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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-03

Study Completion Date

2026-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Achalasia Gastroesophageal Reflux

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

ARAT technique

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No