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

N/ANot Yet RecruitingNCT06106100

Far Eastern Memorial Hospital68 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Interventions

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 procedurePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Improvement of gastroesophageal reflux disease symptoms

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.

Time frame: 3 months

Secondary Outcomes

Complication rate

Recording of all complications related to the ARMA procedure

Time frame: 12 months

PPI dependency

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

Time frame: 12 months

Changes in acid exposure time

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

Time frame: 12 months

Changes in DeMeester score

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

Time frame: 12 months

Changes in lower esophageal sphincter pressure

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

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts