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

Overview

About this study

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.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Wang, M.D.

Open for enrollment

Contact information:

Bryan Linn

(507)284-6050

Linn.Bryan@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Rahul Pannala, M.D.

Open for enrollment

Contact information:

Alexandria Evans

(480) 301-4750

Evans.Alexandria@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Herbert Wolfsen, M.D.

Open for enrollment

Contact information:

Frances Cayer CCRP

(904)953-7778

Cayer.Frances@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20467293

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