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| ID | Type | Description | Link |
|---|---|---|---|
| RC4DK090413 | U.S. NIH Grant/Contract | View source | |
| UL1TR000135 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| American College of Gastroenterology | OTHER |
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The hypothesis of this study was that the comparative effectiveness of unsedated transnasal endoscopy (uTNE) will be greater than sedated endoscopy (sEGD) in population screening for BE.
Barrett's esophagus (BE), a well-known complication of Gastroesophageal Reflux (GER), is the strongest known precursor of esophageal adenocarcinoma. Thus, identifying effective screening approaches for the early detection of BE are highly desired. Current impediments to BE screening include 1) the inability to utilize sedated endoscopy (sEGD) effectively in populations and 2) current GER-based paradigms for detecting BE. Referral center studies demonstrate comparable accuracy between unsedated transnasal endoscopy (uTNE) and sEGD. However, patient acceptability and diagnostic yield with uTNE in general populations remain unknown.
Using the Rochester, Minnesota Epidemiology Project resources, random samples of Olmsted County residents were drawn, and those subjects were mailed validated gastrointestinal symptom questionnaires. These surveys allowed identification of a cohort of community subjects well characterized by the frequency of reflux symptoms. Eligible subjects who were greater than or equal to 50 years old, and who had no previous history of endoscopic evaluation and who were not known to have BE were randomized, stratified by age, sex, and reflux symptoms, and assigned to one of the 3 arms of the study. Subjects in each arm who met the eligibility criteria were initially sent generic invitation letters asking if they agreed to be contacted by phone in two weeks' time to inform them about a research study. If potential subjects explicitly declined to be contacted they were excluded from the study. Eligible subjects were contacted by telephone and only offered the endoscopy technique they had been randomized to. Subjects who accepted and signed an informed consent document were treated according to their randomized assignment and all 3 groups were followed up in the same manner.
Biopsies were taken from any endoscopically suspected BE and from the gastroesophageal junction and squamous mucosa in all subjects. The length of BE segment was defined using Prague criteria. All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete validated tolerability scales and adverse events questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedated Endoscopy | Active Comparator | Sedated esophagogastroduodenoscopy with biopsy |
|
| Transnasal Endoscopy at Hospital Unit | Active Comparator | Unsedated transnasal endoscopy at hospital unit. |
|
| Transnasal Endoscopy at Mobile Unit | Active Comparator | Unsedated transnasal endoscopy in mobile research van |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedated Endoscopy | Device | The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment | This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening. | Approximately 2 weeks after invitation letter was sent |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Successful Intubation | The rate of successful intubation was defined as the ability to traverse the upper esophageal sphincter and visualize the esophageal mucosa and classified as successful or unsuccessful. | Visit 1 |
| Rate of Complete Evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prasad G. Iyer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25488897 | Result | Sami SS, Dunagan KT, Johnson ML, Schleck CD, Shah ND, Zinsmeister AR, Wongkeesong LM, Wang KK, Katzka DA, Ragunath K, Iyer PG. A randomized comparative effectiveness trial of novel endoscopic techniques and approaches for Barrett's esophagus screening in the community. Am J Gastroenterol. 2015 Jan;110(1):148-58. doi: 10.1038/ajg.2014.362. Epub 2014 Dec 9. |
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Eligible participants were identified using the Rochester Epidemiology Project resources from Olmsted County, Minnesota residents. The study took place between 1 April 2011 and 30 October 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sedated Endoscopy | Sedated esophagogastroduodenoscopy with biopsy Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl. |
| FG001 | Transnasal Endoscopy at Hospital Unit | Unsedated transnasal endoscopy at hospital unit. Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure. |
| FG002 | Transnasal Endoscopy at Mobile Unit | Unsedated transnasal endoscopy in mobile research van Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sedated Endoscopy | Sedated esophagogastroduodenoscopy with biopsy Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment | This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening. | The analysis population for this outcome measure was the number of subjects per group who were eligible to contact. | Posted | Number | percentage of participants | Approximately 2 weeks after invitation letter was sent |
|
30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sedated Endoscopy | Sedated esophagogastroduodenoscopy with biopsy Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore Throat | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prasad G. Iyer | Mayo Clinic | 507-284-6469 | iyer.prasad@mayo.edu |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Transnasal Endoscopy | Device | Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure. |
|
The rate of complete evaluation was defined as visualization of the whole esophagus and identification of landmarks: squamocolumnar junction, gastroesophageal junction (upper margin of gastric folds with stomach deflated), and the diaphragmatic hiatus. The categories of evaluation were classified as complete (all three landmarks identified), incomplete (some landmarks identified), or unsuccessful. |
| Visit 1 |
| Rate of Acquisition of Biopsies From the Esophagus | Visit 1 |
| Mean Duration of Procedure | Duration of the procedure was defined as time from the beginning of the procedure (initiation of sedation or local anesthesia) to extubation. | Visit 1 |
| Mean Time From Extubation to Discharge | This outcome measures the recovery time after the procedure. | Visit 1 |
| Mean Tolerability Scores | Validated pain scales (where 0 is none and 10 is severe) were used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure. Overall tolerance was rated on a scale from 0 to 10, where 0 is good, and 10 is poor tolerance. | Day 1 after the procedure |
| Acceptability | Acceptability was defined as the proportion of subjects willing to undergo the procedure again in the future. | Day 1 after the procedure |
| Unable to intubate |
|
| Transnasal Endoscopy at Hospital Unit |
Unsedated transnasal endoscopy at hospital unit. Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure. |
| BG002 | Transnasal Endoscopy at Mobile Unit | Unsedated transnasal endoscopy in mobile research van Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Reflux Symptoms | Number | participants |
|
| Education | Number | participants |
|
| Employment | Number | participants |
|
| Marital Status | Number | participants |
|
| Use of Proton Pump Inhibitor (PPI) | Number | participants |
|
| OG001 | Transnasal Endoscopy at Hospital Unit | Unsedated transnasal endoscopy at hospital unit. Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure. |
| OG002 | Transnasal Endoscopy at Mobile Unit | Unsedated transnasal endoscopy in mobile research van Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure. |
|
|
|
| Secondary | Rate of Successful Intubation | The rate of successful intubation was defined as the ability to traverse the upper esophageal sphincter and visualize the esophageal mucosa and classified as successful or unsuccessful. | The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat). | Posted | Number | percentage of participants | Visit 1 |
|
|
|
|
| Secondary | Rate of Complete Evaluation | The rate of complete evaluation was defined as visualization of the whole esophagus and identification of landmarks: squamocolumnar junction, gastroesophageal junction (upper margin of gastric folds with stomach deflated), and the diaphragmatic hiatus. The categories of evaluation were classified as complete (all three landmarks identified), incomplete (some landmarks identified), or unsuccessful. | The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat). | Posted | Number | procedures | Visit 1 |
|
|
|
|
| Secondary | Rate of Acquisition of Biopsies From the Esophagus | The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat). | Posted | Number | percentage of participants | Visit 1 |
|
|
|
|
| Secondary | Mean Duration of Procedure | Duration of the procedure was defined as time from the beginning of the procedure (initiation of sedation or local anesthesia) to extubation. | The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat). | Posted | Mean | Standard Deviation | minutes | Visit 1 |
|
|
|
|
| Secondary | Mean Time From Extubation to Discharge | This outcome measures the recovery time after the procedure. | The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat). | Posted | Mean | Standard Deviation | minutes | Visit 1 |
|
|
|
|
| Secondary | Mean Tolerability Scores | Validated pain scales (where 0 is none and 10 is severe) were used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure. Overall tolerance was rated on a scale from 0 to 10, where 0 is good, and 10 is poor tolerance. | The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat). | Posted | Mean | Standard Deviation | units on a scale | Day 1 after the procedure |
|
|
|
|
| Secondary | Acceptability | Acceptability was defined as the proportion of subjects willing to undergo the procedure again in the future. | The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat). | Posted | Number | percentage of participants | Day 1 after the procedure |
|
|
|
|
| 0 |
| 61 |
| 14 |
| 61 |
| EG001 | Transnasal Endoscopy at Hospital Unit | Unsedated transnasal endoscopy at hospital unit. Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure. | 0 | 69 | 20 | 69 |
| EG002 | Transnasal Endoscopy at Mobile Unit | Unsedated transnasal endoscopy in mobile research van Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure. | 0 | 76 | 23 | 76 |
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Epitaxis | Blood and lymphatic system disorders | Systematic Assessment | Self-limiting nose bleed |
|
| Nasal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Abdominal/chest discomfort | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| Title | Measurements |
|---|---|
|
| Unsuccessful |
|
| Title | Measurements |
|---|---|
|
|
| Gagging |
|
| Anxiety |
|
| Overall Tolerance |
|
| Kruskal-Wallis |
| <0.001 |
| 2-Sided |
| No |
| Superiority or Other |
| Comparison between the arms for gagging scale | Kruskal-Wallis | <0.001 | 2-Sided | No | Superiority or Other |
| Comparison between the arms for anxiety scale | Kruskal-Wallis | <0.001 | 2-Sided | No | Superiority or Other |
| Comparison between arms for overall tolerance scale | Kruskal-Wallis | <0.001 | 2-Sided | No | Superiority or Other |
| Title | Measurements |
|---|---|
|