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

Not Applicable

Not yet recruiting

• Conditions: Gastroesophageal Reflux Disease; Endoscopy
• Interventions: Procedure: Anti-reflux mucosal ablation; Procedure: Anti-Reflux Mucosectomy

• Registration Number: NCT05422404
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief 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

Study Timeline

• Study First Submitted: 2022-05-19
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-13
• Last Update Submitted: 2022-06-13
• Study First Posted: 2022-06-16
• Last Update Posted: 2022-06-16
• Study Start: 2022-06-30
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic GERD patient reciving Anti-Reflux Mucosal Ablation	Anti-reflux mucosal ablation	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.
Chronic GERD patient reciving Anti-Reflux Mucosectomy	Anti-Reflux Mucosectomy	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

Primary Outcome Measures

Name	Time	Method
Reflux synptom improvement after different treatment.	6 months	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.

Secondary Outcome Measures

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