N/A
N=24
Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus
Barrett Esophagus · GERD
Bottom Line
View on ClinicalTrials.gov: NCT04301986 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: 7 Days Post-EGD Impact of Events Score (IES) — 1.42; 1.21; 0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cytosponge (Device); Transnasal Endoscopy (TNE) (Device); Esophagogastroduodenoscopy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7 Days Post-EGD Impact of Events Score (IES) |
1.42; 1.21; 0 | — |
| SECONDARY Visual Analog Scale (VAS) Score |
14.69; 49.57; 5.5 | — |
| SECONDARY 7 Days Post-EGD Willingness to Repeat |
24; 21; 24; 0; 3; 0 | — |
| SECONDARY 7 Days Post-EGD Ranking of Preferred Screening Modality |
— | — |
| SECONDARY Number of Participants Reporting Preferred Screening Modality |
6; 1; 17 | — |
| SECONDARY Factors Influencing the Preferred Screening Modality |
12; 6; 3; 13; 4 | — |
Summary
To assess patient acceptance and preference among screening modalities, Esophagogastroduodenoscopy (EGD), Transnasal Esophagoscopy (TNE), and Cytosponge for Barrett's esophagus (BE). Subjects will undergo administration of Cytosponge and transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected.
Eligibility Criteria
Inclusion Criteria
- Patients with one of the following: Gastroesophageal Reflux Disease (GERD) OR Barrett's esophagus (BE)
- At least 18 years of age at time of consent
- Able and willing to provide written informed consent
- Able and willing to comply with required study procedures and follow-up schedule
- Presenting to UNC Hospitals for routine care upper endoscopy
Exclusion Criteria
- History of pre-existing esophageal stenosis/ stricture, esophageal diverticulum or significant esophageal anatomic abnormalities (masses, obstructive lesions, etc.)
- History of head and neck malignancy or anatomical abnormalities of the nasopharynx
- Any history of Ear, Nose and Throat (ENT) surgery
- History of significant epistaxis or hereditary hemorrhagic telangiectasia (HHT)
- Sinus or pulmonary infection in the last 4 weeks
- Current use of blood thinners such as coumadin, warfarin, clopidogrel, heparin and/or low molecular weight heparin (requires discontinuation of medication 7 days prior to and 7 days after esophagogastroduodenoscopy [EGD] and Cytosponge administration, aspirin use is OK).
- Known bleeding disorder
- Pregnancy, or planned pregnancy during the course of the study.
- Any history of esophageal varices, liver impairment of moderate or worse severity (Child's- Pugh class B & C) or evidence of varices noted on any past endoscopy
- Any history of esophageal surgery, except for uncomplicated fundoplication
- History of coagulopathy, with international normalised ratio (INR) >1.3 and/or platelet count of <75,000
- General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
- Subject has any condition that, in the opinion of the investigator or sponsor, would interfere with accurate interpretation of the study objectives or preclude participation in the trial
Data sourced from ClinicalTrials.gov (NCT04301986). 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.