Clinical trial NCT05131932: Ablation of Esophageal Inlet Patches in Patients Referred for Bravo pH-Testing
Official title: Ablation of Esophageal Inlet Patches in Patients Referred for pH-Testing Due to Possible Extra-Esophageal Symptoms of Gastro-Esophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: GERD
Cough
Metaplasia
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with suspected extra-esophageal manifestations of gastro-esophageal reflux disease (GERD), such as cough, hoarseness, and globus, are often referred for pH testing. However, many of these symptoms may actually be due to an esophageal inlet patch. We aim to evaluate patients referred for pH testing to see if they have an inlet patch, to perform ablation of the inlet patch if detected, and then compare the outcomes of patients with an inlet patch who underwent ablation versus those without an inlet patch.

Detailed description: Background The diagnosis of gastro-esophageal reflux disease (GERD) is difficult when patients present with extra-esophageal symptoms such as chronic cough, frequent throat clearing, globus sensation, sore throat, and hoarseness, as opposed to the traditional symptoms of heartburn and regurgitation.\[1-4\] These patients are often given a trial of proton pump inhibitors (PPIs) to see if their symptoms improve. They often undergo an upper endoscopy, which is usually unrevealing,\[5\] and they may be evaluated by other specialties such as otolaryngology and pulmonology. Eventually, some of these patients are referred for esophageal pH-testing to evaluate for objective evidence of acid reflux.

The symptoms of extra-esophageal GERD (EE-GERD) are not specific for GERD and many of them overlap with the symptoms from inlet patches, also known as heterotopic gastric mucosa.\[6-7\] Inlet patches consist of small areas of gastric mucosa in the upper esophagus that are capable of producing acid.\[8-10\] Studies in which inlet patches are endoscopically ablated have shown improvement in several extra-esophageal symptoms including globus sensation, sore throat, and cough.\[11-15\] As inlet patches are notoriously overlooked on upper endoscopy\[16\] and can cause many of the same symptoms as EE-GERD, we suspect that they may be responsible for the symptoms in some patients who are referred for pH-testing due to suspected EE-GERD. We believe that a careful inspection of the upper esophagus will reveal inlet patches that were missed on initial endoscopy and that ablation of these inlet patches will help improve the patients' symptoms more than the standard treatment for EE-GERD.

Aims The primary aim of this study is to evaluate the improvement in symptoms of patients referred for pH-testing for suspected EE-GERD that are treated with endoscopic ablation of an inlet patch versus those who receive standard PPI therapy. Secondarily, we seek to determine the prevalence of inlet patches in these patients with reportedly normal endoscopies, as well as percentage of patients in this group with a positive pH study.

Methods Patients referred for pH-testing due to symptoms of possible EE-GERD will be evaluated. These patients will have their prior medical history reviewed. Those with a prior normal endoscopy and inadequate response to PPI therapy will be included.

Patients' symptoms will be assessed via a questionnaire across 8 domains including 6 symptoms of possible EE-GERD and 2 subjective scores of how the symptoms are affecting their lives (see Questionnaire below). A visual Likert scale from 0 to 10 will be used. An overall symptom score will be calculated based on the results of the 8 individual domains.

Patients will then undergo an upper endoscopy. During the endoscopy, care will be taken to assess for possible inlet patches. Advanced imaging techniques such as i-scan imaging will be used to aid in the detection of inlet patches. If one or more inlet patches are found, the number, size, and shape will be recorded, and it will be biopsied for histological confirmation. The inlet patch will then be ablated via the use of argon plasma coagulation (APC) as has been performed in prior studies.\[11-13\] During the endoscopy, a Bravo pH capsule will also be placed per standard protocol to complete a 48-hour pH study. The Bravo data will be interpreted according to standard procedure with a positive study defined as an elevated DeMeester score on either study day. All studies will be performed off of anti-acid medications such as PPIs.

The patients' symptoms will be re-assessed at 2 and 6 months following the endoscopy. This will be performed via telephone interviews with the patients completing the same symptom assessments as prior to the endoscopy. Changes in their medications and treatment as a result of the Bravo pH study results will also be evaluated.

The primary end point will be the symptom improvement in overall score in patients who underwent ablation of inlet patches versus those without inlet patches.

Inclusion Criteria

* Adult patients (age 18 and above)
* Referred for pH-testing for evaluation of possible EE-GERD
* Prior upper endoscopy performed
* Prior trial of PPI with an inadequate response Exclusion Criteria
* Patients who do not give consent
* Patients with abnormalities on their prior endoscopy including a significant hiatal hernia (\>3 cm) or significant erosive esophagitis (Los Angeles class B or greater)
* Patients who did not fail a prior trial of PPI therapy Anticipated number of subjects: 100

Eligibility criteria: Inclusion Criteria:

* Adult patients (age 18 and above)
* Referred for pH-testing for evaluation of possible extraesophageal-GERD
* Prior upper endoscopy performed
* Prior trial of PPI with an inadequate response

Exclusion Criteria:

* Patients who do not give consent
* Patients with abnormalities on their prior endoscopy including a significant hiatal hernia (\>3 cm) or significant erosive esophagitis (Los Angeles class B or greater)
* Patients who did not fail a prior trial of PPI therapy

Primary outcomes:
measure: Symptoms 6 months after procedure
timeFrame: 6 months after procedure
Secondary outcomes:
measure: Symptoms 2 months after procedure
timeFrame: 2 months after procedure
Other outcomes:
Locations:
Study officials:
References:
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