ELECTRONIC: Early Detection of Barrett's Esophagus in Participants With Reflux Symptoms in Primary Care

Sponsor

Radboud University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04656392

Collaborator

Dutch Digestive Diseases Foundation (Other)

450

Enrollment

Location

Arm

32.3

Anticipated Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Barrett Esophagus Esophageal Cancer	Diagnostic Test: Breath test (eNose) followed by uTNE.	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Early Detection of Barrett's Esophagus and Esophageal Cancer: Accuracy and Acceptability of a Novel Screening Strategy in Primary Care

Actual Study Start Date :

Apr 20, 2021

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Breath test (eNose) followed by uTNE. All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.	Diagnostic Test: Breath test (eNose) followed by uTNE. All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.

Arm

Intervention/Treatment

Other: Breath test (eNose) followed by uTNE.

All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.

Diagnostic Test: Breath test (eNose) followed by uTNE.

All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.

Outcome Measures

Primary Outcome Measures

Positive Predictive Value (PPV) of the eNose for detecting confirmed BE [16 weeks after breath test (eNose)]
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.
Negative Predictive Value (NPV) of the eNose for detecting confirmed BE [16 weeks after breath test (eNose)]
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.
Sensitivity of the eNose for detecting confirmed BE [16 weeks after breath test (eNose)]
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.
Specificity of the eNose for detecting confirmed BE [16 weeks after breath test (eNose)]
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.

Secondary Outcome Measures

Patient acceptability (discomfort and overall experience) of the eNose measured on a NPRS. [Directly after breath test (eNose)]
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'.
Patient acceptability (discomfort and overall experience) of uTNE measured on a NPRS. [Directly after uTNE]
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'.
Patient acceptability (discomfort and overall experience) of conventional endoscopy (if applicable) measured on a NPRS. [Directly after conventional endoscopy]
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'.
Willingness to undergo repeat eNose procedure [Directly after breath test (eNose)]
Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'.
Willingness to undergo repeat uTNE procedure [Directly after uTNE]
Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'.
Willingness to undergo repeat conventional endoscopy [Directly after conventional endoscopy]
Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'.
Cancer worry (CWS-8) [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.]
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.
Anxiety (STAI-6) [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.]
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.
Impact of event (IES-15) [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.]
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.
Rate of successful evaluation by uTNE [1 week after the last participant undergoes uTNE.]
The rate of successful intubation and complete evaluation will be measured.
Rate of successful evaluation by breath test (eNose) [1 week after the last participant undergoes breath test (eNose).]
The rate of successful intubation and complete evaluation will be measured.
Safety of uTNE based on reported Adverse Events. [1 week after the last participant undergoes uTNE.]
The safety will be measured based on reported Adverse Events.
Safety of eNose based on reported Adverse Events. [1 week after the last participant undergoes breath test (eNose).]
The safety will be measured based on reported Adverse Events.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient aged 50 to 75 years;
Recorded diagnosis of reflux symptoms >90 days OR
Recorded prescriptions for acid suppressant therapy for this indication for at least 1 year in the past 5 years
Written informed consent.

Exclusion Criteria:

Upper endoscopy in the previous 5 years;
A current or previous diagnosis and/or treatment of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC)) within the last five years;
Already known with a diagnosis of Barrett's esophagus or gastro-esophageal cancer;
Any argument provided by a patient's own general practitioner not to include the patient;
Comorbidities precluding transnasal endoscopy (e.g. inability to discontinue oral anticoagulants, history of recurrent epistaxis, allergy to lidocaine derivatives).