Barrett's Esophagus, Esophageal Neoplasms
Conditions
Keywords
Barrett's Esophagus, Esophageal neoplasms, Radiofrequency ablation, Endoscopic mucosal resection
Brief summary
This clinical trial will evaluate a patient population with Barrett's esophagus(BE) containing high grade dysplasia or intramucosal cancer and compare the effects of endoscopically-guided radiofrequency ablation system(RFA) and endoscopically-guided stepwise endoscopic mucosal resection(S-EMR).
Detailed description
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.
Interventions
DEVICERadiofrequency Ablation(RFA) by HALO device.
RFA or Surveillance every 2 months for 1 year.
DEVICEEndoscopic mucosal resection(EMR) by mucosectomy kit.
EMR or surveillance every 2 months.
Sponsors
American Society for Gastrointestinal Endoscopy
Cook Group Incorporated
Washington University School of Medicine
Columbia University
University of Chicago
Midwest Biomedical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects shall be screened according to the following inclusion criteria. An answer of no to any inclusion criterion disqualifies a subject from participating in this study. * Patients age: \> 18 years * Subject has documented diagnosis of Barrett's esophagus, maximum endoscopic length of no more than C2M5 (i.e. no more than 2cm of circumferential extent and no more than 5cm of tongues) containing HGD/EC as follows: * HGD or EC documented on biopsy within previous 6 months from enrollment * Histology slides reviewed at central pathology service for ERADICATE Trial confirm HGD/EC. * Endoscopically visible lesion/area/pattern in a patient with HGD/EC either by high definition white light endoscopy, narrow band imaging, confocal laser endomicroscopy, or another enhanced imaging tool. * Ability to take oral proton pump inhibitor * For female subjects of childbearing potential, a negative urine pregnancy test within 2 weeks of enrollment and any subsequent endoscopy encounter * Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the investigational plan * Ability to discontinue aspirin/NSAIDs/Clopidogrel 7 days before and after all ablation procedures * Ability of provide written, informed consent and understands the responsibilities of trial participation NOTE: At the Kansas City Veterans Hospital, participants must be eligible for care at the VA in order to be enrolled. Other sites listed are able to enroll non-veterans.
Exclusion criteria
Subjects shall be screened according to the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete histological eradication of Barrett's esophagus | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Complete histological clearance of dysplasia | 12 months |
| Complication rates | 12 months |
Countries
United States
Outcome results
None listed