Barrett Esophagus, GERD
Conditions
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.
Interventions
DEVICECytosponge
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 Seven minutes and 30 seconds to ten minutes after ingestion, the sponge is then withdrawn by gentle traction on the suture.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 \[34° to 54°F\]).
DEVICETransnasal 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 The scope will be withdrawn from the nares following completion of the exam.
DEVICEEsophagogastroduodenoscopy
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).
Sponsors
American Gastroenterological Association
University of North Carolina, Chapel Hill
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TNE Followed by EGD Participants 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.
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.
Esophagogastroduodenoscopy: Laying on the participants' 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). | 0 |
| Cytosponge, Then TNE, Followed by EGD Participants 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: In a seated position, participants 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 \[34° to 54°F\]).
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.
Esophagogastroduodenoscopy: Laying on the participants' 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). | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Cytosponge, Then TNE, Followed by EGD | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 24 Participants |
| Region of Enrollment United States | 24 Participants | 24 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 24 |
| other Total, other adverse events | 0 / 0 | 3 / 24 |
| serious Total, serious adverse events | 0 / 0 | 0 / 24 |
Outcome results
Primary
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.
Time frame: 7 days post-EGD
Population: All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cytosponge | 7 Days Post-EGD Impact of Events Score (IES) | 1.42 units on a scale | Standard Deviation 2.89 |
| Transnasal Endoscopy (TNE) | 7 Days Post-EGD Impact of Events Score (IES) | 1.21 units on a scale | Standard Deviation 2.54 |
| Esophagogastroduodenoscopy (EGD) | 7 Days Post-EGD Impact of Events Score (IES) | 0 units on a scale | Standard Deviation 0 |
Secondary
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.
Time frame: 7 days post-EGD
Population: Preferred screening was inadvertently omitted during form creation and these data were not collected.
Secondary
7 Days Post-EGD Willingness to Repeat
7 days post-EGD participants were asked about their willingness to repeat the maneuvers (Yes/No).
Time frame: 7 days post-EGD
Population: All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cytosponge | 7 Days Post-EGD Willingness to Repeat | Yes | 24 Participants |
| Cytosponge | 7 Days Post-EGD Willingness to Repeat | No | 0 Participants |
| Transnasal Endoscopy (TNE) | 7 Days Post-EGD Willingness to Repeat | No | 3 Participants |
| Transnasal Endoscopy (TNE) | 7 Days Post-EGD Willingness to Repeat | Yes | 21 Participants |
| Esophagogastroduodenoscopy (EGD) | 7 Days Post-EGD Willingness to Repeat | No | 0 Participants |
| Esophagogastroduodenoscopy (EGD) | 7 Days Post-EGD Willingness to Repeat | Yes | 24 Participants |
Secondary
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.
Time frame: 7 days post-EGD
Population: All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cytosponge | Factors Influencing the Preferred Screening Modality | Discomfort/pain | 12 Participants |
| Cytosponge | Factors Influencing the Preferred Screening Modality | Time | 6 Participants |
| Cytosponge | Factors Influencing the Preferred Screening Modality | Cost | 3 Participants |
| Cytosponge | Factors Influencing the Preferred Screening Modality | Sedation | 13 Participants |
| Cytosponge | Factors Influencing the Preferred Screening Modality | Other | 4 Participants |
Secondary
Number of Participants Reporting Preferred Screening Modality
Participants asked Which procedure would you prefer to undergo again? Only one item could be selected.
Time frame: 7 days post-EGD
Population: All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cytosponge | Number of Participants Reporting Preferred Screening Modality | Cytosponge | 6 Participants |
| Cytosponge | Number of Participants Reporting Preferred Screening Modality | TNE | 1 Participants |
| Cytosponge | Number of Participants Reporting Preferred Screening Modality | EGD | 17 Participants |
Secondary
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.
Time frame: Day 1, Post-procedure (<24 hours of procedure completion)
Population: All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cytosponge | Visual Analog Scale (VAS) Score | 14.69 units on a scale | Standard Deviation 15.69 |
| Transnasal Endoscopy (TNE) | Visual Analog Scale (VAS) Score | 49.57 units on a scale | Standard Deviation 28.72 |
| Esophagogastroduodenoscopy (EGD) | Visual Analog Scale (VAS) Score | 5.5 units on a scale | Standard Deviation 11.59 |