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

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05422404

Collaborator

(none)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease Endoscopy	Procedure: Anti-Reflux Mucosectomy Procedure: Anti-reflux mucosal ablation	N/A

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.

st year study:60 patients enrollment, evluation and receiving endoscopy treatment with follow-up
nd year study:60 patients enrollment, evluation and receiving endoscopy treatment with follow-up
rd year study:30 patients enrollment, evluation and receiving endoscopy treatment with follow-up
th year study: complete all patients follow-up, sample processing, data analysis and report writing

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 30, 2022

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: 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	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Active Comparator: Chronic GERD patient reciving Anti-Reflux Mucosectomy

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.

Outcome Measures

Primary Outcome Measures

Reflux synptom improvement after different treatment. [6 months]
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.

Secondary Outcome Measures

Comparisons of GERD DeMeester scores [12 months]
DeMeester scores using 24 hours PH monitor for comparison of ARMS and ARMA groups.
Comparisons of GERD acid exposure time [12 months]
Acid exposure time using 24 hours PH monitor for comparison of ARMS and ARMA groups.
improvement of GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) [6 months]
improvement ofGERD-Health Related Quality of Life Questionnaire (GERD-HRQL) 6 months after ARMS or ARMA procedure.
change of saliva microbiota [2 months]
change of saliva microbiota before and after ARMS or ARMA procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Taipei Veterans General Hospital, Taiwan

Investigators

Study Director: Yen po Wang, Taipei veteran general hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Taipei Veterans General Hospital, Taiwan

ClinicalTrials.gov Identifier:

NCT05422404

Other Study ID Numbers:

2021-02-003C

First Posted:

Jun 16, 2022

Last Update Posted:

Jun 16, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Taipei Veterans General Hospital, Taiwan

Anti-Reflux Mucosal Ablation

Gastroesophageal Reflux Disease

Endoscopic intervention

Anti- Reflux Mucosectomy

Additional relevant MeSH terms:

Gastroesophageal Reflux

Esophagitis, Peptic

Study Results

No Results Posted as of Jun 16, 2022