Comparing Two Different Methods of Ablation of Inlet Patches (APC vs RFA)

November 30, 2025 updated by: Assaf-Harofeh Medical Center

A Prospective Study Comparing Patient Satisfaction and Efficacy of Two Different Methods of Ablation of Inlet Patches: Argon Plasma Coagulation Versus Radio Frequency Ablation

The goal of this prospective study is to compare 2 different treatment options for the ablation of inlet patches in patients with esophageal symptoms. The main questions it aims to answer are:

Is 1 method more effective than the other? Do patients prefer 1 method over the other?

Participants will undergo ablation with either argon plasma or radiofrequency.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Inlet patches (IP) are areas of ectopic gastric mucosa in the proximal esophagus. [1-4] They also been referred to as cervical inlet patch (CIP), heterotopic gastric mucosa (HGM), heterotopic gastric mucosa of the proximal esophagus (HGMPE), and heterotopic gastric mucosa of the upper esophagus (HGMUE). While initially thought to be rare, they are in fact frequently found. Recent studies, including those specifically evaluating for their presence, have found IP in 10-14% of patients undergoing endoscopy [5-10].

While frequently identified as an incidental lesion, there is growing data that IP can cause symptoms, many of which are attributed to their ability to produce acid [11-13]. A recent meta-analysis comparing patients with IP to those without IP identified heartburn, dysphagia, throat discomfort, globus, hoarseness, and cough as being more prevalent in patients with IP [14].

Studies have shown that some throat symptoms have improved with ablation of IP performed during upper endoscopy [15-23]. The initial prospective studies involved treatment using argon plasma coagulation (APC) and showed safety, effective ablation of the IP, and improvement in symptoms [15-17]. Similar results have been shown in more recent larger retrospective studies [18,19], as well as in pediatric populations [20,21]. While most studies used APC to ablate IP, some studies also showed that radio frequency ablation (RFA) was successful in eradicating IP and improving symptoms [22,23]. However, to date, no studies have compared these two ablative methods.

In the investigators' experience, they have successfully used both methods to ablate IP. However, several patients have complained of sore throats after APC ablation, and the investigators have not experienced this after RFA. Additionally, in prior studies, patient satisfaction with these procedures has not been explored.

Aims The aims are to compare two proven methods of ablating IP-APC and RFA. The primary endpoint will be to compare patient satisfaction with the procedures (rated on a 0-10 scale), as well as complaints of pain or discomfort afterwards. Secondarily, the investigators will compare the efficacy of ablation between the two methods in terms of the number of sessions required to achieve complete IP eradication. Finally, the investigators will also assess differences in symptom improvement between the two groups.

Methods Study design and patients This will be a prospective, randomized, single-blinded study. Patients with known IP (at least 5 mm in size) will be included. IP diagnosis will be based on its typical endoscopic appearance. Confirmation by pathology will not be necessary. Patients will need to have symptoms suggesting that the IP is symptomatic and that ablation is indicated. Symptoms include globus sensation, sore throat, cough, hoarseness, or dysphagia. Patients will complete the Reflux Symptom Index (RSI) regarding their symptoms (see below).[24] The RSI is a validated questionnaire assessing nine different aspects of throat symptoms possibly related to acid reflux. Patients will then be randomized to receive either of the two treatment methods (APC or RFA). Patients will be blinded as to which ablation method will be performed.

Treatment methods During standard upper endoscopy, the IP will be ablated per standard protocol. For APC, this includes a power flow of 60W with argon flow set at 2 L/min. [16] The APC catheter will be inserted via the endoscope and ablations will be performed until the entire IP is ablated.

For RFA, the through-the-scope RFA device with be used with an energy density setting of 12 J/cm2.[22] The probe will be inserted via the endoscope and three deliveries of energy will be applied to the IP.

Treatment safety and literature on the subject are detailed in the investigator's brochure.

Additional study components Five days after the endoscopy, patients will be called to assess how they are feeling. This will include questions to assess their satisfaction with the procedure (0-10) and any throat pain or discomfort (0-10). Additionally, they will be asked if they required any pain medication or had any doctor's visits regarding pain/discomfort.

One month after the initial procedure, patients will return for a repeat upper endoscopy. This will be to assess whether complete eradication of the IP was achieved. If residual IP is seen, then a repeat ablation will be performed with the same method as the initial procedure. Prior to the procedure, patients will again complete the RSI to see if there has been any change in their symptoms.

If residual IP is noted on the second endoscopy, then another procedure will be repeated in another month. The investigators will perform up to 3 ablation procedures, which should result in complete ablation in most patients. (See details with literature on the subject in the investigator's brochure). Each time, symptoms will be reassessed via the RSI as previously described.

Outcomes and statistical analysis The main outcome will be the patient satisfaction score assessed five days after the initial ablation. This score (0-10) will be compared between the two groups.

Additional secondary variables that will be compared include: the percentage with pain or requiring medication after the procedure; the number of procedure sessions required to achieve complete IP eradication; and the changes in overall symptom scores (RSI) after ablation has been achieved.

Continuous variables will be compared by using t-tests or the Mann-Whitney U test (depending on the normality of the distribution). Categorical variables will be compared by using the Chi-square test or Fischer's exact test (depending on the number of results). For all statistical calculations, a p-value <0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ẕerifin, Israel
        • Shamir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inlet patch >5 mm in size
  • Esophageal or throat symptoms
  • Willing to participate

Exclusion Criteria:

  • No inlet patch
  • Unwilling to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: APC
Argon plasma coagulation (APC) will be used to ablate the inlet patch
Procedure: Argon plasma coagulation (APC)
During upper endoscopy, the inlet patches with be ablated. One arm with undergo APC ablation while the other arm will undergo RFA ablation.
Active Comparator: RFA
Radio frequency ablation (RFA) will be used to ablate the inlet patch
Procedure: RFA
Patients with have the inlet patch treated by RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 5 days after intervention
The main outcome will be the patient satisfaction score assessed five days after the initial ablation. This score will be on a 0-10 scale where 0 represents a horrible experience and 10 represents a wonderful experience. This score will be compared between the two groups.
5 days after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedures to eradication
Time Frame: 1 month after interventions
The number of procedure sessions required to achieve complete IP eradication
1 month after interventions
Improvement in symptoms
Time Frame: 1 month after interventions
The changes in overall symptom score, assessed via the Reflux Symptom Index (RSI), after ablation has been achieved. The RSI contains 9 symptom domains, each of which is scored between 0 (no symptoms) and 5 (severe symptoms), for a range in total scores between 0 and a maximum of 45.
1 month after interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Estimated)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 30, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0190-25-ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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