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Study to Evaluate Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique

Overview

Información sobre este estudio

The purpose of this study is to investigate if Hybrid Argon Plasma Coagulation (HAPC) is non-inferior to Radiofrequency Ablation (RFA) in the stricture-free eradication of the dysplastic Barrett's Esophagus (BE) epithelium.

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria: 

  • Age of 18-85 years old (inclusive). 
  • Dysplastic BE, confirmed by the central pathologist; specifically: 
    • Low grade dysplasia documented on biopsy within 6 months of consent date; or
    • High grade dysplasia documented on biopsy within 6 months of consent date.
  • Barrett's extent of: C/M≥1 cm and C/M ≤ 6 cm using the Prague criteria [C = circumferential extent of disease / M = maximum extent of disease].
  • Ability to provide written and informed consent.

Exclusion Criteria:

  • Barrett's extent of: C/M <1 cm or a C/M-value > 6 cm using the Prague criteria. 
  • Prior EMR (endoscopic mucosal resection) for G3/G4; L1; V1; R1 (vertical margin only) or submucosal invasion.
  • Presence of endoscopically visible abnormalities at the time of initial study treatment with HAPC or RFA. These participants can undergo EMR and then continue in the trial after a suitable healing period, provided randomization can occur within 90 days of consent. 
  • Presence of invasive cancer on biopsy.
  • Known pregnancy or plans to become pregnant.
  • Complete eradication is not considered a relevant treatment goal or in whom additional treatment is contraindicated pre-existing significant esophageal pain or dysphagia; - BE >80% has been resected by EMR.
  • Incomplete wound healing 3 months post-EMR despite adequate PPImedication.
  • Prior ablative therapy in the esophagus but prior EMR allowed.
  • Active esophagitis or stricture precluding passage of scope.
  • Presence of esophageal varices.
  • Anticoagulant therapy (apart from aspirin or NSAIDS) that cannot be discontinued prior to therapy or uncorrectable hemostatic disorders.
  • Life expectancy less than 2 years.
  • Previous gastrectomy or other gastric surgery other than uncomplicated fundoplication.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Rahul Pannala, M.D.

Cerrado para la inscripción

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Herbert Wolfsen, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20467293

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