Clinical trial NCT04036942: Antireflux Ablation Therapy (ARAT) Vs Antireflux Mucosectomy (ARMS) In The Management Of Gastroesophageal Reflux Disease
Official title: Ablation Of The Esophagogastric Junction With Hybrid Argon Plasma Vs Mucosectomy With Band in Patients With Gastroesophageal Reflux Disease Without Hiatal Hernia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal Reflux Disease (GERD)
ARAT
ARMS
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2019-07-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A simple randomized, comparative (pretreatment and posttreatment), prospective clinical trial will be carried out among the group of patients managed with ARAT and ARMS
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: efficacy of management with ARAT and ARMS in reducing the total percent acid exposure time
timeFrame: 3, 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro Medico Nacional Siglo XXI Hospital de Especialidades
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Oscar V Hernandez Mondragon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.