Gastroesophageal Reflux DiseaseNCT04036942
Antireflux Ablation Therapy (ARAT) Vs Antireflux Mucosectomy (ARMS) In The Management Of Gastroesophageal Reflux Disease
A study testing Ablation of the gastroesophageal junction with hybrid argon plasma and mucosectomy with band of the gastroesophageal junction in people with Gastroesophageal Reflux Disease, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
Gastroesophageal reflux disease has a high global prevalence, proton pump inhibitors are the cornerstone in the management but 10-20% of the patients are refractory to these, surgical treatment being an option of treatment in these patient but its associated with high morbidity, as well as a greater possibility of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Ablation of the gastroesophageal junction with hybrid argon plasma and mucosectomy with band of the gastroesophageal junction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jul 2019to 1 Apr 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes over 18 years and under 90 years with a diagnosis of GERD and who are under medical treatment and who do not want surgical treatment.
- Confirmed diagnosis of GERD as follows:
- Positive pHmetry. Positive endoscopy (Esophagitis grade C, D, stenosis or EB)
- Esophagogastric junction Hill I-III
- Total or partial response to proton pump inhibitors
- Patient who does not wish to take medication for the treatment of gastroesophageal reflux in the long term or indefinitely or refractory GERD
Who cannot join
- Patients who do not accept the signature of the informed consent
- Postoperative fundoplication patients for GERD
- Patients with extraesophageal symptoms.
- Pregnant women.
- Patients with hiatal hernia larger than 3 cm or Hill type IV.
- Patients with major esophageal motility disorders.
Show all 9Show fewer
- Patients with portal hypertension and presence of esophageal varices
- Patients with hemophilia or some haematological disorder that is difficult to control
- Patients with malignant pathology of the esophagus or Gastroesophageal Junction (GEJ).
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro Medico Nacional Siglo XXI Hospital de Especialidades
Mexico City, Mexico City, 06700
About this study
Official title: Ablation Of The Esophagogastric Junction With Hybrid Argon Plasma Vs Mucosectomy With Band in Patients With Gastroesophageal Reflux Disease Without Hiatal Hernia
Gastroesophageal reflux disease has a high global prevalence, proton pump inhibitors are the cornerstone in the management but 10-20% of the patients are refractory to these, surgical treatment being an option of treatment in these patient but its associated with high morbidity, as well as a greater possibility of early therapeutic failure, for these reasons new therapies are in development being the mucosectomy with band and ablation of the esophagogastric junction with hybrid argon plasma options widely available that can offer a viable therapeutic option for patients with difficult control of symptoms or those who does not want to receive continuous medical treatment or surgical treatment. The aims of the study is to evaluate the safety and efficacy of this new techniques in the management or gastroesophageal reflux disease without hiatal hernia.
Read the detailed description
Gastroesophageal reflux disease is a disease with high global prevalence, reaching rates of 19.6 and 40% in our country, for which it is one of the most common reasons for medical care and although a clinical response is obtained in an 80-90% of patients with the use of proton pump inhibitors, the rest of the patients represents a medical challenge; surgical and endoscopic treatment being within the treatment options, the former having a high related morbidity (perforation, vagal nerve injury, postoperative dysphagia, etc), its duration is suboptimal and a second operation is associated with more surgical complications and morbidity, as well as a greater possibility of early therapeutic failure. For all these reasons, new endoluminal therapies have begun to be planned, including transoral fundoplication and radiofrequency ablation of the esophagogastric junction, these with controversial results and with the need of the use of special accessories and instruments that are not widely available; mucosectomy with band and ablation of the esophagogastric junction with hybrid argon plasma are widely available procedures in medical centers, offering a viable therapeutic option for patients with difficult control of symptoms or those who does not want to receive continuous medical treatment or surgical treatment.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Ablation of the gastroesophageal junction with hybrid argon plasma, mucosectomy with band of the gastroesophageal junction
- Keywords
- Gastroesophageal Reflux Disease (GERD), ARAT, ARMS
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation of the gastroesophageal junction with hybrid argon plasmaProcedure or surgery
Also called ARAT
In the management group with argon plasma hybrid after marking 270 degrees of the esophagogastric junction, submucosal elevation and argon plasma burn of the marked and elevated area is performed.
mucosectomy with band of the gastroesophageal junctionProcedure or surgery
Also called ARMS
In the management group with mucosectomy after marking 270 degrees of the esophagogastric junction, a submucosal elevation of the marked area is performed to subsequently perform ligation and resection with a hot snare below the ligation area.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid argon plasma. | Active comparator | After diagnostic endoscopy investigators will proceed to use argon plasma probe for marking 270 grades around the esophagogastric junction preserving part of the mucosa towards the greater curvature, then investigators will use the jet included in the argon plasma probe with effect 20 to 40 system for the injection of the background submucosa in the marking area, applying 0.9% saline solution with methylene blue, to achieve adequate Submucosal elevation for application or argon plasma with high voltages (100 watts, 1.5 liters / min) using forced coagulation mode, applying plasma argon to 1cm above the Z line in the esophageal mucosa and 2cm below it towards the gastric mucosa, argon will be applied until a "carbonization" effect of the mucosa is achieved, once the application of the therapy is performed mucosal lavage and immersion technique to corroborate integrity and continuity of the gastrointestinal tract and rule out immediate complications Receives: Procedure: Ablation of the gastroesophageal junction with hybrid argon plasma |
| Band mucosectomy | Active comparator | After diagnostic endoscopy investigators will proceed to use the tip of a polypectomy snare for marking 270 grades around the esophagogastric junction preserving part of the mucosa towards the greater curvature, then investigators will perform submucosal elevation with the injection of 0.9% saline with carmine indigo and adrenaline 1:10000, after adequate submucosal elevation investigators will proceed with the help of a band ligation cap to suction and release the elastic band in the previously marked and elevated tissue, proceeding to resect the previously ligated tissue with polypectomy loop below the elastic band with forced coagulation (Effect 2, 40 W), until the marked mucosa is completely resected (average used of 5 elastic bands, reviewing the work area for complications like bleeding or perforation. Receives: Procedure: mucosectomy with band of the gastroesophageal junction |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of management with ARAT and ARMS in reducing the total percent acid exposure time
the investigators will compare the percentage of improvement in esophageal Ph metry before and after procedure
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start15 Jul 2019
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: problems with participants enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- 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
- Model description
- A simple randomized, comparative (pretreatment and posttreatment), prospective clinical trial will be carried out among the group of patients managed with ARAT and ARMS
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Oscar V Hernandez Mondragon, MD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036942
- Sponsor's protocol ID
- R-2019-3601-179
- Status last verified
- Apr 2025
- First submitted
- 25 Jul 2019
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hedberg HM, Kuchta K, Ujiki MB. First Experience with Banded Anti-reflux Mucosectomy (ARMS) for GERD: Feasibility, Safety, and Technique (with Video). J Gastrointest Surg. 2019 Jun;23(6):1274-1278. doi: 10.1007/s11605-019-04115-1. Epub 2019 Feb 7.
PubMed 30734179Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362. doi: 10.1136/gutjnl-2017-314722. Epub 2018 Feb 3.
PubMed 29437910Manner H, Neugebauer A, Scharpf M, Braun K, May A, Ell C, Fend F, Enderle MD. The tissue effect of argon-plasma coagulation with prior submucosal injection (Hybrid-APC) versus standard APC: A randomized ex-vivo study. United European Gastroenterol J. 2014 Oct;2(5):383-90. doi: 10.1177/2050640614544315.
PubMed 25360316Inoue H, Ito H, Ikeda H, Sato C, Sato H, Phalanusitthepha C, Hayee B, Eleftheriadis N, Kudo SE. Anti-reflux mucosectomy for gastroesophageal reflux disease in the absence of hiatus hernia: a pilot study. Ann Gastroenterol. 2014;27(4):346-351.
PubMed 25330784Stefanidis D, Hope WW, Kohn GP, Reardon PR, Richardson WS, Fanelli RD; SAGES Guidelines Committee. Guidelines for surgical treatment of gastroesophageal reflux disease. Surg Endosc. 2010 Nov;24(11):2647-69. doi: 10.1007/s00464-010-1267-8. Epub 2010 Aug 20. No abstract available.
PubMed 20725747Gyawali CP, Fass R. Management of Gastroesophageal Reflux Disease. Gastroenterology. 2018 Jan;154(2):302-318. doi: 10.1053/j.gastro.2017.07.049. Epub 2017 Aug 5.
PubMed 28827081Huerta-Iga F, Tamayo-de la Cuesta JL, Noble-Lugo A, Hernandez-Guerrero A, Torres-Villalobos G, Ramos-de la Medina A, Pantoja-Millan JP; el Grupo Mexicano para el Estudio de la Enfermedad por Reflujo Gastroesofagico. [The Mexican consensus on gastroesophageal reflux disease. Part II]. Rev Gastroenterol Mex. 2013 Oct-Dec;78(4):231-9. doi: 10.1016/j.rgmx.2013.05.001. Epub 2013 Nov 28. Spanish.
PubMed 24290724
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation Of The Esophagogastric Junction With Hybrid Argon Plasma Vs Mucosectomy With Band in Patients With Gastroesophageal Reflux Disease Without Hiatal Hernia
- ClinicalTrials.gov ID
- NCT04036942
- Acronym / sponsor ID
- R-2019-3601-179
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal Reflux Disease (GERD), ARAT, ARMS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: problems with participants enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 30 Jul 2019 (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 has a high global prevalence, proton pump inhibitors are the cornerstone in the management but 10-20% of the patients are refractory to these, surgical treatment being an option of treatment in these patient but its associated with high morbidity, as well as a greater possibility of early therapeutic failure, for these reasons new therapies are in development being the mucosectomy with band and ablation of the esophagogastric junction with hybrid argon plasma options widely available that can offer a viable therapeutic option for patients with difficult control of symptoms or those who does not want to receive continuous medical treatment or surgical treatment. The aims of the study is to evaluate the safety and efficacy of this new techniques in the management or gastroesophageal reflux disease without hiatal hernia.
Detailed description
Gastroesophageal reflux disease is a disease with high global prevalence, reaching rates of 19.6 and 40% in our country, for which it is one of the most common reasons for medical care and although a clinical response is obtained in an 80-90% of patients with the use of proton pump inhibitors, the rest of the patients represents a medical challenge; surgical and endoscopic treatment being within the treatment options, the former having a high related morbidity (perforation, vagal nerve injury, postoperative dysphagia, etc), its duration is suboptimal and a second operation is associated with more surgical complications and morbidity, as well as a greater possibility of early therapeutic failure. For all these reasons, new endoluminal therapies have begun to be planned, including transoral fundoplication and radiofrequency ablation of the esophagogastric junction, these with controversial results and with the need of the use of special accessories and instruments that are not widely available; mucosectomy with band and ablation of the esophagogastric junction with hybrid argon plasma are widely available procedures in medical centers, offering a viable therapeutic option for patients with difficult control of symptoms or those who does not want to receive continuous medical treatment or surgical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A simple randomized, comparative (pretreatment and posttreatment), prospective clinical trial will be carried out among the group of patients managed with ARAT and ARMS
| Arm | Type | Receives |
|---|---|---|
| Hybrid argon plasma. | Active comparator | Procedure: Ablation of the gastroesophageal junction with hybrid argon plasmaAfter diagnostic endoscopy investigators will proceed to use argon plasma probe for marking 270 grades around the esophagogastric junction preserving part of the mucosa towards the greater curvature, then investigators will use the jet included in the argon plasma probe with effect 20 to 40 system for the injection of the background submucosa in the marking area, applying 0.9% saline solution with methylene blue, to achieve adequate Submucosal elevation for application or argon plasma with high voltages (100 watts, 1.5 liters / min) using forced coagulation mode, applying plasma argon to 1cm above the Z line in the esophageal mucosa and 2cm below it towards the gastric mucosa, argon will be applied until a "carbonization" effect of the mucosa is achieved, once the application of the therapy is performed mucosal lavage and immersion technique to corroborate integrity and continuity of the gastrointestinal tract and rule out immediate complications |
| Band mucosectomy | Active comparator | Procedure: mucosectomy with band of the gastroesophageal junctionAfter diagnostic endoscopy investigators will proceed to use the tip of a polypectomy snare for marking 270 grades around the esophagogastric junction preserving part of the mucosa towards the greater curvature, then investigators will perform submucosal elevation with the injection of 0.9% saline with carmine indigo and adrenaline 1:10000, after adequate submucosal elevation investigators will proceed with the help of a band ligation cap to suction and release the elastic band in the previously marked and elevated tissue, proceeding to resect the previously ligated tissue with polypectomy loop below the elastic band with forced coagulation (Effect 2, 40 W), until the marked mucosa is completely resected (average used of 5 elastic bands, reviewing the work area for complications like bleeding or perforation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of both sexes over 18 years and under 90 years with a diagnosis of GERD and who are under medical treatment and who do not want surgical treatment.
- Confirmed diagnosis of GERD as follows:
- Positive pHmetry. Positive endoscopy (Esophagitis grade C, D, stenosis or EB)
- Esophagogastric junction Hill I-III
- Total or partial response to proton pump inhibitors
Key exclusion criteria (9 listed)
- Patients who do not accept the signature of the informed consent
- Postoperative fundoplication patients for GERD
- Patients with extraesophageal symptoms.
- Pregnant women.
- Patients with hiatal hernia larger than 3 cm or Hill type IV.
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 |
|---|---|---|
| Ablation of the gastroesophageal junction with hybrid argon plasmaAlso: ARATIn the management group with argon plasma hybrid after marking 270 degrees of the esophagogastric junction, submucosal elevation and argon plasma burn of the marked and elevated area is performed. | Procedure or surgery | Hybrid argon plasma. |
| mucosectomy with band of the gastroesophageal junctionAlso: ARMSIn the management group with mucosectomy after marking 270 degrees of the esophagogastric junction, a submucosal elevation of the marked area is performed to subsequently perform ligation and resection with a hot snare below the ligation area. | Procedure or surgery | Band mucosectomy |
Primary outcome
efficacy of management with ARAT and ARMS in reducing the total percent acid exposure time
Time frame: 3, 6 and 12 months
the investigators will compare the percentage of improvement in esophageal Ph metry before and after procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 30734179Hedberg HM, Kuchta K, Ujiki MB. First Experience with Banded Anti-reflux Mucosectomy (ARMS) for GERD: Feasibility, Safety, and Technique (with Video). J Gastrointest Surg. 2019 Jun;23(6):1274-1278. doi: 10.1007/s11605-019-04115-1. Epub 2019 Feb 7.
- Background: PubMed 29437910Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362. doi: 10.1136/gutjnl-2017-314722. Epub 2018 Feb 3.
- Background: PubMed 25360316Manner H, Neugebauer A, Scharpf M, Braun K, May A, Ell C, Fend F, Enderle MD. The tissue effect of argon-plasma coagulation with prior submucosal injection (Hybrid-APC) versus standard APC: A randomized ex-vivo study. United European Gastroenterol J. 2014 Oct;2(5):383-90. doi: 10.1177/2050640614544315.
- Background: PubMed 25330784Inoue H, Ito H, Ikeda H, Sato C, Sato H, Phalanusitthepha C, Hayee B, Eleftheriadis N, Kudo SE. Anti-reflux mucosectomy for gastroesophageal reflux disease in the absence of hiatus hernia: a pilot study. Ann Gastroenterol. 2014;27(4):346-351.
- Background: PubMed 20725747Stefanidis D, Hope WW, Kohn GP, Reardon PR, Richardson WS, Fanelli RD; SAGES Guidelines Committee. Guidelines for surgical treatment of gastroesophageal reflux disease. Surg Endosc. 2010 Nov;24(11):2647-69. doi: 10.1007/s00464-010-1267-8. Epub 2010 Aug 20. No abstract available.
- Background: PubMed 28827081Gyawali CP, Fass R. Management of Gastroesophageal Reflux Disease. Gastroenterology. 2018 Jan;154(2):302-318. doi: 10.1053/j.gastro.2017.07.049. Epub 2017 Aug 5.
- Background: PubMed 24290724Huerta-Iga F, Tamayo-de la Cuesta JL, Noble-Lugo A, Hernandez-Guerrero A, Torres-Villalobos G, Ramos-de la Medina A, Pantoja-Millan JP; el Grupo Mexicano para el Estudio de la Enfermedad por Reflujo Gastroesofagico. [The Mexican consensus on gastroesophageal reflux disease. Part II]. Rev Gastroenterol Mex. 2013 Oct-Dec;78(4):231-9. doi: 10.1016/j.rgmx.2013.05.001. Epub 2013 Nov 28. Spanish.
- 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.
Oscar V Hernandez Mondragon, MD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation of the gastroesophageal junction with hybrid argon plasma and mucosectomy with band of the gastroesophageal junction in people with Gastroesophageal Reflux Disease, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 24 Apr 2025. 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 Mexico. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of management with ARAT and ARMS in reducing the total percent acid exposure time (time frame: 3, 6 and 12 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 NCT04036942, which also lists 7 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 24 Apr 2025.