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BACKGROUND: For focal radiofrequency ablation of Barrett's oesophagus, a simplified regimen (3 × 15 J/cm2, without cleaning) has proven to be as effective as the standard regimen (2 × 15 J/cm2, followed by cleaning, followed by 2 × 15 J/cm2). However, this simplified regimen seemed to be associated with a higher stenosis rate. Therefore, we lowered the radiofrequency energy and hypothesised that this new simplified regimen would be as effective and safe as the standard regimen. METHODS: This randomised non-inferiority trial included patients with dysplastic Barrett's oesophagus or residual Barrett's oesophagus after endoscopic resection or circumferential radiofrequency ablation, in five European tertiary referral centres. Patients were randomly assigned (1:1) to the new simplified regimen (3 × 12 J/cm2, without cleaning) or the standard regimen, with variable block sizes of four, six, and eight patients, stratified by participating hospital. Focal radiofrequency ablation was done every 3 months, up to a maximum of three treatments, until all Barrett's oesophagus was eradicated. The primary outcome was complete endoscopic and histological regression of dysplasia and intestinal metaplasia after two focal radiofrequency ablation treatments, assessed in the intention-to-treat population. Non-inferiority was assessed on the basis of the difference between groups in the median percentage of Barrett's oesophagus surface regression, with a non-inferiority margin of -15%. This study is registered with www.trialregister.nl, number NTR4994, and is completed. FINDINGS: Between March 25, 2015, and July 25, 2016, 84 patients were randomly assigned to treatment: 44 to receive the simplified regimen and 40 to receive the standard regimen. One patient assigned to the simplified regimen and four assigned to the standard regimen were excluded because they weree found not to be eligible; therefore the final intention-to-treat population consisted of 43 patients in the simplified ablation group and 36 in the standard ablation group. Complete endoscopic and histological regression of dysplasia and intestinal metaplasia after two focal radiofrequency ablation treatments was achieved in 32 (74%, 95% CI 59-87) patients treated with the simplified protocol, versus 30 (83%, 95% CI 67-94) patients treated with the standard protocol (p=0·34). Median Barrett's oesophagus surface regression after two focal radiofrequency ablation sessions was 98% (IQR 95-100) in the simplified regimen group and 100% (97-100) in the standard regimen group. The difference between medians was 2% (95% CI -0·562 to 3·162); thus the simplified regimen was deemed non-inferior to the standard regimen. Stenoses requiring dilatation were observed in four (9%) of 43 patients in the simplified regimen group and four (11%) of 36 in the standard regimen group. Post-procedural bleeding requiring repeat endoscopy occurred in one (2%) patient in the simplified ablation group and three (8%) patients in the standard ablation group. One patient (2%) in the simplified treatment group died 36 days after the second radiofrequency ablation procedure, due to an unknown cause. INTERPRETATION: Based on the results of this study, we conclude that the simplified regimen is the preferred regimen for focal radiofrequency ablation of Barrett's oesophagus. FUNDING: None. ispartof: LANCET GASTROENTEROLOGY & HEPATOLOGY vol:3 issue:8 pages:566-574 ispartof: location:Netherlands status: published

BACKGROUND & AIMS: Radiofrequency ablation (RFA), with or without endoscopic resection effectively eradicates Barrett's esophagus (BE) containing high-grade intraepithelial neoplasia and/or early-stage cancer. We followed patients who received RFA for BE containing high-grade intraepithelial neoplasia and/or early-stage cancer for 5 years to determine the durability of treatment response.METHODS: We followed 54 patients with BE (2-12 cm), previously enrolled in 4 consecutive cohort studies in which they underwent focal endoscopic resection in case of visible lesions (n = 40 [72%]), followed by serial RFA every 3 months. Patients underwent high-resolution endoscopy with narrow-band imaging at 6 and 12 months after treatment and then annually for 5 years (median, 61 months; interquartile range, 53-65 months); random biopsy samples were collected from neosquamous epithelium and gastric cardia. After 5 years, endoscopic ultrasound and endoscopic resection of neosquamous epithelium were performed. Outcomes included sustained complete remission of neoplasia or intestinal metaplasia (IM), IM in gastric cardia, or buried glands in neosquamous epithelium.RESULTS: After 5 years, Kaplan-Meier analysis showed sustained complete remission of neoplasia and intestinal metaplasia in 90% of patients; neoplasia recurred in 3 patients and was managed endoscopically. Focal IM in the cardia was found in 19 of 54 patients (35%), in 53 of 1143 gastric cardia biopsies (4.6%). The incidence of IM of the cardia did not increase over time; and IM was diagnosed based on only a single biopsy in 89% of patients. Buried glands were detected in 3 of 3543 neosquamous epithelium biopsies (0.08%, from 3 patients). No endoscopic resection samples had buried glands.CONCLUSIONS: Among patients who have undergone RFA with or without endoscopic resection for neoplastic BE, 90% remain in remission at 5-year follow-up, with all recurrences managed endoscopically. This treatment approach is therefore an effective and durable alternative to esophagectomy; www.trialregister.nl number, NTR2938.

