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Endoscopic ablation of Barrett's esophagus: a multicenter study with 2.5-year follow-up.

Abstract：

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. DESIGN:Prospective, multicenter clinical trial (NCT00489268). SETTING:Eight U.S. centers, between May 2004 and February 2007. PATIENTS:Seventy subjects with 2 to 6 cm of BE and histologic evidence of intestinal metaplasia (IM). INTERVENTIONS: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. MAIN OUTCOME MEASUREMENTS: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. LIMITATIONS:This was an uncontrolled clinical trial with 2.5-year follow-up. CONCLUSION:Stepwise circumferential and focal ablation resulted in complete eradication of IM in 98% of patients at 2.5-year follow-up.

journal_name

Gastrointest Endosc

journal_title

Gastrointestinal endoscopy

authors

Fleischer DE,Overholt BF,Sharma VK,Reymunde A,Kimmey MB,Chuttani R,Chang KJ,Lightdale CJ,Santiago N,Pleskow DK,Dean PJ,Wang KK

doi

10.1016/j.gie.2008.03.008

subject

Has Abstract

pub_date

2008-11-01 00:00:00

pages

867-76

issue

eissn

0016-5107

issn

1097-6779

pii

S0016-5107(08)00381-7

journal_volume

pub_type

临床试验,杂志文章,多中心研究

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Endoscopic ablation of Barrett's esophagus: a multicenter study with 2.5-year follow-up.