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

• ClinicalTrials.gov Identifier: NCT05425771
• Recruitment Status: Not yet recruiting
• First Posted: June 21, 2022
• Last Update Posted: July 14, 2022
• Sponsor: Klinikum Garmisch-Patenkirchen
• Information provided by (Responsible Party): Klinikum Garmisch-Patenkirchen

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Gastro-esophageal Reflux; Reflux, Gastroesophageal	Procedure: Anti Reflux Mucosa Ablation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Intervention Model Description: Pilot study of mucosal ablation for therapy refractory reflux disease
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ARMA (Antireflux Mucosa Ablation) in Patients With Chronic Refractory Reflux Disease
• Estimated Study Start Date: July 14, 2022
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: May 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. change of GERD-HRQL [ Time Frame: Before and after 2 and 6 Month ]
   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.
2. Rate of major complications [ Time Frame: day 1 ]
   Recording of all major complication which require hospitalization

Secondary Outcome Measures :

1. Technical success nominal scale [ Time Frame: Day 1 ]

   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

2. change of DeMeester Score [ Time Frame: Before and after 2 and 6 Month ]

   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

3. change of reflux events [ Time Frame: Before and after 2 and 6 Month ]
   Measurement of the number of events in the pH/Impendence measurement. A count <74 in 24 hours is considered normal.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Germany

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, Bayern, Germany, 82467

Sponsors and Collaborators

Klinikum Garmisch-Patenkirchen

More Information

• Responsible Party: Klinikum Garmisch-Patenkirchen
• ClinicalTrials.gov Identifier: NCT05425771
• Other Study ID Numbers: ARMA01
• First Posted: June 21, 2022
• Last Update Posted: July 14, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Klinikum Garmisch-Patenkirchen:

Reflux disease; Endoscopic therapy

Additional relevant MeSH terms:

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases