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ObjectiveDue to an annual progression rate of Barrett’s oesophagus (BO) with low-grade dysplasia (LGD) between 9% and 13% per year endoscopic ablation therapy is preferred to surveillance. Since this recommendation is based on only one randomised trial, we aimed at checking these results by another multicentre randomised trial with a similar design.DesignA prospective randomised study was performed in 14 centres comparing radiofrequency ablation (RFA) (maximum of 4 sessions) to annual endoscopic surveillance, including patients with a confirmed diagnosis of BO with LGD. Primary outcome was the prevalence of LGD at 3 years. Secondary outcomes were the prevalence of LGD at 1 year, the complete eradication of intestinal metaplasia (CE-IM) at 3 years, the rate of neoplastic progression at 3 years and the treatment-related morbidity.Results125 patients were initially included, of whom 82 with confirmed LGD (76 men, mean age 62.3 years) were finally randomised, 40 patients in the RFA and 42 in the surveillance group. At 3 years, CE-IM rates were 35% vs 0% in the RFA and surveillance groups, respectively (p<0.001). At the same time, the prevalence LGD was 34.3% (95% CI 18.6 to 50.0) in the RFA group vs 58.1% (95% CI 40.7 to 75.4) in the surveillance group (OR=0.38 (95% CI 0.14 to 1.02), p=0.05). Neoplastic progression was found in 12.5% (RFA) vs 26.2% (surveillance; p=0.15). The complication rate was maximal after the first RFA treatment (16.9%).ConclusionRFA modestly reduced the prevalence of LGD as well as progression risk at 3 years. The risk-benefit balance of endoscopic ablation therapy should therefore be carefully weighted against surveillance in patients with BO with confirmed LGD.Trial registration number NCT01360541.

ObjectiveThere is no evidence-based treatment for persistent dysphagia after laparoscopic fundoplication. The aim of this study was to evaluate the effect of pneumatic dilation on persistent dysphagia after laparoscopic fundoplication.DesignWe performed a multicentre, single-blind, randomised sham-controlled trial of patients with persistent dysphagia (>3 months) after laparoscopic fundoplication. Patients with an Eckardt symptom score ≥4 were randomly assigned to pneumatic dilation (PD) using a 35 mm balloon or sham dilation. Primary outcome was treatment success, defined as an Eckardt score <4 and a minimal reduction of 2 points in the Eckardt score after 30 days. Secondary outcomes included change in stasis on timed barium oesophagogram, change in high-resolution manometry parameters and questionnaires on quality of life, reflux and dysphagia symptoms.ResultsForty-two patients were randomised. In the intention-to-treat analysis, the success rates of PD (7/21 patients (33%)) and sham dilation (8/21 patients (38%)) were similar after 30 days (risk difference −4.7% (95% CI (−33.7% to 24.2%) p=0.747). There was no significant difference in change of stasis on the timed barium oesophagogram after 2 min (PD vs sham: median 0.0 cm, p25–p75 range 0.0–4.3 cm vs median 0.0 cm, p25–p75 range 0.0–0.0; p=0.122) or change in lower oesophageal sphincter relaxation pressure (PD vs sham: 10.54±6.25 vs 14.60±6.17 mm Hg; p=0.052). Quality of life, reflux and dysphagia symptoms were not significantly different between the two groups.ConclusionPneumatic dilation with a 35 mm balloon is not superior to sham dilation for the treatment of persistent dysphagia after fundoplication.

IntroductionEndoscopic evaluation with high-definition white light endoscopy and random 4-quadrant biopsy (Seattle Protocol) is the current standard of care for the detection of Barrett’s esophagus (BE). Recently, enhanced imaging technologies have become available to provide real-time diagnosis of intestinal metaplasia (IM) and dysplasia, reducing the need for tissue biopsy. Probe-based confocal laser endomicroscopy (pCLE) provides dynamic microscopic mucosal views, rapidly capturing digital images that become optical biopsies. This study examined the role of pCLE in BE screening and surveillance as compared to the Seattle Protocol.MethodsPatients undergoing BE screening or surveillance endoscopy were enrolled at eight US centers. Optical biopsy using pCLE was interpreted in real time. Endoscopists performing pCLE were new users with a median experience of 8.5 months and no formal training in surgical pathology. Seattle Protocol biopsies were then taken. Recorded pCLE images were reviewed by a blinded expert in optical biopsy interpretation.ResultsEarly pCLE users identified significantly more patients with IM than the Seattle Protocol overall (99/172 vs. 46/172, p < 0.0001). Early users of pCLE also identified significantly more patients with IM than the Seattle Protocol in the patients with visible columnar lined esophagus (75 vs. 31, p < 0.0001), but not in the 76 patients without columnar lined esophagus (24 vs. 15, p = 0.067). There was no statistically significant difference between early pCLE users and expert review.ConclusionOptical biopsy using pCLE technology allows for the real-time evaluation of entire segments of columnar lined esophagus. Consequently, pCLE is considerably more sensitive in the detection of BE than the Seattle Protocol, which leaves a majority of epithelium unexamined. This effect is seen even in new users and increases with experience. Overall, pCLE provides a promising advance in Barrett’s detection which will likely result in superior identification of individuals at risk for esophageal adenocarcinoma.

Probe-based confocal laser endomicroscopy (pCLE) allows for real-time diagnosis of dysplasia and cancer in Barrett’s esophagus (BE) but is limited by low sensitivity. Even the gold standard of histopathology is hindered by poor agreement between pathologists. We deployed deep-learning-based image and video analysis in order to improve diagnostic accuracy of pCLE videos and biopsy images. Blinded experts categorized biopsies and pCLE videos as squamous, non-dysplastic BE, or dysplasia/cancer, and deep learning models were trained to classify the data into these three categories. Biopsy classification was conducted using two distinct approaches—a patch-level model and a whole-slide-image-level model. Gradient-weighted class activation maps (Grad-CAMs) were extracted from pCLE and biopsy models in order to determine tissue structures deemed relevant by the models. 1970 pCLE videos, 897,931 biopsy patches, and 387 whole-slide images were used to train, test, and validate the models. In pCLE analysis, models achieved a high sensitivity for dysplasia (71%) and an overall accuracy of 90% for all classes. For biopsies at the patch level, the model achieved a sensitivity of 72% for dysplasia and an overall accuracy of 90%. The whole-slide-image-level model achieved a sensitivity of 90% for dysplasia and 94% overall accuracy. Grad-CAMs for all models showed activation in medically relevant tissue regions. Our deep learning models achieved high diagnostic accuracy for both pCLE-based and histopathologic diagnosis of esophageal dysplasia and its precursors, similar to human accuracy in prior studies. These machine learning approaches may improve accuracy and efficiency of current screening protocols.

Background Endoscopic deep learning systems are often developed using high‐quality imagery obtained from expert centers. Therefore, they may underperform in community hospitals where image quality is more heterogeneous. Objective This study aimed to quantify the performance degradation of a computer aided detection system for Barrett's neoplasia, trained on expert images, when exposed to more heterogeneous imaging conditions representative of daily clinical practice. Further, we evaluated strategies to mitigate this performance loss. Methods We developed a computer aided detection system using 1011 high‐quality, expert‐acquired images from 373 Barrett's patients. We assessed its performance on high, moderate and low image quality test sets, each containing images from an independent group of 117 Barrett's patients. These test sets reflected the varied image quality of routine patient care and contained artefacts such as insufficient mucosal cleaning and inadequate esophageal expansion. We then applied three methods to improve the algorithm's robustness to data heterogeneity: inclusion of more diverse training data, domain‐specific pretraining and architectural optimization. Results The computer aided detection system, when trained exclusively on high‐quality data, achieved area under the curve (AUC), sensitivity and specificity scores of 83%, 85% and 67% on the high quality test set. AUC and sensitivity were significantly lower with 80% (p < 0.001) and 62% (p = 0.002) on the moderate‐quality and 71% (p > 0.001) and 47% (p = 0.002) on the low‐quality test set. Incorporating robustness‐enhancing strategies significantly improved the AUC, sensitivity and specificity to 92% (p = 0.004), 88% (p = 0.84) and 81% (p = 0.003) on the high‐quality test set, 93% (p = 0.006), 86% (p = 0.01) and 83% (p = 0.09) on the moderate‐quality test set and 84% (p = 0.001), 78% (p = 0.002) and 77% (p = 0.23) on the low‐quality test set. Conclusion Endoscopic deep learning systems trained solely on high‐quality images may not perform well when exposed to heterogeneous imagery, as found in routine practice. Robustness‐enhancing training strategies can increase the likelihood of successful clinical implementation.

Introduction Barrett’s esophagus (BE) is recognized as a premalignant lesion for esophageal adenocarcinoma. BE appears as a consequence of gastroesophageal reflux disease (GERD), which is increased among obese population. Laparoscopic Roux-en-Y gastric bypass (LRYGB) is the best treatment option for obesity combined with GERD. However, data on evolution of BE after LRYGB are scarce. Methods and procedures Patients were studied with esophagogastroduodenoscopy (EGD) and gastric biopsy preoperatively. If BE was suspected, esophageal biopsy was performed. If BE was confirmed, LRYGB was indicated with yearly surveillance EGD with biopsies. LRYGB patients who had BE with at least 1-year follow-up were included. Results Between 10/07 and 1/16, 2144 patients underwent laparoscopic bariatric surgery at our institution. There were 1681 (78 %) LRYGB, 399 (19 %) laparoscopic sleeve gastrectomies, and 64 (3 %) revisions. Nineteen patients (0.9 %) had BE preoperatively, and they all underwent LRYGB; 11 of them (58 %) were eligible for this study. There were 6 women and 5 men, mean age 49 ± 11 years, initial BMI 44 ± 6 kg/m 2 . Mean follow-up was 41 ± 31 months; there were 9 short-segment BE (SSBE) and 2 long-segment BE (LSBE). On pre- and post-op EGD, BE length was 2.1 ± 1.6 and 1.2 ± 1.2 cm, respectively ( p  = NS). Post-op EGD was compatible with BE in all cases, although esophageal biopsy showed remission in 4 (36 %) cases: three short-segment BE (SSBE) and one long-segment BE (LSBE). One patient was indefinite for dysplasia and remained the same after the operation. Conclusion Our preliminary data showed that LRYGB is a suitable treatment option for obese patients with BE, demonstrated by 36 % regression rate of this premalignant disease. Although BE persisted in the remaining patients, no progression to dysplasia was observed. A larger number of patients and longer follow-up are needed for more definitive conclusions.

\"Push\" or \"pull\" techniques with the use of snares, forceps, baskets, and grasping devices are conventionally used to manage esophageal food bolus impaction (FBI). A novel cap-assisted technique has recently been advocated to reduce time taken for food bolus (FB) removal. This study aimed to compare the effectiveness of the cap-assisted technique against conventional methods of esophageal FB removal in a randomized controlled trial. Consecutive patients with esophageal FBI requiring endoscopic removal, from 3 Australian tertiary hospitals between 2017 and 2019, were randomized to either the cap-assisted technique or the conventional technique. Primary outcomes were technical success and FB retrieval time. Secondary outcomes were technical success rate, en bloc removal rate, procedure-related complication, length of hospital stay, and cost of consumables. Over 24 months, 342 patients with esophageal FBI were randomized to a cap-assisted (n = 171) or conventional (n = 171) technique. Compared with the conventional approach, the cap-assisted technique was associated with (i) shorter FB retrieval time (4.5 ± 0.5 minutes vs 21.7 ± 0.9 minutes, P < 0.001), (ii) shorter total procedure time (23.0 ± 0.6 minutes vs 47.0 ± 1.3 minutes, P < 0.0001), (iii) higher technical success rate (170/171 vs 160/171, P < 0.001), (iv) higher rate of en bloc removal (159/171 vs 48/171, P < 0.001), and (v) lower rate of procedure-related mucosal tear and bleeding (0/171 vs 13/171, P < 0.001). There were no major adverse events or deaths within 30 days in either group. The total cost of consumables was higher in the conventional group (A$19,644.90 vs A$6,239.90). This multicenter randomized controlled trial confirmed that the cap-assisted technique is more effective and less costly than the conventional approach and should be first-line treatment for esophageal FBI.

Barrett's esophagus (BE) is an abnormality arising from gastroesophageal reflux disease that can progressively evolve into a sequence of dysplasia and adenocarcinoma. Progression of Barrett's esophagus into dysplasia is monitored with endoscopic surveillance. The current surveillance standard requests random biopsies plus targeted biopsies of suspicious lesions under white-light endoscopy, known as the Seattle protocol. Recently, published evidence has shown that narrow-band imaging (NBI) can guide targeted biopsies to identify dysplasia and reduce the need for random biopsies. We aimed to assess the health economic implications of adopting NBI-guided targeted biopsy vs. the Seattle protocol from a National Health Service England perspective. A decision tree model was developed to undertake a cost-consequence analysis. The model estimated total costs (i.e. staff and overheads; histopathology; adverse events; capital equipment) and clinical implications of monitoring a cohort of patients with known/suspected BE, on an annual basis. In the simulation, BE patients (N = 161,657 at Year 1; estimated annual increase: +20%) entered the model every year and underwent esophageal endoscopy. After 7 years, the adoption of NBI with targeted biopsies resulted in cost reduction of £458.0 mln vs. HD-WLE with random biopsies (overall costs: £1,966.2 mln and £2,424.2 mln, respectively). The incremental investment on capital equipment to upgrade hospitals with NBI (+£68.3 mln) was offset by savings due to the reduction of histological examinations (-£505.2 mln). Reduction of biopsies also determined savings for avoided adverse events (-£21.1 mln). In the base-case analysis, the two techniques had the same accuracy (number of correctly identified cases: 1.934 mln), but NBI was safer than HD-WLE. Budget impact analysis and cost-effectiveness analyses confirmed the findings of the cost-consequence analysis. In conclusion, NBI-guided targeted biopsies was a cost-saving strategy for NHS England, compared to current practice for detection of dysplasia in patients with BE, whilst maintaining at least comparable health outcomes for patients.

BackgroundSevere endoscopically detected esophageal thermal lesions (EDELs) have been associated with higher risk of progression to atrio-esophageal fistula (AEF) following radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF). We sought to evaluate safety and feasibility of active esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) to limit frequency or severity of EDELs.ObjectiveWe sought To evaluate safety and feasibility of active esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) to limit frequency or severity of EDELsMethodsConsecutive patients undergoing first-time RFCA were randomized in a 1:1 fashion to esophageal cooling (device group) or standard temperature monitoring (control group). Ablation on the posterior wall was performed with a maximum power of 30W for up to 20s. All patients underwent EGD within 48 h. Endoscopy findings were classified as 1, erythema–mild injury; 2, superficial ulceration–moderate injury; 3, deep ulceration–significant injury; and 4, fistula/perforation. Severe EDELs were defined as grade 3 or 4 lesions.ResultsForty-four patients completed the study (22 device group, 22 control group). Adjunctive posterior wall isolation was performed more frequently in the device group (11/22, 50% vs. 4/22, 18%). EDELs were detected in 5/22 (23%) control group patients, with mild or moderate injury in 2/5 patients (40%) and severe thermal injury in 3/5 patients (60%). In the device group, EDELs were detected in 8/22 (36%) patients, with mild or moderate injury in 7/8 (87%) patients and severe thermal injury in 1/8 (12%) patients. There was no acute perforation or AEF during follow-up.ConclusionsActive esophageal cooling may reduce the occurrence of severe EDELs. A larger randomized study is warranted to further evaluate the benefit of this strategy.

Ultrasound has been increasingly utilized for the identification of endotracheal tube (ETT) location after an intubation attempt, particularly among patients in cardiac arrest. However, prior studies have varied with respect to the choice of transducer and no studies have directly compared the accuracy between transducer types. Our study is the first to directly compare the accuracy of ETT confirmation between the linear and curvilinear transducer. This study was performed in a cadaver lab using three different cadavers chosen to represent varying neck circumferences. Cadavers were randomized to tracheal or esophageal intubation. Blinded sonographers assessed the location of the ETT using either a linear or curvilinear transducer in an alternating sequence. Accuracy of sonographer identification, time to identification, and operator confidence were assessed. Four hundred and five assessments were performed with 198 (48.9%) tracheal and 207 (51.1%) esophageal intubations. The linear transducer was 98% (95% CI 95.1% to 99.2%) accurate. The curvilinear transducer was 95% (95% CI 91.1% to 97.3%) accurate. The mean time to identification was significantly lower with the linear transducer [7.46 s (95% CI 6.23 to 8.7 s)] as compared with the curvilinear transducer [11.63 s (95% CI 9.05 to 14.2 s)]. The mean operator confidence was significantly higher with the linear transducer [4.84/5.0 (95% CI 4.76 to 4.91)] than with the curvilinear transducer [4.44/5.0 (95% CI 4.3 to 4.57)]. All operators preferred the linear transducer over the curvilinear transducer. The diagnostic accuracy of ultrasound for ETT confirmation did not significantly differ between ultrasound transducer types, but the curvilinear transducer was associated with a longer time to confirmation and lower operator confidence. Further studies are needed to determine if the accuracy would change with more novice providers or in specific patient populations.