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

NCT04065516 | Enrolling By Invitation DMC

• 1 other identifier: R-2019-3601-135
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Achalasia; Gastroesophageal Reflux

Keywords

Achalasia; Gastroesophageal Reflux; Argon Plasma Coagulation; Peroral Endoscopic Myotomy

Outcome Measures

Primary Outcomes (3)

• 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

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

• 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)

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

• 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

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

Study Arms (1)

Argon Plasma Coagulation of the gastroesophageal junction

EXPERIMENTAL

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

Procedure: ARAT technique

Interventions

ARAT technique PROCEDURE

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.

Argon Plasma Coagulation of the gastroesophageal junction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Centro Medico Nacional Siglo XXI Hospital de Especialidades

Mexico City, Mexico City, 06700, Mexico

Location

Related Publications (5)

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

  PMID: 25965233 BACKGROUND

• 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.

  PMID: 23871090 BACKGROUND

• 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.

  PMID: 23877351 BACKGROUND

• 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.

  PMID: 27617421 BACKGROUND

• 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.

  PMID: 30169645 BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Oscar V Hernandez, MD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 22, 2019
• Study Start: July 3, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)