N/A N=459 Randomized Screening

Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus

Barrett's Esophagus

Bottom Line

View on ClinicalTrials.gov: NCT01288612 ↗

Enrolled (actual)

459

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcome: Primary: Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment — 40.7; 45.7; 47.5 percentage of participants — p=0.25

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sedated Endoscopy (Device); Transnasal Endoscopy (Device)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment	40.7; 45.7; 47.5	0.25
SECONDARY Rate of Successful Intubation	100; 95.8; 100	0.06
SECONDARY Rate of Complete Evaluation	61; 69; 75; 0; 0; 1	0.08
SECONDARY Rate of Acquisition of Biopsies From the Esophagus	100; 83.3; 79.0; 0; 16.7; 21	0.001 sig
SECONDARY Mean Duration of Procedure	9.3; 8.0; 8.5	<0.001 sig
SECONDARY Mean Time From Extubation to Discharge	67.3; 18.5; 15.5	<0.001 sig
SECONDARY Mean Tolerability Scores	0.1; 2.7; 3.2; 0; 0.8; 0.6	<0.001 sig
SECONDARY Acceptability	93.4; 83.3; 78.9; 6.6; 16.7; 21.1	0.001 sig

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.

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01288612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.