ARMA (Antireflux Mucosa Ablation) in Patients With Chronic Refractory Reflux Disease (ARMA)

Pilot study of the possible clinical response to anti reflux mucosal ablation in patients with chronic refractory reflux disease

Study Overview

• Status: Not yet recruiting
• Conditions: Reflux, Gastroesophageal; Gastro-esophageal Reflux
• Intervention / Treatment: Procedure: Anti Reflux Mucosa Ablation

Detailed Description

Prospective, non-controlled, monocentric pilot study in patients with therapy-refractory reflux symptoms under proton pump inhibitor (PPI) therapy or intolerance of the necessary therapy or rapid recurrence of the symptoms with tapering therapy.

The symptoms must have existed for >6 months. Gastroesophageal reflux disease (GERD) must be diagnosed before inclusion in the study. This is the case if either erosive reflux esophagitis according to Los Angeles classification grades A-D is present or non-erosive reflux disease (NERD) has been confirmed by a 24-hour pH measurement/impedance measurement. The measurement must show either an increased number of reflux events or a prolonged time under reflux. In addition, there must be a high correlation between symptoms and reflux events when reporting symptom events. The GERD-HRQL score is queried for the clinical quantification of symptoms.

An esophageal motility disorder, especially achalasia or relevant hypomotility must be ruled out in an high resolution esophageal manometry. A relevant gastric emptying disorder is ruled out using a C13 octanoate breath test.

Patients with a Hill IV axial hernia, a paraesophageal hernia, or Barrett's esophagus are not included. Pregnancy must be ruled out in women of childbearing age.

The ARMA procedure is explained to the patient in detail with the expected benefits and risks in oral and written form. In addition, alternative treatments such as surgical fundoplication are discussed.

In the ARMA procedure, a gastroscopy is performed under sedation with propofol. Argon plasma coagulation (APC) is performed in inversion at the gastroesophageal junction in a crescent or horseshoe shape over a width of 1.5 - 2 cm, as described in the original publication. The intended destruction of the uppermost layer of the gastroesophageal junction is intended to induce an inflammatory reaction with subsequent shrinkage of the corresponding tissue section. This leads to a tightening of the gastroesophageal junction with subsequent improved tightness, so that reflux events occur less frequently.

Patients will be monitored in hospital for 48 hours. The existing drug therapy is continued for 4 weeks and then tapered off.

Endoscopic and clinical follow-up checks take place after 2 and 6 months using gastroscopy and GERD-HRQL score.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • Garmisch-Partenkirchen, Bayern, Germany, 82467
      • Klinikum Garmisch-Partenkirchen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• typical reflux symptoms more than 2x per week during PPI therapy more than 6 month
• proof of gastro-esophageal reflux in pH metry oder pH/Impedance measurement

Exclusion Criteria:

• age < 18 y
• primary motility disorder of the esophagus
• hiatal hernia > 3 cm
• Hill classification > III
• pregnancy
• coagulation disorder
• mandatory intake of oral anticoagulation drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mucosa Ablation Arm; Treatment group	Procedure: Anti Reflux Mucosa Ablation; Mucosa ablation with Argon plasma coagulation performed in inversion at the gastroesophageal junction in a crescent or horseshoe shape over a width of 1.5 - 2 cm in patients with refractory reflux symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of GERD-HRQL	The Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) is a standardized questionaire and a quantitative method of measuring symptom severity in gastroesophageal reflux disease (GERD). The results are from minimal 0 points up to 50 points. The higher the points, the greater the complaints.	Before and after 2 and 6 Month
Rate of major complications	Recording of all major complication which require hospitalization	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success nominal scale	In this case, the abortion of the procedure or the subjective assessment of the examiner apply immediately after the end of the procedure. The examiner evaluates the complete technical success as successful or unsuccessful	Day 1
change of DeMeester Score	The DeMeester score is a scoring system at pH/Impendence measurement that quantifies esophageal acid exposure time in long-term pH monitoring. A DeMeester score of ≤ 14.72 is considered physiological. The score includes the following values: Percentage of time with esophageal pH < 4 of total measurement time Percentage of time with pH < 4 during the waking phase (upright position) Percentage of time with pH < 4 during the sleep phase (lying position) Total number of reflux episodes during the measurement time Number of reflux episodes lasting > 5 min Duration of the longest reflux episode	Before and after 2 and 6 Month
change of reflux events	Measurement of the number of events in the pH/Impendence measurement. A count <74 in 24 hours is considered normal.	Before and after 2 and 6 Month

Collaborators and Investigators

• Sponsor: Klinikum Garmisch-Patenkirchen

Study record dates

Study Major Dates

• Study Start (Anticipated): July 14, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Reflux disease; Endoscopic therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: ARMA01

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
• product manufactured in and exported from the U.S.: No