- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065516
ARAT for Reflux Disease After Peroral Endoscopic Myotomy in Patients With Achalasia (ARAT)
Safety and Efficacy of Antireflux Ablation Therapy (ARAT) at Esophagogastric Junction in Patients With Reflux Disease After Peroral Endoscopic Myotomy (POEM) in Achalasia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mexico City, Mexico, 06700
- Centro Medico Nacional Siglo XXI Hospital de Especialidades
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Argon Plasma Coagulation of the gastroesophageal junction
Participants with abnormal acid exposure after peroral endoscopic myotomy for achalasia, will be treated by ablation of the gastroesophageal junction with hybrid argon plasma coagulation
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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
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measures will be performed at 3,6 and 12 months after ARAT
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A change in esophageal acid exposure assessed by pHmetry study after ARAT
Time Frame: measures will be performed at 3,6 and 12 months after ARAT
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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)
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measures will be performed at 3,6 and 12 months after ARAT
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A change in clinical symptoms of reflux disease assessed with a gastroesophageal reflux questionnaire after ARAT
Time Frame: measures will be performed at 3,6 and 12 months after ARAT
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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
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measures will be performed at 3,6 and 12 months after ARAT
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Collaborators and Investigators
Investigators
- Principal Investigator: Oscar V Hernandez, MD, Instituto Mexicano del Seguro Social
Publications and helpful links
General Publications
- 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.
- Pandolfino JE, Gawron AJ. Achalasia: a systematic review. JAMA. 2015 May 12;313(18):1841-52. doi: 10.1001/jama.2015.2996.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-2019-3601-135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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