Radiofrequency ablation in Barrett's esophagus with dysplasia

Nicholas J. Shaheen, Prateek Sharma, Bergein F. Overholt, Herbert C. Wolfsen, Richard E. Sampliner, Kenneth K. Wang, Joseph A. Galanko, Mary P. Bronner, John R. Goldblum, Ana E. Bennett, Blair A. Jobe, Glenn M. Eisen, M. Brian Fennerty, John G. Hunter, David E. Fleischer, Virender K. Sharma, Robert H. Hawes, Brenda J. Hoffman, Richard I. Rothstein, Stuart R. GordonHiroshi Mashimo, Kenneth J. Chang, V. Raman Muthusamy, Steven A. Edmundowicz, Stuart J. Spechler, Ali A. Siddiqui, Rhonda F. Souza, Anthony Infantolino, Gary W. Falk, Michael B. Kimmey, Ryan D. Madanick, Amitabh Chak, Charles J. Lightdale

Research output: Contribution to journalArticle

923 Citations (Scopus)

Abstract

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.)

Original languageEnglish (US)
Pages (from-to)2277-2288
Number of pages12
JournalNew England Journal of Medicine
Volume360
Issue number22
DOIs
StatePublished - May 28 2009

Fingerprint

Barrett Esophagus
Metaplasia
Control Groups
Disease Progression
Esophageal Stenosis
Intention to Treat Analysis
Gastrointestinal Hemorrhage
Random Allocation
Chest Pain
Esophagus
Adenocarcinoma

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Shaheen, N. J., Sharma, P., Overholt, B. F., Wolfsen, H. C., Sampliner, R. E., Wang, K. K., ... Lightdale, C. J. (2009). Radiofrequency ablation in Barrett's esophagus with dysplasia. New England Journal of Medicine, 360(22), 2277-2288. https://doi.org/10.1056/NEJMoa0808145

Radiofrequency ablation in Barrett's esophagus with dysplasia. / Shaheen, Nicholas J.; Sharma, Prateek; Overholt, Bergein F.; Wolfsen, Herbert C.; Sampliner, Richard E.; Wang, Kenneth K.; Galanko, Joseph A.; Bronner, Mary P.; Goldblum, John R.; Bennett, Ana E.; Jobe, Blair A.; Eisen, Glenn M.; Fennerty, M. Brian; Hunter, John G.; Fleischer, David E.; Sharma, Virender K.; Hawes, Robert H.; Hoffman, Brenda J.; Rothstein, Richard I.; Gordon, Stuart R.; Mashimo, Hiroshi; Chang, Kenneth J.; Muthusamy, V. Raman; Edmundowicz, Steven A.; Spechler, Stuart J.; Siddiqui, Ali A.; Souza, Rhonda F.; Infantolino, Anthony; Falk, Gary W.; Kimmey, Michael B.; Madanick, Ryan D.; Chak, Amitabh; Lightdale, Charles J.

In: New England Journal of Medicine, Vol. 360, No. 22, 28.05.2009, p. 2277-2288.

Research output: Contribution to journalArticle

Shaheen, NJ, Sharma, P, Overholt, BF, Wolfsen, HC, Sampliner, RE, Wang, KK, Galanko, JA, Bronner, MP, Goldblum, JR, Bennett, AE, Jobe, BA, Eisen, GM, Fennerty, MB, Hunter, JG, Fleischer, DE, Sharma, VK, Hawes, RH, Hoffman, BJ, Rothstein, RI, Gordon, SR, Mashimo, H, Chang, KJ, Muthusamy, VR, Edmundowicz, SA, Spechler, SJ, Siddiqui, AA, Souza, RF, Infantolino, A, Falk, GW, Kimmey, MB, Madanick, RD, Chak, A & Lightdale, CJ 2009, 'Radiofrequency ablation in Barrett's esophagus with dysplasia', New England Journal of Medicine, vol. 360, no. 22, pp. 2277-2288. https://doi.org/10.1056/NEJMoa0808145
Shaheen NJ, Sharma P, Overholt BF, Wolfsen HC, Sampliner RE, Wang KK et al. Radiofrequency ablation in Barrett's esophagus with dysplasia. New England Journal of Medicine. 2009 May 28;360(22):2277-2288. https://doi.org/10.1056/NEJMoa0808145
Shaheen, Nicholas J. ; Sharma, Prateek ; Overholt, Bergein F. ; Wolfsen, Herbert C. ; Sampliner, Richard E. ; Wang, Kenneth K. ; Galanko, Joseph A. ; Bronner, Mary P. ; Goldblum, John R. ; Bennett, Ana E. ; Jobe, Blair A. ; Eisen, Glenn M. ; Fennerty, M. Brian ; Hunter, John G. ; Fleischer, David E. ; Sharma, Virender K. ; Hawes, Robert H. ; Hoffman, Brenda J. ; Rothstein, Richard I. ; Gordon, Stuart R. ; Mashimo, Hiroshi ; Chang, Kenneth J. ; Muthusamy, V. Raman ; Edmundowicz, Steven A. ; Spechler, Stuart J. ; Siddiqui, Ali A. ; Souza, Rhonda F. ; Infantolino, Anthony ; Falk, Gary W. ; Kimmey, Michael B. ; Madanick, Ryan D. ; Chak, Amitabh ; Lightdale, Charles J. / Radiofrequency ablation in Barrett's esophagus with dysplasia. In: New England Journal of Medicine. 2009 ; Vol. 360, No. 22. pp. 2277-2288.
@article{6b22aa4cea1d49b3aa4a0750035cb0d5,
title = "Radiofrequency ablation in Barrett's esophagus with dysplasia",
abstract = "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.)",
author = "Shaheen, {Nicholas J.} and Prateek Sharma and Overholt, {Bergein F.} and Wolfsen, {Herbert C.} and Sampliner, {Richard E.} and Wang, {Kenneth K.} and Galanko, {Joseph A.} and Bronner, {Mary P.} and Goldblum, {John R.} and Bennett, {Ana E.} and Jobe, {Blair A.} and Eisen, {Glenn M.} and Fennerty, {M. Brian} and Hunter, {John G.} and Fleischer, {David E.} and Sharma, {Virender K.} and Hawes, {Robert H.} and Hoffman, {Brenda J.} and Rothstein, {Richard I.} and Gordon, {Stuart R.} and Hiroshi Mashimo and Chang, {Kenneth J.} and Muthusamy, {V. Raman} and Edmundowicz, {Steven A.} and Spechler, {Stuart J.} and Siddiqui, {Ali A.} and Souza, {Rhonda F.} and Anthony Infantolino and Falk, {Gary W.} and Kimmey, {Michael B.} and Madanick, {Ryan D.} and Amitabh Chak and Lightdale, {Charles J.}",
year = "2009",
month = "5",
day = "28",
doi = "10.1056/NEJMoa0808145",
language = "English (US)",
volume = "360",
pages = "2277--2288",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "22",

}

TY - JOUR

T1 - Radiofrequency ablation in Barrett's esophagus with dysplasia

AU - Shaheen, Nicholas J.

AU - Sharma, Prateek

AU - Overholt, Bergein F.

AU - Wolfsen, Herbert C.

AU - Sampliner, Richard E.

AU - Wang, Kenneth K.

AU - Galanko, Joseph A.

AU - Bronner, Mary P.

AU - Goldblum, John R.

AU - Bennett, Ana E.

AU - Jobe, Blair A.

AU - Eisen, Glenn M.

AU - Fennerty, M. Brian

AU - Hunter, John G.

AU - Fleischer, David E.

AU - Sharma, Virender K.

AU - Hawes, Robert H.

AU - Hoffman, Brenda J.

AU - Rothstein, Richard I.

AU - Gordon, Stuart R.

AU - Mashimo, Hiroshi

AU - Chang, Kenneth J.

AU - Muthusamy, V. Raman

AU - Edmundowicz, Steven A.

AU - Spechler, Stuart J.

AU - Siddiqui, Ali A.

AU - Souza, Rhonda F.

AU - Infantolino, Anthony

AU - Falk, Gary W.

AU - Kimmey, Michael B.

AU - Madanick, Ryan D.

AU - Chak, Amitabh

AU - Lightdale, Charles J.

PY - 2009/5/28

Y1 - 2009/5/28

N2 - 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.)

AB - 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.)

UR - http://www.scopus.com/inward/record.url?scp=66249084112&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=66249084112&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa0808145

DO - 10.1056/NEJMoa0808145

M3 - Article

C2 - 19474425

AN - SCOPUS:66249084112

VL - 360

SP - 2277

EP - 2288

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 22

ER -