Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus (ERADICATE)
|Barrett's Esophagus Esophageal Neoplasms||Device: Radiofrequency Ablation(RFA) by HALO device. Device: Endoscopic mucosal resection(EMR) by mucosectomy kit.|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Endoscopic Resection or Ablation for Patients With Dysplasia or Intramucosal Cancer in Barrett's Esophagus|
- Complete histological eradication of Barrett's esophagus [ Time Frame: 12 months ]
- Complete histological clearance of dysplasia [ Time Frame: 12 months ]
- Complication rates [ Time Frame: 12 months ]
|Study Start Date:||September 2011|
|Study Completion Date:||May 2017|
|Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Active Comparator: RFA arm
Under this arm, study patients will undergo radiofrequency ablation.
Device: Radiofrequency Ablation(RFA) by HALO device.
RFA or Surveillance every 2 months for 1 year.
Other Name: HALO Ablation Technology(BÂRRX Medical, Inc).
Active Comparator: EMR arm
Under this arm, the individuals will undergo endoscopic mucosal resection.
Device: Endoscopic mucosal resection(EMR) by mucosectomy kit.
EMR or surveillance every 2 months.
Other Name: Duette multi-band mucosectomy kit (Cook Medical).
This is a multi-center prospective, randomized controlled trial conducted at 4 centers. The patients with high grade dysplasia(HGD) and/or esophageal cancer(EC) who meet the study criteria will be enrolled, undergo a baseline diagnostic EMR and then be randomized in a 1:1 ratio to undergo treatment by either S-EMR or radiofrequency ablation(RFA). The initial staging EMR will not extend more than 50% of the esophageal circumference or more than 2 cm in longitudinal extent. Patients in the S-EMR group will undergo step-wise eradication of the BE segment using the Duette multi-band mucosectomy kit (Cook Medical, FDA approved) whereas those in the RFA group will undergo BE ablation using the endoscopically-guided HALO radiofrequency ablation system (Barrx Medical, FDA approved).
Both treatment groups will undergo their respective treatment sessions every 2 months until either no Barrett's esophagus is seen or until a maximum of 4 treatment sessions. Once there is no visible Barrett's esophagus, patients will undergo surveillance biopsies (random 4 quadrant biopsies every 1 cm of the neo-squamous mucosa and random biopsies of the cardia) to evaluate for complete eradication of Barrett's esophagus. Regardless of whether there is visible Barrett's esophagus, all patients will undergo repeat endoscopy every 2 months for 1 year after enrollment. If no visible Barrett's esophagus is seen during the endoscopy, then surveillance biopsies to evaluate for dysplasia will be taken. Regardless of whether this is any visible Barrett's esophagus, all patients will undergo surveillance biopsies at 12 months after enrollment.
The objective of this study is to compare the proportion of patients with complete eradication of Barrett's esophagus using S-EMR versus RFA at 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572987
|United States, Illinois|
|University Of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63141|
|United States, New York|
|New York, New York, United States, 10032|
|Principal Investigator:||Prateek Sharma, MD||Kansas City VA Medical Center|