Balloon-based, circumferential, endoscopic radiofrequency ablation of Barrett's esophagus: 1-year follow-up of 100 patients

Virender K. Sharma, Kenneth K. Wang, Bergein F. Overholt, Charles J. Lightdale, M (Brian) Fennerty, Patrick J. Dean, Douglas K. Pleskow, Ram Chuttani, Alvaro Reymunde, Nilda Santiago, Kenneth J. Chang, Michael B. Kimmey, David E. Fleischer

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Abstract

Objective: To assess the dose-response, safety, and efficacy of circumferential endoscopic ablation of Barrett's esophagus (BE) by using an endoscopic balloon-based ablation device (HALO360 System). Design: This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device that delivers a pre-set amount of energy density (J/cm2) to BE tissue. The dosimetry phase evaluated the dose-response and the safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 (delivered twice [×2]) for all patients, followed by EGD with biopsies at 1, 3, 6, and 12 months. A second ablation procedure was performed if BE was present at 1 or 3 months. Patients received esomeprazole 40 mg twice a day for 1 month after ablation, and 40 mg every day thereafter. Postablation symptoms were quantified by using a 14-day symptom diary (scale, 0-100). A complete response (CR) was defined as all biopsy specimens negative for BE at 12 months. Setting: Eight U.S. centers, between September 2003 and September 2005. Patients: Patients were 18 to 75 years of age, with a diagnosis of BE (without dysplasia), with histopathology reconfirmation of the diagnosis within 6 months of enrollment. Results: In the dosimetry phase, 32 patients (29 men; mean age, 56.8 years) were enrolled. Median symptom scores returned to a score of 0 of 100 by day 3. There were no dose-related serious adverse events, and the outcomes at 1 and 3 months permitted the selection of 10 J/cm2 (×2) for the subsequent effectiveness phase of the study. In the effectiveness phase, 70 patients (52 men, 18 women; mean age, 55.7 years) were enrolled. Median symptom scores returned to a score of 0 of 100 by day 4. At 12 months (n = 69; mean, 1.5 sessions), a CR for BE was achieved in 70% of patients. There were no strictures and no buried glandular mucosa in either study phase (4306 biopsy fragments evaluated). Conclusions: Circumferential ablation of nondysplastic BE by using this balloon-based ablation device can be performed with no subsequent strictures or buried glands and with complete elimination of BE in 70% of patients at 1-year follow-up.

Original languageEnglish (US)
Pages (from-to)185-195
Number of pages11
JournalGastrointestinal Endoscopy
Volume65
Issue number2
DOIs
StatePublished - Feb 2007
Externally publishedYes

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Barrett Esophagus
Biopsy
Equipment and Supplies
Pathologic Constriction
Esomeprazole
Safety
Mucous Membrane

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Balloon-based, circumferential, endoscopic radiofrequency ablation of Barrett's esophagus : 1-year follow-up of 100 patients. / Sharma, Virender K.; Wang, Kenneth K.; Overholt, Bergein F.; Lightdale, Charles J.; Fennerty, M (Brian); Dean, Patrick J.; Pleskow, Douglas K.; Chuttani, Ram; Reymunde, Alvaro; Santiago, Nilda; Chang, Kenneth J.; Kimmey, Michael B.; Fleischer, David E.

In: Gastrointestinal Endoscopy, Vol. 65, No. 2, 02.2007, p. 185-195.

Research output: Contribution to journalArticle

Sharma, VK, Wang, KK, Overholt, BF, Lightdale, CJ, Fennerty, MB, Dean, PJ, Pleskow, DK, Chuttani, R, Reymunde, A, Santiago, N, Chang, KJ, Kimmey, MB & Fleischer, DE 2007, 'Balloon-based, circumferential, endoscopic radiofrequency ablation of Barrett's esophagus: 1-year follow-up of 100 patients', Gastrointestinal Endoscopy, vol. 65, no. 2, pp. 185-195. https://doi.org/10.1016/j.gie.2006.09.033
Sharma, Virender K. ; Wang, Kenneth K. ; Overholt, Bergein F. ; Lightdale, Charles J. ; Fennerty, M (Brian) ; Dean, Patrick J. ; Pleskow, Douglas K. ; Chuttani, Ram ; Reymunde, Alvaro ; Santiago, Nilda ; Chang, Kenneth J. ; Kimmey, Michael B. ; Fleischer, David E. / Balloon-based, circumferential, endoscopic radiofrequency ablation of Barrett's esophagus : 1-year follow-up of 100 patients. In: Gastrointestinal Endoscopy. 2007 ; Vol. 65, No. 2. pp. 185-195.
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abstract = "Objective: To assess the dose-response, safety, and efficacy of circumferential endoscopic ablation of Barrett's esophagus (BE) by using an endoscopic balloon-based ablation device (HALO360 System). Design: This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device that delivers a pre-set amount of energy density (J/cm2) to BE tissue. The dosimetry phase evaluated the dose-response and the safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 (delivered twice [×2]) for all patients, followed by EGD with biopsies at 1, 3, 6, and 12 months. A second ablation procedure was performed if BE was present at 1 or 3 months. Patients received esomeprazole 40 mg twice a day for 1 month after ablation, and 40 mg every day thereafter. Postablation symptoms were quantified by using a 14-day symptom diary (scale, 0-100). A complete response (CR) was defined as all biopsy specimens negative for BE at 12 months. Setting: Eight U.S. centers, between September 2003 and September 2005. Patients: Patients were 18 to 75 years of age, with a diagnosis of BE (without dysplasia), with histopathology reconfirmation of the diagnosis within 6 months of enrollment. Results: In the dosimetry phase, 32 patients (29 men; mean age, 56.8 years) were enrolled. Median symptom scores returned to a score of 0 of 100 by day 3. There were no dose-related serious adverse events, and the outcomes at 1 and 3 months permitted the selection of 10 J/cm2 (×2) for the subsequent effectiveness phase of the study. In the effectiveness phase, 70 patients (52 men, 18 women; mean age, 55.7 years) were enrolled. Median symptom scores returned to a score of 0 of 100 by day 4. At 12 months (n = 69; mean, 1.5 sessions), a CR for BE was achieved in 70{\%} of patients. There were no strictures and no buried glandular mucosa in either study phase (4306 biopsy fragments evaluated). Conclusions: Circumferential ablation of nondysplastic BE by using this balloon-based ablation device can be performed with no subsequent strictures or buried glands and with complete elimination of BE in 70{\%} of patients at 1-year follow-up.",
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T1 - Balloon-based, circumferential, endoscopic radiofrequency ablation of Barrett's esophagus

T2 - 1-year follow-up of 100 patients

AU - Sharma, Virender K.

AU - Wang, Kenneth K.

AU - Overholt, Bergein F.

AU - Lightdale, Charles J.

AU - Fennerty, M (Brian)

AU - Dean, Patrick J.

AU - Pleskow, Douglas K.

AU - Chuttani, Ram

AU - Reymunde, Alvaro

AU - Santiago, Nilda

AU - Chang, Kenneth J.

AU - Kimmey, Michael B.

AU - Fleischer, David E.

PY - 2007/2

Y1 - 2007/2

N2 - Objective: To assess the dose-response, safety, and efficacy of circumferential endoscopic ablation of Barrett's esophagus (BE) by using an endoscopic balloon-based ablation device (HALO360 System). Design: This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device that delivers a pre-set amount of energy density (J/cm2) to BE tissue. The dosimetry phase evaluated the dose-response and the safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 (delivered twice [×2]) for all patients, followed by EGD with biopsies at 1, 3, 6, and 12 months. A second ablation procedure was performed if BE was present at 1 or 3 months. Patients received esomeprazole 40 mg twice a day for 1 month after ablation, and 40 mg every day thereafter. Postablation symptoms were quantified by using a 14-day symptom diary (scale, 0-100). A complete response (CR) was defined as all biopsy specimens negative for BE at 12 months. Setting: Eight U.S. centers, between September 2003 and September 2005. Patients: Patients were 18 to 75 years of age, with a diagnosis of BE (without dysplasia), with histopathology reconfirmation of the diagnosis within 6 months of enrollment. Results: In the dosimetry phase, 32 patients (29 men; mean age, 56.8 years) were enrolled. Median symptom scores returned to a score of 0 of 100 by day 3. There were no dose-related serious adverse events, and the outcomes at 1 and 3 months permitted the selection of 10 J/cm2 (×2) for the subsequent effectiveness phase of the study. In the effectiveness phase, 70 patients (52 men, 18 women; mean age, 55.7 years) were enrolled. Median symptom scores returned to a score of 0 of 100 by day 4. At 12 months (n = 69; mean, 1.5 sessions), a CR for BE was achieved in 70% of patients. There were no strictures and no buried glandular mucosa in either study phase (4306 biopsy fragments evaluated). Conclusions: Circumferential ablation of nondysplastic BE by using this balloon-based ablation device can be performed with no subsequent strictures or buried glands and with complete elimination of BE in 70% of patients at 1-year follow-up.

AB - Objective: To assess the dose-response, safety, and efficacy of circumferential endoscopic ablation of Barrett's esophagus (BE) by using an endoscopic balloon-based ablation device (HALO360 System). Design: This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device that delivers a pre-set amount of energy density (J/cm2) to BE tissue. The dosimetry phase evaluated the dose-response and the safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 (delivered twice [×2]) for all patients, followed by EGD with biopsies at 1, 3, 6, and 12 months. A second ablation procedure was performed if BE was present at 1 or 3 months. Patients received esomeprazole 40 mg twice a day for 1 month after ablation, and 40 mg every day thereafter. Postablation symptoms were quantified by using a 14-day symptom diary (scale, 0-100). A complete response (CR) was defined as all biopsy specimens negative for BE at 12 months. Setting: Eight U.S. centers, between September 2003 and September 2005. Patients: Patients were 18 to 75 years of age, with a diagnosis of BE (without dysplasia), with histopathology reconfirmation of the diagnosis within 6 months of enrollment. Results: In the dosimetry phase, 32 patients (29 men; mean age, 56.8 years) were enrolled. Median symptom scores returned to a score of 0 of 100 by day 3. There were no dose-related serious adverse events, and the outcomes at 1 and 3 months permitted the selection of 10 J/cm2 (×2) for the subsequent effectiveness phase of the study. In the effectiveness phase, 70 patients (52 men, 18 women; mean age, 55.7 years) were enrolled. Median symptom scores returned to a score of 0 of 100 by day 4. At 12 months (n = 69; mean, 1.5 sessions), a CR for BE was achieved in 70% of patients. There were no strictures and no buried glandular mucosa in either study phase (4306 biopsy fragments evaluated). Conclusions: Circumferential ablation of nondysplastic BE by using this balloon-based ablation device can be performed with no subsequent strictures or buried glands and with complete elimination of BE in 70% of patients at 1-year follow-up.

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