Gastroesophageal Reflux Disease With UlcerationMARRGONCT05745012
Anti-Reflux Mucosectomy in the Treatment of Refractory Gastro-esophageal Reflux
A study testing endoscopic mucosal resection in people with Gastroesophageal Reflux Disease With Ulceration, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Gastroesophageal reflux disease (GERD) is one of the most common digestive diseases in Western countries, affecting 8% of the population in its typical and frequent form. For typical GERD without alarming symptoms, treatment combines PPI therapy and lifestyle modifications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease With Ulceration
- What is being tested?
- endoscopic mucosal resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
- Patient that have read the information form and signed consent
- Patient covered with health insurance
- GERD with typical symptom of pyrosis, or atypical symptoms with clinical symptomatic correlation confirmed by pre-operative Ph-Impedencemetry performed in the last 6 months
- GERD evolving for at least 1 year, and refractory to medical treatment, which is defined by the persistence of daily GERD related symptoms despite PPI at 20mg twice daily associated with local topics and hygiene-dietary measures
- High-resolution manometry (HRM) to eliminate severe motor disorder and research lower esophageal sphincter hypotony performed in the last 6 months
- Eso-gastro-duodenoscopy (EGD) to confirm the absence of severe esophagitis, hiatal hernia, and complicated Barret's esophagus performed in the last 3 months
Who cannot join
- Grade C peptic esophagitis (Los Angeles classification), persisting despite medical treatment at pre-inclusion gastroscopy (< 6 months)
- Hiatal hernia > 2cm at preoperative gastroscopy
- Barret's Esophagus > C0-M2 with relief abnormalities or confirmed high-grade dysplasia (2 endoscopies within 6 months)
- History of esophageal or gastric surgery
- Severe esophageal motility disorder at HRM such as achalasia or spastic disorder (Chicago classification); minor motility disorders may be included
- No french language comprehension
- Patient under tutelle or curatelle
- Patient already enrolled in interventional research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
AP-HM
Marseille, 13015
Jean-Michel Gonzalez, PR, jean-michel.gonzalez@ap-hm.fr
About this study
Official title: Anti-Reflux Mucosectomy (ARMS) in the Treatment of Refractory Gastro-esophageal Reflux (GERD): a Prospective Randomized Comparative Study
Gastroesophageal reflux disease (GERD) is one of the most common digestive diseases in Western countries, affecting 8% of the population in its typical and frequent form. For typical GERD without alarming symptoms, treatment combines PPI therapy and lifestyle modifications. Patients with an incomplete response to optimized PPI therapy have so-called refractory GERD. Anti-reflux mucosectomy (ARMS) is a recent technique that achieves endoscopic fundoplication by scar-induced tissue retraction using a mucosal ligation system combined with resection, known as the banded ligation system (ARM-b) [6]. Several studies have shown efficacy of approximately 65-70% on symptom resolution and quality of life improvement, including our pilot study of 21 patients, and without serious adverse events.
The purpose of this study is therefore to prospectively evaluate in a randomized blinded comparison to a sham procedure and conventional medical follow-up, the efficacy of anti-reflux mucosectomy (ARMS) in the treatment of refractory GERD.
Read more
The hypothesis is that we can achieve a clinical efficacy rate of 65% in the treatment group versus 35% in the control group.
The primary objective is to demonstrate the superiority in terms of clinical efficacy (self-reported symptom-related GERD rate, GERD-SLR) of RAS compared to the sham procedure combined with optimized medical treatment at 1 year. The primary endpoint will be clinical efficacy, defined as a greater than 50% decrease in the number of GERD-associated symptoms, assessed using the GERD-HRQL score.
Secondary objectives will be:
Assessing clinical efficacy at 6 months. Assess the impact on PPI use Assess changes in procedure-induced abnormal esophageal acid exposure by Ph-metry Assess the impact of this technique on patient quality of life; To document the adverse effects of the technique (AGREE, Clavien Dindo and ASGE score) The duration of follow-up will be 1 year, and based on our hypothesis the number of patients to be included will be 130.
- Being tested
- endoscopic mucosal resection, sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic mucosal resectionProcedure or surgery
The procedure consists of performing endoscopic mucosal resection of the 3/4 of the circumference of the esogastric junction using the Duette system (Cook Endoscopy, USA). The procedure will be performed under general anesthesia in an intubated patient, and realized in ambulatory setting.
shamProcedure or surgery
The procedure consists of performing endoscopic exploration, no mucosal resection
| Study group | Role | What they receive |
|---|---|---|
| group A: control group | Sham comparator | Not described Receives: Procedure: sham |
| group B: ARMS procedure | Experimental | Not described Receives: Procedure: endoscopic mucosal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
demonstrate superiority of ARMS
the clinical efficacy defined as the decreasing of self-reported related-symptom GERD assessed using the GERD-HRQL score of more than 50% at one year
Measured: one year
Secondary outcomes (13)
Assessing the clinical efficacy at 6 months
The clinical efficacy, as defined above, at 6 months
Measured: 6 months
Evaluating the impact on PPIs use after ARMS and sham procedures, respectively;
The rate (and the date) of complete disruption of PPIs at 1 year if so, or, in case of decreasing the mean daily or weekly dose compared to before the intervention
Measured: one year
Assessing the changes in abnormal exposure to esophageal acid induced by the procedure
The % time with Ph under 4 on post-operative (3 months) Ph-impedencemetry, compared to pre-operative
Measured: 3 months
Assessing the changes in abnormal exposure to esophageal acid induced by the procedure
the De Meester score. The interpretation of the score is as follows:
- DMS <14.72 No GERD
- DMS 14.72 - 50 Mild GERD
- DMS 51 - 100 Moderate GERD
- DMS >100 Severe GERD
Measured: 3 months
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 2 months These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Measured: 2 months
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 4 months These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Measured: 4 months
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 6 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Measured: 6 months
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 1 year. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Measured: one year
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on SF12 scores at 2 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Measured: 2 months
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on SF12 scores at 4 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Measured: 4 months
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on SF12 scores at 6 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Measured: 6 months
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on SF12 scores at 1 year. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Measured: one year
Documenting the adverse events of the technique;
The adverse events rate of ARMS procedure, evaluated per-operatively and until 30 post-operative days, their severity assessed using the AGREE classification, and their management
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Feb 2023
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease With UlcerationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745012
- Sponsor's protocol ID
- 2022-A00599-34
- Acronym
- MARRGO
- Status last verified
- Feb 2023
- First submitted
- 5 Sep 2022
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Reflux Mucosectomy (ARMS) in the Treatment of Refractory Gastro-esophageal Reflux (GERD): a Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05745012
- Acronym / sponsor ID
- MARRGO / 2022-A00599-34
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Feb 2023 (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.
Gastroesophageal reflux disease (GERD) is one of the most common digestive diseases in Western countries, affecting 8% of the population in its typical and frequent form. For typical GERD without alarming symptoms, treatment combines PPI therapy and lifestyle modifications. Patients with an incomplete response to optimized PPI therapy have so-called refractory GERD. Anti-reflux mucosectomy (ARMS) is a recent technique that achieves endoscopic fundoplication by scar-induced tissue retraction using a mucosal ligation system combined with resection, known as the banded ligation system (ARM-b) [6]. Several studies have shown efficacy of approximately 65-70% on symptom resolution and quality of life improvement, including our pilot study of 21 patients, and without serious adverse events.
The purpose of this study is therefore to prospectively evaluate in a randomized blinded comparison to a sham procedure and conventional medical follow-up, the efficacy of anti-reflux mucosectomy (ARMS) in the treatment of refractory GERD.
The hypothesis is that we can achieve a clinical efficacy rate of 65% in the treatment group versus 35% in the control group.
