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

• ClinicalTrials.gov Identifier: NCT04301986
• Recruitment Status: Recruiting
• First Posted: March 10, 2020
• Last Update Posted: August 26, 2020
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: American Gastroenterological Association
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

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.

Condition or disease	Intervention/treatment	Phase
Barrett Esophagus; GERD	Device: Cytosponge; Device: Transnasal Endoscopy (TNE); Device: Esophagogastroduodenoscopy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus
• Actual Study Start Date: August 11, 2020
• Estimated Primary Completion Date: August 2021
• Estimated Study Completion Date: August 2021

Arms and Interventions

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 Name: 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 Name: 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: 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 Name: Cytosponge Cell Collection Device; 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 Name: 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 Name: EGD

Outcome Measures

Primary Outcome Measures :

1. 7 days post-EGD Impact of Events Score (IES) - Cytosponge [ Time Frame: 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.
2. 7 days post-EGD Impact of Events Score (IES) - TNE [ Time Frame: 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.
3. 7 days post-EGD Impact of Events Score (IES) - EGD [ Time Frame: 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 :

1. Visual Analog Scale (VAS) Score - Cytosponge [ Time Frame: Day 1, Post-Cytosponge procedure ]
   Visual Analog Scale (VAS): 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
2. Visual Analog Scale (VAS) Score - TNE [ Time Frame: Day 1, Post-TNE procedure ]
   Visual Analog Scale (VAS): 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
3. Visual Analog Scale (VAS) Score - EGD [ Time Frame: Day 1, Post-EGD Procedure ]
   Visual Analog Scale (VAS): 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
4. 7 days post-EGD Willingness to repeat - Cytosponge [ Time Frame: 7 days post-EGD ]
   7 days post-EGD Willingness to repeat (Y/N) - Cytosponge
5. 7 days post-EGD Willingness to repeat - TNE [ Time Frame: 7 days post-EGD ]
   7 days post-EGD Willingness to repeat (Y/N) - TNE
6. 7 days post-EGD Willingness to repeat - EGD [ Time Frame: 7 days post-EGD ]
   7 days post-EGD Willingness to repeat (Y/N) - EGD
7. 7 days post-EGD Ranking of preferred screening modality [ Time Frame: 7 days post-EGD ]
   Subjects will be asked to rank of 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.
8. Number of participants reporting preferred screening modality [ Time Frame: 7 days post-EGD ]
   Participants will be asked what factors influenced preference in choosing preferred screening modality.

Eligibility Criteria

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

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 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

Contacts and Locations

Contacts

Contact: Ariel E Watts; 9198430821; ariel_watts@med.unc.edu

Contact: Susie Moist; 919-966-7655; susan_moist@med.unc.edu

Locations

United States, North Carolina

University of North Carolina at Chapel Hill; Recruiting

Chapel Hill, North Carolina, United States, 27599

Contact: Ariel E Watts 919-843-0821 ariel_watts@med.unc.edu

Contact: Susie Moist 919-966-7655 susan_moist@med.unc.edu

Principal Investigator: Swathi Eluri, MD

Sponsors and Collaborators

University of North Carolina, Chapel Hill

American Gastroenterological Association

Investigators

• Principal Investigator: Swathi Eluri, MD; University of North Carolina, Chapel Hill

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT04301986
• Other Study ID Numbers: 18-3290
• First Posted: March 10, 2020
• Last Update Posted: August 26, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Barrett Esophagus; Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases