Clinical trial NCT04301986: Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus
Official title: Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Esophagus
GERD
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: American Gastroenterological Association
First posted: 2020-03-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: Potential subjects will be identified via protocol and Institutional Review Board (IRB) methods prior to obtaining written informed consent. Once written informed consent is obtained and baseline demographic and medical history is collected, 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

Primary outcomes:
measure: 7 Days Post-EGD Impact of Events Score (IES)
timeFrame: 7 days post-EGD
Secondary outcomes:
measure: Visual Analog Scale (VAS) Score
timeFrame: Day 1, Post-procedure (<24 hours of procedure completion)
measure: 7 Days Post-EGD Willingness to Repeat
timeFrame: 7 days post-EGD
measure: 7 Days Post-EGD Ranking of Preferred Screening Modality
timeFrame: 7 days post-EGD
measure: Number of Participants Reporting Preferred Screening Modality
timeFrame: 7 days post-EGD
measure: Factors Influencing the Preferred Screening Modality
timeFrame: 7 days post-EGD
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Swathi Eluri, MD
role: PRINCIPAL_INVESTIGATOR
References: