Gastro Esophageal RefluxARATNCT03548298
Antireflux Ablation Therapy (ARAT) for Gastroesophageal Reflux Treatment
A study testing ARAT in people with Gastro Esophageal Reflux, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
Gastroesophageal Reflux Disease (GERD) is defined as the rise of gastric or gastroduodenal contents above the esophagogastric junction (EGJ), generating symptoms and/or esophageal lesions. It is estimated a failure to treatment with PPI(proton pump inhibitor) between 10%-40% of patients with GERD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- ARAT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteMexico
- Study dates
- 10 Jan 2016to 10 Sep 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes of age with a diagnosis of GERD and who are under medical treatment and who do not wish to undergo surgical treatment
- Confirmed diagnosis of GERD in the following way:
- Positive pHmetry
- Positive endoscopy (GERD with esophagitis of any degree) or negative
- Positive symptoms questionnaire for GERD
- Manometry without evidence of esophageal motor disorder
- Total or partial response to proton pump inhibitors
Who cannot join
- Patients who do not accept the signature of the informed consent
- Patients previously treated by surgery for GERD
- Pregnant women.
- Patients with hiatal hernia greater than 3 cm or Hill type IV
- Patients with esophageal motility disorders
- Patients in whom, for any reason, any antireflux surgery or endoscopic treatment has been contraindicated.
Show all 9Show fewer
- Patients who want to undergo surgical treatment as an initial option.
- Patients with portal hypertension and the presence of esophageal varices
- Patients with hemophilia or a haematological disorder that is difficult to control
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro Medico Nacional Siglo XXI, Hospital de Especialidades
Mexico City, 06720
About this study
Official title: Antireflux Ablation Therapy (ARAT) With Hybrid-APC (Argon Plasma Coagulation) for GERD Treatment in Patients Without Hiatal Hernia
Gastroesophageal Reflux Disease (GERD) is defined as the rise of gastric or gastroduodenal contents above the esophagogastric junction (EGJ), generating symptoms and/or esophageal lesions. It is estimated a failure to treatment with PPI(proton pump inhibitor) between 10%-40% of patients with GERD. The main disadvantages of surgical treatment include perforation (0-4%), bleeding (<1%) and pneumothorax (0-10%), the most common late complication is gastric fullness, which occurs in almost all patients, approximately 25% of patients may experience persistent dysphagia 3 months after surgery and the most worrisome late complication is the need of a new surgical intervention. The aims of treatment at EGJ is to reduce gastroesophageal reflux contents into the esophagus. Hybrid-APC with ablation of EGJ (ARAT) is a new technique with could generate a scar remodeling this region and consequently reducing reflux disease. Our objective is to evaluate the safety and efficacy of ARAT in a group of patients with GERD without hiatal hernia.
Read the detailed description
Gastroesophageal reflux disease is a condition in which there is a rise of gastroduodenal contents into the esophageal lumen, causing mucosal damage. Among treatments, medications are the most common used ones but up to 10%-40% doesn't respond to this type of treatment. Surgical treatment has been considered as the gold standard; however, with complications such as bleeding, perforation, or dysphagia after surgery. Moreover, not all patients are candidates to receive this type of treatment. Based on these data, new techniques have been explored in order to reduce morbidity, mortality and costs in the treatment of these patients.
Among different endoscopical treatments, ablation of EGJ is a new promising technique which can be used to perform a closure at this level throughout the scar secondary to hybrid-APC treatment, consequently decreasing gastroesophageal reflux. So, the aim of this study is to evaluate safety and efficacy of ARAT in a group of patients with confirmed GERD.
This is a quasi experimental study that will be conducted in a tertiary care center in Mexico city, Mexico. In an endoscopy department at the Mexican Institute of Social Security between January 2018 and July 2019. Those patients diagnosed with gastroesophageal reflux who are candidates and who accept this type of treatment will be evaluated. Patients who meet the inclusion criteria will be the definitive candidates. The risks and benefits of this type of endoscopic treatment will be explained as well as the potential scope of this endoscopic alternative. We will evaluate safety and efficacy of this new procedure.
The technique of the procedure involves ablation of the mucosa of the EGJ using Hybrid-APC (ARAT). The ablation field is initially marked with a Hybrid-APC. Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature. The approximate duration of the procedure is 40min.
Follow-up will include objective evaluation of reflux disease with: upper endoscopy, manometry, pHmetry, reflux questionnaire, and need of PPI (proton-pump inhibitor) dose quantification.
- Conditions
- Gastro Esophageal Reflux
- Being tested
- ARAT
- Keywords
- GERD, Hybrid-APC, efficacy, safety, ARAT
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARATProcedure or surgery
After confirmation of GERD, participants will undergo to ablation with Hybrid-APC (ARAT). Participant will be admitted to hospital 24 hrs before procedure. Technique consist in ablation with hybrid-APC, submucosal injection of saline solution with methylene blue at 3-4 cm from 60-70% cardias and 1 cm esophageal. After procedure they will be kept on surveillance and will be followed-up with clinical, endoscopic, esophageal manometry and pHmetry up to 1 year after procedure.
| Study group | Role | What they receive |
|---|---|---|
| GERD without hiatal hernia | Experimental | Participants with GERD without hernia hiatal will receive ARAT Receives: Procedure: ARAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of ARAT with Hybrid-APC in patients with GERD without hiatal hernia
The efficacy of this treatment will be defined as: The decrease of ≥ 50 percent of the total percentage of acid exposure at 24 hrs (DeMeester Score)
Measured: One year
Secondary outcomes (1)
Safety of ARAT with hybrid-APC in patients with GERD without hiatal hernia
We will document any adverse event presented during or after application of ARAT therapy
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 posted7 Jun 2018
- Study start10 Jan 2016
- Primary completion1 Jul 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Gastro Esophageal RefluxStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Men and women with diagnosis of GERD confirmed by endoscopy or pHmetry, GERD questionnaire and that accept this new treatment.
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Oscar V Hernández Mondragón, MD, Principal investigator, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548298
- Sponsor's protocol ID
- R-2018-3601-014
- Acronym
- ARAT
- Status last verified
- Jul 2019
- First submitted
- 23 May 2018
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mezerville Cantillo Ld, Cabas Sanchez J, Contreras F, Castellanos Garcia LF, Dondis JE, Galdamez J, Garcia-Maradiaga R, Grullon Dickson F, Jerez Gonzalez LE, Mayo DiBello M, Mejia Rivas MA, Moreno Padilla P, Sanchez Hernandez MA, Velasco SR, Vela MF, Valdovinos-Diaz MA, Remes-Troche JM. [Practice guideline of the Centroamerican and Carribean Association of Gastroenterology and Gastrointestinal Endoscopy for the management of gastroesophageal reflux disease]. Acta Gastroenterol Latinoam. 2014 Jun;44(2):138-53. No abstract available. Spanish.
PubMed 25199309Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available.
PubMed 23419381Bolier EA, Kessing BF, Smout AJ, Bredenoord AJ. Systematic review: questionnaires for assessment of gastroesophageal reflux disease. Dis Esophagus. 2015 Feb-Mar;28(2):105-20. doi: 10.1111/dote.12163. Epub 2013 Dec 18.
PubMed 24344627Hansdotter I, Bjor O, Andreasson A, Agreus L, Hellstrom P, Forsberg A, Talley NJ, Vieth M, Wallner B. Hill classification is superior to the axial length of a hiatal hernia for assessment of the mechanical anti-reflux barrier at the gastroesophageal junction. Endosc Int Open. 2016 Mar;4(3):E311-7. doi: 10.1055/s-0042-101021. Epub 2016 Feb 10.
PubMed 27004249Villa N, Vela MF. Impedance-pH testing. Gastroenterol Clin North Am. 2013 Mar;42(1):17-26. doi: 10.1016/j.gtc.2012.11.003.
PubMed 23452628Wileman SM, McCann S, Grant AM, Krukowski ZH, Bruce J. Medical versus surgical management for gastro-oesophageal reflux disease (GORD) in adults. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD003243. doi: 10.1002/14651858.CD003243.pub2.
PubMed 20238321Nabi Z, Reddy DN. Endoscopic Management of Gastroesophageal Reflux Disease: Revisited. Clin Endosc. 2016 Sep;49(5):408-416. doi: 10.5946/ce.2016.133. Epub 2016 Sep 30.
PubMed 27744659Inoue 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 25330784Manner 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 25360316Manner H, May A, Kouti I, Pech O, Vieth M, Ell C. Efficacy and safety of Hybrid-APC for the ablation of Barrett's esophagus. Surg Endosc. 2016 Apr;30(4):1364-70. doi: 10.1007/s00464-015-4336-1. Epub 2015 Jun 24.
PubMed 26104794Hernandez Mondragon OV, Zamarripa Mottu RA, Garcia Contreras LF, Gutierrez Aguilar RA, Solorzano Pineda OM, Blanco Velasco G, Murcio Perez E. Clinical feasibility of a new antireflux ablation therapy on gastroesophageal reflux disease (with video). Gastrointest Endosc. 2020 Dec;92(6):1190-1201. doi: 10.1016/j.gie.2020.04.046. Epub 2020 Apr 25.
PubMed 32343977
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antireflux Ablation Therapy (ARAT) With Hybrid-APC (Argon Plasma Coagulation) for GERD Treatment in Patients Without Hiatal Hernia
- ClinicalTrials.gov ID
- NCT03548298
- Acronym / sponsor ID
- ARAT / R-2018-3601-014
- Conditions
- Gastro Esophageal Reflux
- Keywords
- GERD, Hybrid-APC, efficacy, safety, ARAT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 7 Jun 2018 (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 defined as the rise of gastric or gastroduodenal contents above the esophagogastric junction (EGJ), generating symptoms and/or esophageal lesions. It is estimated a failure to treatment with PPI(proton pump inhibitor) between 10%-40% of patients with GERD. The main disadvantages of surgical treatment include perforation (0-4%), bleeding (<1%) and pneumothorax (0-10%), the most common late complication is gastric fullness, which occurs in almost all patients, approximately 25% of patients may experience persistent dysphagia 3 months after surgery and the most worrisome late complication is the need of a new surgical intervention. The aims of treatment at EGJ is to reduce gastroesophageal reflux contents into the esophagus. Hybrid-APC with ablation of EGJ (ARAT) is a new technique with could generate a scar remodeling this region and consequently reducing reflux disease. Our objective is to evaluate the safety and efficacy of ARAT in a group of patients with GERD without hiatal hernia.
Detailed description
Gastroesophageal reflux disease is a condition in which there is a rise of gastroduodenal contents into the esophageal lumen, causing mucosal damage. Among treatments, medications are the most common used ones but up to 10%-40% doesn't respond to this type of treatment. Surgical treatment has been considered as the gold standard; however, with complications such as bleeding, perforation, or dysphagia after surgery. Moreover, not all patients are candidates to receive this type of treatment. Based on these data, new techniques have been explored in order to reduce morbidity, mortality and costs in the treatment of these patients.
Among different endoscopical treatments, ablation of EGJ is a new promising technique which can be used to perform a closure at this level throughout the scar secondary to hybrid-APC treatment, consequently decreasing gastroesophageal reflux. So, the aim of this study is to evaluate safety and efficacy of ARAT in a group of patients with confirmed GERD.
This is a quasi experimental study that will be conducted in a tertiary care center in Mexico city, Mexico. In an endoscopy department at the Mexican Institute of Social Security between January 2018 and July 2019. Those patients diagnosed with gastroesophageal reflux who are candidates and who accept this type of treatment will be evaluated. Patients who meet the inclusion criteria will be the definitive candidates. The risks and benefits of this type of endoscopic treatment will be explained as well as the potential scope of this endoscopic alternative. We will evaluate safety and efficacy of this new procedure.
The technique of the procedure involves ablation of the mucosa of the EGJ using Hybrid-APC (ARAT). The ablation field is initially marked with a Hybrid-APC. Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature. The approximate duration of the procedure is 40min.
Follow-up will include objective evaluation of reflux disease with: upper endoscopy, manometry, pHmetry, reflux questionnaire, and need of PPI (proton-pump inhibitor) dose quantification.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Men and women with diagnosis of GERD confirmed by endoscopy or pHmetry, GERD questionnaire and that accept this new treatment.
| Arm | Type | Receives |
|---|---|---|
| GERD without hiatal hernia | Experimental | Procedure: ARATParticipants with GERD without hernia hiatal will receive ARAT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes of age with a diagnosis of GERD and who are under medical treatment and who do not wish to undergo surgical treatment
- Confirmed diagnosis of GERD in the following way:
- Positive pHmetry
- Positive endoscopy (GERD with esophagitis of any degree) or negative
- Positive symptoms questionnaire for GERD
Key exclusion criteria (9 listed)
- Patients who do not accept the signature of the informed consent
- Patients previously treated by surgery for GERD
- Pregnant women.
- Patients with hiatal hernia greater than 3 cm or Hill type IV
- Patients with esophageal motility disorders
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 |
|---|---|---|
| ARATAfter confirmation of GERD, participants will undergo to ablation with Hybrid-APC (ARAT). Participant will be admitted to hospital 24 hrs before procedure. Technique consist in ablation with hybrid-APC, submucosal injection of saline solution with methylene blue at 3-4 cm from 60-70% cardias and 1 cm esophageal. After procedure they will be kept on surveillance and will be followed-up with clinical, endoscopic, esophageal manometry and pHmetry up to 1 year after procedure. | Procedure or surgery | GERD without hiatal hernia |
Primary outcome
Efficacy of ARAT with Hybrid-APC in patients with GERD without hiatal hernia
Time frame: One year
The efficacy of this treatment will be defined as: The decrease of ≥ 50 percent of the total percentage of acid exposure at 24 hrs (DeMeester Score)
1 secondary outcome
Safety of ARAT with hybrid-APC in patients with GERD without hiatal hernia
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Results publication: PubMed 25199309Mezerville Cantillo Ld, Cabas Sanchez J, Contreras F, Castellanos Garcia LF, Dondis JE, Galdamez J, Garcia-Maradiaga R, Grullon Dickson F, Jerez Gonzalez LE, Mayo DiBello M, Mejia Rivas MA, Moreno Padilla P, Sanchez Hernandez MA, Velasco SR, Vela MF, Valdovinos-Diaz MA, Remes-Troche JM. [Practice guideline of the Centroamerican and Carribean Association of Gastroenterology and Gastrointestinal Endoscopy for the management of gastroesophageal reflux disease]. Acta Gastroenterol Latinoam. 2014 Jun;44(2):138-53. No abstract available. Spanish.
- Results publication: PubMed 23419381Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available.
- Results publication: PubMed 24344627Bolier EA, Kessing BF, Smout AJ, Bredenoord AJ. Systematic review: questionnaires for assessment of gastroesophageal reflux disease. Dis Esophagus. 2015 Feb-Mar;28(2):105-20. doi: 10.1111/dote.12163. Epub 2013 Dec 18.
- Results publication: PubMed 27004249Hansdotter I, Bjor O, Andreasson A, Agreus L, Hellstrom P, Forsberg A, Talley NJ, Vieth M, Wallner B. Hill classification is superior to the axial length of a hiatal hernia for assessment of the mechanical anti-reflux barrier at the gastroesophageal junction. Endosc Int Open. 2016 Mar;4(3):E311-7. doi: 10.1055/s-0042-101021. Epub 2016 Feb 10.
- Results publication: PubMed 23452628Villa N, Vela MF. Impedance-pH testing. Gastroenterol Clin North Am. 2013 Mar;42(1):17-26. doi: 10.1016/j.gtc.2012.11.003.
- Results publication: PubMed 20238321Wileman SM, McCann S, Grant AM, Krukowski ZH, Bruce J. Medical versus surgical management for gastro-oesophageal reflux disease (GORD) in adults. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD003243. doi: 10.1002/14651858.CD003243.pub2.
- Results publication: PubMed 27744659Nabi Z, Reddy DN. Endoscopic Management of Gastroesophageal Reflux Disease: Revisited. Clin Endosc. 2016 Sep;49(5):408-416. doi: 10.5946/ce.2016.133. Epub 2016 Sep 30.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 26104794Manner H, May A, Kouti I, Pech O, Vieth M, Ell C. Efficacy and safety of Hybrid-APC for the ablation of Barrett's esophagus. Surg Endosc. 2016 Apr;30(4):1364-70. doi: 10.1007/s00464-015-4336-1. Epub 2015 Jun 24.
- Derived from this study: PubMed 32343977Hernandez Mondragon OV, Zamarripa Mottu RA, Garcia Contreras LF, Gutierrez Aguilar RA, Solorzano Pineda OM, Blanco Velasco G, Murcio Perez E. Clinical feasibility of a new antireflux ablation therapy on gastroesophageal reflux disease (with video). Gastrointest Endosc. 2020 Dec;92(6):1190-1201. doi: 10.1016/j.gie.2020.04.046. Epub 2020 Apr 25.
- 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 Hernández Mondragón, MD principal investigator
IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARAT in people with Gastro Esophageal Reflux, 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 7 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: finished, as of the sponsor's last update on 18 Sep 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 ARAT with Hybrid-APC in patients with GERD without hiatal hernia (time frame: One year). 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 NCT03548298, which also lists 11 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 18 Sep 2019.