Background and study aims: Radiofrequency ablation (RFA) is safe and effective for the eradication of neoplastic Barrett's esophagus; however, occasionally there is minimal regression after initial circumferential balloon-based RFA (c-RFA). This study aimed to identify predictive factors for a poor response 3 months after c-RFA, and to relate the percentage regression at 3 months to the final treatment outcome. Methods: We included consecutive patients from 14 centers who underwent c-RFA for high grade dysplasia at worst. Patient and treatment characteristics were registered prospectively. "Poor initial responseo" was defined as < 50 % regression of the Barrett's esophagus 3 months after c-RFA, graded by two expert endoscopists using endoscopic images. Predictors of initial response were identified through logistic regression analysis. Results: There were 278 patients included (median Barrett's segment C4M6). In poor initial responders (n = 36; 13 %), complete response for neoplasia (CR-neoplasia) was ultimately achieved in 86 % (vs. 98 % in good responders; P < 0.01) and complete response for intestinal metaplasia (CR-IM) in 66 % (vs. 95 %; P < 0.01). Poor responders required 13 months treatment (vs. 7 months; P < 0.01) for a median of four RFA sessions (vs. three; P < 0.01). We identified four independent baseline predictors of poor response: active reflux esophagitis (odds ratio [OR] 37.4; 95 % confidence interval [CI] 3.2 - 433.2); endoscopic resection scar regeneration with Barrett's epithelium (OR 4.7; 95 %CI 1.1 - 20.0); esophageal narrowing pre-RFA (OR 3.9; 95 %CI 1.0 - 15.1); and years of neoplasia pre-RFA (OR 1.2; 95 %CI 1.0 - 1.4). Conclusions: Patients with a poor initial response to c-RFA have a lower ultimate success rate for CR-neoplasia/CR-IM, require more treatment sessions, and a longer treatment period. A poor initial response to c-RFA occurs more frequently in patients who regenerate their endoscopic resection scar with Barrett's epithelium, and those with ongoing reflux esophagitis, neoplasia in Barrett's esophagus for a longer time, or a narrow esophagus.

Immunotherapy for solid cancers, such as oesophageal adenocarcinoma (OAC), is generally hampered by an unfavourable immunological tumour microenvironment. This prompted us to investigate the nature of the OAC environment. Biopsies of tumour and normal control tissues were collected from 17 OAC patients, and investigated using fluorescent immunohistochemistry (IHC) for the expression of cyclooxygenase-2 (COX-2), vascular endothelial growth factor (VEGF), transforming growth factor-beta, indoleamine 2-3 dioxygenase, CXCL3 and CXCR1, and for measuring a panel of cytokines by cytometric bead array (CBA), and for Granzyme B (GrB), Perforin and PI9 detection by semi-quantitative PCR (QPCR). IHC showed that expression of all the above-mentioned factors is upregulated in 80-93% of the tumours. By QPCR, the cytokine interleukin (IL)-8 was significantly upregulated in tumour samples (P < 0.05). IL-6, IL-10, GrB and Perforin did not show any significant difference between normal and tumour samples, whereas PI9 levels were significantly higher in normal when compared with the tumour samples. CBA confirmed upregulation of IL-8 and show upregulation of IL-1beta in the tumours (P < 0.05). Regarding IL-6 and interferon (IFN)-gamma, no significant differences were observed between normal and tumour tissues. The OAC microenvironment is characterized by a lack of cytokines and factors that normally would enhance anti-cancer responses, such as IFN-gamma and GrB, and by a high expression of several immuno-suppressive factors, such as COX-2, VEGF and IL-8. For future improvement of treatment efficacy of OAC patients, it will be of importance to combine immunotherapy with immune-modulating agents.

Background and study aims: Stepwise circumferential and focal ablation of nondysplastic Barrett's esophagus has proven safe and effective. This study assessed the efficacy and safety of ablation for Barrett's esophagus with high-grade dysplasia (HGD), and residual Barrett's esophagus with dysplasia after prior endoscopic resection for visible lesions. Patients and methods: This was a prospective cohort study. All visible abnormalities were resected prior to ablation. Persistence of dysplasia and absence of invasive cancer was confirmed with biopsies after endoscopic resection. A balloon-based electrode was used for primary circumferential ablation and an endoscope-mounted electrode was used for secondary focal ablation. Eradication of dysplasia and Barrett's esophagus was the main outcome measure. Results: Eleven patients (eight men; median age 60 years) were treated (median Barrett's length 5 cm). Visible abnormalities were removed with endoscopic resection in six patients. The worst pathological grade of residual Barrett's esophagus after endoscopic resection and prior to ablation was LGD (n=2) and HGD (n=9). Patients underwent a median of two circumferential and two focal ablation sessions. Complete remission of dysplasia and complete endoscopic and histological removal of Barrett's esophagus was achieved in 11/11 patients (100%). There were no adverse events or strictures, and in none of the 473 biopsies of neo-squamous mucosa was subsquamous Barrett's esophagus ("buried Barrett's") observed. During a median follow-up period of 14 months after the last treatment session and a median number of two follow-up endoscopies, none of the patients showed recurrence of dysplasia or endoscopic signs of recurrent Barrett's mucosa. Conclusions: Stepwise circumferential and focal ablation appears to be a safe and effective treatment for complete removal of Barrett's esophagus containing HGD, and can be safely performed after prior endoscopic resection for endoscopically visible abnormalities.

Esophageal adenocarcinoma (EA) and esophageal squamous cell carcinoma (ESCC) are the two main types of esophageal cancer. Despite extensive research the exact molecular basis of these cancers is unclear. Therefore we evaluated the transcriptome of EA in comparison to non-dysplastic Barrett’s esophagus (BE), the metaplastic epithelium that predisposes for EA, and compared the transcriptome of ESCC to normal esophageal squamous epithelium. For obtaining the transcriptomes tissue biopsies were used and serial analysis of gene expression (SAGE) was applied. Validation of results by RT-PCR and immunoblotting was performed using tissues of an additional 23 EA and ESCC patients. Over 58,000 tags were sequenced. Between EA and BE 1013, and between ESCC and normal squamous epithelium 1235 tags were significantly differentially expressed (p < 0.05). The most up-regulated genes in EA compared to BE were SRY-box 4 and Lipocalin2, whereas the most down-regulated genes in EA were Trefoil factors and Annexin A10. The most up-regulated genes in ESCC compared to normal squamous epithelium were BMP4, E-Cadherin and TFF3. The results could suggest that the BE expression profile is closer related to normal squamous esophagus then to EA. In addition, several uniquely expressed genes are identified.

Study aims: The aim of the current study was to evaluate the efficacy and safety of stepwise circumferential and focal ablation using the HALO system for Barrett's esophagus containing flat, high-grade dysplasia (HGD) or residual dysplasia after endoscopic resection for HGD or intramucosal cancer (IMC). Methods: Visible abnormalities were removed with endoscopic resection prior to ablation. Persistence of dysplasia and absence of IMC were confirmed with biopsy after endoscopic resection. A balloon-based electrode was used for primary circumferential ablation and an endoscope-mounted electrode was used for secondary focal ablation. Results: Twelve patients (nine men: median age 70 years) were treated (median Barrett's length 7 cm). Visible abnormalities were removed by endoscopic resection in seven patients. The worst pathological grade of residual Barrett's esophagus after resection and prior to ablation was low-grade dysplasia (LGD) (n=1) and HGD (n=11). Patients underwent a median of one circumferential and two focal ablation sessions. Complete remission of dysplasia was achieved in 12/12 patients (100%). Complete endoscopic and histological removal of Barrett's esophagus was achieved in 12/12 patients (100%). There were no ablation-related stenoses, and no subsquamous Barrett's esophagus was observed in 363 biopsies obtained from post-ablation neo-squamous mucosa. Protocolized cleaning of the ablation zone and electrode in between ablations resulted in superior regression of Barrett's esophagus compared with previous studies. During a median follow-up of 14 months no recurrence of dysplasia or Barrett's esophagus was observed. Conclusions: Stepwise circumferential and focal ablation for Barrett's esophagus with flat HGD or for Barrett's with residual dysplasia after endoscopic resection for HGD/IMC is a safe and effective treatment modality. Its success rate and safety profile compare favorably with alternatives such as esophagectomy, widespread endoscopic resection or photodynamic therapy.

BACKGROUND: The currently recommended regimen for focal radiofrequency ablation (RFA) of Barrett's esophagus (BE) comprises 2 applications of energy, cleaning of the device and ablation zone, and 2 additional applications of energy. A simplified regimen may be of clinical utility if it is faster, easier, and equally safe and effective.OBJECTIVE: To compare the efficacy of 2 focal RFA regimens.SETTING: Three tertiary referral centers.PATIENTS: Consecutive patients scheduled for focal RFA of BE with flat type BE with at least 2 BE islands or mosaic groups of islands were enrolled.INTERVENTIONS: BE areas were paired: 1 area was randomized to the "standard" regimen (2 × 15 J/cm(2)-clean-2 × 15 J/cm(2)) or to the "simplified" regimen (3 × 15 J/cm(2)-no clean), allocating the second area automatically to the other regimen. The percentage of surface area regression of each area was scored at 2 months by the endoscopist (blinded).OUTCOME MEASURE: Proportion of completely removed BE areas at 2 months. Calculated sample size was 46 pairs of BE areas using a noninferiority design. Noninferiority was defined as RESULTS: Forty-five equivalent pairs of BE areas were included in 41 patients. The proportion of completely removed BE areas at 2 months after focal RFA was 30 (67%) for standard and 33 (73%) for simplified. Noninferiority was demonstrated by a 7% difference (95% CI, -10.6 to +20.9).LIMITATIONS: Tertiary referral centers.CONCLUSIONS: The results of this multicenter randomized trial suggest that a simplified 3 × 15 J/cm(2) focal ablation regimen is not inferior to the standard regimen, regarding the endoscopic removal of residual Barrett islands.

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.

Objective: After focal endoscopic resection (ER) of high-grade dysplasia (HGD) or early cancer (EC) in Barrett's oesophagus (BO), eradication of all remaining BO reduces the recurrence risk. The aim of this study was to compare the safety of stepwise radical ER (SRER) versus focal ER followed by radiofrequency ablation (RFA) for complete eradication of BO containing HGD/EC. Methods: A multicentre randomised clinical trial was carried out in three tertiary centres. Patients with BO ≤5 cm containing HGD/EC were randomised to SRER or ER/RFA. Patients in the SRER group underwent piecemeal ER of 50% of BO followed by serial ER. Patients in the ER/RFA group underwent focal ER for visible lesions followed by serial RFA. Follow-up endoscopy with biopsies (four-quadrant/2 cm BO) was performed at 6 and 12 months and then annually. The main outcome measures were: stenosis rate; complications; complete histological response for neoplasia (CR-neoplasia); and complete histological response for intestinal metaplasia (CR-IM). Results: CR-neoplasia was achieved in 25/25 (100%) SRER and in 21/22 (96%) ER/RFA patients. CR-IM was achieved in 23 (92%) SRER and 21 (96%) ER/RFA patients. The stenosis rate was significantly higher in SRER (88%) versus ER/RFA (14%; p

OBJECTIVES: Endoscopic radiofrequency ablation (RFA) eradicates intestinal metaplasia and intraepithelial neoplasia associated with Barrett's esophagus (BE), restoring an endoscopically normal neosquamous epithelium (NSE). We evaluated the post-RFA NSE for genetic abnormalities and buried glandular mucosa. METHODS: Eligible patients underwent RFA for BE containing early cancer and/or high-grade intraepithelial neoplasia with subsequent complete histological reversion to normal NSE. At baseline, the BE was sampled by brush cytology and biopsies. At least 2 months after RFA, the NSE was sampled by brush cytology, keyhole biopsies, and endoscopic resection. The untreated squamous epithelium was biopsied as a control. The baseline BE and post-RFA NSE were evaluated for immunohistochemical expression of Ki-67 and p53, and genetic abnormalities (DNA-fluorescent in situ hybridization: chromosome 1 and 9, p16 and p53). In addition, biopsy depth was compared for biopsies from the NSE and untreated squamous epithelium. The presence of buried glandular mucosa in NSE was assessed with primary and keyhole biopsy, and endoscopic resection. RESULTS: All pretreatment specimens from all 22 patients showed abnormalities on immunohistochemical staining and fluorescent in situ hybridization, whereas all post-RFA NSE specimens were normal. All the post-RFA biopsies from the NSE contained full epithelia, whereas 37% contained lamina propria, a finding no different from biopsies from untreated squamous epithelium (36% lamina propria). Deeper keyhole biopsies contained lamina propria in 51%. All endoscopic resection specimens contained submucosa, whereas no biopsy or endoscopic resection specimen contained buried glandular mucosa. CONCLUSIONS: Rigorous evaluation of the post-RFA NSE in patients who, at baseline, had BE containing early cancer high-grade intraepithelial neoplasia, showed neither persistent genetic abnormalities nor buried glandular mucosa

See Editorial on page 7. BACKGROUND & AIMS: Radiofrequency ablation (RFA) is safe and effective for eradicating intestinal metaplasia and neoplasia in patients with Barrett’s esophagus. We sought to assess the safety and efficacy of RFA in conjunction with baseline endoscopic resection for high-grade intraepithelial neoplasia (HGIN) and early cancer. METHODS: This multicenter, prospective cohort study included 24 patients (mean age, 65 years; median Barrett’s esophagus, 8 cm), with Barrett’s esophagus of 12 cm containing HGIN or early cancer, from 3 European tertiary-care medical centers. Visible lesions were endoscopically resected, followed by serial RFA. Focal escape endoscopic resection was used if Barrett tissue persisted despite RFA. Complete response, defined as all biopsies negative for intestinal metaplasia and neoplasia, was assessed during endoscopy with 4-quadrant biopsies taken every 1 cm of the original Barrett’s segment 2 months after the patient was last treated. RESULTS: Twenty-three patients underwent pre-RFA endoscopic resection for visible lesions; 16 patients had early cancer and 7 patients had HGIN. The worst residual histology results, pre-RFA (after any endoscopic resection) were: HGIN (10 patients), low-grade intraepithelial neoplasia (11 patients), and intestinal metaplasia (3 patients). Neoplasia and intestinal metaplasia were eradicated in 95% and 88% of patients, respectively; after escape endoscopic resection in 2 patients, rates improved to 100% and 96%, respectively. Complications after RFA included melena (n 1) and dysphagia (n 1). After additional follow-up (median, 22 months; interquartile range, 17.2–23.8 months) no neoplasia recurred. CONCLUSIONS: This European multicenter study to show that early neoplasia in Barrett’s esophagus can be effectively and safely treated with RFA, in combination with prior endoscopic resection of visible lesions.

BACKGROUND: Radiofrequency ablation is safe and effective for complete eradication of nondysplastic Barrett esophagus (BE). The aim was to report the combined results of two published and two ongoing studies on radiofrequency ablation of BE with early neoplasia, as presented at SSAT presidential plenary session DDW 2008. METHODS: Enrolled patients had BE

Background For selected patients with high-grade dysplasia (HGD) and/or early esophageal squamous cell cancer (ESCC), endoscopic therapy represents a nonsurgical treatment option. For widespread lesions, however, current endoscopic treatment modalities (eg, endoscopic resection, argon plasma coagulation, photodynamic therapy) are associated with considerable drawbacks, of which esophageal stricturing is the most significant. Balloon-based radiofrequency (RF) ablation (HALO System) is a promising technology for endoscopic treatment of Barrett's esophagus, and may also play a role in treating widespread HGD and early ESCC. Objective We describe a case report of balloon-based RF ablation for HGD and early ESCC. Design Case report. Setting Tertiary care institution, Academic Medical Center, Amsterdam, The Netherlands. Patient A 66-year-old male with a 35-mm large, flat-type ESCC with surrounding HGD. Intervention Balloon-based RF ablation (HALO System). Main Outcome Measurements Endoscopic and histological eradication of HGD and ESCC, and adverse events. Results RF ablation resulted in complete endoscopic and histological eradication of HGD and ESCC without adverse events such as dysphagia or esophageal narrowing. Limitations Single patient report, limited follow-up. Conclusions This is the first report of balloon-based RF ablation for esophageal HGD and early ESCC. The treatment resulted in complete eradication of a 35-mm flat ESCC with no adverse events. This suggests that this ablation technique deserves further study for the management of widespread HGD or flat-type ESCC.

Esophageal cancer is a highly malignant disease that despite surgery and adjuvant therapies has an extremely poor outcome. Dendritic cell (DC) immunotherapy as a novel promising strategy could be an alternative for treating this malignancy. Effective DC-mediated immune responses can be achieved by raising cytotoxic T lymphocyte (CTL) response against multiple antigens through loading DCs with total tumor RNA. However, the efficacy of this strategy first needs to be evaluated in a pre-clinical setting. The aim of the study was to set up an ex vivo autologous human readout assay for assessing the effects of DC-mediated cytotoxic responses, using total tumor RNA as an antigen load. Biopsy specimens of seven esophageal cancer patients were used to establish primary cultures of normal and cancer cells and to obtain autologous RNA for loading DCs. Mature DCs loaded with either normal or tumor RNA were obtained and subsequently used to raise various lymphocytes populations. Apoptosis levels of the autologous cultures were measured before and after incubating the cultures with the different lymphocytes populations. The mean apoptosis levels in the tumor cell cultures, induced by lymphocytes instructed by DCs loaded with tumor RNA, significantly increased with 15.6% +/- 2.9 SEM (range 3.4-24.5%, t-test, P

Radiofrequency Ablation /Endoscopic Resection for Barrett’s Esophagus With High-Grade Dysplasia and/or Early Cancer: Durability of the Post-Treatment Neosquamous Epithelium At 5-Year Follow-Up Kai Yi N. Phoa, Roos E. Pouw, Frederike G. Van Vilsteren, Carine Sondermeijer, Lorenza Alvarez Herrero, Fiebo J. Ten Kate, Mike Visser, Mark I. Van Berge Henegouwen, Bas L. Weusten, Rosalie C. Mallant-Hent, Jacques J. Bergman Gastroenterology, Academic Medical Center, Amsterdam, Netherlands; Gastroenterology, St Antonius hospital, Nieuwegein, Netherlands; Pathology, Academic Medical Center, Amsterdam, Netherlands; Surgery, Academic Medical Center, Amsterdam, Netherlands; Gastroenterology, Flevoziekenhuis, Almere, Netherlands Background: Radiofrequency ablation (RFA) is safe and effective for complete eradication of Barrett’s esophagus (BE) with high-grade dysplasia (HGD) and/or early cancer (EC), and may be safely preceded by focal endoscopic resection (ER) to remove visible lesions. Less is known regarding the long-term (5-year) durability of the neosquamous epithelium (NSE) that repopulates the esophagus after RFA. Aim: In a prospective cohort of BE patients with HGD/EC, all of whom achieved complete epithelial reversion after RFA /focal ER at 1-year follow-up, we assessed the 5-year durability of the treatment response. Methods: At study entry, patients had BE 10cm with HGD or EC( T1sm1) confirmed by an expert pathologist. We removed visible lesions with focal ER, followed by repeat biopsy to establish the post-ER diagnosis. We performed RFA at 2-month intervals until all Barrett’s mucosa was visibly eradicated. Annually thereafter we performed high-resolution endoscopy with NBI, taking biopsies (4Q/2cm) from the NSE above the top of the gastric folds. Additionally, biopsies were obtained distal to the neosquamocolumnar junction (gastric cardia, analyzed separately). During and after treatment patients received high-dose PPI maintenance medication. Primary outcomes: 1) complete histological remission of HGD/EC (CR-neo), 2) complete histological remission of intestinal metaplasia (CR-IM) in esophageal biopsies. Secondary outcome: presence of IM in biopsies from the gastric cardia. Results: Twenty-three patients were analyzed (17 men, mean age 63.4, median BE C4M7). Entry ER was performed in 13 patients for lesions showing: EC (n 4), HGD (n 6) or LGD (n 3). Worst grade post-ER (pre-RFA): HGD(n 20), LGD(n 3). All patients achieved CR-neo/CR-IM at 1-year (2 required focal escape ER). Three patients exited the study at 16, 28 and 44 mo due to unrelated comorbidity. All were CR-neo/CR-IM at last follow-up. Median follow-up (n 23) since study entry was 52 mo (IQR 44-55). Follow-up endoscopy with biopsies was performed a median of 5 (IQR 4-5) times per patient (mean 77 38 biopsies per pt (61 NSE, 17 cardia)). All patients (n 23, 100%) demonstrated sustained CR-neo and CR-IM at every biopsy session during follow-up. None of the 1780 NSE biopsies demonstrated subsquamous IM. In 37 of the 379 gastric cardia biopsies (9 pts) focal non-dysplastic IM was detected (not treated). Conclusion: We have previously reported that RFA /focal ER for BE with HGD and/or EC is safe and effective, resulting in 100% CR-neo and CRIM at 1-year. The results of the present long-term follow-up of this cohort suggest that the histologically normal NSE achieved after treatment at 1-year is further durable at 5-year follow-up. No patient in this cohort developed invasive cancer or sustained BE-related morbidity. The clinical relevance of focal IM in a normal appearing cardia remains unknown.

Circumferential Balloon-Based Radiofrequency Ablation of Barrett’s Esophagus Using the HALO 360 Ablation System Preserves the Inner Diameter of the Esophagus and Prevents Subsequent Narrowing and Compliance Reduction Jacques J. Bergman, Carine Sondermeijer, Femke P. Peters, Fiebo J. Ten Kate, Paul Fockens Background: Circumferential balloon-based radiofrequency (RF) energy ablation is a promising endoscopic technique for treatment of dysplasia in Barrett’s esophagus (BE). Previous studies suggest that RF ablation, contrary to other ablative and resective techniques, does not result in significant scarring or stricturing. Patients and Methods: Patients with BE and high-grade dysplasia (HGD) or low-grade dysplasia (LGD) were included. Visible abnormalities were removed by endoscopic resection (ER) at least 6 weeks prior to ablation. Patients used esomeprazole 40 mg BID during the study. Prior to ablation, the inner diameter (ID) of the esophagus was measured with a non-compliant balloon (HALO-360 System, BÂRRX Medical, Sunnyvale, CA), introduced over a guidewire and positioned 3 cm above the proximal margin of BE. The balloon was inflated to 4 psi (0.28 atm) for 6 secs. The ID was calculated based on baseline balloon volume/geometry, and the inflated pressure/volume. Sizing was repeated for every 1 cm of BE until the transition to cardia was detected by a rapid increase in ID. An ablation catheter was selected according to esophageal ID. Circumferential RF ablation was performed from the proximal margin of BE to the top of the gastric folds using 12 J/cm delivered twice. Results: 11 patients (8 male) with a median age of 60 yrs (IQR 55-67) and a median BE length of 5 cm (IQR 3-7) were included. At baseline, 10 patients had HGD and one patient had LGD. There were no serious adverse events associated with sizing or ablation. At 10 weeks, there were no strictures or narrowing and the median reduction in BE surface area was 90% (range 60-99%), with only small foci or tongues remaining. The median esophageal ID was 28.6 mm (IQR 25.6-32.8 mm) at baseline and 28.6 mm (IQR 25.8 31.1 mm) at 10 weeks (p Z 0.48, paired Student t-test). Conclusion: This is the first report of the effects of circumferential RF ablation of BE on the ID of the treated esophagus. As measured with this pressure/volume system, ID is related to compliance. There was no difference between baseline and 10 weeks post-ablation ID/compliance of the treated esophagus, suggesting that a functional esophagus is preserved after this treatment. Other potential applications of this sizing device may be the characterization of esophageal motility complaints and assessment of stricture dilation results.