Circumferential balloon-based radiofrequency ablation of Barrett's esophagus with dysplasia can be simplified, yet efficacy maintained, by omitting the cleaning phase

Frederike G I van Vilsteren; K Nadine Phoa; Lorenza Alvarez Herrero; Roos E Pouw; Carine M T Sondermeijer; Ineke van Lijnschoten; Kees A Seldenrijk; Mike Visser; Sybren L Meijer; Mark I van Berge Henegouwen; Bas L A M Weusten; Erik J Schoon; Jacques J G H M Bergman

doi:10.1016/j.cgh.2012.12.005

Circumferential balloon-based radiofrequency ablation of Barrett's esophagus with dysplasia can be simplified, yet efficacy maintained, by omitting the cleaning phase

Frederike G I van Vilsteren, K Nadine Phoa, Lorenza Alvarez Herrero, Roos E Pouw, Carine M T Sondermeijer, Ineke van Lijnschoten, Kees A Seldenrijk, Mike Visser, Sybren L Meijer, Mark I van Berge Henegouwen, Bas L A M Weusten, Erik J Schoon, Jacques J G H M Bergman

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND & AIMS: The current procedure for circumferential balloon-based radiofrequency ablation (c-RFA) for the removal of dysplastic Barrett's esophagus (BE) is labor intensive, comprising 2 ablation passes with a cleaning step to remove debris from the ablation zone and electrode. We compared the safety and efficacy of 3 different c-RFA ablation regimens.

METHODS: We performed a prospective trial of consecutive patients with flat-type BE with high-grade dysplasia. Fifty-seven patients (45 men; age, 64 ± 15 y; 28 with prior endoscopic resection) were assigned randomly to groups that underwent c-RFA with a double application of RFA (12 J/cm(2)). The standard group received c-RFA, with device removal and cleaning, followed by c-RFA; the simple-with-cleaning group underwent c-RFA, with device cleaning without removal, followed by c-RFA; and the simple-no-cleaning group received 2 applications of c-RFA, and the device was not removed or cleaned. The primary outcome was surface regression of BE 3 months later, graded by 2 blinded expert endoscopists. Calculated sample size was 57 patients, based on a noninferiority design.

RESULTS: Median BE surface regression at 3 months was 83% in the standard group, 78% in the simple-with-cleaning group, and 88% in the simple-no-cleaning group (P = .14). RF ablation time was 20 minutes (interquartile range [IQR], 18-25 min) for the standard group, 13 minutes (IQR, 11-15 min) for the simple-with-cleaning group, and 5 minutes (IQR, 5-9 min) for the simple-no-cleaning group (P < .01). The median number of introductions (RFA devices/endoscope) for the standard group was 7, vs 4 for the simple groups (P < .01).

CONCLUSIONS: This randomized, prospective study suggests that c-RFA is easier and faster, but equally safe and effective, when the cleaning phase between ablations is omitted or simplified. Trialregister.nl, NTR 2495.

Original language	English
Pages (from-to)	491-98.e1
Journal	Clinical Gastroenterology and Hepatology
Volume	11
Issue number	5
DOIs	https://doi.org/10.1016/j.cgh.2012.12.005
Publication status	Published - May 2013

Keywords

Adult
Aged
Aged, 80 and over
Barrett Esophagus/pathology
Catheter Ablation/adverse effects
Female
Humans
Male
Middle Aged
Prospective Studies
Time Factors
Treatment Outcome

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10.1016/j.cgh.2012.12.005

Cite this

van Vilsteren, F. G. I., Phoa, K. N., Alvarez Herrero, L., Pouw, R. E., Sondermeijer, C. M. T., van Lijnschoten, I., Seldenrijk, K. A., Visser, M., Meijer, S. L., van Berge Henegouwen, M. I., Weusten, B. L. A. M., Schoon, E. J., & Bergman, J. J. G. H. M. (2013). Circumferential balloon-based radiofrequency ablation of Barrett's esophagus with dysplasia can be simplified, yet efficacy maintained, by omitting the cleaning phase. Clinical Gastroenterology and Hepatology, 11(5), 491-98.e1. https://doi.org/10.1016/j.cgh.2012.12.005

@article{b79f7ddcbe0349e7b81cb46594dd4cdf,

title = "Circumferential balloon-based radiofrequency ablation of Barrett's esophagus with dysplasia can be simplified, yet efficacy maintained, by omitting the cleaning phase",

abstract = "BACKGROUND & AIMS: The current procedure for circumferential balloon-based radiofrequency ablation (c-RFA) for the removal of dysplastic Barrett's esophagus (BE) is labor intensive, comprising 2 ablation passes with a cleaning step to remove debris from the ablation zone and electrode. We compared the safety and efficacy of 3 different c-RFA ablation regimens.METHODS: We performed a prospective trial of consecutive patients with flat-type BE with high-grade dysplasia. Fifty-seven patients (45 men; age, 64 ± 15 y; 28 with prior endoscopic resection) were assigned randomly to groups that underwent c-RFA with a double application of RFA (12 J/cm(2)). The standard group received c-RFA, with device removal and cleaning, followed by c-RFA; the simple-with-cleaning group underwent c-RFA, with device cleaning without removal, followed by c-RFA; and the simple-no-cleaning group received 2 applications of c-RFA, and the device was not removed or cleaned. The primary outcome was surface regression of BE 3 months later, graded by 2 blinded expert endoscopists. Calculated sample size was 57 patients, based on a noninferiority design.RESULTS: Median BE surface regression at 3 months was 83% in the standard group, 78% in the simple-with-cleaning group, and 88% in the simple-no-cleaning group (P = .14). RF ablation time was 20 minutes (interquartile range [IQR], 18-25 min) for the standard group, 13 minutes (IQR, 11-15 min) for the simple-with-cleaning group, and 5 minutes (IQR, 5-9 min) for the simple-no-cleaning group (P < .01). The median number of introductions (RFA devices/endoscope) for the standard group was 7, vs 4 for the simple groups (P < .01).CONCLUSIONS: This randomized, prospective study suggests that c-RFA is easier and faster, but equally safe and effective, when the cleaning phase between ablations is omitted or simplified. Trialregister.nl, NTR 2495.",

keywords = "Adult, Aged, Aged, 80 and over, Barrett Esophagus/pathology, Catheter Ablation/adverse effects, Female, Humans, Male, Middle Aged, Prospective Studies, Time Factors, Treatment Outcome",

author = "{van Vilsteren}, {Frederike G I} and Phoa, {K Nadine} and {Alvarez Herrero}, Lorenza and Pouw, {Roos E} and Sondermeijer, {Carine M T} and {van Lijnschoten}, Ineke and Seldenrijk, {Kees A} and Mike Visser and Meijer, {Sybren L} and {van Berge Henegouwen}, {Mark I} and Weusten, {Bas L A M} and Schoon, {Erik J} and Bergman, {Jacques J G H M}",

year = "2013",

month = may,

doi = "10.1016/j.cgh.2012.12.005",

language = "English",

volume = "11",

pages = "491--98.e1",

journal = "Clinical Gastroenterology and Hepatology",

issn = "1542-3565",

publisher = "W.B. Saunders Ltd",

number = "5",

}

van Vilsteren, FGI, Phoa, KN, Alvarez Herrero, L, Pouw, RE, Sondermeijer, CMT, van Lijnschoten, I, Seldenrijk, KA, Visser, M, Meijer, SL, van Berge Henegouwen, MI, Weusten, BLAM, Schoon, EJ & Bergman, JJGHM 2013, 'Circumferential balloon-based radiofrequency ablation of Barrett's esophagus with dysplasia can be simplified, yet efficacy maintained, by omitting the cleaning phase', Clinical Gastroenterology and Hepatology, vol. 11, no. 5, pp. 491-98.e1. https://doi.org/10.1016/j.cgh.2012.12.005

Circumferential balloon-based radiofrequency ablation of Barrett's esophagus with dysplasia can be simplified, yet efficacy maintained, by omitting the cleaning phase. / van Vilsteren, Frederike G I; Phoa, K Nadine; Alvarez Herrero, Lorenza et al.
In: Clinical Gastroenterology and Hepatology, Vol. 11, No. 5, 05.2013, p. 491-98.e1.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Circumferential balloon-based radiofrequency ablation of Barrett's esophagus with dysplasia can be simplified, yet efficacy maintained, by omitting the cleaning phase

AU - van Vilsteren, Frederike G I

AU - Phoa, K Nadine

AU - Alvarez Herrero, Lorenza

AU - Pouw, Roos E

AU - Sondermeijer, Carine M T

AU - van Lijnschoten, Ineke

AU - Seldenrijk, Kees A

AU - Visser, Mike

AU - Meijer, Sybren L

AU - van Berge Henegouwen, Mark I

AU - Weusten, Bas L A M

AU - Schoon, Erik J

AU - Bergman, Jacques J G H M

PY - 2013/5

Y1 - 2013/5

N2 - BACKGROUND & AIMS: The current procedure for circumferential balloon-based radiofrequency ablation (c-RFA) for the removal of dysplastic Barrett's esophagus (BE) is labor intensive, comprising 2 ablation passes with a cleaning step to remove debris from the ablation zone and electrode. We compared the safety and efficacy of 3 different c-RFA ablation regimens.METHODS: We performed a prospective trial of consecutive patients with flat-type BE with high-grade dysplasia. Fifty-seven patients (45 men; age, 64 ± 15 y; 28 with prior endoscopic resection) were assigned randomly to groups that underwent c-RFA with a double application of RFA (12 J/cm(2)). The standard group received c-RFA, with device removal and cleaning, followed by c-RFA; the simple-with-cleaning group underwent c-RFA, with device cleaning without removal, followed by c-RFA; and the simple-no-cleaning group received 2 applications of c-RFA, and the device was not removed or cleaned. The primary outcome was surface regression of BE 3 months later, graded by 2 blinded expert endoscopists. Calculated sample size was 57 patients, based on a noninferiority design.RESULTS: Median BE surface regression at 3 months was 83% in the standard group, 78% in the simple-with-cleaning group, and 88% in the simple-no-cleaning group (P = .14). RF ablation time was 20 minutes (interquartile range [IQR], 18-25 min) for the standard group, 13 minutes (IQR, 11-15 min) for the simple-with-cleaning group, and 5 minutes (IQR, 5-9 min) for the simple-no-cleaning group (P < .01). The median number of introductions (RFA devices/endoscope) for the standard group was 7, vs 4 for the simple groups (P < .01).CONCLUSIONS: This randomized, prospective study suggests that c-RFA is easier and faster, but equally safe and effective, when the cleaning phase between ablations is omitted or simplified. Trialregister.nl, NTR 2495.

AB - BACKGROUND & AIMS: The current procedure for circumferential balloon-based radiofrequency ablation (c-RFA) for the removal of dysplastic Barrett's esophagus (BE) is labor intensive, comprising 2 ablation passes with a cleaning step to remove debris from the ablation zone and electrode. We compared the safety and efficacy of 3 different c-RFA ablation regimens.METHODS: We performed a prospective trial of consecutive patients with flat-type BE with high-grade dysplasia. Fifty-seven patients (45 men; age, 64 ± 15 y; 28 with prior endoscopic resection) were assigned randomly to groups that underwent c-RFA with a double application of RFA (12 J/cm(2)). The standard group received c-RFA, with device removal and cleaning, followed by c-RFA; the simple-with-cleaning group underwent c-RFA, with device cleaning without removal, followed by c-RFA; and the simple-no-cleaning group received 2 applications of c-RFA, and the device was not removed or cleaned. The primary outcome was surface regression of BE 3 months later, graded by 2 blinded expert endoscopists. Calculated sample size was 57 patients, based on a noninferiority design.RESULTS: Median BE surface regression at 3 months was 83% in the standard group, 78% in the simple-with-cleaning group, and 88% in the simple-no-cleaning group (P = .14). RF ablation time was 20 minutes (interquartile range [IQR], 18-25 min) for the standard group, 13 minutes (IQR, 11-15 min) for the simple-with-cleaning group, and 5 minutes (IQR, 5-9 min) for the simple-no-cleaning group (P < .01). The median number of introductions (RFA devices/endoscope) for the standard group was 7, vs 4 for the simple groups (P < .01).CONCLUSIONS: This randomized, prospective study suggests that c-RFA is easier and faster, but equally safe and effective, when the cleaning phase between ablations is omitted or simplified. Trialregister.nl, NTR 2495.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Barrett Esophagus/pathology

KW - Catheter Ablation/adverse effects

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Prospective Studies

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1016/j.cgh.2012.12.005

DO - 10.1016/j.cgh.2012.12.005

M3 - Article

C2 - 23267867

SN - 1542-3565

VL - 11

SP - 491-98.e1

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

IS - 5

ER -

Circumferential balloon-based radiofrequency ablation of Barrett's esophagus with dysplasia can be simplified, yet efficacy maintained, by omitting the cleaning phase

Abstract

Keywords

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