Antireflux Ablation Therapy (ARAT) Vs Antireflux Mucosectomy (ARMS) In The Management Of Gastroesophageal Reflux Disease

July 21, 2022 updated by: Coordinación de Investigación en Salud, Mexico

Ablation Of The Esophagogastric Junction With Hybrid Argon Plasma Vs Mucosectomy With Band in Patients With Gastroesophageal Reflux Disease Without Hiatal Hernia

Gastroesophageal reflux disease has a high global prevalence, proton pump inhibitors are the cornerstone in the management but 10-20% of the patients are refractory to these, surgical treatment being an option of treatment in these patient but its associated with high morbidity, as well as a greater possibility of early therapeutic failure, for these reasons new therapies are in development being the mucosectomy with band and ablation of the esophagogastric junction with hybrid argon plasma options widely available that can offer a viable therapeutic option for patients with difficult control of symptoms or those who does not want to receive continuous medical treatment or surgical treatment. The aims of the study is to evaluate the safety and efficacy of this new techniques in the management or gastroesophageal reflux disease without hiatal hernia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gastroesophageal reflux disease is a disease with high global prevalence, reaching rates of 19.6 and 40% in our country, for which it is one of the most common reasons for medical care and although a clinical response is obtained in an 80-90% of patients with the use of proton pump inhibitors, the rest of the patients represents a medical challenge; surgical and endoscopic treatment being within the treatment options, the former having a high related morbidity (perforation, vagal nerve injury, postoperative dysphagia, etc), its duration is suboptimal and a second operation is associated with more surgical complications and morbidity, as well as a greater possibility of early therapeutic failure. For all these reasons, new endoluminal therapies have begun to be planned, including transoral fundoplication and radiofrequency ablation of the esophagogastric junction, these with controversial results and with the need of the use of special accessories and instruments that are not widely available; mucosectomy with band and ablation of the esophagogastric junction with hybrid argon plasma are widely available procedures in medical centers, offering a viable therapeutic option for patients with difficult control of symptoms or those who does not want to receive continuous medical treatment or surgical treatment.

Study Type

Interventional

Enrollment (Anticipated)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
      • Mexico City, Mexico, 06700
        • Recruiting
        • Centro Medico Nacional Siglo XXI Hospital de Especialidades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of both sexes over 18 years and under 90 years with a diagnosis of GERD and who are under medical treatment and who do not want surgical treatment.
  • Confirmed diagnosis of GERD as follows:

Positive pHmetry. Positive endoscopy (Esophagitis grade C, D, stenosis or EB)

  • Esophagogastric junction Hill I-III
  • Total or partial response to proton pump inhibitors
  • Patient who does not wish to take medication for the treatment of gastroesophageal reflux in the long term or indefinitely or refractory GERD

Exclusion Criteria:

  • Patients who do not accept the signature of the informed consent
  • Postoperative fundoplication patients for GERD
  • Patients with extraesophageal symptoms.
  • Pregnant women.
  • Patients with hiatal hernia larger than 3 cm or Hill type IV.
  • Patients with major esophageal motility disorders.
  • Patients with portal hypertension and presence of esophageal varices
  • Patients with hemophilia or some haematological disorder that is difficult to control
  • Patients with malignant pathology of the esophagus or Gastroesophageal Junction (GEJ).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hybrid argon plasma.
After diagnostic endoscopy investigators will proceed to use argon plasma probe for marking 270 grades around the esophagogastric junction preserving part of the mucosa towards the greater curvature, then investigators will use the jet included in the argon plasma probe with effect 20 to 40 system for the injection of the background submucosa in the marking area, applying 0.9% saline solution with methylene blue, to achieve adequate Submucosal elevation for application or argon plasma with high voltages (100 watts, 1.5 liters / min) using forced coagulation mode, applying plasma argon to 1cm above the Z line in the esophageal mucosa and 2cm below it towards the gastric mucosa, argon will be applied until a "carbonization" effect of the mucosa is achieved, once the application of the therapy is performed mucosal lavage and immersion technique to corroborate integrity and continuity of the gastrointestinal tract and rule out immediate complications
Procedure: Ablation of the gastroesophageal junction with hybrid argon plasma
In the management group with argon plasma hybrid after marking 270 degrees of the esophagogastric junction, submucosal elevation and argon plasma burn of the marked and elevated area is performed.
Other Names:
  • ARAT
Active Comparator: Band mucosectomy
After diagnostic endoscopy investigators will proceed to use the tip of a polypectomy snare for marking 270 grades around the esophagogastric junction preserving part of the mucosa towards the greater curvature, then investigators will perform submucosal elevation with the injection of 0.9% saline with carmine indigo and adrenaline 1:10000, after adequate submucosal elevation investigators will proceed with the help of a band ligation cap to suction and release the elastic band in the previously marked and elevated tissue, proceeding to resect the previously ligated tissue with polypectomy loop below the elastic band with forced coagulation (Effect 2, 40 W), until the marked mucosa is completely resected (average used of 5 elastic bands, reviewing the work area for complications like bleeding or perforation.
Procedure: mucosectomy with band of the gastroesophageal junction
In the management group with mucosectomy after marking 270 degrees of the esophagogastric junction, a submucosal elevation of the marked area is performed to subsequently perform ligation and resection with a hot snare below the ligation area.
Other Names:
  • ARMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of management with ARAT and ARMS in reducing the total percent acid exposure time
Time Frame: 3, 6 and 12 months
the investigators will compare the percentage of improvement in esophageal Ph metry before and after procedure
3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 21, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2019-3601-179

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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