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AzTrials

AchalasiaARATNCT04065516

ARAT for Reflux Disease After Peroral Endoscopic Myotomy in Patients With Achalasia

A study testing ARAT technique in people with Achalasia and Gastroesophageal Reflux, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

The peroral endoscopic myotomy for the treatment of achalasia is associated with a higher incidence of gastroesophageal reflux disease compared with Heller's myotomy. Remodeling of the esophagogastric junction with hybrid argon plasma could decrease the passage of gastric or gastroduodenal content into the esophagus. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Achalasia, Gastroesophageal Reflux
What is being tested?
ARAT technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteMexico
Study dates
3 Jul 2019to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Achalasia type I, II, III
  • Treatment with POEM (Peroral Endoscopic Myotomy)
  • Abnormal acid exposure (>6%) in the 24h-pHmetry test more than three months after the procedure
  • Signed informed consent

Who cannot join

  • Patients who do not accept the treatment
  • Previous antireflux surgery
  • Previous Heller's Myotomy
  • Hiatal hernia greater than 3 centimeters
  • Hill's Classification Grade IV
  • Pregnancy
  • Patients with any contraindication for an endoscopy
  • Patients with esophageal or gastric varices

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mexico1 site

  • Centro Medico Nacional Siglo XXI Hospital de Especialidades

    Mexico City, Mexico City, 06700

Other trials in Mexico

About this study

Official title: Safety and Efficacy of Antireflux Ablation Therapy (ARAT) at Esophagogastric Junction in Patients With Reflux Disease After Peroral Endoscopic Myotomy (POEM) in Achalasia

The peroral endoscopic myotomy for the treatment of achalasia is associated with a higher incidence of gastroesophageal reflux disease compared with Heller's myotomy. Remodeling of the esophagogastric junction with hybrid argon plasma could decrease the passage of gastric or gastroduodenal content into the esophagus.

Read the detailed description

Achalasia is the inability of the lower esophageal sphincter to relax in the context of dysfunction of esophageal peristalsis. Peroral endoscopic myotomy for the treatment of achalasia has an efficacy above 90%, being comparable with Heller's myotomy. The treatment of achalasia by peroral endoscopic myotomy is associated with a higher incidence of gastroesophageal reflux disease, compared with alternative therapies such as Heller's myotomy or pneumatic dilatation. Hybrid argon plasma at the level of the esophagogastric junction could generate remodeling of this region generating a partial stenosis and thereby decrease the passage of gastric or gastroduodenal content into the esophagus.

A clinical trial will be carried out, including all patients with achalasia, treated by peroral myotomy older than 18 years old, with abnormal acid exposure in the pHmetry test 3 months or more after treatment, who accept the management of ablation with hybrid argon plasma. To whom the ablation will be performed with Hybrid Argon Plasma and its effectiveness will be evaluated by clinical questionnaires, endoscopy and pHmetry measurement at the beginning, 3 months, 6 months and 12 months after the procedure.

Demographic and clinical data will be recorded in a data collection sheet, detailing the reflux questionnaire(GERDQ), Eckardt score, endoscopic findings of esophagitis according to Los Angeles classification and abnormal acid exposure in each evaluation. The data will be condensed into a database for subsequent statistical analysis and publication of results.

Being tested
ARAT technique
Keywords
Achalasia, Gastroesophageal Reflux, Argon Plasma Coagulation, Peroral Endoscopic Myotomy
Medical subject headings
Esophageal Achalasia, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARAT techniqueProcedure or surgery

    After an initial endoscopic evaluation, ARAT technique will be performed with marking, submucosal elevation at esophagogastric junction and then ablation with 100-120w of 270-300 degrees at esophagogastric junction, once the application of the therapy is performed mucosal lavage and immersion technique will be made to corroborate integrity and continuity of the gastrointestinal tract and rule out immediate complications.

Study groups in NCT04065516
Study groupRoleWhat they receive
Argon Plasma Coagulation of the gastroesophageal junctionExperimentalParticipants with abnormal acid exposure after peroral endoscopic myotomy for achalasia, will be treated by ablation of the gastroesophageal junction with hybrid argon plasma coagulation
Receives: Procedure: ARAT technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A change in erosive esophagitis grade assessed by upper endoscopy after ARAT

    Upper endoscopy is going to be used to measure the erosive esophagitis grade using the Los Angeles Esophagitis scale(grade A=mild, Grade B=moderate, Grade C=moderate high and Grade D=severe) after after ARAT

    Measured: measures will be performed at 3,6 and 12 months after ARAT

  2. A change in esophageal acid exposure assessed by pHmetry study after ARAT

    A 24-hours pHmetry study is going to be used to measure esophageal acid exposure in esophagus after ARAT. DeMeester Score and the percentage of esophagic acid exposure will be used to assess pathologic reflux (>14.73 and > 6%, respectively)

    Measured: measures will be performed at 3,6 and 12 months after ARAT

  3. A change in clinical symptoms of reflux disease assessed with a gastroesophageal reflux questionnaire after ARAT

    The clinical evaluation of reflux disease is going to be assessed by the use of a clinical gastroesophageal reflux disease questionnaire (GERD-Q) after ARAT. Reflux disease was considered positive when >4 points is observed

    Measured: measures will be performed at 3,6 and 12 months after ARAT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2019
  2. Study start3 Jul 2019
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
A clinical trial will be carried out, including all patients with achalasia, treated by peroral myotomy older than 18 years old, with abnormal acid exposure in the pHmetry test 3 months or more after treatment, who accept the management of ablation with hybrid argon plasma. To whom the ablation will be performed with Hybrid Argon Plasma and its effectiveness will be evaluated by clinical questionnaires, endoscopy and pH measurement at the beginning, 2 months, 6 months and 12 months after the procedure.
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04065516
Sponsor's protocol ID
R-2019-3601-135
Acronym
ARAT
Status last verified
Apr 2025
First submitted
26 Jul 2019
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pandolfino JE, Gawron AJ. Achalasia: a systematic review. JAMA. 2015 May 12;313(18):1841-52. doi: 10.1001/jama.2015.2996.

    PubMed 25965233

  • Boeckxstaens GE, Zaninotto G, Richter JE. Achalasia. Lancet. 2014 Jan 4;383(9911):83-93. doi: 10.1016/S0140-6736(13)60651-0. Epub 2013 Jul 17.

    PubMed 23871090

  • Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. Am J Gastroenterol. 2013 Aug;108(8):1238-49; quiz 1250. doi: 10.1038/ajg.2013.196. Epub 2013 Jul 23.

    PubMed 23877351

  • Akintoye E, Kumar N, Obaitan I, Alayo QA, Thompson CC. Peroral endoscopic myotomy: a meta-analysis. Endoscopy. 2016 Dec;48(12):1059-1068. doi: 10.1055/s-0042-114426. Epub 2016 Sep 12.

    PubMed 27617421

  • Zaninotto G, Bennett C, Boeckxstaens G, Costantini M, Ferguson MK, Pandolfino JE, Patti MG, Ribeiro U Jr, Richter J, Swanstrom L, Tack J, Triadafilopoulos G, Markar SR, Salvador R, Faccio L, Andreollo NA, Cecconello I, Costamagna G, da Rocha JRM, Hungness ES, Fisichella PM, Fuchs KH, Gockel I, Gurski R, Gyawali CP, Herbella FAM, Holloway RH, Hongo M, Jobe BA, Kahrilas PJ, Katzka DA, Dua KS, Liu D, Moonen A, Nasi A, Pasricha PJ, Penagini R, Perretta S, Sallum RAA, Sarnelli G, Savarino E, Schlottmann F, Sifrim D, Soper N, Tatum RP, Vaezi MF, van Herwaarden-Lindeboom M, Vanuytsel T, Vela MF, Watson DI, Zerbib F, Gittens S, Pontillo C, Vermigli S, Inama D, Low DE. The 2018 ISDE achalasia guidelines. Dis Esophagus. 2018 Sep 1;31(9). doi: 10.1093/dote/doy071.

    PubMed 30169645

Questions about this trial

What is this clinical trial studying?

A study testing ARAT technique in people with Achalasia and Gastroesophageal 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 4 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: enrolling by invitation, as of the sponsor's last update on 25 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?

This study is still under way. Results are not available in the source record yet.

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?

A change in erosive esophagitis grade assessed by upper endoscopy after ARAT (time frame: measures will be performed at 3,6 and 12 months after ARAT). The study lists 3 primary outcomes in all. 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 NCT04065516, which also lists 5 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 25 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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