Ablation of Esophageal Inlet Patches in Patients Referred for Bravo pH-Testing

NCT05131932 | Unknown

• 1 other identifier: 0205-21-ASF
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

GERD; Cough; Metaplasia

Outcome Measures

Primary Outcomes (1)

• Symptoms 6 months after procedure

  The overall symptoms score

  6 months after procedure

Secondary Outcomes (1)

• Symptoms 2 months after procedure

  2 months after procedure

Study Arms (2)

Inlet patch

EXPERIMENTAL

Patients found to have an inlet patch on upper endoscopy

Procedure: Endoscopic ablation of inlet patch

Controls

NO INTERVENTION

Patients without an inlet patch on upper endoscopy

Interventions

Endoscopic ablation of inlet patch PROCEDURE

Endoscopic ablation of inlet patch using argon plasma coagulation (APC)

Inlet patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Related Publications (16)

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  PMID: 8404414 BACKGROUND

• Meining A, Bajbouj M, Preeg M, Reichenberger J, Kassem AM, Huber W, Brockmeyer SJ, Hannig C, Hofler H, Prinz C, Schmid RM. Argon plasma ablation of gastric inlet patches in the cervical esophagus may alleviate globus sensation: a pilot trial. Endoscopy. 2006 Jun;38(6):566-70. doi: 10.1055/s-2006-925362.

  PMID: 16802267 BACKGROUND

• Bajbouj M, Becker V, Eckel F, Miehlke S, Pech O, Prinz C, Schmid RM, Meining A. Argon plasma coagulation of cervical heterotopic gastric mucosa as an alternative treatment for globus sensations. Gastroenterology. 2009 Aug;137(2):440-4. doi: 10.1053/j.gastro.2009.04.053. Epub 2009 May 4.

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  PMID: 24157960 BACKGROUND

• Dunn JM, Sui G, Anggiansah A, Wong T. Radiofrequency ablation of symptomatic cervical inlet patch using a through-the-scope device: a pilot study. Gastrointest Endosc. 2016 Dec;84(6):1022-1026.e2. doi: 10.1016/j.gie.2016.06.037. Epub 2016 Jul 1.

  PMID: 27373671 BACKGROUND

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  PMID: 28701149 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux; Cough; Metaplasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 23, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share