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

Primary Purpose

Barrett Esophagus, GERD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cytosponge
Transnasal Endoscopy (TNE)
Esophagogastroduodenoscopy
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Barrett Esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TNE Followed by EGD

Cytosponge, then TNE, followed by EGD

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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."
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 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.
Number of Participants Reporting Preferred Screening Modality
Participants asked "Which procedure would you prefer to undergo again?" Only one item could be selected.
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.

Full Information

First Posted
February 24, 2020
Last Updated
May 4, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
American Gastroenterological Association
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1. Study Identification

Unique Protocol Identification Number
NCT04301986
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
American Gastroenterological Association

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus, GERD

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNE Followed by EGD
Arm Type
Experimental
Arm Description
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.
Arm Title
Cytosponge, then TNE, followed by EGD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cytosponge
Other Intervention Name(s)
Cytosponge Cell Collection Device
Intervention Description
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]).
Intervention Type
Device
Intervention Name(s)
Transnasal Endoscopy (TNE)
Other Intervention Name(s)
Olympus Neonatal (ultrathin) endoscope
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Esophagogastroduodenoscopy
Other Intervention Name(s)
EGD
Intervention Description
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).
Primary Outcome Measure Information:
Title
7 Days Post-EGD Impact of Events Score (IES)
Description
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.
Time Frame
7 days post-EGD
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Score
Description
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."
Time Frame
Day 1, Post-procedure (<24 hours of procedure completion)
Title
7 Days Post-EGD Willingness to Repeat
Description
7 days post-EGD participants were asked about their willingness to repeat the maneuvers (Yes/No).
Time Frame
7 days post-EGD
Title
7 Days Post-EGD Ranking of Preferred Screening Modality
Description
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.
Time Frame
7 days post-EGD
Title
Number of Participants Reporting Preferred Screening Modality
Description
Participants asked "Which procedure would you prefer to undergo again?" Only one item could be selected.
Time Frame
7 days post-EGD
Title
Factors Influencing the Preferred Screening Modality
Description
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.
Time Frame
7 days post-EGD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swathi Eluri, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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