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• W3044131208 abstract "Cryotherapy is often used for dysplastic Barrett's esophagus (BE) refractory to radiofrequency ablation (RFA).1Trindade A.J. et al.Dig Endosc. 2017; (published online March 16)https://doi.org/10.1111/den.12869Crossref PubMed Scopus (20) Google Scholar Recent prospective data have shown it to be less painful than RFA in patients who are treatment naïve, and thus it may be a preferred method for eradication of dysplastic Barrett's (BE).2Solomon S.S. et al.J Clin Gastroenterol. 2018; https://doi.org/10.1097/MCG.0000000000000999Crossref Scopus (27) Google Scholar,3van Munster S.N. et al.Gastrointest Endosc. 2018; (published online June)https://doi.org/10.1016/j.gie.2018.06.015Abstract Full Text Full Text PDF Scopus (40) Google Scholar Prospective studies in cryotherapy are promising and similar to eradication rates of BE with dysplasia in RFA.4Schölvinck D.W. et al.Endoscopy. 2015; 47: 1106-1112Crossref PubMed Scopus (37) Google Scholar, 5Canto M.I. et al.Gastrointest Endosc. 2018; (published online April 5)https://doi.org/10.1016/j.gie.2018.03.024Abstract Full Text Full Text PDF Scopus (44) Google Scholar, 6Orman E.S. et al.Clin Gastroenterol Hepatol. 2013; 11: 1245-1255Abstract Full Text Full Text PDF PubMed Scopus (215) Google Scholar There are 2 systems for endoscopic cryotherapy that are available. The spray cryotherapy system (truFreeze, Steris Endoscopy, Mentro, OH) delivers liquid nitrogen through a low-pressure, noncontact, 213 cm long, 7F spray catheter and results in flash freezing the mucosa to −196°C, while the other one uses a cryogenic balloon catheter (C2 Cryoballoon, Pentax Medical, Montvale, NJ) that requires direct contact with the target tissue that delivers cryogenic nitrous oxide (−85°C) into an inflated balloon.7Parsi M.A. et al.VideoGIE. 2017; 2https://doi.org/10.1016/j.vgie.2017.01.021Abstract Full Text Full Text PDF Scopus (17) Google Scholar There have been no studies directly comparing these 2 forms of cryotherapy. The aim of this study was to compare the 2 modalities for primary therapy in BE with dysplasia. This is a retrospective study from a tertiary care center from 2015 to 2019. See supplemental methods for treatment modality stratification. Patients were included if (1) they had confirmed BE with dysplasia on histology reviewed at our institution, (2) underwent cryotherapy every 3 months for a minimum of 2 sessions (3) were treatment naïve to ablation prior to cryotherapy (4) had at least 12 months follow up or achieved complete eradication of intestinal metaplasia (CE-IM) with at least one subsequent endoscopic biopsy confirmation. Primary outcomes were complete eradication of dysplasia (CE-D) and CE-IM at 18 months. The secondary outcome was measurement of adverse events. See supplemental methods for statistical methods and post-hoc sample size calculations. A total of 71 patients were analyzed. Forty-six underwent cryoballoon ablation and 25 underwent cryospray therapy. There was no crossover between groups. Patient characteristics are in Table 1. CE-D and CE-IM were achieved in 95.6% and 84.75% in the cryoballoon group versus 96% and 80% in the cryospray group respectively. When stratified by baseline histology there was no significant statistical difference in outcomes (Table 2). Similarly there was no significant difference in the number of patients who developed strictures requiring endoscopic dilation between both groups (8.7% vs 12%, P = 0.65).Table 1Patient baseline characteristics and cryotherapy outcomes.Cryoballoon (N = 46)Cryospray (N = 25)P valueAll patients (N = 71)Gender (%Male)38/4682.6%21/2584%0.8883%Age range, (Mean)45–83 (65.6)49–84 (65)0.7965.4Barrett's maximum length range, (mean)1–9 cm (3.2 cm)1–12 cm (3.6 cm)0.513.4 cmEMR% performed prior to therapy21/4645.65%15//2560%0.24850.7%Duration of follow up—range, (mean)6–15 (13)9–18 (15)0.3514Number of sessions—range, (mean)2–5 (2.45)2–5 (2.8)0.142.57Complete remission of dysplasia, n (%)44/4695.6%24/2596%0.9468/7195.77%Complete remission of intestinal metaplasia, n (%)39/4684.75%20/2580%0.6183.1%Stricture, n (%)4/468.7%3/2512%0.659.9%Chi square test was used for comparison of categorical variables. Paired t-test was used for comparison of means.Abbreviations: LGD, low-grade dysplasia; HGD, high-grade dysplasia; IMC, intramucosal cancer, EMR, endoscopic mucosal resection. Open table in a new tab Table 2Patient baseline characteristics and cryotherapy outcomes stratified according to grade of dysplasia.Cryoballoon (LGD) N = 25Cryospray (LGD)N = 9P valueCryoballoon (HGD/IMC) N = 21Cryospray (HGD/IMC) N = 16P valueGender (%Male)22/2588%6/966.66%0.1616/2176.19%15/1693.75%0.16Age, Mean65.865.20.8564.865.50.84Barrett's maximum length, mean3.64 cm3.61 cm0.982.8 cm3.5 cm0.30EMR% performed prior to