Clinical trial NCT05425771: ARMA (Antireflux Mucosa Ablation) in Patients With Chronic Refractory Reflux Disease
Official title: ARMA (Antireflux Mucosa Ablation) in Patients With Chronic Refractory Reflux Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastro-esophageal Reflux
Reflux, Gastroesophageal
Keywords: Reflux disease
Endoscopic therapy
Lead sponsor: Klinikum Garmisch-Patenkirchen
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Pilot study of mucosal ablation for therapy refractory reflux disease
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: change of GERD-HRQL
timeFrame: Before and after 2 and 6 Month
measure: Rate of major complications
timeFrame: day 1
Secondary outcomes:
measure: Technical success nominal scale
timeFrame: Day 1
measure: change of DeMeester Score
timeFrame: Before and after 2 and 6 Month
measure: change of reflux events
timeFrame: Before and after 2 and 6 Month
Other outcomes:
Locations:
city: Garmisch-Partenkirchen
country: Germany
facility: Klinikum Garmisch-Partenkirchen
state: Bayern
Study officials:
References: