Antireflux Ablation Therapy (ARAT) for Gastroesophageal Reflux Treatment

NCT03548298 | Completed DMC

• 1 other identifier: R-2018-3601-014
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastro Esophageal Reflux

Keywords

GERD, Hybrid-APC, efficacy, safety; ARAT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety of ARAT with hybrid-APC in patients with GERD without hiatal hernia

  One Year

Study Arms (1)

GERD without hiatal hernia

EXPERIMENTAL

Participants with GERD without hernia hiatal will receive ARAT

Procedure: ARAT

Interventions

ARAT PROCEDURE

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.

GERD without hiatal hernia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Centro Medico Nacional Siglo XXI, Hospital de Especialidades

Mexico City, 06720, Mexico

Location

Related Publications (11)

• Mezerville Cantillo Ld, Cabas Sanchez J, Contreras F, Castellanos Garcia LF, Dondis JE, Galdamez J, Garcia-Maradiaga R, Grullon Dickson F, Jerez Gonzalez LE, Mayo DiBello M, Mejia Rivas MA, Moreno Padilla P, Sanchez Hernandez MA, Velasco SR, Vela MF, Valdovinos-Diaz MA, Remes-Troche JM. [Practice guideline of the Centroamerican and Carribean Association of Gastroenterology and Gastrointestinal Endoscopy for the management of gastroesophageal reflux disease]. Acta Gastroenterol Latinoam. 2014 Jun;44(2):138-53. No abstract available. Spanish.

  PMID: 25199309 RESULT

• 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. No abstract available.

  PMID: 23419381 RESULT

• 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.

  PMID: 24344627 RESULT

• Hansdotter I, Bjor O, Andreasson A, Agreus L, Hellstrom 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 junction. Endosc Int Open. 2016 Mar;4(3):E311-7. doi: 10.1055/s-0042-101021. Epub 2016 Feb 10.

  PMID: 27004249 RESULT

• 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.

  PMID: 23452628 RESULT

• 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.

  PMID: 20238321 RESULT

• Nabi Z, Reddy DN. Endoscopic Management of Gastroesophageal Reflux Disease: Revisited. Clin Endosc. 2016 Sep;49(5):408-416. doi: 10.5946/ce.2016.133. Epub 2016 Sep 30.

  PMID: 27744659 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 26104794 RESULT

• Hernandez Mondragon OV, Zamarripa Mottu RA, Garcia Contreras LF, Gutierrez Aguilar RA, Solorzano Pineda OM, Blanco Velasco G, Murcio Perez E. Clinical feasibility of a new antireflux ablation therapy on gastroesophageal reflux disease (with video). Gastrointest Endosc. 2020 Dec;92(6):1190-1201. doi: 10.1016/j.gie.2020.04.046. Epub 2020 Apr 25.

  PMID: 32343977 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Officials

• Oscar V Hernández Mondragón, MD

  IMSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Men and women with diagnosis of GERD confirmed by endoscopy or pHmetry, GERD questionnaire and that accept this new treatment.

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 7, 2018
• Study Start: January 10, 2016
• Primary Completion: July 1, 2019
• Study Completion: September 10, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)