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Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique (BURN)

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ClinicalTrials.gov Identifier: NCT03621319
Recruitment Status : Not yet recruiting
First Posted : August 8, 2018
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
Erbe USA Incorporated
Kansas City Veteran Affairs Medical Center
Emissary International LLC
Information provided by (Responsible Party):
Erbe Elektromedizin GmbH

Brief Summary:
Lay summary: Barrett's Esophagus (BE) involves a change of the esophagus lining (BE epithelium) which in a small proportion of patients could be the starting point for the development of cancer (esophageal adenocarcinoma). Currently, there is evidence that this change is initiated by acid reflux from the stomach which then could progress in a stepwise manner from the healthy epithelium to cellular changes (intestinal metaplasia, low-grade and high-grade dysplasia) and finally to adenocarcinoma. Surgery is considered the standard therapy for this cancer which involves the risk of death and complications with quality of life impairments. New possibilities for treatment have evolved with endoscopic therapies which allow for treatment of early changes of the epithelium (intestinal metaplasia and dysplasia) prior to the occurrence of cancer using either argon plasma coagulation (APC) or radiofrequency ablation (RFA). Both are established methods for eradication of BE by thermal ablation of the BE epithelium using high frequency current (HF). More advanced BE epithelium with early visible cancers are being treated by endoscopic mucosal resection (EMR). After EMR the residual Barrett's epithelium can also be removed by ablation with RFA or APC. Currently radiofrequency ablation (RFA) has been suggested as the standard therapy for BE treatment. Although effective in the eradication of the BE epithelium after RFA treatment the re-appearance of BE epithelium and the occurrence of complications such as strictures causing swallowing impairments for food have also been observed in clinical studies. A recently developed method is Hybrid argon plasma coagulation (ablation) [HybridAPC® (HAPC)] which combines argon plasma coagulation (APC) with a fluid injection function by a water beam. The water beam allows to establish a fluid cushion (normal sterile saline) right beneath the BE-epithelium prior to thermal ablation thereby protecting the esophagus wall from heat during ablation of epithelium with APC. The goal of this randomized controlled study is to investigate if HAPC is non-inferior to RFA in the stricture-free eradication of the dysplastic BE epithelium.

Condition or disease Intervention/treatment Phase
Barrett's Esophagus High-grade Dysplasia in Barrett Esophagus Low Grade Dysplasia in Barrett Esophagus Device: Hybrid argon plasma ablation (HAPC) Device: Radiofrequency ablation (RFA) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique (BURN)
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Active Comparator: Hybrid argon plasma ablation (HAPC)
Eligible participants will be randomized to receive ablation of dysplasia with Hybrid argon plasma coagulation (HAPC) after EMR of visible lesions (if present) has been performed as per standard of care.
Device: Hybrid argon plasma ablation (HAPC)
-The assigned HAPC ablation will be performed at 8 to 12 week intervals until eradication of BE has been achieved or a total of 4 treatments have been performed

Active Comparator: Radiofrequency ablation (RFA)
Eligible participants will be randomized to receive treatment of dysplasia with RFA after EMR of visible lesions (if present) has been performed as per standard of care.
Device: Radiofrequency ablation (RFA)
-The assigned RFA procedure will be performed at 8 to 12 week intervals until eradication of BE has been achieved or a total of 4 treatments have been performed




Primary Outcome Measures :
  1. Rate of stricture-free eradication of dysplastic BE [ Time Frame: 12 months ]
    Freedom from strictures and complete eradication of dysplasia (CE-D) within 12 months after the last treatment will be measured as a composite safety and effectiveness endpoint. The composite endpoint evaluation is a traditional responder analysis with a single measure. The composite endpoint will have two possible outcome responses for each study subject: success or failure. The study or control treatment will be considered a success for a study subject only if both conditions are met: freedom from strictures and complete eradication of dysplasia. The number of successes and failures allows the estimation of success rates in the two study arms. These rates will be compared using standard statistical methods for rates (that is, binomial proportions).


Secondary Outcome Measures :
  1. Rate of eradication of intestinal metaplasia (CE-IM) [ Time Frame: 12 months ]
    Eradication of intestinal metaplasia (CE-IM) within 12 months after the last treatment will be measured

  2. Post-operative pain [ Time Frame: 7 days ]
    Post-operative pain score at baseline and at 1st and 7th day visits post treatment utilizing a visual analog scale (VAS). The VAS scale consists of a straight line with the scale endpoints defining extreme limits such as 'no pain' at "0" up to 'worst possible pain' at "10". The higher the value in the scale, the higher the pain intensity. A continuous 10 cm interval on which a subject marks a position is turned into a measurement (usually a fractional value like 5.5 cm). A lower value is thus a better outcome whereas a higher number indicates a worse outcome, with respect to pain intensity.

  3. Major complications [ Time Frame: 12 months ]
    Complications requiring additional Intervention (bleeding with drop of hemoglobin (Hb > 2 g/dl), fever persisting more than 24 hours, stricture, perforation)

  4. Minor complications [ Time Frame: 12 months ]
    Complications without need for additional endotherapy (bleeding with drop in hemoglobin (Hb < 2 g/dl) fever persisting less than 24 hours, dysphagia)

  5. Recurrence rate of dysplasia (CE-D) [ Time Frame: 12 months ]
    The recurrence rate of dysplasia after CE-D has been achieved will be measured

  6. Recurrence rate of intestinal metaplasia (CE-IM) [ Time Frame: 12 months ]
    The recurrence rate of intestinal metaplasia after CE-IM has been achieved will be measured

  7. Cost-effectiveness of HAPC vs. RFA in the treatment of dysplastic BE [ Time Frame: 12 months ]
    The cost effectiveness of HAPC compared to RFA for achieving CE-D will be based on a comparison of average treatment cost between the two groups. Data regarding the type of off-study medical services utilized during the study period that are possibly or definitely related to the ablative treatment will be collected.



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Ages Eligible for Study:   18 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18-85 years (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621319


Contacts
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Contact: April Higbee, R.N., B.S.N. 816-861-4700 ext 57456 april.higbee@va.gov

Sponsors and Collaborators
Erbe Elektromedizin GmbH
Erbe USA Incorporated
Kansas City Veteran Affairs Medical Center
Emissary International LLC
Investigators
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Principal Investigator: Prateek Sharma, MD Kansas City Veterans Affairs Medical

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Responsible Party: Erbe Elektromedizin GmbH
ClinicalTrials.gov Identifier: NCT03621319     History of Changes
Other Study ID Numbers: 2015_1
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Erbe Elektromedizin GmbH:
Hybrid argon plasma coagulation
Submucosal injection

Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases