Endoscopic Resection or Ablation for Patients With Dysplasia or Intramucosal Cancer in Barrett's Esophagus
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete histological eradication of Barrett's esophagus
12 months
No
Prateek Sharma, MD
Principal Investigator
Kansas City VA Medical Center
United States: Federal Government
PS0058
NCT01572987
September 2011
May 2013
Name | Location |
---|---|
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Columbia University | New York, New York 10032-3784 |
University of Chicago | Chicago, Illinois 60637 |