NCT05422404

Anti-Reflux Mucosal Ablation(ARMA) and Anti-Reflux Mucosectomy(ARMS) in Gastroesophageal Reflux Disease

Comparison of Anti-Reflux Mucosal Ablation(ARMA) With Anti- Reflux Mucosectomy(ARMS) in Treatment of Gastroesophageal Reflux Disease- A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

According to the current published data and treatment mechanism, ARMS may led to more stenosis while ARMA may be less effective in long term follow-up. The changes of patient's life quality , UGI tract microbiota before and after different endoscopic treatment are also limited. So we want to conduct a exploratory prospective randomized controlled study in evaluating the mucosal healing, demand of PPI, life quality, emotion status, sleep quality, esophageal motility/ acid exposure and saliva microbiota between chronic GERD patients receiving ARMS and ARMA treatment.

Detailed description

In this study, we will enroll 150 patients with chronic GERD. Estimated 40% of patients will be excluded from the inclusion and exclusion criteria. Of 90 patients eligible for the study, estimating 20% may drop out before receiving ARMS or ARMA. Estimated 72 patients will be randomized to receive ARMS or ARMA for GERD treatment. After ARMA, all patients will receive 4 weeks of PPI treatment. Endoscopy and questionnaire follow-up will be performed on week 2, 2 months, 6 months and 12 months after treatment while HRM and 24 hours pH impedance study will be performed 6 months after treatment. The study will be carried out in 4 years. In the 1st to 3rd year of study, estimating 60,60,30 patients will be evaluated and entered the study in the 1st, 2nd and fisr half of 3rd year. Then all the patients will be followed until the first half of 4th year. At the second half of the 4th year, the saliva sample will be processed, data will be analyzed, and the result will be written. 1. st year study:60 patients enrollment, evluation and receiving endoscopy treatment with follow-up 2. nd year study:60 patients enrollment, evluation and receiving endoscopy treatment with follow-up 3. rd year study:30 patients enrollment, evluation and receiving endoscopy treatment with follow-up 4. th year study: complete all patients follow-up, sample processing, data analysis and report writing

Conditions

• Gastroesophageal Reflux Disease
• Endoscopy

Interventions

Type	Name	Description
PROCEDURE	Anti-Reflux Mucosectomy	ARMS will be performed using gastroscope . The preparation and endoscopy procedure will be done as in regular practice with conscious sedation. The upper gastrointestinal tract will be evaluated in detail first. Then Endoscopic mucosal resection(EMR) will performed at E-C junction, gastric cardia side. About 50%-70% of the EGJ circumference will be resected to create artificial ulcer which will lead to mucosal contraction during the healing process.
PROCEDURE	Anti-reflux mucosal ablation	ARMA will be performed using gastroscope . The preparation and endoscopy procedure will be done as in regular practice with conscious sedation. Mucosal ablation will be performed in retroflex fashion following. Then APC with soft coagulation(effect 2, 40W) will be used to mark the area that not going to be ablated at gastric carida over the great curvature direction, about 1.5 scope width. Then submucosa injection with saline and indigo carmine dye will be performed using a 25 guage needle.

Timeline

• Start date: 2022-06-30
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2022-06-16
• Last updated: 2022-06-16