N/A
Completed N=459
Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus
Source: ClinicalTrials.gov NCT01288612 ↗Enrolled (actual)
459
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment — 40.7; 45.7; 47.5 percentage of participants — p=0.25
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.
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 |
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).
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. Informational only — not medical advice.