Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus

Not Applicable

Completed

• Conditions: GERD; Barrett Esophagus
• Interventions: Device: Transnasal Endoscopy (TNE); Device: Cytosponge; Device: Esophagogastroduodenoscopy

• Registration Number: NCT04301986
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-10
• Study Start: 2020-08-11
• Primary Completion: 2022-05-10
• Study Completion: 2022-05-10
• Status Verified: 2022-09
• Results First Submitted: 2023-04-10
• Results First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Results First Posted: 2023-05-08
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNE Followed by EGD	Transnasal Endoscopy (TNE)	Subjects will undergo administration of a 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.
TNE Followed by EGD	Esophagogastroduodenoscopy	Subjects will undergo administration of a 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.
Cytosponge, then TNE, followed by EGD	Cytosponge	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.
Cytosponge, then TNE, followed by EGD	Esophagogastroduodenoscopy	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.
Cytosponge, then TNE, followed by EGD	Transnasal Endoscopy (TNE)	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.

Primary Outcome Measures

Name	Time	Method
7 Days Post-EGD Impact of Events Score (IES)	7 days post-EGD	Impact of Events Score (IES): scale was developed to assess the distress associated with a specific life event. IES scores range from 0-75, with higher scores indicating more severe distress associated from an event. Scores ≥ 44 indicate a event has severe impact on self-reported distress while scores ≤ 25 indicate the event may have an effect on distress.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Score	Day 1, Post-procedure (<24 hours of procedure completion)	Visual Analog Scale (VAS): 100-mm horizontal line on which the participant's pain intensity is represented by a point between the extremes of 0 reflecting "no pain at all" and 100 reflecting the "worst pain imaginable."
Factors Influencing the Preferred Screening Modality	7 days post-EGD	Participants asked what factors influenced preference in choosing preferred screening modality. Selection options were: discomfort/pain; time (preparation time and post-procedure); cost; and sedation. Participants could provide multiple response selections.
7 Days Post-EGD Ranking of Preferred Screening Modality	7 days post-EGD	Participants asked to rank preferred screening modality in order (1,2,3). Scores range from 0-3. Scores of 1 indicate a preference, while scores of 3 indicate aversion.
7 Days Post-EGD Willingness to Repeat	7 days post-EGD	7 days post-EGD participants were asked about their willingness to repeat the maneuvers (Yes/No).
Number of Participants Reporting Preferred Screening Modality	7 days post-EGD	Participants asked "Which procedure would you prefer to undergo again?" Only one item could be selected.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States