Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa

Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa - a Prospective Randomized Sham-controlled Trial - the RAGE Study

Sponsors

Lead Sponsor: Medical University of Vienna

Source Medical University of Vienna
Brief Summary

The heterotopic gastric mucosa found in the cervical esophagus was first described in 1805 and affects 10-15% of individuals undergoing esophagogastroduodenoscopy. It leads to laryngopharyngeal reflux (LPR), which causes symptoms like globus sensation, hoarseness and chronic cough. The Reflux Symptom Index (RSI) that ranges from 0-45 measures LPR. Scores greater than 13 are considered to be pathologic. Currently, patients that suffer from symptoms of LPR and present with a heterotopic gastric mucosa are routinely offered radiofrequency ablation (RFA) as curative treatment. Up to now, around 40 patients were already treated at the department of Surgery with 90% histologic eradication rates after 2 treatment sessions and no reported serious adverse event. Nevertheless, the placebo effect could also be responsible for perception of improving symptoms. Therefore, this prospective sham-controlled trial was designed to exclude the placebo effect. As the device is already approved and routinely used for focal ablation safety data are already available. Up to now, there were no major adverse events, whereas only 10% of patients describe a sensation of irritated throat that dissolves within the first three days after treatment.

Overall Status Recruiting
Start Date April 16, 2018
Completion Date December 16, 2020
Primary Completion Date September 16, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Normalization of the Reflux Symptom Index 6 months after first RFA treatment/or sham procedure
Secondary Outcome
Measure Time Frame
Histological eradication rate after radiofrequency ablation or sham treatment 6 months after first RFA treatment/or sham procedure
SF-12 quality of life At enrollment (therefore before ablations or sham treatment) and 6 months after first radiofrequency ablation/sham treatment
Reflux Finding Score Evaluated at the first intervention at study completion after 6 months
Enrollment 44
Condition
Intervention

Intervention Type: Device

Intervention Name: Radiofrequency ablation

Description: Radiofrequency ablation is performed using the Barrx Channel endoscopic catheter (Medtronic, Dublin, Republic of Ireland) generating an energy density level of 12 Joule/cm2. The energy is applied using a simplified protocol of three ablations without removal of coagulated tissue. The device is used on a routinely basis all around the world and already approved. The ablation catheter is applied through the working channel of the endoscope.

Arm Group Label: treatment arm

Intervention Type: Procedure

Intervention Name: esophagoscopy

Description: Patients receive an esophagoscopy without radiofrequency ablation under sedation

Arm Group Label: sham-treatment

Eligibility

Criteria:

Inclusion Criteria:

- Histological proven presence of heterotopic gastric mucosa,

- pathologic Reflux Symptom Index (>25)

- age: 18-70

- presence of symptoms > 6 months,

- no effect on the Reflux Symptom Index to 12 weeks of standard dose proton pump inhibitor treatment

- negative symptom correlation for symptoms with reflux events in ambulatory pH monitoring

Exclusion Criteria:

- Not willing to participate in this study

- pregnancy

- lactation period

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Contact

Last Name: Ivan Kristo, MD

Phone: +43140 40056210

Email: [email protected]

Location
Facility: Status: Contact: Medical University of Vienna Ivan Kristo, MD +434040056210 [email protected]
Location Countries

Austria

Verification Date

February 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Medical University of Vienna

Investigator Full Name: Dr. Ivan Kristo

Investigator Title: MD, Attending surgeon, Vize-Chair of the esophageal functional testing laboratory

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: sham-treatment

Type: Sham Comparator

Description: Patients with symptomatic large heterotopic gastric mucosa receive an esophagoscopy without radiofrequency ablation under sedation

Label: treatment arm

Type: Active Comparator

Description: Patients with symptomatic large hetertotopic gastric mucosa receive an esophagoscopy with radiofrequency ablation (12J/cm2) using the Barrx channel RFA endoscopic catheter (Medtronic)

Acronym RAGE
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: randomized sham-controlled

Primary Purpose: Treatment

Masking: Single (Participant)

Masking Description: Patients are blinded either to sham or treatment and unblinded after 24 weeks after final examination

Source: ClinicalTrials.gov