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

Reflux, Gastroesophageal Clinical Trial

— ARMA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05425771
• Other study ID #: ARMA01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 14, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2022
• Source: Klinikum Garmisch-Patenkirchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: May 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastro-esophageal Reflux
• Gastroesophageal Reflux
• Reflux, Gastroesophageal

Intervention

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

Locations

Country	Name	City	State
Germany	Klinikum Garmisch-Partenkirchen	Garmisch-Partenkirchen	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Garmisch-Patenkirchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rate of major complications	Recording of all major complication which require hospitalization	day 1
Secondary	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
Secondary	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
Secondary	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