Clinical trial NCT04656392: Early Detection of Barrett's Esophagus in Participants With Reflux Symptoms in Primary Care
Official title: Early Detection of Barrett's Esophagus and Esophageal Cancer: Accuracy and Acceptability of a Novel Screening Strategy in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Esophagus
Esophageal Cancer
Keywords: Barrett Esophagus
Esophageal Cancer
Primary care
General practice
Screening
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Digestive Diseases Foundation
First posted: 2020-12-07
Enrollment: 449
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Positive Predictive Value (PPV) of the eNose for detecting confirmed BE
timeFrame: 16 weeks after breath test (eNose)
measure: Negative Predictive Value (NPV) of the eNose for detecting confirmed BE
timeFrame: 16 weeks after breath test (eNose)
measure: Sensitivity of the eNose for detecting confirmed BE
timeFrame: 16 weeks after breath test (eNose)
measure: Specificity of the eNose for detecting confirmed BE
timeFrame: 16 weeks after breath test (eNose)
Secondary outcomes:
measure: Patient acceptability (discomfort and overall experience) of the eNose measured on a NPRS.
timeFrame: Directly after breath test (eNose)
measure: Patient acceptability (discomfort and overall experience) of uTNE measured on a NPRS.
timeFrame: Directly after uTNE
measure: Patient acceptability (discomfort and overall experience) of conventional endoscopy (if applicable) measured on a NPRS.
timeFrame: Directly after conventional endoscopy
measure: Willingness to undergo repeat eNose procedure
timeFrame: Directly after breath test (eNose)
measure: Willingness to undergo repeat uTNE procedure
timeFrame: Directly after uTNE
measure: Willingness to undergo repeat conventional endoscopy
timeFrame: Directly after conventional endoscopy
measure: Cancer worry (CWS-8)
timeFrame: 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.
measure: Anxiety (STAI-6)
timeFrame: 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.
measure: Impact of event (IES-15)
timeFrame: 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.
measure: Rate of successful evaluation by uTNE
timeFrame: 1 week after the last participant undergoes uTNE.
measure: Rate of successful evaluation by breath test (eNose)
timeFrame: 1 week after the last participant undergoes breath test (eNose).
measure: Safety of uTNE based on reported Adverse Events.
timeFrame: 1 week after the last participant undergoes uTNE.
measure: Safety of eNose based on reported Adverse Events.
timeFrame: 1 week after the last participant undergoes breath test (eNose).
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center Nijmegen
name: Peter D. Siersema, Prof.dr.
role: PRINCIPAL_INVESTIGATOR
References: