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Comparison of focal cryoballoon ablation with 10- and 8-second doses for treatment of Barrett’s esophagus–related neoplasia: results from a prospective European multicenter study (with video)
Focal cryoballoon ablation (FCBA) is currently being investigated for the treatment of Barrett’s esophagus (BE)-related neoplasia in a European multicenter study (Euro-Coldplay study). After inclusion of 28 of 107 patients, the initial dose of 10 seconds was lowered to 8 seconds. The current study a...
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Published in: | Gastrointestinal endoscopy 2022-11, Vol.96 (5), p.743-751.e4 |
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creator | Frederiks, Charlotte N. Overwater, Anouk Alvarez Herrero, Lorenza Alkhalaf, Alaa Schenk, Ed Repici, Alessandro Bergman, Jacques J.G. H.M. Pouw, Roos E. Bisschops, Raf Haidry, Rehan J. Beyna, Torsten Neuhaus, Horst Weusten, Bas L.A. M. |
description | Focal cryoballoon ablation (FCBA) is currently being investigated for the treatment of Barrett’s esophagus (BE)-related neoplasia in a European multicenter study (Euro-Coldplay study). After inclusion of 28 of 107 patients, the initial dose of 10 seconds was lowered to 8 seconds. The current study aimed to compare the efficacy and safety of a single FCBA treatment session with 10 seconds versus 8 seconds.
Treatments were performed at 7 European BE referral centers. All 28 patients treated with 10 seconds were compared with 28 consecutive patients treated with 8 seconds. The gastroesophageal junction was ablated circumferentially followed by all visible BE. To assess efficacy and safety, 3 expert adjudicators, blinded to physician and dose, compared pre- and post-treatment images. Primary outcomes were median BE surface regression and stricture rate after single-session FCBA.
We included 56 patients (10-second cohort, n = 28; 8-second cohort, n = 28) with a median BE length of C0M2 (Prague classification). Baseline characteristics did not significantly differ between the cohorts. The median BE surface regression after a single FCBA session was comparable for 10 seconds and 8 seconds (80% [95% confidence interval {CI}, 75-90] and 80% [95% CI, 66-90], respectively; P = .65). Strictures requiring dilation were seen in 19% (95% CI, 4-33) and 15% (95% CI, 4-30) of the 10-second and 8-second groups, respectively (P = 1.00). Two patients in the 10-second group developed a severe stricture requiring >3 dilations.
In patients with limited BE, single-session FCBA with 8 seconds showed similar BE surface regression as compared with 10 seconds and may theoretically result in fewer and less severe strictures. Therefore, we suggest using 8 seconds as the standard dose for FCBA. (Clinical trial registration number: NL7253.) |
doi_str_mv | 10.1016/j.gie.2022.06.017 |
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Treatments were performed at 7 European BE referral centers. All 28 patients treated with 10 seconds were compared with 28 consecutive patients treated with 8 seconds. The gastroesophageal junction was ablated circumferentially followed by all visible BE. To assess efficacy and safety, 3 expert adjudicators, blinded to physician and dose, compared pre- and post-treatment images. Primary outcomes were median BE surface regression and stricture rate after single-session FCBA.
We included 56 patients (10-second cohort, n = 28; 8-second cohort, n = 28) with a median BE length of C0M2 (Prague classification). Baseline characteristics did not significantly differ between the cohorts. The median BE surface regression after a single FCBA session was comparable for 10 seconds and 8 seconds (80% [95% confidence interval {CI}, 75-90] and 80% [95% CI, 66-90], respectively; P = .65). Strictures requiring dilation were seen in 19% (95% CI, 4-33) and 15% (95% CI, 4-30) of the 10-second and 8-second groups, respectively (P = 1.00). Two patients in the 10-second group developed a severe stricture requiring >3 dilations.
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Treatments were performed at 7 European BE referral centers. All 28 patients treated with 10 seconds were compared with 28 consecutive patients treated with 8 seconds. The gastroesophageal junction was ablated circumferentially followed by all visible BE. To assess efficacy and safety, 3 expert adjudicators, blinded to physician and dose, compared pre- and post-treatment images. Primary outcomes were median BE surface regression and stricture rate after single-session FCBA.
We included 56 patients (10-second cohort, n = 28; 8-second cohort, n = 28) with a median BE length of C0M2 (Prague classification). Baseline characteristics did not significantly differ between the cohorts. The median BE surface regression after a single FCBA session was comparable for 10 seconds and 8 seconds (80% [95% confidence interval {CI}, 75-90] and 80% [95% CI, 66-90], respectively; P = .65). Strictures requiring dilation were seen in 19% (95% CI, 4-33) and 15% (95% CI, 4-30) of the 10-second and 8-second groups, respectively (P = 1.00). Two patients in the 10-second group developed a severe stricture requiring >3 dilations.
In patients with limited BE, single-session FCBA with 8 seconds showed similar BE surface regression as compared with 10 seconds and may theoretically result in fewer and less severe strictures. Therefore, we suggest using 8 seconds as the standard dose for FCBA. (Clinical trial registration number: NL7253.)</description><issn>0016-5107</issn><issn>1097-6779</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp9kUGO1DAQRSMEEs3AAdh5OSySsZ20ncAKWsOANBIbWFsVpzzjVhIH22nUu7kDK87DTeYkVNOsWblk_f9Uv35RvBa8Elyoq31157GSXMqKq4oL_aTYCN7pUmndPS02nETlVnD9vHiR0p5z3spabIrfuzAtEH0KMwuOuWBhZDYeQw_jGOgT-hGyp-GHz_dM8JLBPLC2TGgDDUNImMgWWY4IecI5nzgfIEbM-fHhV2KYwnIPd2t6fPgZkWg4sBnDMkLy8JZFTOuYiRHDxIAtMaQFbfYHZNdrDAvCzCZSeEtsjCzldTiyy7_rHPyA4c3L4pmDMeGrf-9F8e3j9dfdp_L2y83n3fvb0ta6zqVqGhBNK1veCG2Fo_xdC3qQ29Zai61Fzd22q50CJ3ivlHW6F9i4Xg6yIflFcXnm0o7fV0zZTD5ZHEegOGsyUulO1qrhgqTiLLUUJ0V0Zol-gng0gptTYWZvqDBzKsxwZagw8rw7e5AyHDxGk6zH2eLgIx3EDMH_x_0Hp7ukjA</recordid><startdate>202211</startdate><enddate>202211</enddate><creator>Frederiks, Charlotte N.</creator><creator>Overwater, Anouk</creator><creator>Alvarez Herrero, Lorenza</creator><creator>Alkhalaf, Alaa</creator><creator>Schenk, Ed</creator><creator>Repici, Alessandro</creator><creator>Bergman, Jacques J.G. H.M.</creator><creator>Pouw, Roos E.</creator><creator>Bisschops, Raf</creator><creator>Haidry, Rehan J.</creator><creator>Beyna, Torsten</creator><creator>Neuhaus, Horst</creator><creator>Weusten, Bas L.A. M.</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202211</creationdate><title>Comparison of focal cryoballoon ablation with 10- and 8-second doses for treatment of Barrett’s esophagus–related neoplasia: results from a prospective European multicenter study (with video)</title><author>Frederiks, Charlotte N. ; Overwater, Anouk ; Alvarez Herrero, Lorenza ; Alkhalaf, Alaa ; Schenk, Ed ; Repici, Alessandro ; Bergman, Jacques J.G. H.M. ; Pouw, Roos E. ; Bisschops, Raf ; Haidry, Rehan J. ; Beyna, Torsten ; Neuhaus, Horst ; Weusten, Bas L.A. M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c373t-644a148280417c1f23198a7d258ccce8ce70f593f6af10b66cf7b1e4fb2d24f23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Frederiks, Charlotte N.</creatorcontrib><creatorcontrib>Overwater, Anouk</creatorcontrib><creatorcontrib>Alvarez Herrero, Lorenza</creatorcontrib><creatorcontrib>Alkhalaf, Alaa</creatorcontrib><creatorcontrib>Schenk, Ed</creatorcontrib><creatorcontrib>Repici, Alessandro</creatorcontrib><creatorcontrib>Bergman, Jacques J.G. H.M.