Status:
UNKNOWN
Anti-Reflux Mucosal Ablation(ARMA) and Anti-Reflux Mucosectomy(ARMS) in Gastroesophageal Reflux Disease
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Conditions:
Gastroesophageal Reflux Disease
Endoscopy
Eligibility:
All Genders
25-75 years
Phase:
NA
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 trac...
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...
Eligibility Criteria
Inclusion
- 20-75 years of age,
- History of GERD over 1 year
Exclusion
- 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
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05422404
Start Date
June 30 2022
End Date
July 31 2025
Last Update
June 16 2022
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