ARAT for Reflux Disease After Peroral Endoscopic Myotomy in Patients With

Status Enrolling by invitation

Clinical 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04065516
Study type	Interventional
Source	Coordinación de Investigación en Salud, Mexico
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	July 3, 2019
Completion date	December 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05561179` - Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease	N/A
Withdrawn	`NCT02213887` - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications	Phase 4
Completed	`NCT01946971` - Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)	Phase 1/Phase 2
Recruiting	`NCT01825473` - Study of Erythromycin in GER-Associated Apnea of the Newborn	N/A
Completed	`NCT00614536` - Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period	Phase 4
Completed	`NCT00284908` - Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers	Phase 1
Completed	`NCT00373997` - Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux	Phase 4
Completed	`NCT00365300` - Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)	Phase 3
Completed	`NCT00215787` - Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease	N/A
Completed	`NCT00567021` - German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms	N/A
Completed	`NCT00226044` - Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.	Phase 3
Completed	`NCT00291746` - Validation of RDQ Questionnaire	Phase 4
Completed	`NCT01167543` - Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease	N/A
Completed	`NCT00141960` - Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease	Phase 2/Phase 3
Completed	`NCT01048840` - Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
Completed	`NCT00181805` - Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
Terminated	`NCT01281553` - A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease	Phase 4
Completed	`NCT05486169` - Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy	N/A
Completed	`NCT04034017` - Gastroesophageal Reflux Disease Among College Students
Terminated	`NCT03226054` - Determining Risk Factors for Successful PPI Weaning	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms