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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065516
Recruitment Status : Enrolling by invitation
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Coordinación de Investigación en Salud, Mexico

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.

Condition or disease Intervention/treatment Phase
Achalasia Gastroesophageal Reflux Procedure: ARAT technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD

Arm Intervention/treatment
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
Procedure: ARAT technique
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.




Primary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    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)

  3. 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 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065516


Locations
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Mexico
Centro Medico Nacional Siglo XXI Hospital de Especialidades
Mexico City, Mexico, 06700
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
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Principal Investigator: Oscar V Hernandez, MD Instituto Mexicano del Seguro Social
Publications:
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Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT04065516    
Other Study ID Numbers: R-2019-3601-135
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Coordinación de Investigación en Salud, Mexico:
Achalasia
Gastroesophageal Reflux
Argon Plasma Coagulation
Peroral Endoscopic Myotomy
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases