Complete Eradication Of Dysplasia Research Articles

Radio frequency ablation of dysplastic Barrett's esophagus: Outcomes of a single-center registry.

Barrett's esophagus (BE) is associated with an increased risk of esophageal adenocarcinoma. The use of radio frequency ablation (RFA) for complete eradication of BE with confirmed low-grade dysplasia (LGD) or high-grade dysplasia (HGD) has been promising in multicenter trials. Our aim was to evaluate the safety and efficacy outcomes associated with RFA for patients with BE and LGD/HGD in a single-center setting. This was a retrospective single-center study conducted at Department of Surgery and Transplantation, Rigshospitalet, Denmark. Data were collected from all patients who had undergone RFA for LGD or HGD from January 2014 to December 2018. Effectiveness outcomes were based on histology: complete eradication of dysplasia (CE-D), defined as all esophageal biopsies being negative for dysplasia at the last biopsy session, and complete eradication of intestinal metaplasia (CE-IM) defined as esophageal biopsies being without intestinal metaplasia. Safety outcomes were based on the proportion of complications to the RFA treatment. A total of 107 patients were identified during the follow-up period (75% men, median age = 65 years); 83% had LGD and 17% had HGD. The median follow-up was 25 months. After the last RFA treatment, CE-D was achieved in 89%. CE-D and CE-IM were achieved in 60%. Complications occurred in 6.5% of the patients. In patients with BE and confirmed LGD or HGD, RFA was associated with a high rate of CE-D and a low risk of complications. The observed safety and efficacy outcomes were comparable with those previously reported in multicenter trials, showing that the Danish treatment of BE with LGD and HGD is comparable with those of larger European expert centers.

Rio de Janeiro Global Consensus on Landmarks, Definitions, and Classifications in Barrett’s Esophagus: World Endoscopy Organization Delphi Study

Despite the significant advances made in the diagnosis and treatment of Barrett's esophagus (BE), there is still a need for standardized definitions, appropriate recognition of endoscopic landmarks, and consistent use of classification systems. Current controversies in basic definitions of BE and the relative lack of anatomic knowledge are significant barriers to uniform documentation. We aimed to provide consensus-driven recommendations for uniform reporting and global application. The World Endoscopy Organization Barrett's Esophagus Committee appointed leaders to develop an evidence-based Delphi study. A working group of 6 members identified and formulated 23 statements, and 30 internationally recognized experts from 18 countries participated in 3 rounds of voting. We defined consensus as agreement by ≥80% of experts for each statement and used the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tool to assess the quality of evidence and the strength of recommendations. After 3 rounds of voting, experts achieved consensus on 6 endoscopic landmarks (palisade vessels, gastroesophageal junction, squamocolumnar junction, lesion location, extraluminal compressions, and quadrant orientation), 13 definitions (BE, hiatus hernia, squamous islands, columnar islands, Barrett's endoscopic therapy, endoscopic resection, endoscopic ablation, systematic inspection, complete eradication of intestinal metaplasia, complete eradication of dysplasia, residual disease, recurrent disease, and failure of endoscopic therapy), and 4 classification systems (Prague, Los Angeles, Paris, and Barrett's International NBI Group). In round 1, 18 statements (78%) reached consensus, with 12 (67%) receiving strong agreement from more than half of the experts. In round 2, 4 of the remaining statements (80%) reached consensus, with 1 statement receiving strong agreement from 50% of the experts. In the third round, a consensus was reached on the remaining statement. We developed evidence-based, consensus-driven statements on endoscopic landmarks, definitions, and classifications of BE. These recommendations may facilitate global uniform reporting in BE.

A127 ENDOSCOPIC MUCOSAL RESECTION FOR DYSPLASTIC AND NEOPLASTIC BARRETT’S ESOPHAGUS: FINDINGS FROM A FOREGUT NEOPLASIA MULTIDISCIPLINARY DATABASE

Abstract Background Previously, Barrett’s esophagus with high grade dysplasia (HGD) or neoplasia was treated with esophagectomy, which is associated with a high postoperative morbidity and mortality rate. Recent guidelines support the use of endoscopic mucosal resection (EMR) for T1a esophageal adenocarcinoma (EAC) and potentially T1b EAC; however, data on long term outcomes of endoscopic treatment is lacking. We created a combined prospective and retrospective multidisciplinary database to monitor outcomes of patients with Barrett’s esophagus undergoing endoscopic treatment. Aims Our primary aim was to compare outcomes of EMR and esophagectomy in patients presenting with BE and HGD, and/or early EAC. Methods A collaboration of gastroenterologists, general surgeons and thoracic surgeons from the University of Alberta, Edmonton, Alberta, provided input on the development of the database. All patients referred to the Northern Alberta Endoscopic Ablation Program from 2009–2021 who received at least one endoscopic treatment were included. A sub-analysis of all patients with pathologic confirmation of HGD, and/or early EAC was conducted to compare outcomes of EMR and esophagectomy. Results A total of 212 patients have been entered into the database. The most common findings were HGD, low grade dysplasia (LGD), and adenocarcinoma, respectively. All patients (n=48) who had at least LGD reached complete eradication of dysplasia (CE-D) and 95.8% reached complete eradication of intestinal metaplasia (CE-IM). Of those patients that reached CE-D, 8.3% developed recurrence of dysplasia (n=4). In the sub-analysis, 74 patients (76.3%) received endoscopic therapy while 23 patients (23.7%) received endoscopic therapy then ultimately an esophagectomy. There were significantly more T1b lesions in the esophagectomy group compared to the EMR group ( p<0.0001). Of all the patients in the EMR group, only 5.4% (n=4) had treatment related complications. Of patients receiving an esophagectomy, 60.9% (n=14) experienced treatment related complications. The mean length of stay for patients in the EMR group was 1.03 +/- 0.2 days, compared to 16.5 +/- 11.8 days for esophagectomy ( p<0.0001). Conclusions EMR provides definitive and durable treatment for BE lesions classified as T1b or less severe, with fewer complications and a shorter length of hospital stay than esophagectomy. Funding Agencies Alberta Innovates Health Solutions

Durability of Cryoballoon Ablation in Neoplastic Barrett's Esophagus

BACKGROUND AND AIMSEndoscopic ablation can eradicate neoplastic Barrett's esophagus (BE) without visible lesions. Cryoballoon ablation (CBA) is an established but relatively newer ablative technique that can eliminate BE but data on the durability of its treatment effects are lacking. We assessed the durability of CBA treatment for neoplastic BE. METHODSWe performed a single-center cohort study of consecutive BE patients with confirmed low-grade dysplasia, high-grade dysplasia or intramucosal cancer treated with CBA to eradicate all BE. We excluded patients with prior ablative therapy. Visible lesions were removed with endoscopic mucosal resection prior to CBA. Outcomes included complete eradication of dysplasia (CE-D) and complete eradication of intestinal metaplasia (CE-IM) at 1 year, durability at 2 and 3 years after initial ablation, cumulative recurrence rate of dysplasia and IM, and rate of neoplastic progression. RESULTSFifty-nine patients (55.9% with high-grade dysplasia; 20.3% with prior endoscopic mucosal resection) were tracked for a median of 54.3 months. CE-D and CE-IM at 1 year were 94.6% (53/56) and 75% (42/56), respectively. Allowing for retreatment, rates of maintained CE-D and CE-IM for those who have achieved CE-D or CE-IM were 100% (53/53) and 98% (47/48) at 2 years; 100% (45/45) and 98% (40/41), at 3 years, respectively. Cumulative recurrence rate was 1.9% (1/53) for dysplasia and 14.6% (7/48) for IM (not allowing for retreatment). There was no neoplastic progression. CONCLUSIONIn treatment-naïve patients with dysplastic BE, CBA is a durable endoscopic eradication therapy but endoscopic surveillance after eradication is still warranted.

Predictors of recurrence of dysplasia or cancer in patients with dysplastic Barrett's esophagus following complete eradication of dysplasia: a single-center retrospective cohort study.

Endoscopic mucosal resection (EMR) and radiofrequency ablation (RFA) for Barrett's esophagus (BE)-related high-grade dysplasia (HGD) and early esophageal adenocarcinoma (EAC) are considered effective treatments for eradication of BE. Little is known about the impact of achieving complete eradication of intestinal metaplasia (CE-IM) following the complete eradication of neoplasia (CE-N), specifically if CE-IM reduces the risk of recurrent dysplasia. Retrospective cohort study of consecutive patients with BE and HGD or intramucosal cancer (IMC)-treated endoscopically at a tertiary referral center between 2001 and 2019. Association between CE-IM and recurrent dysplasia after CE-N was evaluated. A total of 433 patients treated with EMR and/or RFA were included. Of these, 381 (88%) achieved CE-N, of which 345 (80%) had adequate follow-up for inclusion in the analysis. A total of 266 (77%) patients achieved CE-IM; with a median follow-up since initial treatment for HGD/IMC of 45.9months (IQR 25.9, 93.1); 20 patients (5.8%) had recurrent dysplasia after achieving CE-N. Kaplan Meier survival curves revealed that time free of recurrence in those who achieved CE-IM was significantly higher (p = 0.002). In the multivariable analysis, CE-IM was associated with a significant lower hazard of recurrence (HR 0.2, 95% CI 0.1, 0.6), whereas the number of endoscopic treatments to achieve CE-N was associated with a significant higher hazard of recurrence (HR 1.1, 95% CI 1.0, 1.2). Achieving CE-IM following CE-N reduces the risk of recurrent dysplasia and should be considered a treatment target among patients with BE undergoing endoscopic therapies for HGD or EAC.

S0347 Cryoballoon and Cryospray Ablation Therapy Are Equivalent for Eradication of Barrett’s Esophagus in a Barrett’s Referral Center

INTRODUCTION: Cryotherapy is often used for dysplastic Barrett’s esophagus (BE) refractory to radiofrequency ablation (RFA).There are 2 systems for endoscopic cryotherapy that are available for clinical use in the gastrointestinal (GI) tract. The spray cryotehrapy system that delivers liquid nitrogen through a low-pressure, non-contact, 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 that requires direct contact with the target tissue that delivers cryogenic nitrous oxide (−85 °C) into an inflated balloon. There has been no studies directly comparing the two forms of cryotherapy. The aim of this study was to compare the two modalities for primary therapy in BE with dysplasia. METHODS: This is a retrospective study from a tertiary care center from 2015 to 2019. Patients were included if: 1) they had confirmed BE with dysplasia on histology 2) underwent cryotherapy every 3 months for a minimum of 2 sessions 2) were treatment naïve to ablation prior to cryotherapy 3) had at least 12 months follow up or achieved complete eradication of intestinal metaplasia (CE-IM) with at least one subsequent endoscopic biopsy conformation. Primary outcome measures stratified by histology were: (a) complete eradication of dysplasia (CE-D) and CE-IM at 18 months. The secondary outcome was measurement of adverse events. RESULTS: A total of 71 patients were analyzed. 46 underwent cryoballoon ablation and 25 underwent cryospray therapy. Patient characteristics and are in Table 1. CE-D and CE-IM were achieved in 95.6% and 84.75% in the cryoballoon group vs. 96% and 80% in the cryospray group respectively. When stratified by baseline histology there was no significant statistical difference in CE-D or CE-IM between the groups (Table 2). There was no statistical difference for grades of dysplasia between groups (Table 2). Similarly there was no significant difference patients developed strictures requiring endoscopic dilation between both groups. CONCLUSION: In this study we show that cryoballon and cryopsray therapy can have the same efficacy as RFA therapy when looking at CE-IM and CE-D rates. This study is important as cryotherapy has a more favorable post-procedural pain profile vs RFA. In conclusion, our study showed that both cryotherapy modalities are equally effective in eradication of dysplastic Barrett’s. Baseline histology is not a predictor of cryotherapy response. Prospective studies are needed to conform this data.Table 1.: Patient baseline characteristics and cryotherapy outcomes.Table 2.: Patient baseline characteristics and cryotherapy outcomes stratified according to grade of dysplasia.

293 NITROUS OXIDE CRYOBALLOON ABLATION IS A SAFE, EFFECTIVE AND DURABLE ENDOSCOPIC TREATMENT FOR DYSPLASTIC TREATMENT-NAïVE AND PREVIOUSLY-ABLATED NEOPLASTIC BARRETT’S ESOPHAGUS

Abstract Nitrous oxide cryoballoon (CB) ablation can effectively and safely eradicate dysplasia and intestinal metaplasia (IM) in patients with dysplastic BE but the durability of treatment effect is unknown. We evaluated the safety, efficacy and durability of CB ablation for complete eradication of dysplasia and IM Methods We analyzed the outcomes of consecutive BE patients treated with CB at a single academic medical center for dysplastic BE. We excluded patients with adenocarcinoma and those treated primarily with radiofrequency ablation (RFA). CB ablation was applied to all visible BE using the CB focal ablation system and default cryogen dose of 10 seconds, after eradication of neoplastic-type lesions with endoscopic mucosal resection (EMR). Primary endpoints were complete eradication of dysplasia (CE-D) and intestinal metaplasia (CE-IM) at 1, 2, 3, 4 years. Kaplan-Meir analysis was performed to assess durability where any recurrence was considered a failure. Results 70 patients (HGD = 64%; 65.7% = treatment-naive) were followed up for median of 27.4 months. CE-D and CE-IM at 1 year were 96.7% and 73.8%, respectively. The median number of CB sessions to achieve CE-IM at 1 year was 3 (IQR 2-3.5). The rates of CE-D and CE-IM allowing for re-treatment with CB or “touch-up” APC were above 90% at 2, 3 and 4 years, with no difference between treatment-naïve and previously-ablated patients. The durability of CB response in patients who achieved CE-D or CE-IM at 1 year followed until last follow-up or recurrence of dysplasia or IM are presented in Figure 1. Conclusion Recurrence rate of IM after initial CB eradication is low patient with no patients progressing to cancer or beyond their baseline dysplasia grade. CB ablation has high efficacy, safety, and durability for eradicating dysplasia and intestinal metaplasia in dysplastic BE as a primary or rescue therapy.

Outcomes of radiofrequency ablation by manual versus self-sizing circumferential balloon catheters for the treatment of dysplastic Barrett’s esophagus: a multicenter comparative cohort study

Radiofrequency ablation (RFA) is the preferred ablative modality for treating dysplastic Barrett's esophagus. The recently introduced self-sizing circumferential ablation catheter eliminates the need for a sizing balloon. Although it enhances efficiency, outcomes have not been compared with the previous manual-sizing catheter. We evaluated the comparative safety and efficacy of these 2 ablation systems in a large, multicenter cohort. Patients undergoing RFA at 3 tertiary care centers from 2005 to 2018 were included. Circumferential RFA was performed in a standard fashion, followed by focal RFA as needed. Outcomes were compared between the self-sizing and manual-sizing groups. The primary outcome was the rate of adverse events, including strictures, perforation, and bleeding. Secondary outcomes were procedure time and treatment efficacy, as assessed by rates and time to complete eradication of dysplasia (CE-D) and intestinal metaplasia (CE-IM). Three hundred eighteen patients were included, 90 (28.3%) treated with the self-sizing catheter and 228 (71.7%) with the manual-sizing catheter. Twenty-one patients (6.6%) developed strictures (8 [8.9%] in the self-sizing group and 13 [5.7%] in the manual-sizing group, P= .32). Of the self-sizing strictures, 75% occurred at the 12J dose before widespread adoption of the current 10J treatment standard. One patient developed bleeding, and no perforations were encountered. Procedure time was significantly shorter in the self-sizing group. No significant differences were observed in rates of and time to CE-D and CE-IM. These findings suggest that both systems are comparable in safety and efficacy. The use of the self-sizing system may enhance the efficiency of RFA for treating dysplastic Barrett's esophagus.

Cryoballoon and Cryospray Ablation Therapies are Equivalent for Eradication of Barrett's Esophagus

Abstract Background Cryotherapy ablation has emerged as an alternative to radiofrequency ablation for eradication of Barrett's esophagus. Limited comparative data exists on cryoballoon versus cryospray ablation. The aim was to compare these two modalities in treatment naive dysplastic Barrett's esophagus. Methods This is a retrospective study comparing cryoballoon ablation to cryospray ablation. 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 naive 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. Results A total of 71 patients were analyzed. Forty-six underwent cryoballoon ablation and 25 underwent cryospray therapy. There was no crossover between groups. CE-D and CE-IM were achieved in 95.6% and 84.75% in the cryoballoon group vs. 96% and 80% in the cryospray group respectively (p = 0.94 and 0.61 respectively). Conclusions Cryoballoon and cryospray ablation were equivalent in a tertiary care center. Prospective studies are needed to conform this study.

Mo1257 NITROUS OXIDE CRYOBALLOON ABLATION IS A SAFE, EFFECTIVE AND DURABLE ENDOSCOPIC TREATMENT FOR DYSPLASTIC TREATMENT-NAÏVE AND PREVIOUSLY-ABLATED BARRETT’S ESOPHAGUS

Nitrous oxide cryoballoon (CB) ablation can effectively and safely eradicate dysplasia and intestinal metaplasia (IM) in patients with dysplastic BE but the durability of treatment effect is unknown. We evaluated the safety, efficacy, and durability of CB ablation for complete eradication of dysplasia and IM. We analyzed the outcomes of consecutive BE patients treated with CB at a single academic medical center for dysplastic BE from 2015 to 2018. We excluded patients with invasive adenocarcinoma, those treated primarily with radiofrequency ablation (RFA), and those enrolled in ongoing clinical trials. CB ablation was applied to all the gastric cardia and all visible BE using the CB focal ablation system and default cryogen dose of 10 seconds, after eradication of neoplastic-type lesions with endoscopic mucosal resection (EMR). “Touch-up” ablation was performed using CB or argon plasma coagulation for small residual columnar islands. Primary endpoints were complete eradication of dysplasia (CE-D) and intestinal metaplasia (CE-IM) at 1, 2, 3, 4 years. Secondary endpoints were adverse events, disease progression, recurrence rate, time to recurrence, treatment success after recurrence. Patients who achieved CE-IM were included for the durability analysis. Kaplan-Meir analysis was performed to assess durability where any recurrence was considered a failure. 70 patients (mean age 67.6 years, 88.6% male, mean BE Prague C 2.5+/- 4.3 cm, Prague M 4.3 +/- 4.6 cm), HGD=64%, LGD 36%) were studied. 65.7% of the patients were treatment naïve, the rest had prior EMR (n=6), RFA (n=13) or both (n=5). Median follow-up was 27.4 months (IQR 16.1-43.4). CE-D and CE-IM at 1 year were 96.7% and 73.8%, respectively. The median number of CB sessions to achieve CE-IM at 1 year was 3 (IQR 2-3.5). Table 1 shows the rates of CE-D and CE-IM for years 1-4, allowing for re-treatment with CB or “touch-up” APC. The rate of CE-IM was above 90% at 2, 3 and 4 years, with no difference between treatment-naïve and previously-ablated The durability (rates of CE-D and CE-IM) of CB response in 45 patients who achieved CE-D or CE-IM at 1 year followed until last follow-up or recurrence of dysplasia or IM are presented in Figure 1. One patient had an LGD recurrence at 21.7 months and 3(4.3%) patients had a recurrence of IM; all were successfully re-treated with CB ablation. The median time to recurrence was 18.6 months (Figure 1). No patient progressed beyond their baseline dysplasia grade or developed cancer. The incidence of stricture requiring dilation was 7.1%. 1 patient (1.4 %) developed self-limited bleeding. Recurrence rate of IM after initial CB eradication is low. CB ablation has high efficacy, safety, and durability for eradicating dysplasia and intestinal metaplasia in dysplastic BE as a primary or rescue therapy.Figure 1Kaplan-Meier analysis of the durability of complete eradication of dysplasia and intestinal metaplasia. All subjects in this analysis achieved either complete eradication of dysplasia (n=58) or intestinal metaplasia (n=45) at 12 months. Time 0 for this analysis is the first finding of complete eradication of dysplasia or intestinal metaplasia at 12 months. Any recurrent dysplasia (n=1 LGD) or IM (n=3; 2 HGD, 1 LGD) noted after achieving CE-D or CE-IM was considered a failure, even if it was subsequently successfully eradicated by cryoballoon ablation.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Efficacy of Cryotherapy as a Primary Endoscopic Ablation Modality for Dysplastic Barrett's Esophagus and Early Esophageal Neoplasia: A Systematic Review and Meta-Analysis.

Introduction:Cryotherapy is a cold-based ablative therapy used primarily as second line therapy in patients with Barrett’s esophagus (BE) who have persistent dysplasia after undergoing endoscopic treatment with radiofrequency ablation (RFA). Few studies have described the use of cryotherapy as a primary treatment modality for dysplastic or neoplastic BE.Aim:To evaluate the efficacy of cryotherapy as primary treatment of dysplastic and/or neoplastic BE by conducting a systemic review and meta-analysis.Methods:A systematic search of Medline, Embase, and Web of Science was performed from January 2000 through March 2020. Articles included were observational studies and clinical trials which included patients who had biopsy confirmed dysplastic or neoplastic BE (i.e., high grade dysplasia (HGD), low grade dysplasia (LGD) or intramucosal adenocarcinoma (ImCA)), underwent ≥1 session of cryotherapy, and had a follow-up endoscopy. Primary outcomes were pooled proportions of patients achieving complete eradication of dysplasia (CE-D) and/or intestinal metaplasia (CE-IM) by using a random effects model.Results:Fourteen studies making up 405 patients with follow-up ranging from 3-54 months were included. In 13 studies, a total of 321/405 patients achieved CE-D with a pooled proportion of 84.8% (95% confidence interval [CI] 72.2-94.4), with substantial heterogeneity (I2 = 88.3%). In 13 studies, a total of 321/405 patients achieved CE-D with a pooled proportion of 84.8% (95% confidence interval [CI] 72.2-94.4), with substantial heterogeneity (I2 = 88.3%). Subgroup analysis of only high-quality studies revealed a pooled proportion of CE-D 91.3% (95% CI, 83.0-97.4, I2 = 69.5%) and pooled proportion of CE-IM of 71.6% (95% CI, 59.0-82.9, I2 = 80.9%). Adverse events were reported in 12.2% patients.Conclusion:Cryotherapy is a safe and effective primary therapy for dysplastic/early neoplastic BE. CE-D and CE-IM rates are comparable to those for other ablation modalities, including RFA. Cryotherapy should be considered for primary therapy of dysplastic BE and early esophageal neoplasia.

Salvage cryotherapy in patients undergoing endoscopic eradication therapy for complicated Barrett's esophagus.

Background and study aims Some patients with dysplastic Barrett’s esophagus (BE) experience suboptimal response to radiofrequency ablation (RFA), endoscopic mucosal resection (EMR), or the combination. Cryotherapy has been used as salvage therapy in these patients, but outcomes data are limited. We aimed to assess clinical outcomes among a large cohort of patients with dysplastic BE whose condition had failed to respond to RFA and/or EMR. Patients and methods This was a retrospective cohort study of consecutive cases of dysplastic BE or intramucosal carcinoma (IMC) treated with salvage cryotherapy at a tertiary-care academic medical center. The primary goal of cryotherapy treatment was eradication of all neoplasia. The secondary goal was eradication of all intestinal metaplasia. The proportion of patients undergoing salvage cryotherapy who achieved complete eradication of dysplasia (CE-D) and metaplasia (CE-IM), as well as the time to CE-D and CE-IM were calculated. Results Over a 12-year period, 46 patients received salvage cryotherapy. All patients underwent RFA prior to cryotherapy, either at our center or prior to referral, and 50 % of patients underwent EMR. A majority of patients (54 %) had high-grade dysplasia (HGD) at referral, while 33 % had low-grade dysplasia (LGD), and 13 % had IMC. Overall, 38 patients (83 %) reached CE-D and 21 (46 %) reached CE-IM. Median time to CE-D was 18 months, median number of total interventions (RFA, cryotherapy, and EMR) was five, and median number of cryotherapy sessions was two. Conclusion Salvage cryotherapy appears safe and effective for treating BE that is refractory to RFA and/or EMR.

A single-step sizing and radiofrequency ablation catheter for circumferential ablation of Barrett's esophagus: Results of a pilot study.

BackgroundThe 360 Express balloon catheter (360 Express) has the ability to self-adjust to the esophageal lumen, ensuring optimal tissue contact.ObjectiveThe objective of this article is to evaluate the efficacy and safety of the 360 Express for radiofrequency ablation (RFA) treatment of Barrett's esophagus (BE).MethodsBE patients with low-grade dysplasia (LGD), high-grade dysplasia (HGD) or early cancer (EC) were included. Visible lesions were removed by endoscopic resection (ER) prior to RFA. RFA was performed with the 360 Express using the standard ablation regimen (12J/cm2–clean–12J/cm2). Primary outcome: BE regression percentage at three months. Secondary outcomes: procedure time, adverse events, complete eradication of dysplasia (CE-D) and intestinal metaplasia (CE-IM).ResultsThirty patients (median BE C4M6) were included. Eight patients underwent ER prior to RFA. Median BE regression: 90%. Median procedure time: 31 minutes. Adverse events (13%): laceration (n = 1); atrial fibrillation (n = 1); vomiting and dysphagia (n = 1); dysregulated diabetes (n = 1). After subsequent treatment CE-D and CE-IM was achieved in 97% and 87%, respectively. In 10% a stenosis developed during additional treatment requiring a median of one dilation.ConclusionThis study shows that circumferential RFA using the 360 Express may shorten procedure time, while maintaining efficacy compared to standard circumferential RFA.

Cryotherapy and Radiofrequency Ablation for Eradication of Barrett's Esophagus with Dysplasia or Intramucosal Cancer.

Endoscopic ablation therapy has become the mainstay of treatment of Barrett's associated dysplasia and intramucosal cancer (IMC). The widely available techniques for ablation are radiofrequency ablation (RFA) and cryotherapy. Our aim was to compare eradication rates of metaplasia and dysplasia with both these modalities. Retrospective review of prospectively collected database of patients who underwent endoscopic therapy for Barrett's dysplasia or IMC from 2006 to 2011 was performed. Demographic features, comorbidities, and endoscopic data including length of Barrett's segment, hiatal hernia size, interventions during the endoscopy and histological results were reviewed. Among 154 patients included, 73 patients were in the RFA and 81 patients were in the cryotherapy group. There was complete eradication of intestinal metaplasia (CE-IM) in 81 (52.6%), complete eradication of dysplasia (CE-D) in 133 (86.4%), and persistent dysplasia or cancer in 19 patients (12.3%). Compared to RFA, cryotherapy patients were found to be older and less likely to have undergone endoscopic mucosal resection. On multivariate analysis, patients who underwent RFA had a threefold higher odds of having CE-IM than those who underwent cryotherapy (odds ratio [OR] 2.9, 95% confidence interval [CI] 1.4-6.0, p = 0.004), but CE-D were similar between the two groups (OR 1.7, 95% CI 0.66-4.3, p = 0.28). Endoscopic therapy is highly effective in eradication of Barrett's associated neoplasia. Patients who underwent cryotherapy were equally likely to achieve CE-D but not CE-IM than patients who underwent RFA. Patient characteristics and preferences may effect choice of treatment selection and outcomes.

Effectiveness of Endoscopic Therapy in Patients With Barrettʼs Esophagus (BE) With Early Cancer Is Comparable to That of BE With High-Grade Dysplasia (HGD): Results From an International, Multi-center Consortium: 2017 Category Award (Esophagus)

Introduction: Endoscopic therapy, the current treatment of choice for BE patients with HGD, is also a noninvasive alternative to surgery for treatment of BE with intra-mucosal cancer (IMC). There are limited data comparing the outcomes of endoscopic therapy in BE patients with IMC and HGD. We aimed to compare the rates of complete eradication of intestinal metaplasia (CE-IM), complete eradication of dysplasia (CE-D) and recurrent IM (Re-IM) between the two groups -IMC and HGD.Table: Table. Baseline characteristics and outcomes of endoscopic therapy in IMC and HGDMethods: We reviewed all BE subjects with HGD and IMC who underwent endoscopic therapy in a multicenter prospective registry. Patients were treated with endoscopic mucosal resection if visible lesions were noted and/or mucosal ablation (RFA, cryotherapy, APC) for the flat BE. Patients who underwent at least four EGDs with endoscopic therapy were included in the study. CEIM and CED was defined as histologic absence of intestinal metaplasia (IM) and dysplasia respectively. Re-IM was defined as histologic evidence of BE (IM, dysplasia or esophageal adenocarcinoma (EAC)) after achieving CEIM. Rates of CEIM, CED and Re-IM were calculated for the two study groups - IMC and HGD. Cox proportional hazard models were used to compare the outcomes of endoscopic therapy between the two groups. Results: 276 subjects (70 with IMC and 206 with HGD) with BE who underwent endoscopic therapy were included in the study. The median (IQR) age was 66.0 (58.0, 73.0) years. 232 (84.1%) were males. There were no differences in baseline characteristics (age, sex and BE segment length) between the IMC and HGD groups (table 1). In the IMC group, 57 (81.4%) and 62 (88.6%) subjects achieved CE-IM and CE-D respectively. In the HGD group, 173 (84.0%) and 185 (89.8%) subjects achieved CE-IM and CE-D respectively. There was no statistical difference in the proportion of subjects who achieved CE-IM (P=0.62) and CE-D (P=0.77) in the two groups. On multivariate analysis adjusting for age, sex and BE length, there was no statistical difference in the CE-IM (IMC vs HGD; HR 1.15, 95% CI 0.38 - 3.51, P=0.81) and CE-D (IMC vs HGD; HR 1.21, 95% CI 0.31-4.66, P=0.79) rates between the two groups. There were 25 (43.9%) Re-IM in the IMC group and 60 (34.7%) Re-IM in the HGD group (P=0.21). Conclusion: In this large well-defined cohort of BE patients, effectiveness of endoscopic therapy in IMC is comparable to that of HGD. Consideration of endoscopic therapy in BE patients with early cancer could reduce the need for invasive surgery.

Cryotherapy in Barrettʼs Esophagus Refractory to Radiofrequency Ablation: 2017 Presidential Poster Award

Introduction: Endoscopic ablative therapy is recommended in patients with nonnodular Barrett's esophagus (BE)-related dysplasia/neoplasia. Radiofrequency ablation (RFA) is effective, but a proportion of patients will have persistent dysplasia and/or intestinal metaplasia (IM) despite ablative therapy. Although cryotherapy ablation is often performed in this setting, its efficacy is not well defined. We aimed to assess the efficacy of salvage cryotherapy ablation in patients with RFA-refractory BE. Methods: We analyzed prospectively collected data on patients with BE-related dysplasia/neoplasia undergoing RFA at a tertiary referral center from 2008-2016. Before receiving RFA, all visible esophageal nodularity was removed by endoscopic mucosal resection (EMR). Patients with BE-related low-grade dysplasia (LGD), high-grade dysplasia (HGD), or intramucosal carcinoma (IMC) underwent RFA performed by 1 of 2 BE experts every 3 months until eradication of BE or progression to cancer. Biopsies were obtained prior to each RFA session to assess for complete eradication of dysplasia (CE-D) and complete eradication of intestinal metaplasia (CE-IM). At each endoscopist's discretion, patients with persistent dysplasia or IM were offered liquid nitrogen based cryotherapy ablation. Patients with a minimum 3 RFA sessions followed by a minimum 2 cryotherapy sessions with subsequent follow-up endoscopy with biopsies were included for further review. Results: 23 patients had persistent dysplasia or IM following a minimum of 3 RFA sessions and received cryotherapy ablation. Their baseline characteristics are shown in Table 1. The majority of patients had BE-HGD (61%) and BE-LGD (35%) at baseline, with a median maximum BE length of 9 cm. After a median 4 RFA sessions, 15/23 (65%) had persistent dysplasia and 8/23 (35%) had persistent IM. The overall median BE length decreased to 5 cm. Following a median 3 cryotherapy sessions, 6/15 (40%) achieved CE-D and 3/23 (13%) achieved CE-IM. The overall median BE length decreased to 3 cm. Overall, 13/23 (57%) experienced an improvement in histologic grade and 15/23 (65%) in BE length after salvage cryotherapy ablation (Table 2). However, during this time period, 3/23 (13%) patients experienced histologic progression (2 IMC, 1 HGD).Table: Table. Baseline CharacteristicsTable: Table. Outcomes of salvage cryotherapyConclusion: In our experience with RFA-refractory BE, salvage cryotherapy ablation achieves CE-D in less than half of patients and CE-IM in a minority of patients. Progression in this group is a significant concern. Ongoing efforts are necessary to determine the optimal clinical strategy in this group of patients refractory to traditional treatment.

Ablation of Dysplastic Barrettʼs Mucosa in Scleroderma-Type Esophagus: Cold Spray over RFA: 2016 ACG Presidential Poster Award

Radiofrequency ablation (RFA) is currently the first line endoscopic therapy for eradication of dysplastic Barrett's esophagus (BE). In this modality, high frequency radio waves are applied to the esophageal mucosa by direct contact. Another option is spray cryotherapy, where liquid nitrogen is sprayed onto the mucosa, rapidly freezing the tissue as the liquid evaporates. RFA is not always successful at ablating the BE mucosa. We believe we have identified a subset of patients in whom RFA was not effective due to a dilated baggy esophagus.First described in patients with systemic sclerosis, the “scleroderma-type” esophagus is typified by a dilated, aperistaltic esophagus with an incompetent lower esophageal sphincter. Esophageal dysmotility of this kind was later described in patients with other conditions, and in those with no systemic disease at all. This population is prone to esophageal adenocarcinoma. We hypothesized that cryotherapy would be a useful adjunct in this patient population. As it does not require direct contact with the sagging esophagus, cryotherapy may succeed where RFA had failed due to difficulty in establishing tension with the baggy mucosa of scleroderma-type esophagus.We present a retrospective case series of 4 patients with endoscopic features of scleroderma-type esophagus who were treated for dysplastic BE with RFA followed by adjunctive cryotherapy. Two patients had features of systemic sclerosis (Table 1). Three patients had high-grade dysplasia (HGD), one had indefinite dysplasia (ID). The indications for adjunctive cryotherapy were persistent dysplasia and persistent metaplasia despite RFA.All patients had reduction of their BE segment length with adjunctive cryotherapy. All 3 dysplasia patients had reduction in their grade of dysplasia with cryotherapy and 2 achieved complete eradication of dysplasia (CE-D). One patient achieved complete eradication of intestinal metaplasia (CEIM). (Table 2).Table 1: Patient Demographics and Baseline CharacteristicsTable 2: Patient OutcomesIn our case series, cryotherapy was a useful complement to RFA, and achieved CE-D in most cases as well as improvement of dysplastic histology and reduction of BE length in all cases. We hypothesize that due to the non-contact nature of spray cryotherapy it may be better suited than contact RFA for treating the sagging scleroderma-type esophagus. Weaknesses of this study are its small sample size and retrospective nature. Future research may investigate cryotherapy as a first line treatment in this population.

Safety and efficacy of endoscopic spray cryotherapy for Barrett's dysplasia: results of the National Cryospray Registry.

Retrospective series have shown the efficacy of endoscopic spray cryotherapy in eradicating high-grade dysplasia (HGD) in Barrett's esophagus (BE); however, prospective data are lacking, and efficacy for low-grade dysplasia (LGD) is unclear. The aim of this study was to assess the efficacy and safety of spray cryotherapy in patients with LGD or HGD. A multicenter, prospective open-label registry enrolled patients with dysplastic BE. Spray cryotherapy was performed every 2-3 months until there was no endoscopic evidence of BE and no histological evidence of dysplasia, followed by surveillance endoscopies up to 2 years. Primary outcome measures were complete eradication of dysplasia (CE-D) and complete eradication of all intestinal metaplasia (CE-IM). Ninety-six subjects with Barrett's dysplasia (67% HGD; 65% long-segment BE; mean length 4.5 cm) underwent 321 treatments (mean 3.3 per subject). Mean age was 67 years, 83% were male. Eighty patients (83%) completed treatment with follow-up endoscopy (mean duration 21 months). In patients with LGD, rate of CE-D was 91% (21/23) and rate of CE-IM was 61% (14/23). In HGD, CE-D rate was 81% (46/57) and CE-IM was 65% (37/57). In patients with short-segment BE (SSBE) with any dysplasia, CE-D was achieved in 97% (30/31) and CE-IM in 77% (24/31). There were no esophageal perforations or related deaths. One subject developed a stricture, which did not require dilation. One patient was hospitalized for bleeding in the setting of non-steroidal anti-inflammatory drug use. In the largest prospective cohort to date, data suggest endoscopic spray cryotherapy is a safe and effective modality for eradication of BE with LGD or HGD, particularly with SSBE.

Minor Anesthesia-Related Events During Radiofrequency Ablation for Barrett's Esophagus Are Associated with an Increased Number of Treatment Sessions.

There is limited data regarding the prevalence and clinical impact of sedation-related adverse events (SRAEs) during radiofrequency ablation (RFA) for dysplastic Barrett's esophagus (BE). Our primary aim was to measure SRAE during RFA. Secondary aims were to identify risk factors for adverse events, and to determine whether SRAEs impacted the number of RFA treatments to achieve complete eradication of dysplasia (CE-D). We conducted a retrospective analysis of 120 consecutive patients undergoing initial RFA for dysplastic BE between 2008 and 2014. The main outcome measures were SRAEs and the number of RFA sessions required to achieve CE-D. Of 120 initial RFA procedures, 83% were performed with MAC and 17% with GET. SRAEs occurred in 32%, including 25% of MAC patients (25/100) and 65% (12/20) GET patients. The most frequent SRAE was hypotension (23%, n=27/120), followed by hypoxia (n=9/120), arrhythmia (n=4/120), and one unplanned intubation. There were no premature procedure terminations. After adjusting for length of BE mucosa and ASA score, the occurrence of a SRAE was associated with requiring more (>4)RFA sessions to achieve CE-D, OR 3.45 (95% CI 1.49-7.99). Mean RFA sessions required to achieve CE-D was 5±1 in patients with SRAE, compared to 3±0.7 in patients without SRAE during the first treatment session (p<0.001). SRAE during RFA for dysplastic BE occurs at a rate typical of other advanced endoscopic procedures. Patients who experience minor events related to anesthesia during the first RFA are likely to require more RFA treatment sessions to achieve CE-D.

Effects of preceding endoscopic mucosal resection on the efficacy and safety of radiofrequency ablation for treatment of Barrett's esophagus: results from the United States Radiofrequency Ablation Registry.

The effects of preceding endoscopic mucosal resection (EMR) on the efficacy and safety of radiofrequency ablation (RFA) for treatment of nodular Barrett's esophagus (BE) is poorly understood. Prior studies have been limited to case series from individual tertiary care centers. We report the results of a large, multicenter registry. We assessed the effects of preceding EMR on the efficacy and safety of RFA for nodular BE with advanced neoplasia (high-grade dysplasia or intramucosal carcinoma) using the US RFA Registry, a nationwide study of BE patients treated with RFA at 148 institutions. Safety outcomes included stricture, gastrointestinal bleeding, and hospitalization. Efficacy outcomes included complete eradication of intestinal metaplasia (CEIM), complete eradication of dysplasia (CED), and number of RFA treatments needed to achieve CEIM. Analyses comparing patients with EMR before RFA to patients undergoing RFA alone were performed with Student's t-test, Chi-square test, logistic regression, and Kaplan-Meier analysis. Four hundred six patients were treated with EMR before RFA for nodular BE, and 857 patients were treated with RFA only for non-nodular BE. The total complication rates were 8.4% in the EMR-before-RFA group and 7.2% in the RFA-only group (P = 0.48). Rates of stricture, bleeding, and hospitalization were not significantly different between patients treated with EMR before RFA and patients treated with RFA alone. CEIM was achieved in 84% of patients treated with EMR before RFA, and 84% of patients treated with RFA only (P = 0.96). CED was achieved in 94% and 92% of patients in EMR-before-RFA and RFA-only group, respectively (P = 0.17). Durability of eradication did not differ between the groups. EMR-before-RFA for nodular BE with advanced neoplasia is effective and safe. The preceding EMR neither diminished the efficacy nor increased complication rate of RFA treatment compared to patients with advanced neoplasia who had RFA with no preceding EMR. Preceding EMR is not associated with poorer outcomes in RFA.