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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
449
All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 weeks after breath test (eNose)
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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: Directly after uTNE
Willingness to undergo repeat conventional endoscopy
Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week after the last participant undergoes breath test (eNose).
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