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| Name | Class |
|---|---|
| Dutch Digestive Diseases Foundation | OTHER |
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In the Netherlands, the incidence of esophageal adenocarcinoma (EAC) is increasing. In addition, EAC has a dismal prognosis. Therefore, screening for Barrett's Esophagus (BE) has stimulated interest. Although BE is a known precursor of EAC, a minority of patients with EAC are known with a previous diagnosis of BE. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.
The ongoing increasing incidence of esophageal adenocarcinoma (EAC) in the Netherlands during the last few decades and the still dismal prognosis has stimulated interest in screening for Barrett's esophagus (BE). Although BE is a known precursor of EAC, a minority of patients with EAC (<10%) are known with a previous diagnosis of BE, and hence, most cases of BE are undiagnosed. Screening programs to detect BE followed by endoscopic surveillance and treatment of dysplasia or early neoplasia seem able to reduce the incidence of EAC and improve survival. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. uTNE offers the possibility of a more acceptable and accurate endoscopic assessment of the esophagus with almost neglectable risks and lower costs compared to conventional endoscopy. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breath test (eNose) followed by uTNE. | Other | All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath test (eNose) followed by uTNE. | Diagnostic Test | All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value (PPV) of the eNose for detecting confirmed BE | PPV of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care. | 16 weeks after breath test (eNose) |
| Negative Predictive Value (NPV) of the eNose for detecting confirmed BE | NPV of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care. | 16 weeks after breath test (eNose) |
| Sensitivity of the eNose for detecting confirmed BE | Sensitivity of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care. | 16 weeks after breath test (eNose) |
| Specificity of the eNose for detecting confirmed BE | Specificity of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care. | 16 weeks after breath test (eNose) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient acceptability (discomfort and overall experience) of the eNose measured on a NPRS. | Patient acceptability consists of two questions regarding discomfort and overall experience of the eNose. Discomfort is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'none' and 10 being 'severe'. Overall experience is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'the worst experience', 5 being 'neither pleasant nor unpleasant' and 10 being 'the best experience'. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter D. Siersema, Prof.dr. | Radboud University Medical Center Nijmegen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Center | Nijmegen | Gelderland | 6525 GA | Netherlands |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D001944 | Breath Tests |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The study design is a multi-site prospective cohort study in eight general practices. All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.
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| Directly after breath test (eNose) |
| Patient acceptability (discomfort and overall experience) of uTNE measured on a NPRS. | Patient acceptability consists of two questions regarding discomfort and overall experience of uTNE. Discomfort is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'none' and 10 being 'severe'. Overall experience is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'the worst experience', 5 being 'neither pleasant nor unpleasant' and 10 being 'the best experience'. | Directly after uTNE |
| Patient acceptability (discomfort and overall experience) of conventional endoscopy (if applicable) measured on a NPRS. | Patient acceptability consists of two questions regarding discomfort and overall experience of conventional endoscopy. Discomfort is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'none' and 10 being 'severe'. Overall experience is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'the worst experience', 5 being 'neither pleasant nor unpleasant' and 10 being 'the best experience'. | Directly after conventional endoscopy |
| Willingness to undergo repeat eNose procedure | Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'. | Directly after breath test (eNose) |
| Willingness to undergo repeat uTNE procedure | Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'. | Directly after uTNE |
| Willingness to undergo repeat conventional endoscopy | Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'. | Directly after conventional endoscopy |
| Cancer worry (CWS-8) | The Cancer Worry Scale (CWS-8) is used to measure cancer worry. Scores are ranging from 8 to 32, and higher scores indicate more cancer worry. | At baseline, 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure. |
| Anxiety (STAI-6) | The State-Trait Anxiety Inventory (STAI-6) is used to measure anxiety. Scores are ranging from 6 to 24, and higher scores indicate more anxiety. | At baseline, 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure. |
| Impact of event (IES-15) | The Impact of Event Scale (IES-15) is used to measure impact of event. Scores are ranging from 0 to 75, and higher scores indicate more impact of event. | 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure. |
| Rate of successful evaluation by uTNE | The rate of successful intubation and complete evaluation will be measured. | 1 week after the last participant undergoes uTNE. |
| Rate of successful evaluation by breath test (eNose) | The rate of successful intubation and complete evaluation will be measured. | 1 week after the last participant undergoes breath test (eNose). |
| Safety of uTNE based on reported Adverse Events. | The safety will be measured based on reported Adverse Events. | 1 week after the last participant undergoes uTNE. |
| Safety of eNose based on reported Adverse Events. | The safety will be measured based on reported Adverse Events. | 1 week after the last participant undergoes breath test (eNose). |
| D004066 |
| Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |