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

NCT04036942 | Withdrawn DMC

• 1 other identifier: R-2019-3601-179
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal Reflux Disease (GERD); ARAT; ARMS

Outcome Measures

Primary Outcomes (1)

• efficacy of management with ARAT and ARMS in reducing the total percent acid exposure time

  the investigators will compare the percentage of improvement in esophageal Ph metry before and after procedure

  3, 6 and 12 months

Study Arms (2)

Hybrid argon plasma.

ACTIVE COMPARATOR

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

Band mucosectomy

ACTIVE COMPARATOR

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

Interventions

Ablation of the gastroesophageal junction with hybrid argon plasma PROCEDURE

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.

Also known as: ARAT

Hybrid argon plasma.

mucosectomy with band of the gastroesophageal junction PROCEDURE

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.

Also known as: ARMS

Band mucosectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

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 (7)

• Hedberg HM, Kuchta K, Ujiki MB. First Experience with Banded Anti-reflux Mucosectomy (ARMS) for GERD: Feasibility, Safety, and Technique (with Video). J Gastrointest Surg. 2019 Jun;23(6):1274-1278. doi: 10.1007/s11605-019-04115-1. Epub 2019 Feb 7.

  PMID: 30734179 BACKGROUND

• Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362. doi: 10.1136/gutjnl-2017-314722. Epub 2018 Feb 3.

  PMID: 29437910 BACKGROUND

• Manner H, Neugebauer A, Scharpf M, Braun K, May A, Ell C, Fend F, Enderle MD. The tissue effect of argon-plasma coagulation with prior submucosal injection (Hybrid-APC) versus standard APC: A randomized ex-vivo study. United European Gastroenterol J. 2014 Oct;2(5):383-90. doi: 10.1177/2050640614544315.

  PMID: 25360316 BACKGROUND

• Inoue H, Ito H, Ikeda H, Sato C, Sato H, Phalanusitthepha C, Hayee B, Eleftheriadis N, Kudo SE. Anti-reflux mucosectomy for gastroesophageal reflux disease in the absence of hiatus hernia: a pilot study. Ann Gastroenterol. 2014;27(4):346-351.

  PMID: 25330784 BACKGROUND

• Stefanidis D, Hope WW, Kohn GP, Reardon PR, Richardson WS, Fanelli RD; SAGES Guidelines Committee. Guidelines for surgical treatment of gastroesophageal reflux disease. Surg Endosc. 2010 Nov;24(11):2647-69. doi: 10.1007/s00464-010-1267-8. Epub 2010 Aug 20. No abstract available.

  PMID: 20725747 BACKGROUND

• Gyawali CP, Fass R. Management of Gastroesophageal Reflux Disease. Gastroenterology. 2018 Jan;154(2):302-318. doi: 10.1053/j.gastro.2017.07.049. Epub 2017 Aug 5.

  PMID: 28827081 BACKGROUND

• Huerta-Iga F, Tamayo-de la Cuesta JL, Noble-Lugo A, Hernandez-Guerrero A, Torres-Villalobos G, Ramos-de la Medina A, Pantoja-Millan JP; el Grupo Mexicano para el Estudio de la Enfermedad por Reflujo Gastroesofagico. [The Mexican consensus on gastroesophageal reflux disease. Part II]. Rev Gastroenterol Mex. 2013 Oct-Dec;78(4):231-9. doi: 10.1016/j.rgmx.2013.05.001. Epub 2013 Nov 28. Spanish.

  PMID: 24290724 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Officials

• Oscar V Hernandez Mondragon, MD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator in charge of capturing the data will only know if the patients received an A or B treatment without knowing the meaning of these letters; the endoscopist who carries out the procedure and the patient will be aware that group A corresponds to management with ARAT and group B to management with ARMS
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A simple randomized, comparative (pretreatment and posttreatment), prospective clinical trial will be carried out among the group of patients managed with ARAT and ARMS

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 30, 2019
• Study Start: July 15, 2019
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)