Anti-reflux Mucosal Ablation Therapy Randomized Sham Control Trial for Gastroesophageal Reflux Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antireflux mucosal ablation, Sham procedure.
- Who it may be relevant to
- Registry conditions: Gastroesophageal Reflux Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Endoscopic Anti-reflux Mucosal Ablation Therapy for Gastroesophageal Reflux Disease: a Single Blind Randomized Sham Controlled Trial
Overview
The goal of this randomized clinical trial is to investigate the efficacy and safety of antireflux mucosal ablation (ARMA) for patients with refractory gastroesophageal reflux disease (GERD). The trial aim to evaluate : * Efficacy of ARMA comparing with medical treatment alone (proton pump inhibitor (PPI)), using GERD-Health Related Quality of Life Questionnaire (GERD- HRQL questionnaire), improvement of acid exposure time and DeMeester score * Safety and complications of ARMA Participants will be randomly divided into 2 groups. The intervention group will be undergone ARMA, and the control group will be undergone sham endoscopic treatment. The primary endpoint will be symptoms relief (GERD-HRQL decreases \> 50%). The secondary endpoint will be dosage adjustment of PPI, complications, improvement of acid exposure time and DeMeester score.
Interventions
- Procedure Antireflux mucosal ablation
Patients are instructed to fast for 6 hours pre-procedurally, which are performed under intravenous propofol sedation. Retroflexion endoscopy to visualize the cardia is performed, followed by mucosa markings with straight-fire APC catheter (ERBE Electromedizin, Tübingen, Germany) in forced coagulation mode (VIO300D, ERBE Electromedizin, Tübingen, Germany, 20W). The marking site at 1-cm and 2-cm distal to squamocolumnar junction at anterior-posterior and lesser curvature site, respectively, spari - Procedure Sham procedure
Patients are instructed to fast for 6 hours pre-procedurally, which are performed under intravenous propofol sedation. Retroflexion endoscopy to visualize the cardia is performed. Using the straight-fire APC catheter to touch the marking sites similar to the treatment group without electrocauterization is performed.
Primary outcome measures
- Improvement of gastroesophageal reflux disease symptoms [Time frame: 3 months]
Secondary outcome measures (5)
- Complication rate [Time frame: 12 months]
- PPI dependency [Time frame: 12 months]
- Changes in acid exposure time [Time frame: 12 months]
- Changes in DeMeester score [Time frame: 12 months]
- Changes in lower esophageal sphincter pressure [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Adults aged over 18 years old
- History of GERD for over 6 months, who had received PPIs for over 6 months but still had symptoms of typical GERD symptoms (GERD-HRQL score of >8, acid reflux sensation or heartburn), and/or other symptoms as lump throat, night cough, acid related chest tightness (without other possible explanation of these symptoms)
- Acid exposure time > 6%
- DeMeester score ≥ 14.72
Exclusion criteria
- Pregnancy
- BMI>=35
- Hiatal hernia > 2cm or Flap Valve Hill grade III/IV
- GERD LA grade C/D or esophageal ulcer
- Abnormal anatomy of esophagus (esophagectomy, stricture, diverticulum)
- Barrett's esophagus with dysplasia
- Esophageal motility disorders
- History of gastroparesis
- Cirrhosis
- Esophageal and gastric varices
- Previous gastric surgery and anti-reflux procedures
- History of scleroderma or dermatomyositis
- Coagulation disorders (Bleeding tendency and coagulopathy)
- History of oncological disease (not active within 2 years)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06106100 · 112122-F