Radiofrequency ablation in Barrett's esophagus with dysplasia.
BACKGROUND
Barrett's esophagus, a condition of intestinal metaplasia of the esophagus, is associated with an increased risk of esophageal adenocarcinoma. We assessed whether endoscopic radiofrequency ablation could eradicate dysplastic Barrett's esophagus and decrease the rate of neoplastic progression.


METHODS
In a multicenter, sham-controlled trial, we randomly assigned 127 patients with dysplastic Barrett's esophagus in a 2:1 ratio to receive either radiofrequency ablation (ablation group) or a sham procedure (control group). Randomization was stratified according to the grade of dysplasia and the length of Barrett's esophagus. Primary outcomes at 12 months included the complete eradication of dysplasia and intestinal metaplasia.


RESULTS
In the intention-to-treat analyses, among patients with low-grade dysplasia, complete eradication of dysplasia occurred in 90.5% of those in the ablation group, as compared with 22.7% of those in the control group (P<0.001). Among patients with high-grade dysplasia, complete eradication occurred in 81.0% of those in the ablation group, as compared with 19.0% of those in the control group (P<0.001). Overall, 77.4% of patients in the ablation group had complete eradication of intestinal metaplasia, as compared with 2.3% of those in the control group (P<0.001). Patients in the ablation group had less disease progression (3.6% vs. 16.3%, P=0.03) and fewer cancers (1.2% vs. 9.3%, P=0.045). Patients reported having more chest pain after the ablation procedure than after the sham procedure. In the ablation group, one patient had upper gastrointestinal hemorrhage, and five patients (6.0%) had esophageal stricture.


CONCLUSIONS
In patients with dysplastic Barrett's esophagus, radiofrequency ablation was associated with a high rate of complete eradication of both dysplasia and intestinal metaplasia and a reduced risk of disease progression. (ClinicalTrials.gov number, NCT00282672.)
Shaheen
Nicholas J
NJ
Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, CB 7080, Chapel Hill, NC 27599-7080, USA. nshaheen@med.unc.edu
Sharma
Prateek
P
Overholt
Bergein F
BF
Wolfsen
Herbert C
HC
Sampliner
Richard E
RE
Wang
Kenneth K
KK
Galanko
Joseph A
JA
Bronner
Mary P
MP
Goldblum
John R
JR
Bennett
Ana E
AE
Jobe
Blair A
BA
Eisen
Glenn M
GM
Fennerty
M Brian
MB
Hunter
John G
JG
Fleischer
David E
DE
Sharma
Virender K
VK
Hawes
Robert H
RH
Hoffman
Brenda J
BJ
Rothstein
Richard I
RI
Gordon
Stuart R
SR
Mashimo
Hiroshi
H
Chang
Kenneth J
KJ
Muthusamy
V Raman
VR
Edmundowicz
Steven A
SA
Spechler
Stuart J
SJ
Siddiqui
Ali A
AA
Souza
Rhonda F
RF
Infantolino
Anthony
A
Falk
Gary W
GW
Kimmey
Michael B
MB
Madanick
Ryan D
RD
Chak
Amitabh
A
Lightdale
Charles J
CJ
D000368:Aged; D000369:Aged, 80 and over; D001471:Barrett Esophagus / Q000473:pathology / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects; D018450:Disease Progression; D004947:Esophagus / Q000473:pathology* / Q000601:surgery; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008679:Metaplasia / Q000601:surgery; D008875:Middle Aged; D016896:Treatment Outcome