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

Study Overview
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Brief Summary
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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
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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. st year study:60 patients enrollment, evluation and receiving endoscopy treatment with follow-up nd year study:60 patients enrollment, evluation and receiving endoscopy treatment with follow-up rd year study:30 patients enrollment, evluation and receiving endoscopy treatment with follow-up th year study: complete all patients follow-up, sample processing, data analysis and report writing

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

Conditions
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Gastroesophageal Reflux Disease, Endoscopy

Intervention / Treatment
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* Procedure: Anti-Reflux Mucosectomy
* Procedure: Anti-reflux mucosal ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-75 years of age, History of GERD over 1 year Exclusion Criteria: body mass index (BMI) > 35 Hiatal hernia > 2cm Esophageal ulcer Esophageal stricture Barrett's esophagus (Prague criteria: C>1cm, M>=2cm) Major esophageal motility disorders Gastroparesis Pregnancy or plans for pregnancy in the next 12 months Immunosuppressive therapy Cirrhosis Portal hypertension and/or varices Previous gastric or esophageal surgery Esophageal diverticulum Scleroderma or dermatomyositis Coagulation disorders Anti-platelet or anticoagulants use

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chronic GERD patient reciving Anti-Reflux Mucosal Ablation<br>150 chronic GERD patients will be enrolled from our outpatient clinic. The inclusion criteria are as following: 20-75 years of age, history of GERD over 1 year, who had received daily PPIs or H2 antagonists over 6 month for GERD treatment, and having persistent typical GERD symptoms (acid reflux sensation or heartburn) or atypical GERD symptoms (hoarseness, cough, acid related chest pain, laryngitis) when off PPI or H2 antagonists therapy, defective gastroesophageal Defective junction reciving Anti-Reflux Mucosal Ablation. | Procedure: Anti-reflux mucosal ablation<br>* 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.<br>|
| Active Comparator: Chronic GERD patient reciving Anti-Reflux Mucosectomy<br>150 chronic GERD patients will be enrolled from our outpatient clinic. The inclusion criteria are as following: 20-75 years of age, history of GERD over 1 year, who had received daily PPIs or H2 antagonists over 6 month for GERD treatment, and having persistent typical GERD symptoms (acid reflux sensation or heartburn) or atypical GERD symptoms (hoarseness, cough, acid related chest pain, laryngitis) when off PPI or H2 antagonists therapy, defective gastroesophageal Defective junction reciving Anti-Reflux Mucosectomy | Procedure: Anti-Reflux Mucosectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux synptom improvement after different treatment. | Reflux synptom improvement in 6 months after ARMS and ARMA. Complete remission group will be defined as GERD-Q score of <8 and discontinuing PPI medication. Patients with post- ARMS GERD-Q score of <8 and reduced PPI medication will be allocated to the partial response group. Others will be defined as non-response group. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparisons of GERD DeMeester scores | DeMeester scores using 24 hours PH monitor for comparison of ARMS and ARMA groups. | 12 months | 
| Comparisons of GERD acid exposure time | Acid exposure time using 24 hours PH monitor for comparison of ARMS and ARMA groups. | 12 months | 
| improvement of GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) | improvement ofGERD-Health Related Quality of Life Questionnaire (GERD-HRQL) 6 months after ARMS or ARMA procedure. | 6 months | 
| change of saliva microbiota | change of saliva microbiota before and after ARMS or ARMA procedure. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-Reflux Mucosal Ablation, Gastroesophageal Reflux Disease, Endoscopic intervention, Anti- Reflux Mucosectomy