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NCT Number: NCT06106100

Anti-reflux Mucosal Ablation Therapy Randomized Sham Control Trial for Gastroesophageal Reflux Disease

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Antireflux mucosal ablation

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, 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, sparing the greater curvature site of cardia, is done. After marking, mucosal ablation (forced coagulation mode, 1L/min, 80W) is performed at marking site in a hoarse-shoe shape. Adequate ablation depth is defined as reaching the submucosal layer with blackish discolored tissue with carbonization

Sham Procedure

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 outcomes

  1. Improvement of gastroesophageal reflux disease symptoms

    Time frame: 3 months

    Clinical success is defined as more than 50% improvement of the GERD-HRQL questionnaire at 3 months after the ARMA procedure. The results are from minimal 0 points up to 50 points. The higher the points, the greater the symptoms.

Secondary outcomes

  1. Complication rate

    Time frame: 12 months

    Recording of all complications related to the ARMA procedure

  2. PPI dependency

    Time frame: 12 months

    Requirement and dose of PPI at 3, 6 and 12 months after ARMA

  3. Changes in acid exposure time

    Time frame: 12 months

    Changes in acid exposure time in 24 pH meter at 3 and 12 months after ARMA

  4. Changes in DeMeester score

    Time frame: 12 months

    Changes in DeMeester score in 24 pH meter at 3 and 12 months after ARMA. A DeMeester score of ≤ 14.72 is considered physiological.

  5. Changes in lower esophageal sphincter pressure

    Time frame: 12 months

    Changes in lower esophageal sphincter pressure in high resolution manometry at 3 and 12 months after ARMA

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng-Shuan Chung

CONTACT

[email protected]

+886 910667236

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

Efficacy and Safety of Endoscopic Anti-reflux Mucosal Ablation Therapy for Gastroesophageal Reflux Disease: a Single Blind Randomized Sham Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 30, 2023
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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