NCT05425771

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Klinikum Garmisch-Patenkirchen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastro-esophageal Reflux
• Reflux, Gastroesophageal

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-14
• Primary completion: 2022-12-31
• Completion: 2023-05-31
• First posted: 2022-06-21
• Last updated: 2022-07-14

Locations

1 site across 1 country: Germany