Clinical trial NCT05422404: Anti-Reflux Mucosal Ablation(ARMA) and Anti-Reflux Mucosectomy(ARMS) in Gastroesophageal Reflux Disease
Official title: Comparison of Anti-Reflux Mucosal Ablation(ARMA) With Anti- Reflux Mucosectomy(ARMS) in Treatment of Gastroesophageal Reflux Disease- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Endoscopy
Keywords: Anti-Reflux Mucosal Ablation
Gastroesophageal Reflux Disease
Endoscopic intervention
Anti- Reflux Mucosectomy
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2022-06-16
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Reflux synptom improvement after different treatment.
timeFrame: 6 months
Secondary outcomes:
measure: Comparisons of GERD DeMeester scores
timeFrame: 12 months
measure: Comparisons of GERD acid exposure time
timeFrame: 12 months
measure: improvement of GERD-Health Related Quality of Life Questionnaire (GERD-HRQL)
timeFrame: 6 months
measure: change of saliva microbiota
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Taipei veteran general hospital
name: Yen po Wang
role: STUDY_DIRECTOR
References:
citation: Eusebi LH, Ratnakumaran R, Yuan Y, Solaymani-Dodaran M, Bazzoli F, Ford AC. Global prevalence of, and risk factors for, gastro-oesophageal reflux symptoms: a meta-analysis. Gut. 2018 Mar;67(3):430-440. doi: 10.1136/gutjnl-2016-313589. Epub 2017 Feb 23.
citation: Chen TS, Chang FY. The prevalence and risk factors of reflux esophagitis among adult Chinese population in Taiwan. J Clin Gastroenterol. 2007 Oct;41(9):819-22. doi: 10.1097/01.mcg.0000225658.30803.79.
citation: Hung LJ, Hsu PI, Yang CY, Wang EM, Lai KH. Prevalence of gastroesophageal reflux disease in a general population in Taiwan. J Gastroenterol Hepatol. 2011 Jul;26(7):1164-8. doi: 10.1111/j.1440-1746.2011.06750.x.