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

Not Applicable

Not yet recruiting

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: NCT06106100
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-10-22
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-10-30
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23
• Study Start: 2024-03
• Primary Completion: 2026-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement of gastroesophageal reflux disease symptoms	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 Outcome Measures

Name	Time	Method
Complication rate	12 months	Recording of all complications related to the ARMA procedure
PPI dependency	12 months	Requirement and dose of PPI at 3, 6 and 12 months after ARMA
Changes in DeMeester score	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.
Changes in acid exposure time	12 months	Changes in acid exposure time in 24 pH meter at 3 and 12 months after ARMA
Changes in lower esophageal sphincter pressure	12 months	Changes in lower esophageal sphincter pressure in high resolution manometry at 3 and 12 months after ARMA