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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06106100
• Other study ID #: 112122-F
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: October 2027

Study information

• Verified date: September 2023
• Source: Far Eastern Memorial Hospital
• Contact: Cheng-Shuan Chung
• Phone: +886 910667236
• Email: chungchenshuan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: October 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

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, 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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	Complication rate	Recording of all complications related to the ARMA procedure	12 months
Secondary	PPI dependency	Requirement and dose of PPI at 3, 6 and 12 months after ARMA	12 months
Secondary	Changes in acid exposure time	Changes in acid exposure time in 24 pH meter at 3 and 12 months after ARMA	12 months
Secondary	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.	12 months
Secondary	Changes in lower esophageal sphincter pressure	Changes in lower esophageal sphincter pressure in high resolution manometry at 3 and 12 months after ARMA	12 months