</creatorcontrib><creatorcontrib>Pouw, Roos E.</creatorcontrib><creatorcontrib>Bisschops, Raf</creatorcontrib><creatorcontrib>Haidry, Rehan J.</creatorcontrib><creatorcontrib>Beyna, Torsten</creatorcontrib><creatorcontrib>Neuhaus, Horst</creatorcontrib><creatorcontrib>Weusten, Bas L.A. M.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Gastrointestinal endoscopy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Frederiks, Charlotte N.</au><au>Overwater, Anouk</au><au>Alvarez Herrero, Lorenza</au><au>Alkhalaf, Alaa</au><au>Schenk, Ed</au><au>Repici, Alessandro</au><au>Bergman, Jacques J.G. H.M.</au><au>Pouw, Roos E.</au><au>Bisschops, Raf</au><au>Haidry, Rehan J.</au><au>Beyna, Torsten</au><au>Neuhaus, Horst</au><au>Weusten, Bas L.A. M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of focal cryoballoon ablation with 10- and 8-second doses for treatment of Barrett’s esophagus–related neoplasia: results from a prospective European multicenter study (with video)</atitle><jtitle>Gastrointestinal endoscopy</jtitle><date>2022-11</date><risdate>2022</risdate><volume>96</volume><issue>5</issue><spage>743</spage><epage>751.e4</epage><pages>743-751.e4</pages><issn>0016-5107</issn><eissn>1097-6779</eissn><abstract>Focal cryoballoon ablation (FCBA) is currently being investigated for the treatment of Barrett’s esophagus (BE)-related neoplasia in a European multicenter study (Euro-Coldplay study). After inclusion of 28 of 107 patients, the initial dose of 10 seconds was lowered to 8 seconds. The current study aimed to compare the efficacy and safety of a single FCBA treatment session with 10 seconds versus 8 seconds.
Treatments were performed at 7 European BE referral centers. All 28 patients treated with 10 seconds were compared with 28 consecutive patients treated with 8 seconds. The gastroesophageal junction was ablated circumferentially followed by all visible BE. To assess efficacy and safety, 3 expert adjudicators, blinded to physician and dose, compared pre- and post-treatment images. Primary outcomes were median BE surface regression and stricture rate after single-session FCBA.
We included 56 patients (10-second cohort, n = 28; 8-second cohort, n = 28) with a median BE length of C0M2 (Prague classification). Baseline characteristics did not significantly differ between the cohorts. The median BE surface regression after a single FCBA session was comparable for 10 seconds and 8 seconds (80% [95% confidence interval {CI}, 75-90] and 80% [95% CI, 66-90], respectively; P = .65). Strictures requiring dilation were seen in 19% (95% CI, 4-33) and 15% (95% CI, 4-30) of the 10-second and 8-second groups, respectively (P = 1.00). Two patients in the 10-second group developed a severe stricture requiring >3 dilations.
In patients with limited BE, single-session FCBA with 8 seconds showed similar BE surface regression as compared with 10 seconds and may theoretically result in fewer and less severe strictures. Therefore, we suggest using 8 seconds as the standard dose for FCBA. (Clinical trial registration number: NL7253.)</abstract><pub>Elsevier Inc</pub><doi>10.1016/j.gie.2022.06.017</doi><oa>free_for_read</oa></addata></record> |
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title | Comparison of focal cryoballoon ablation with 10- and 8-second doses for treatment of Barrett’s esophagus–related neoplasia: results from a prospective European multicenter study (with video) |
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