Trial Outcomes & Findings for Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus (NCT NCT04301986)
NCT ID: NCT04301986
Last Updated: 2023-05-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
7 days post-EGD
Results posted on
2023-05-08
Participant Flow
Participant milestones
| Measure |
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 The scope will be withdrawn from the nares following completion of the exam.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).
|
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 Seven minutes and 30 seconds to ten minutes after ingestion, the sponge is then withdrawn by gentle traction on the suture.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).
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
24
|
|
Overall Study
COMPLETED
|
0
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus
Baseline characteristics by cohort
| Measure |
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).
|
Cytosponge, Then TNE, Followed by EGD
n=24 Participants
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).
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
—
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
—
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
—
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
—
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days post-EGDPopulation: All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by 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.
Outcome measures
| Measure |
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).
|
Cytosponge
n=24 Participants
Participants will undergo administration of Cytosponge.
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)
n=24 Participants
Participants will undergo administration of TNE. 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 (EGD)
n=24 Participants
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).
|
|---|---|---|---|---|
|
7 Days Post-EGD Impact of Events Score (IES)
|
—
|
1.42 units on a scale
Standard Deviation 2.89
|
1.21 units on a scale
Standard Deviation 2.54
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 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).
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."
Outcome measures
| Measure |
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).
|
Cytosponge
n=23 Participants
Participants will undergo administration of Cytosponge.
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)
n=23 Participants
Participants will undergo administration of TNE. 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 (EGD)
n=24 Participants
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).
|
|---|---|---|---|---|
|
Visual Analog Scale (VAS) Score
|
—
|
14.69 units on a scale
Standard Deviation 15.69
|
49.57 units on a scale
Standard Deviation 28.72
|
5.5 units on a scale
Standard Deviation 11.59
|
SECONDARY outcome
Timeframe: 7 days post-EGDPopulation: All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD).
7 days post-EGD participants were asked about their willingness to repeat the maneuvers (Yes/No).
Outcome measures
| Measure |
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).
|
Cytosponge
n=24 Participants
Participants will undergo administration of Cytosponge.
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)
n=24 Participants
Participants will undergo administration of TNE. 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 (EGD)
n=24 Participants
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).
|
|---|---|---|---|---|
|
7 Days Post-EGD Willingness to Repeat
Yes
|
—
|
24 Participants
|
21 Participants
|
24 Participants
|
|
7 Days Post-EGD Willingness to Repeat
No
|
—
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 days post-EGDPopulation: Preferred screening was inadvertently omitted during form creation and these data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 days post-EGDPopulation: All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD).
Participants asked "Which procedure would you prefer to undergo again?" Only one item could be selected.
Outcome measures
| Measure |
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).
|
Cytosponge
n=24 Participants
Participants will undergo administration of Cytosponge.
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)
Participants will undergo administration of TNE. 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 (EGD)
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).
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|---|---|---|---|---|
|
Number of Participants Reporting Preferred Screening Modality
Cytosponge
|
—
|
6 Participants
|
—
|
—
|
|
Number of Participants Reporting Preferred Screening Modality
TNE
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Preferred Screening Modality
EGD
|
—
|
17 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days post-EGDPopulation: All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by 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.
Outcome measures
| Measure |
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).
|
Cytosponge
n=24 Participants
Participants will undergo administration of Cytosponge.
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)
Participants will undergo administration of TNE. 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 (EGD)
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).
|
|---|---|---|---|---|
|
Factors Influencing the Preferred Screening Modality
Discomfort/pain
|
—
|
12 Participants
|
—
|
—
|
|
Factors Influencing the Preferred Screening Modality
Time
|
—
|
6 Participants
|
—
|
—
|
|
Factors Influencing the Preferred Screening Modality
Cost
|
—
|
3 Participants
|
—
|
—
|
|
Factors Influencing the Preferred Screening Modality
Sedation
|
—
|
13 Participants
|
—
|
—
|
|
Factors Influencing the Preferred Screening Modality
Other
|
—
|
4 Participants
|
—
|
—
|
Adverse Events
TNE Followed by EGD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cytosponge, Then TNE, Followed by EGD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
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).
|
Cytosponge, Then TNE, Followed by EGD
n=24 participants at risk
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).
|
|---|---|---|
|
Gastrointestinal disorders
Pain - Throat/Esophageal
|
—
0/0 • From the time of informed consent through seven days post-intervention, a total of 8 days.
All procedures were completed sequentially during the same visit with study staff inquiring about the occurence of adverse events following completion of all procedures. Thus, determination of which particular device to which an event might be attributable is not possible.
|
12.5%
3/24 • Number of events 3 • From the time of informed consent through seven days post-intervention, a total of 8 days.
All procedures were completed sequentially during the same visit with study staff inquiring about the occurence of adverse events following completion of all procedures. Thus, determination of which particular device to which an event might be attributable is not possible.
|
Additional Information
Ariel E. Watts, Assistant Director of Clinical Trial Operations
UNC Center for Esophageal Diseases & Swallowing
Phone: 919-962-7316
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place