Gastroesophageal Reflux DiseaseNCT05422404
Anti-Reflux Mucosal Ablation(ARMA) and Anti-Reflux Mucosectomy(ARMS) in Gastroesophageal Reflux Disease
A study testing Anti-Reflux Mucosectomy and Anti-reflux mucosal ablation in people with Gastroesophageal Reflux Disease and Endoscopy, run by Taipei Veterans General Hospital, Taiwan.
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Endoscopy
- What is being tested?
- Anti-Reflux Mucosectomy and Anti-reflux mucosal ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-75 years of age,
- History of GERD over 1 year
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Anti-Reflux Mucosal Ablation(ARMA) With Anti- Reflux Mucosectomy(ARMS) in Treatment of Gastroesophageal Reflux Disease- A Randomized Controlled Trial
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.
Read the 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
- Conditions
- Gastroesophageal Reflux Disease, Endoscopy
- Being tested
- Anti-Reflux Mucosectomy, Anti-reflux mucosal ablation
- Keywords
- Anti-Reflux Mucosal Ablation, Gastroesophageal Reflux Disease, Endoscopic intervention, Anti- Reflux Mucosectomy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Reflux MucosectomyProcedure or surgery
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 ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic GERD patient reciving Anti-Reflux Mucosal Ablation | Experimental | 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. Receives: Procedure: Anti-reflux mucosal ablation |
| Chronic GERD patient reciving Anti-Reflux Mucosectomy | Active comparator | 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 Receives: Procedure: Anti-Reflux Mucosectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Comparisons of GERD DeMeester scores
DeMeester scores using 24 hours PH monitor for comparison of ARMS and ARMA groups.
Measured: 12 months
Comparisons of GERD acid exposure time
Acid exposure time using 24 hours PH monitor for comparison of ARMS and ARMA groups.
Measured: 12 months
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.
Measured: 6 months
change of saliva microbiota
change of saliva microbiota before and after ARMS or ARMA procedure.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start30 Jun 2022 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yen po Wang, Study director, Taipei veteran general hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422404
- Sponsor's protocol ID
- 2021-02-003C
- Status last verified
- Jun 2022
- First submitted
- 19 May 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28232473Chen 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.
PubMed 17881927Hung 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.
PubMed 21517967
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anti-Reflux Mucosal Ablation(ARMA) With Anti- Reflux Mucosectomy(ARMS) in Treatment of Gastroesophageal Reflux Disease- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05422404
- Acronym / sponsor ID
- 2021-02-003C
- Conditions
- Gastroesophageal Reflux Disease, Endoscopy
- Keywords
- Anti-Reflux Mucosal Ablation, Gastroesophageal Reflux Disease, Endoscopic intervention, Anti- Reflux Mucosectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic GERD patient reciving Anti-Reflux Mucosal Ablation | Experimental | Procedure: Anti-reflux mucosal ablation150 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. |
| Chronic GERD patient reciving Anti-Reflux Mucosectomy | Active comparator | Procedure: Anti-Reflux Mucosectomy150 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 |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20-75 years of age,
- History of GERD over 1 year
Key exclusion criteria (16 listed)
- body mass index (BMI) > 35
- Hiatal hernia > 2cm
- Esophageal ulcer
- Esophageal stricture
- Barrett's esophagus (Prague criteria: C>1cm, M>=2cm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Reflux MucosectomyARMS 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. | Procedure or surgery | Chronic GERD patient reciving Anti-Reflux Mucosectomy |
| Anti-reflux mucosal ablationARMA 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. | Procedure or surgery | Chronic GERD patient reciving Anti-Reflux Mucosal Ablation |
Primary outcome
Reflux synptom improvement after different treatment.
Time frame: 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.
4 secondary outcomes
Comparisons of GERD DeMeester scores
Time frame: 12 months
Comparisons of GERD acid exposure time
Time frame: 12 months
improvement of GERD-Health Related Quality of Life Questionnaire (GERD-HRQL)
Time frame: 6 months
change of saliva microbiota
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Background: PubMed 28232473Eusebi 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.
- Background: PubMed 17881927Chen 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.
- Background: PubMed 21517967Hung 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.
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen po Wang study director
Taipei veteran general hospital
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Reflux Mucosectomy and Anti-reflux mucosal ablation in people with Gastroesophageal Reflux Disease and Endoscopy, run by Taipei Veterans General Hospital, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yen po Wang (+886-921682101, ulnafu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux synptom improvement after different treatment. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05422404, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.