Antireflux Ablation Therapy (ARAT) for Gastroesophageal Reflux Treatment

Gastro Esophageal Reflux Clinical Trial

— ARAT  

Official title:

Antireflux Ablation Therapy (ARAT) With Hybrid-APC (Argon Plasma Coagulation) for GERD Treatment in Patients Without Hiatal Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03548298
• Other study ID #: R-2018-3601-014
• Status: Completed
• Phase: N/A
• Start date: January 10, 2016
• Est. completion date: September 10, 2019

Study information

• Verified date: July 2019
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gastroesophageal Reflux Disease (GERD) is defined as the rise of gastric or gastroduodenal contents above the esophagogastric junction (EGJ), generating symptoms and/or esophageal lesions. It is estimated a failure to treatment with PPI(proton pump inhibitor) between 10%-40% of patients with GERD. The main disadvantages of surgical treatment include perforation (0-4%), bleeding (<1%) and pneumothorax (0-10%), the most common late complication is gastric fullness, which occurs in almost all patients, approximately 25% of patients may experience persistent dysphagia 3 months after surgery and the most worrisome late complication is the need of a new surgical intervention. The aims of treatment at EGJ is to reduce gastroesophageal reflux contents into the esophagus. Hybrid-APC with ablation of EGJ (ARAT) is a new technique with could generate a scar remodeling this region and consequently reducing reflux disease. Our objective is to evaluate the safety and efficacy of ARAT in a group of patients with GERD without hiatal hernia.

Description:

Gastroesophageal reflux disease is a condition in which there is a rise of gastroduodenal contents into the esophageal lumen, causing mucosal damage. Among treatments, medications are the most common used ones but up to 10%-40% doesn't respond to this type of treatment. Surgical treatment has been considered as the gold standard; however, with complications such as bleeding, perforation, or dysphagia after surgery. Moreover, not all patients are candidates to receive this type of treatment. Based on these data, new techniques have been explored in order to reduce morbidity, mortality and costs in the treatment of these patients.

Among different endoscopical treatments, ablation of EGJ is a new promising technique which can be used to perform a closure at this level throughout the scar secondary to hybrid-APC treatment, consequently decreasing gastroesophageal reflux. So, the aim of this study is to evaluate safety and efficacy of ARAT in a group of patients with confirmed GERD.

This is a quasi experimental study that will be conducted in a tertiary care center in Mexico city, Mexico. In an endoscopy department at the Mexican Institute of Social Security between January 2018 and July 2019. Those patients diagnosed with gastroesophageal reflux who are candidates and who accept this type of treatment will be evaluated. Patients who meet the inclusion criteria will be the definitive candidates. The risks and benefits of this type of endoscopic treatment will be explained as well as the potential scope of this endoscopic alternative. We will evaluate safety and efficacy of this new procedure.

The technique of the procedure involves ablation of the mucosa of the EGJ using Hybrid-APC (ARAT). The ablation field is initially marked with a Hybrid-APC. Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature. The approximate duration of the procedure is 40min.

Follow-up will include objective evaluation of reflux disease with: upper endoscopy, manometry, pHmetry, reflux questionnaire, and need of PPI (proton-pump inhibitor) dose quantification.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: September 10, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients of both sexes of age with a diagnosis of GERD and who are under medical treatment and who do not wish to undergo surgical treatment

• Confirmed diagnosis of GERD in the following way:

• Positive pHmetry

• Positive endoscopy (GERD with esophagitis of any degree) or negative

• Positive symptoms questionnaire for GERD

• Manometry without evidence of esophageal motor disorder

• Total or partial response to proton pump inhibitors

Exclusion Criteria:

• Patients who do not accept the signature of the informed consent

• Patients previously treated by surgery for GERD

• Pregnant women.

• Patients with hiatal hernia greater than 3 cm or Hill type IV

• Patients with esophageal motility disorders

• Patients in whom, for any reason, any antireflux surgery or endoscopic treatment has been contraindicated.

• Patients who want to undergo surgical treatment as an initial option.

• Patients with portal hypertension and the presence of esophageal varices

• Patients with hemophilia or a haematological disorder that is difficult to control

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

Procedure:
• ARAT
After confirmation of GERD, participants will undergo to ablation with Hybrid-APC (ARAT). Participant will be admitted to hospital 24 hrs before procedure. Technique consist in ablation with hybrid-APC, submucosal injection of saline solution with methylene blue at 3-4 cm from 60-70% cardias and 1 cm esophageal. After procedure they will be kept on surveillance and will be followed-up with clinical, endoscopic, esophageal manometry and pHmetry up to 1 year after procedure.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (10)

Bolier EA, Kessing BF, Smout AJ, Bredenoord AJ. Systematic review: questionnaires for assessment of gastroesophageal reflux disease. Dis Esophagus. 2015 Feb-Mar;28(2):105-20. doi: 10.1111/dote.12163. Epub 2013 Dec 18. Review. — View Citation

Hansdotter I, Björ O, Andreasson A, Agreus L, Hellström P, Forsberg A, Talley NJ, Vieth M, Wallner B. Hill classification is superior to the axial length of a hiatal hernia for assessment of the mechanical anti-reflux barrier at the gastroesophageal junct — 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

Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. Erratum in: Am J Gastroenterol. 2013 Oct;108(10 — View Citation

Manner H, May A, Kouti I, Pech O, Vieth M, Ell C. Efficacy and safety of Hybrid-APC for the ablation of Barrett's esophagus. Surg Endosc. 2016 Apr;30(4):1364-70. doi: 10.1007/s00464-015-4336-1. Epub 2015 Jun 24. Erratum in: Surg Endosc. 2016 Apr;30(4):137 — 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 — View Citation

Mezerville Cantillo Ld, Cabas Sánchez J, Contreras F, Castellanos Garcia LF, Dondis JE, Galdámez J, García-Maradiaga R, Grullón Dickson F, Jerez González LE, Mayo DiBello M, Mejía Rivas MA, Moreno Padilla P, Sánchez Hernández MA, Velasco SR, Vela MF, Vald — View Citation

Nabi Z, Reddy DN. Endoscopic Management of Gastroesophageal Reflux Disease: Revisited. Clin Endosc. 2016 Sep;49(5):408-416. Epub 2016 Sep 30. Review. — View Citation

Villa N, Vela MF. Impedance-pH testing. Gastroenterol Clin North Am. 2013 Mar;42(1):17-26. doi: 10.1016/j.gtc.2012.11.003. Review. — View Citation

Wileman SM, McCann S, Grant AM, Krukowski ZH, Bruce J. Medical versus surgical management for gastro-oesophageal reflux disease (GORD) in adults. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD003243. doi: 10.1002/14651858.CD003243.pub2. Review. Update in: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of ARAT with Hybrid-APC in patients with GERD without hiatal hernia	The efficacy of this treatment will be defined as: The decrease of = 50 percent of the total percentage of acid exposure at 24 hrs (DeMeester Score)	One year
Secondary	Safety of ARAT with hybrid-APC in patients with GERD without hiatal hernia	We will document any adverse event presented during or after application of ARAT therapy	One Year