Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa

NCT03518905 | Unknown

• 1 other identifier: 1340/2017
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagus Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

sham-treatment

SHAM COMPARATOR

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

Procedure: esophagoscopy

treatment arm

ACTIVE COMPARATOR

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

Device: Radiofrequency ablation

Interventions

Radiofrequency ablation DEVICE

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.

treatment arm

esophagoscopy PROCEDURE

Patients receive an esophagoscopy without radiofrequency ablation under sedation

sham-treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not willing to participate in this study
• pregnancy
• lactation period

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Esophageal Diseases

Interventions

Radiofrequency Ablation; Esophagoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures

Central Study Contacts

Ivan Kristo, MD

CONTACT

+43140 40056210; ivan.kristo@meduniwien.ac.at

Sebastian Schoppmann, MD

CONTACT

+43140 40056210; sebastian.schoppmann@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are blinded either to sham or treatment and unblinded after 24 weeks after final examination
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Attending surgeon, Vize-Chair of the esophageal functional testing laboratory

Model Details: randomized sham-controlled

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: May 8, 2018
• Study Start: April 16, 2018
• Primary Completion: September 16, 2020
• Study Completion: December 16, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)