rate of Complete Evaluation
timeFrame: Visit 1
measure: Rate of Acquisition of Biopsies From the Esophagus
timeFrame: Visit 1
measure: Mean Duration of Procedure
timeFrame: Visit 1
measure: Mean Time From Extubation to Discharge
timeFrame: Visit 1
measure: Mean Tolerability Scores
timeFrame: Day 1 after the procedure
measure: Acceptability
timeFrame: Day 1 after the procedure
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Prasad G. Iyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sami SS, Dunagan KT, Johnson ML, Schleck CD, Shah ND, Zinsmeister AR, Wongkeesong LM, Wang KK, Katzka DA, Ragunath K, Iyer PG. A randomized comparative effectiveness trial of novel endoscopic techniques and approaches for Barrett's esophagus screening in the community. Am J Gastroenterol. 2015 Jan;110(1):148-58. doi: 10.1038/ajg.2014.362. Epub 2014 Dec 9.