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Completed

NCT Number: NCT04656392

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

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.

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Precancerous Conditions

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Positive Predictive Value (PPV) of the eNose for detecting confirmed BE

    Time frame: 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.

  2. Negative Predictive Value (NPV) of the eNose for detecting confirmed BE

    Time frame: 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.

  3. Sensitivity of the eNose for detecting confirmed BE

    Time frame: 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.

  4. Specificity of the eNose for detecting confirmed BE

    Time frame: 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 outcomes

  1. Patient acceptability (discomfort and overall experience) of the eNose measured on a NPRS.

    Time frame: 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'.

  2. Patient acceptability (discomfort and overall experience) of uTNE measured on a NPRS.

    Time frame: 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'.

  3. Patient acceptability (discomfort and overall experience) of conventional endoscopy (if applicable) measured on a NPRS.

    Time frame: 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'.

  4. Willingness to undergo repeat eNose procedure

    Time frame: Directly after breath test (eNose)

    Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'.

  5. Willingness to undergo repeat uTNE procedure

    Time frame: Directly after uTNE

    Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'.

  6. Willingness to undergo repeat conventional endoscopy

    Time frame: Directly after conventional endoscopy

    Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'.

  7. Cancer worry (CWS-8)

    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.

    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.

  8. Anxiety (STAI-6)

    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.

    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.

  9. Impact of event (IES-15)

    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.

    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.

  10. Rate of successful evaluation by uTNE

    Time frame: 1 week after the last participant undergoes uTNE.

    The rate of successful intubation and complete evaluation will be measured.

  11. Rate of successful evaluation by breath test (eNose)

    Time frame: 1 week after the last participant undergoes breath test (eNose).

    The rate of successful intubation and complete evaluation will be measured.

  12. Safety of uTNE based on reported Adverse Events.

    Time frame: 1 week after the last participant undergoes uTNE.

    The safety will be measured based on reported Adverse Events.

  13. Safety of eNose based on reported Adverse Events.

    Time frame: 1 week after the last participant undergoes breath test (eNose).

    The safety will be measured based on reported Adverse Events.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Dutch Digestive Diseases Foundation

Registry information

Official study title

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

Acronym: ELECTRONIC

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2020
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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