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

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.

Study Overview

• Status: Completed
• Conditions: GERD; Barrett Esophagus
• Intervention / Treatment: Device: Transnasal Endoscopy (TNE); Device: Esophagogastroduodenoscopy; Device: Cytosponge

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TNE Followed by EGD; 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.	Device: Transnasal Endoscopy (TNE); In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam.; Other Names: Olympus Neonatal (ultrathin) endoscope; Device: Esophagogastroduodenoscopy; Laying on the subjects' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ).; Other Names: EGD
Experimental: Cytosponge, then TNE, followed by EGD; 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.	Device: Transnasal Endoscopy (TNE); In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam.; Other Names: Olympus Neonatal (ultrathin) endoscope; Device: Esophagogastroduodenoscopy; Laying on the subjects' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ).; Other Names: EGD; Device: Cytosponge; In a seated position, subjects will swallow the Cytosponge capsule with 150-250 mL of water. Seven minutes and 30 seconds to ten minutes after ingestion, the sponge is then withdrawn by gentle traction on the suture. After retrieval, the string is cut and the retrieved foam sphere containing the cytological specimen is immersed in fixative and stored refrigerated (1° to 12°C [34° to 54°F]).; Other Names: Cytosponge Cell Collection Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7 Days Post-EGD Impact of Events Score (IES)	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.	7 days post-EGD

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Score	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."	Day 1, Post-procedure (<24 hours of procedure completion)
7 Days Post-EGD Willingness to Repeat	7 days post-EGD participants were asked about their willingness to repeat the maneuvers (Yes/No).	7 days post-EGD
7 Days Post-EGD Ranking of Preferred Screening Modality	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
Number of Participants Reporting Preferred Screening Modality	Participants asked "Which procedure would you prefer to undergo again?" Only one item could be selected.	7 days post-EGD
Factors Influencing the Preferred Screening Modality	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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: American Gastroenterological Association
• Investigators: Principal Investigator: Swathi Eluri, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 18-3290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No