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

Taipei Veterans General Hospital

Status: Not yet enrolling

Conditions: Gastroesophageal Reflux Disease; Endoscopy

Treatments: Procedure: Anti-reflux mucosal ablation; Procedure: Anti-Reflux Mucosectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05422404

2021-02-003C

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Chronic GERD patient reciving Anti-Reflux Mucosal Ablation

Experimental group

Description:

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.

Treatment:

Procedure: Anti-reflux mucosal ablation

Chronic GERD patient reciving Anti-Reflux Mucosectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Anti-Reflux Mucosectomy