Endoscopic ablation of Barrett's esophagus: a multicenter study with 2.5-year follow-up.
BACKGROUND
For patients with Barrett's esophagus (BE), life-long surveillance endoscopy is recommended because of an elevated risk for developing dysplasia and esophageal adenocarcinoma. Various endoscopic therapies have been used to eradicate BE. Recently circumferential radiofrequency ablation has been used with encouraging short-term results.


OBJECTIVE
To provide longer follow-up and to assess the long-term safety and efficacy of step-wise circumferential ablation with the addition of focal ablation for BE.


METHODS
Prospective, multicenter clinical trial (NCT00489268).


METHODS
Eight U.S. centers, between May 2004 and February 2007.


METHODS
Seventy subjects with 2 to 6 cm of BE and histologic evidence of intestinal metaplasia (IM).


METHODS
Circumferential ablation was performed at baseline and repeated at 4 months if there was residual IM. Follow-up biopsy specimens were obtained at 1, 3, 6, 12, and 30 months. Specimens were reviewed by a central pathology board. Focal ablation was performed after the 12-month follow-up for histological evidence of IM at the 12-month biopsy (absolute indication) or endoscopic appearance suggestive of columnar-lined esophagus (relative indication). Subjects received esomeprazole for control of esophageal reflux.


METHODS
Complete absence of IM per patient from biopsy specimens obtained at 12 and 30 months, defined as complete remission-IM (CR-IM).


RESULTS
At 12 months, CR-IM was achieved in 48 of 69 available patients (70% per protocol [PP], 69% intention to treat [ITT]). At 30 months after additional focal ablative therapy, CR-IM was achieved in 60 of 61 available patients (98% PP, 97% ITT). There were no strictures or buried glandular mucosa detected by the standardized biopsy protocol at 12 or 30 months, and there were no serious adverse events.


CONCLUSIONS
This was an uncontrolled clinical trial with 2.5-year follow-up.


CONCLUSIONS
Stepwise circumferential and focal ablation resulted in complete eradication of IM in 98% of patients at 2.5-year follow-up.
Fleischer
David E
DE
Mayo Clinic, Scottsdale, Arizona 85259, USA.
Overholt
Bergein F
BF
Sharma
Virender K
VK
Reymunde
Alvaro
A
Kimmey
Michael B
MB
Chuttani
Ram
R
Chang
Kenneth J
KJ
Lightdale
Charles J
CJ
Santiago
Nilda
N
Pleskow
Douglas K
DK
Dean
Patrick J
PJ
Wang
Kenneth K
KK
D001471:Barrett Esophagus / Q000473:pathology / Q000601:surgery*; D001707:Biopsy, Needle; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods; D004945:Esophagoscopy; D004947:Esophagus / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged