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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05422404
• Other study ID #: 2021-02-003C
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Yen po Wang
• Phone: +886-921682101
• Email: ulnafu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Endoscopy
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Procedure:
• Anti-Reflux Mucosectomy
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.
• Anti-reflux mucosal ablation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparisons of GERD DeMeester scores	DeMeester scores using 24 hours PH monitor for comparison of ARMS and ARMA groups.	12 months
Secondary	Comparisons of GERD acid exposure time	Acid exposure time using 24 hours PH monitor for comparison of ARMS and ARMA groups.	12 months
Secondary	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
Secondary	change of saliva microbiota	change of saliva microbiota before and after ARMS or ARMA procedure.	2 months