The primary objective is to demonstrate the superiority in terms of clinical efficacy (self-reported symptom-related GERD rate, GERD-SLR) of RAS compared to the sham procedure combined with optimized medical treatment at 1 year. The primary endpoint will be clinical efficacy, defined as a greater than 50% decrease in the number of GERD-associated symptoms, assessed using the GERD-HRQL score.
Secondary objectives will be:
Assessing clinical efficacy at 6 months. Assess the impact on PPI use Assess changes in procedure-induced abnormal esophageal acid exposure by Ph-metry Assess the impact of this technique on patient quality of life; To document the adverse effects of the technique (AGREE, Clavien Dindo and ASGE score) The duration of follow-up will be 1 year, and based on our hypothesis the number of patients to be included will be 130.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A: control group | Sham comparator | Procedure: sham |
| group B: ARMS procedure | Experimental | Procedure: endoscopic mucosal resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient over 18 years old
- Patient that have read the information form and signed consent
- Patient covered with health insurance
- GERD with typical symptom of pyrosis, or atypical symptoms with clinical symptomatic correlation confirmed by pre-operative Ph-Impedencemetry performed in the last 6 months
- GERD evolving for at least 1 year, and refractory to medical treatment, which is defined by the persistence of daily GERD related symptoms despite PPI at 20mg twice daily associated with local topics and hygiene-dietary measures
Key exclusion criteria (8 listed)
- Grade C peptic esophagitis (Los Angeles classification), persisting despite medical treatment at pre-inclusion gastroscopy (< 6 months)
- Hiatal hernia > 2cm at preoperative gastroscopy
- Barret's Esophagus > C0-M2 with relief abnormalities or confirmed high-grade dysplasia (2 endoscopies within 6 months)
- History of esophageal or gastric surgery
- Severe esophageal motility disorder at HRM such as achalasia or spastic disorder (Chicago classification); minor motility disorders may be included
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 |
|---|---|---|
| endoscopic mucosal resectionThe procedure consists of performing endoscopic mucosal resection of the 3/4 of the circumference of the esogastric junction using the Duette system (Cook Endoscopy, USA). The procedure will be performed under general anesthesia in an intubated patient, and realized in ambulatory setting. | Procedure or surgery | group B: ARMS procedure |
| shamThe procedure consists of performing endoscopic exploration, no mucosal resection | Procedure or surgery | group A: control group |
Primary outcome
demonstrate superiority of ARMS
Time frame: one year
the clinical efficacy defined as the decreasing of self-reported related-symptom GERD assessed using the GERD-HRQL score of more than 50% at one year
13 secondary outcomes
Assessing the clinical efficacy at 6 months
Time frame: 6 months
Evaluating the impact on PPIs use after ARMS and sham procedures, respectively;
Time frame: one year
Assessing the changes in abnormal exposure to esophageal acid induced by the procedure
Time frame: 3 months
Assessing the changes in abnormal exposure to esophageal acid induced by the procedure
Time frame: 3 months
Evaluating the impact of this technique on patients' quality of life;
Time frame: 2 months
Evaluating the impact of this technique on patients' quality of life;
Time frame: 4 months
Evaluating the impact of this technique on patients' quality of life;
Time frame: 6 months
Evaluating the impact of this technique on patients' quality of life;
Time frame: one year
Evaluating the impact of this technique on patients' quality of life;
Time frame: 2 months
Evaluating the impact of this technique on patients' quality of life;
Time frame: 4 months
Evaluating the impact of this technique on patients' quality of life;
Time frame: 6 months
Evaluating the impact of this technique on patients' quality of life;
Time frame: one year
Documenting the adverse events of the technique;
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic mucosal resection in people with Gastroesophageal Reflux Disease With Ulceration, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 7 inclusion and 8 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 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Jean-Michel Gonzalez, MD (0491368737 ext. +33, jean-michel.gonzalez@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
demonstrate superiority of ARMS (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2023.