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Durability of radiofrequency ablation in Barrett's esophagus with dysplasia.

ABSTRACT: Radiofrequency ablation (RFA) can eradicate dysplasia and intestinal metaplasia in patients with dysplastic Barrett's esophagus (BE), and reduce rates of esophageal adenocarcinoma. We assessed long-term rates of eradication, durability of neosquamous epithelium, disease progression, and safety of RFA in patients with dysplastic BE.We performed a randomized trial of 127 subjects with dysplastic BE; after cross-over subjects were included, 119 received RFA. Subjects were followed for a mean time of 3.05 years; the study was extended to 5 years for patients with eradication of intestinal metaplasia at 2 years. Outcomes included eradication of dysplasia or intestinal metaplasia after 2 and 3 years, durability of response, disease progression, and adverse events.After 2 years, 101 of 106 patients had complete eradication of all dysplasia (95%) and 99 of 106 had eradication of intestinal metaplasia (93%). After 2 years, among subjects with initial low-grade dysplasia, all dysplasia was eradicated in 51 of 52 (98%) and intestinal metaplasia was eradicated in 51 of 52 (98%); among subjects with initial high-grade dysplasia, all dysplasia was eradicated in 50 of 54 (93%) and intestinal metaplasia was eradicated in 48 of 54 (89%). After 3 years, dysplasia was eradicated in 55 of 56 of subjects (98%) and intestinal metaplasia was eradicated in 51 of 56 (91%). Kaplan-Meier analysis showed that dysplasia remained eradicated in >85% of patients and intestinal metaplasia in >75%, without maintenance RFA. Serious adverse events occurred in 4 of 119 subjects (3.4%); the rate of stricture was 7.6%. The rate of esophageal adenocarcinoma was 1 per 181 patient-years (0.55%/patient-years); there was no cancer-related morbidity or mortality. The annual rate of any neoplastic progression was 1 per 73 patient-years (1.37%/patient-years).In subjects with dysplastic BE, RFA therapy has an acceptable safety profile, is durable, and is associated with a low rate of disease progression, for up to 3 years.

SUBMITTER: Shaheen NJ

PROVIDER: S-EPMC3152658 | biostudies-literature | 2011 Aug

REPOSITORIES: biostudies-literature

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Durability of radiofrequency ablation in Barrett's esophagus with dysplasia.

Shaheen Nicholas J NJ Overholt Bergein F BF Sampliner Richard E RE Wolfsen Herbert C HC Wang Kenneth K KK Fleischer David E DE Sharma Virender K VK Eisen Glenn M GM Fennerty M Brian MB Hunter John G JG Bronner Mary P MP Goldblum John R JR Bennett Ana E AE Mashimo Hiroshi H Rothstein Richard I RI Gordon Stuart R SR Edmundowicz Steven A SA Madanick Ryan D RD Peery Anne F AF Muthusamy V Raman VR Chang Kenneth J KJ Kimmey Michael B MB Spechler Stuart J SJ Siddiqui Ali A AA Souza Rhonda F RF Infantolino Anthony A Dumot John A JA Falk Gary W GW Galanko Joseph A JA Jobe Blair A BA Hawes Robert H RH Hoffman Brenda J BJ Sharma Prateek P Chak Amitabh A Lightdale Charles J CJ

Gastroenterology 20110506 2

<h4>Background & aims</h4>Radiofrequency ablation (RFA) can eradicate dysplasia and intestinal metaplasia in patients with dysplastic Barrett's esophagus (BE), and reduce rates of esophageal adenocarcinoma. We assessed long-term rates of eradication, durability of neosquamous epithelium, disease progression, and safety of RFA in patients with dysplastic BE.<h4>Methods</h4>We performed a randomized trial of 127 subjects with dysplastic BE; after cross-over subjects were included, 119 received RFA ...[more]

PMID: 21679712

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Project description:BackgroundAfter endoscopic radiofrequency ablation (RFA) of dysplastic Barrett's esophagus (BE), endoscopic biopsy samples are obtained to assess response to therapy. Whether these biopsies are of adequate depth to assess efficacy is unknown.ObjectiveTo compare the depth of endoscopic biopsy samples after RFA with those of untreated controls and to determine the prevalence of subepithelial structures in endoscopic biopsy fragments.DesignSecondary analysis of the AIM Dysplasia Trial, a multicenter, randomized, sham-controlled study.SettingNineteen treatment centers.PatientsSubjects with dysplastic BE, either status post RFA or ablation naïve (sham).Main outcome measurementsThe proportion of biopsy samples demonstrating subepithelial structures, stratified by tissue type (columnar vs squamous) in sham- and RFA-treated subjects.ResultsA total of 5648 biopsy fragments were analyzed from 113 subjects (78 RFA, 35 sham; mean 50.0 fragments per subject). Most fragments (4653, 82.4%) contained subepithelium. Squamous biopsy samples from RFA and sham subjects demonstrated subepithelium at similar rates (78.4% vs 79.1%, respectively, P = not significant [NS]). Columnar biopsy samples from RFA and sham subjects also included subepithelium at similar rates (99.0% vs 98.8%, respectively, P = NS). Regardless of treatment assignment, more columnar than squamous biopsy samples demonstrated subepithelium (98.8% vs 78.5%, P < .001).LimitationsBiopsy samples were not individually mounted.ConclusionsIn both squamous and columnar tissue, endoscopic biopsy samples after RFA were as likely to demonstrate subepithelium as untreated controls. Almost 80% of all biopsy samples were adequate to evaluate for subsquamous intestinal metaplasia. The primary determinant of biopsy depth is the type of epithelium that underwent biopsy, with squamous less likely to yield subepithelium than columnar. Biopsy samples after RFA appear to be of adequate depth to assess response to therapy. (Clinical trial registration number NCT00282672.).

Project description:BACKGROUND & AIMS:Barrett's esophagus (BE) recurs in 25% or more of patients treated successfully with radiofrequency ablation (RFA), so surveillance endoscopy is recommended after complete eradication of intestinal metaplasia (CEIM). The frequency of surveillance is informed only by expert opinion. We aimed to model the incidence of neoplastic recurrence, validate the model in an independent cohort, and propose evidence-based surveillance intervals. METHODS:We collected data from the United States Radiofrequency Ablation Registry (US RFA, 2004-2013) and the United Kingdom National Halo Registry (UK NHR, 2007-2015) to build and validate models to predict the incidence of neoplasia recurrence after initially successful RFA. We developed 3 categories of risk and modeled intervals to yield 0.1% risk of recurrence with invasive adenocarcinoma. We fit Cox proportional hazards models assessing discrimination by C statistic and 95% confidence limits. RESULTS:The incidence of neoplastic recurrence was associated with most severe histologic grade before CEIM, age, endoscopic mucosal resection, sex, and baseline BE segment length. In multivariate analysis, a model based solely on most severe pre-CEIM histology predicted neoplastic recurrence with a C statistic of 0.892 (95% confidence limit, 0.863-0.921) in the US RFA registry. This model also performed well when we used data from the UK NHR. Our model divided patients into 3 risk groups based on baseline histologic grade: non-dysplastic BE; indefinite for dysplasia, low-grade dysplasia, and high-grade dysplasia; or intramucosal adenocarcinoma. For patients with low-grade dysplasia, we propose surveillance endoscopy at 1 and 3 years after CEIM; for patients with high-grade dysplasia or intramucosal adenocarcinoma, we propose surveillance endoscopy at 0.25, 0.5, and 1 year after CEIM, then annually. CONCLUSION:In analyses of data from the US RFA and UK NHR for BE, a much-attenuated schedule of surveillance endoscopy would provide protection from invasive adenocarcinoma. Adherence to the recommended surveillance intervals could decrease the number of endoscopies performed yet identify unresectable cancers at rates less than 1/1000 endoscopies.

Project description:Background and aimsBarrett's esophagus with low-grade dysplasia (BE-LGD) carries a risk of progression to Barrett's esophagus with high-grade dysplasia (BE-HGD) and esophageal adenocarcinoma (EAC). Radiofrequency ablation (RFA) appears to be a safe and efficacious method to eradicate Barrett's esophagus. However, a confirmed consensus regarding treatment of BE-LGD with RFA vs. endoscopic surveillance is lacking. Therefore, this study aimed to elucidate the efficacy and safety for RFA vs. endoscopic surveillance in decreasing the risk of BE-LGD progression to BE-HGD or EAC.MethodsRelevant studies published before May 1, 2021 were identified by searching relevant medical databases. The primary outcome was the rate of progression BE-LGD to HGD and/or EAC after treatment with RFA and endoscopic surveillance. The secondary outcome was the rate of complete eradication of dysplasia (CE-D) and complete eradication of intestinal metaplasia (CE-IM) after treatment with RFA and endoscopic surveillance. Adverse events were also extracted and evaluated.ResultsThree randomized controlled trials were eligible for analysis. The pooled estimate of rate of neoplastic progression of BE-LGD to HGD or EAC was much lower in the RFA group than the endoscopic surveillance group (RR, 0.25; 95% CI, 0.07-0.93; P = 0.04), with moderate heterogeneity (I2 = 55%). Subgroup analysis based on progression grade was performed. The pooled rate of progression of BE-LGD to HGD was much lower in the RFA group than the endoscopic surveillance group (RR, 0.25; 95% CI, 0.07-0.71; P = 0.01), with low heterogeneity (I2 = 15%). Although the pooled risk of progression of BE-LGD to EAC was slightly lower in the RFA group than the endoscopic surveillance group (RR, 0.56; 95% CI, 0.05-6.76), the result was not statistically significant (P = 0.65). RFA also was associated a higher rate of CE-D and CE-IM both at the end of endoscopic treatment and during follow-up. However, the rate of adverse events was slightly higher after RFA treatment.ConclusionRFA decreases the risk of BE-LGD progression to BE-HGD. However, given the uncertain course of LGD and the potential for esophageal stricture after RFA, treatment options should be fully considered and weighed.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021266128, identifier PROSPERO (CRD42021266128).

Dataset Information

Durability of radiofrequency ablation in Barrett's esophagus with dysplasia.

Publications

Durability of radiofrequency ablation in Barrett's esophagus with dysplasia.

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