Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa

Esophagus Disorder Clinical Trial

— RAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03518905
• Other study ID #: 1340/2017
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: December 16, 2020

Study information

• Verified date: February 2020
• Source: Medical University of Vienna
• Contact: Ivan Kristo, MD
• Phone: +43140 40056210
• Email: ivan.kristo[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 16, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Diseases
• Esophagus Disorder

Intervention

Device:
• Radiofrequency ablation
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.

Procedure:
• esophagoscopy
Patients receive an esophagoscopy without radiofrequency ablation under sedation

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalization of the Reflux Symptom Index	Normalization of the Reflux Symptom Index (RSI <14) after two treatment/sham sessions evaluated 3 months after the second (sham-) treatment (therefore 6 months after the first endoscopy with/without RFA). Proton-pump inhibitors are paused 8 weeks before assessment	6 months after first RFA treatment/or sham procedure
Secondary	Histological eradication rate after radiofrequency ablation or sham treatment	Histologic eradication rate after RFA treatment/sham procedure measured after finalization of RFA (normalization of Reflux Symptom Index/or a maximum of two treatment sessions) or at the time of second sham treatment.	6 months after first RFA treatment/or sham procedure
Secondary	SF-12 quality of life		At enrollment (therefore before ablations or sham treatment) and 6 months after first radiofrequency ablation/sham treatment
Secondary	Reflux Finding Score	the Reflux Finding Score is measured by using laryngofibroscopy to document potential absence of laryngopharyngeal reflux. The reflux finding score (RFS) represents an objective and validated instrument to analyze physical findings and severity of laryngopharyngeal reflux. An 8-item checklist with excellent inter-observer reliability grades abnormalities documented during laryngoscopy from 0-26 points. The total score is reported and summed from an 8 item checklist providing 0-4 points. Statistically, total scores greater than 7 have a likelihood of 95% to reflect LPR. Higher scores represent worse outcomes.	Evaluated at the first intervention at study completion after 6 months