therapy7/2528%2/922.22%0.7414/2166.66%13/1681.25%0.33Mean number of sessions in 12 months2.322.550.552.612.930.29Complete remission of dysplasia, n (%)24/2596%9/9100%0.5520/2195.23%15/1693.75%0.84Complete remission of intestinal metaplasia, n (%)21/2584%7/977.77%0.6718/2185.71%13/1681.25%0.72Stricture, n (%)2/258%0/900.392/219.52%2/1618.75%0.42Chi square test was used for comparison of categorical variables. Paired t-test was used for comparison of means.Abbreviations: LGD, low-grade dysplasia; HGD, high-grade dysplasia; IMC, intramucosal. Open table in a new tab Chi square test was used for comparison of categorical variables. Paired t-test was used for comparison of means. Abbreviations: LGD, low-grade dysplasia; HGD, high-grade dysplasia; IMC, intramucosal cancer, EMR, endoscopic mucosal resection. Chi square test was used for comparison of categorical variables. Paired t-test was used for comparison of means. Abbreviations: LGD, low-grade dysplasia; HGD, high-grade dysplasia; IMC, intramucosal. In this study we show that cryoballon and cryopsray therapies can have the same efficacy in regards to CE-IM and CE-D in a tertiary care referral center; with similar outcomes to RFA.6Orman E.S. et al.Clin Gastroenterol Hepatol. 2013; 11: 1245-1255Abstract Full Text Full Text PDF PubMed Scopus (215) Google Scholar Technical aspects regarding advantages and disadvantages of each system are discussed in the supplemental methods. It should be noted that the cryoballoon system does not have significant capital costs. Overall, this study is important as cryotherapy has a more favorable postprocedural pain profile vs RFA.2Solomon S.S. et al.J Clin Gastroenterol. 2018; https://doi.org/10.1097/MCG.0000000000000999Crossref Scopus (27) Google Scholar,3van Munster S.N. et al.Gastrointest Endosc. 2018; (published online June)https://doi.org/10.1016/j.gie.2018.06.015Abstract Full Text Full Text PDF Scopus (40) Google Scholar Postprocedural pain is an important patient centered outcome. In our experience patients have refused a second RFA treatment due to postprocedural pain. The results of our study show a higher rate of CE-IM as compared to two meta-analyses that showed CE-IM rates of 69% and 57% for cryotherapy.8Mohan B.P. et al.Dis esophagus Off J Int Soc Dis Esophagus. 2019; 32https://doi.org/10.1093/dote/doy130Crossref Scopus (14) Google Scholar,9Hamade N. et al.Dis esophagus Off J Int Soc Dis Esophagus. 2019; 32https://doi.org/10.1093/dote/doz040Crossref Scopus (11) Google Scholar More recent studies do show CE-IM rates as high as 88%5Canto M.I. et al.Gastrointest Endosc. 2018; (published online April 5)https://doi.org/10.1016/j.gie.2018.03.024Abstract Full Text Full Text PDF Scopus (44) Google Scholar and perhaps a learning curve component or advances in technology are factors associated with the lower CE-IM rates. Our study has notable strengths. First, we only included BE patients with confirmed dysplasia by 2 GI pathologists. Second, the study includes 2 high-volume endoscopists who perform cryoballoon, cryospray, and RFA therapy routinely. Including 2 endoscopists makes the study more generalizable. The postprocedure protocol regarding diet, antacid medication, and endoscopic follow-up were identical for both groups. This allows for an equal comparison. Our study does have limitations. The study was retrospective and thus has limitations inherent to this. Second, the patients were not randomized to therapy and thus there is a potential for selection bias. Third, based on the post-hoc sample size calculations, the cryospray cohort is underpowered by 4 patients. Finally this study is only applicable to tertiary care Barrett's referral centers. In conclusion, our study showed that both cryotherapy modalities are equally effective in eradication of dysplastic Barrett's. Prospective studies are needed to confirm this data. Download .docx (.11 MB) Help with docx files Erratum Regarding Declaration of Ethical Statements in Previously Published ArticlesTechniques and Innovations in Gastrointestinal EndoscopyVol. 24Issue 2PreviewPreviously published content in Techniques and Innovations in Gastrointestinal Endoscopy did not include explicit ethical statements. This erratum is to confirm that ethical guidelines were followed in all instances and research published within the journal adheres to ethical standards as outlined in the Instructions for Authors. See https://www.tigejournal.org/content/authorinfo#Ethical%20Standards for full details. The appropriate ethical statements, provided by the Authors, are included below: Full-Text PDF" @default.
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• W3044131208 title "Cryoballoon and Cryospray Ablation Therapies are Equivalent for Eradication of Barrett's Esophagus" @default.
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