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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• Improvement of gastroesophageal reflux disease symptoms [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Complication rate [Срок оценки: 12 months]
• PPI dependency [Срок оценки: 12 months]
• Changes in acid exposure time [Срок оценки: 12 months]
• Changes in DeMeester score [Срок оценки: 12 months]
• Changes in lower esophageal sphincter pressure [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06106100 · 112122-F

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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