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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04036942
• Other study ID #: R-2019-3601-179
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2022
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: Oscar V Hernandez Mondragon, MD
• Phone: +525556276900
• Email: mondragonmd[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Centro Medico Nacional Siglo XXI Hospital de Especialidades	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

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. Review. — View 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. Review. — View 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. — View Citation

Huerta-Iga F, Tamayo-de la Cuesta JL, Noble-Lugo A, Hernández-Guerrero A, Torres-Villalobos G, Ramos-de la Medina A, Pantoja-Millán JP; el Grupo Mexicano para el Estudio de la Enfermedad por Reflujo Gastroesofágico. [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. Review. Spanish. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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