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
|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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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).
- 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
- 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.
- 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)
- 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)
- Recurrence rate of dysplasia (CE-D) [ Time Frame: 12 months ]The recurrence rate of dysplasia after CE-D has been achieved will be measured
- 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
- 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.
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
|Contact: April Higbee, R.N., B.S.N.||816-861-4700 ext firstname.lastname@example.org|
|Principal Investigator:||Prateek Sharma, MD||Kansas City Veterans Affairs Medical|