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

NCT ID: NCT05422404

Last Updated: 2022-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2025-07-31

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

Conditions

Gastroesophageal Reflux Disease; Endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Chronic GERD patient reciving 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.

Group Type: EXPERIMENTAL

Anti-reflux mucosal ablation

Intervention Type: PROCEDURE

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.

Chronic GERD patient reciving 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

Group Type: ACTIVE_COMPARATOR

Anti-Reflux Mucosectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yen po Wang

Role: STUDY_DIRECTOR

Taipei veteran general hospital

Central Contacts

Yen po Wang

Role: CONTACT

ulnafu@gmail.com

+886-921682101

References

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.

Reference Type: BACKGROUND

PMID: 28232473 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17881927 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21517967 (View on PubMed)

Other Identifiers

2021-02-003C

Identifier Type: -

Identifier Source: org_study_id