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

Esophageal Cancer Clinical Trial

— ELECTRONIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04656392
• Other study ID #: 110769
• Status: Completed
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: March 11, 2024

Study information

• Verified date: April 2024
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: March 11, 2024
• Est. primary completion date: March 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Dutch Digestive Diseases Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Secondary	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'.	Directly after breath test (eNose)
Secondary	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
Secondary	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
Secondary	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)
Secondary	Willingness to undergo repeat uTNE procedure	Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'.	Directly after uTNE
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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.
Secondary	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).