Adjunctive Use of WATS-3D in Symptomatic GERD Patients Increases Detection of Barrett's Esophagus and Dysplasia.

BACKGROUND: Patients with gastroesophageal reflux (GERD) symptoms undergoing screening upper endoscopy for Barrett's esophagus (BE) frequently demonstrate columnar-lined epithelium (CLE), with forceps biopsies (FB) failing to yield intestinal metaplasia (IM). Repeat endoscopy is often necessary. AIM: Assess the yield of IM leading to a diagnosis of BE by the addition of Wide-Area Trans-epithelial Sampling (WATS-3D) to FB in the screening of GERD patients. METHODS: We performed a prospective registry study of GERD patients undergoing screening upper endoscopy. Patients had both WATS-3D and FB. Patients were classified by their Z line appearance: regular, irregular (<1 cm CLE), possible short-segment BE (1-<3cm), and possible long-segment BE (≥3cm). Demographics, IM yield, and dysplasia yield were calculated. Adjunctive yield was defined as cases identified by WATS-3D not detected by FB, divided by cases detected by FB. Clinicians were asked if WATS-3D results impacted patient management. RESULTS: Of 23,933 patients, 6,829(28.5%) met endoscopic criteria for BE. Of these, 2,878(42.1%) had IM identified by either FB or WATS-3D. Among patients fulfilling endoscopic criteria for BE, the adjunctive yield of WATS-3D was 76.5%, and absolute yield was 18.1%. 1,317 patients (19.3%) who fulfilled endoscopic BE criteria had IM detected solely by WATS-3D. Of 240 patients with dysplasia, 107(44.6%) were found solely by WATS-3D. Among patients with positive WATS-3D but negative FB, the care plan changed in 90.7%. CONCLUSION: The addition of WATS-3D to FB in GERD patients being screened for BE resulted in confirmation of BE in an additional 1/5 th of patients. Furthermore, dysplasia diagnoses approximately doubled.

Algorithm Training and Testing for a Nonendoscopic Barrett's Esophagus Detection Test in Prospective Multicenter Cohorts.

BACKGROUND & AIMS: Endoscopic Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) detection is invasive and expensive. Nonendoscopic BE/EAC detection tools are guideline-endorsed alternatives. We previously described a 5-methylated DNA marker (MDM) panel assayed on encapsulated sponge cell collection device (CCD) specimens. We aimed to train a new algorithm using a 3-MDM panel and test its performance in an independent cohort. METHODS: Algorithm training and test samples were from 2 prospective multicenter cohorts. All BE cases had esophageal intestinal metaplasia (with or without dysplasia/EAC); control subjects had no endoscopic evidence of BE. The CCD procedure was followed by endoscopy. From CCD cell lysates, DNA was extracted, bisulfite treated, and MDMs were blindly assayed. The algorithm was set and locked using cross-validated logistic regression (training set) and its performance was assessed in an independent test set. RESULTS: Training (N = 352) and test (N = 125) set clinical characteristics were comparable. The final panel included 3 MDMs (NDRG4, VAV3, ZNF682). Overall sensitivity was 82% (95% CI, 68%-94%) at 90% (79%-98%) specificity and 88% (78%-94%) sensitivity at 84% (70%-93%) specificity in training and test sets, respectively. Sensitivity was 90% and 68% for all long- and short-segment BE, respectively. Sensitivity for BE with high-grade dysplasia and EAC was 100% in training and test sets. Overall sensitivity for nondysplastic BE was 82%. Areas under the receiver operating characteristic curves for BE detection were 0.92 and 0.94 in the training and test sets, respectively. CONCLUSIONS: A locked 3-MDM panel algorithm for BE/EAC detection using a nonendoscopic CCD demonstrated excellent sensitivity for high-risk BE cases in independent validation samples. (Clinical trials.gov: NCT02560623, NCT03060642.).

A Delphi Method for Development of a Barrett's Esophagus Question Prompt List as a Communication Tool for Optimal Patient-physician Communication.

BACKGROUND METHODS: The question prompt list content was derived through a modified Delphi process consisting of 3 rounds. In round 1, experts provided 5 answers to the prompts "What general questions should patients ask when given a new diagnosis of Barrett's esophagus" and "What questions do I not hear patients asking, but given my expertise, I believe they should be asking?" Questions were reviewed and categorized into themes. In round 2, experts rated questions on a 5-point Likert scale. In round 3, experts rerated questions modified or reduced after the previous rounds. Only questions rated as "essential" or "important" were included in Barrett's esophagus question prompt list (BE-QPL). To improve usability, questions were reduced to minimize redundancy and simplified to use language at an eighth-grade level (Fig. 1). RESULTS: Twenty-one esophageal medical and surgical experts participated in both rounds (91% males; median age 52 years). The expert panel comprised of 33% esophagologists, 24% foregut surgeons, and 24% advanced endoscopists, with a median of 15 years in clinical practice. Most (81%), worked in an academic tertiary referral hospital. In this 3-round Delphi technique, 220 questions were proposed in round 1, 122 (55.5%) were accepted into the BE-QPL and reduced down to 76 questions (round 2), and 67 questions (round 3). These 67 questions reached a Flesch Reading Ease of 68.8, interpreted as easily understood by 13 to 15 years olds. CONCLUSIONS: With multidisciplinary input, we have developed a physician-derived BE-QPL to optimize patient-physician communication. Future directions will seek patient feedback to distill the questions further to a smaller number and then assess their usability.

Benefit of adjunctive wide-area transepithelial sampling with 3-dimensional computer-assisted analysis plus forceps biopsy based on Barrett's esophagus segment length.

BACKGROUND AND AIMS: Wide-area transepithelial sampling with 3-dimensional computer-assisted analysis (WATS-3D) has been shown to increase the diagnostic yield of intestinal metaplasia (IM) and dysplasia within a segment of suspected or known Barrett's esophagus (BE) when used as an adjunct to forceps biopsies. Few data are available regarding how segment length affects WATS-3D yield. The purpose of this study was to evaluate adjunctive WATS-3D use in patients with varying lengths of BE. METHODS: A total of 8471 patients (52.5% male; mean age, 63 years) enrolled in 2 registry studies were included in this study. All patients were being screened or surveyed for BE with both forceps biopsies and WATS-3D. The adjunctive and absolute yield of WATS-3D was calculated according to the length of the patient's BE segment. RESULTS: The overall adjunctive and absolute increased diagnostic yields with WATS-3D were 47.6% and 17.5%, respectively, for detection of IM, and 139% and 2.4% for detection of dysplasia. IM and dysplasia detection both increased with the use of WATS-3D regardless of segment length. Increase in IM diagnostic yield was significantly higher in short- versus long-segment cases but higher in long-segment cases for dysplasia detection. CONCLUSIONS: This study shows that when WATS-3D is added as an adjunct to forceps biopsies, it is effective at increasing the diagnostic yield of both BE and associated dysplasia in patients with both short and long segments of esophageal columnar-lined epithelium.

Benefits of EUS-guided gastroenterostomy over surgical gastrojejunostomy in the palliation of malignant gastric outlet obstruction: a large multicenter experience.

BACKGROUND AND AIMS: Palliation of malignant gastric outlet obstruction (mGOO) allows resumption of peroral intake. Although surgical gastrojejunostomy (SGJ) provides durable relief, it may be associated with a higher morbidity, interfere with chemotherapy, and require an optimum nutritional status. EUS-guided gastroenterostomy (EUS-GE) has emerged as a minimally invasive alternative. We aimed to conduct the largest comparative series to date between EUS-GE and SGJ for mGOO. METHODS: This multicenter retrospective study included consecutive patients undergoing SGJ or EUS-GE at 6 centers. Primary outcomes included time to resumption of oral intake, length of stay (LOS), and mortality. Secondary outcomes included technical and clinical success, reintervention rates, adverse events (AEs), and resumption of chemotherapy. RESULTS: A total of 310 patients were included (EUS-GE, n = 187; SGJ, n = 123). EUS-GE exhibited significantly lower time to resumption of oral intake (1.40 vs 4.06 days, P < .001), at lower albumin levels (2.95 vs 3.33 g/dL, P < .001), and a shorter LOS (5.31 vs 8.54 days, P < .001) compared with SGJ; there was no difference in mortality (48.1% vs 50.4%, P = .78). Technical (97.9% and 100%) and clinical (94.1% vs 94.3%) success was similar in the EUS-GE and SGJ groups, respectively. EUS-GE had lower rates of AEs (13.4% vs 33.3%, P < .001) but higher reintervention rates (15.5% vs 1.63%, P < .001). EUS-GE patients exhibited significantly lower interval time to resumption of chemotherapy (16.6 vs 37.8 days, P < .001). Outcomes between the EUS-GE and laparoscopic (n = 46) surgical approach showed that EUS-GE had shorter interval time to initiation/resumption of oral intake (3.49 vs 1.46 days, P < .001), decreased LOS (9 vs 5.31 days, P < .001), and a lower rate of AEs (11.9% vs 17.9%, P = .003). CONCLUSIONS: This is the largest study to date showing that EUS-GE can be performed among nutritionally deficient patients without affecting the technical and clinical success compared with SGJ. EUS-GE is associated with fewer AEs while allowing earlier resumption of diet and chemotherapy.

Missed opportunities to screen for Barrett's esophagus in the primary care setting of a large health system.

BACKGROUND AND AIMS: The rate of esophageal adenocarcinoma (EAC) is rising. This is partly due to the lack of identification of Barrett's esophagus (BE), the main risk factor for EAC. Identifying neoplastic BE can allow for endoscopic therapy to prevent EAC. Our aim was to determine how many patients eligible for screening are actually being screened for BE in the primary care setting of a large health system. METHODS: A digital search algorithm was constructed using the established gastroenterology guidelines and the Kunzmann model for screening for BE. The algorithm was then applied to the electronic medical record of all patients seen in the primary care setting of the health system. A manual review of charts of the identified patients was performed to confirm the high-risk status and determine if screening occurred. RESULTS: Of 936,371 primary care charts analyzed by the algorithm, 3535 patients (.4%) were determined to be high-risk for BE. Of these 3535 patients, only 1077 (30%) were screened for BE in clinical practice with endoscopy. The algorithm identified 2458 (70%) additional high-risk patients. Of the patients screened in clinical practice, 105 (10%) were found to have BE (10% with neoplasia). CONCLUSIONS: Numerous screening opportunities for BE are missed in the primary care setting of a large health system. Collaboration between gastroenterology and primary care services is needed to improve the screening rate.

Clinical trial transparency in gastrointestinal endoscopy research.

BACKGROUND: Under-reporting of clinical trial results can lead to negative consequences that include inhibiting propagation of knowledge, limiting the understanding of how devices work, affecting conclusions of meta-analyses, and failing to acknowledge patient participation. Therefore clinical trial transparency, through publication of trial results on ClinicalTrials.gov or in manuscript form, is important. We aimed to examine clinical trial transparency in endoscopic clinical trials. METHODS: The ClinicalTrials.gov database was searched for endoscopy trials up to October 2019. Adherence to the reporting of results to the database or in publication form was recorded for each trial. RESULTS: The final analysis included 923 trials, of which 801 were completed and 122 were either terminated or suspended. Results were available either on ClinicalTrials.gov or in publication for 751/923 trials (81.4 %). Other fields have reported a publication rate of 40 %-63 %. Results were available on ClinicalTrials.gov for 168 trials (18.2 %) and in the form of a publication for 720 trails (78.0 %). CONCLUSIONS: Compared with other fields in medicine, endoscopy clinical trials have a high rate of clinical trial transparency. However, there is room for improvements as close to one-fifth of trials fail to report results and 81.8 % do not report results to ClinicalTrials.gov.

Utilization trends for endoscopic ablation therapy and esophagectomy in Barrett's esophagus from 2005 to 2019.

Guidelines have shifted to now recommend endoscopic eradication therapy for Barrett's esophagus (BE) with low and high-grade dysplasia. Previously, esophagectomy was the standard therapy for high-grade dysplasia. However, it is unclear to what degree ablation therapy has affected utilization of esophagectomy. In this retrospective observational cohort study of BE patients without cancer from the Premier Healthcare Database, the prevalence of utilization of endoscopic ablation therapy and of esophagectomy in BE were calculated and temporal trends were evaluated. A total of 938, 333 BE cases were included in the study. There was a significantly increasing trend of ablation over the period 2006 to 2010 (Annual Percentage Change (APC); 95% CI 0.56% [0.51%, 0.61%]), a significantly decreasing trend for the period 2011 to 2015 (APC; 95% CI - 0.15% [- 0.20%, - 0.11%]), and a shallow increasing trend for the period 2016 to 2019 (APC; 95% CI 0.09% [0.06%, 0.11%]). For esophagectomy, there was a significantly decreasing trend for the period 2006 to 2009 (APC; 95% CI - 0.03% [- 0.04%, - 0.02%]; P < 0.001) that corresponded to the uptrend in utilization of endoscopic ablation. There was a stable trend of esophagectomy over the period 2010 to 2019 (APC; 95% CI - 0.0006% [- 0.0002%, 0.0005%]; P = 0.1947). Adoption and increased utilization of endoscopic ablation therapy for BE has coincided with a decrease in esophagectomy, and is the predominate method of therapy for BE with dysplasia.

Artificial intelligence-enhanced volumetric laser endomicroscopy improves dysplasia detection in Barrett's esophagus in a randomized cross-over study.

Volumetric laser endomicroscopy (VLE) is an advanced endoscopic imaging tool that can improve dysplasia detection in Barrett's esophagus (BE). However, VLE scans generate 1200 cross-sectional images that can make interpretation difficult. The impact of a new VLE artificial intelligence algorithm called Intelligent Real-time Image Segmentation (IRIS) is not well-characterized. This is a randomized prospective cross-over study of BE patients undergoing endoscopy who were randomized to IRIS-enhanced or unenhanced VLE first followed by the other (IRIS-VLE vs. VLE-IRIS, respectively) at expert BE centers. The primary outcome was image interpretation time, which served as a surrogate measure for ease of interpretation. The secondary outcome was diagnostic yield of dysplasia for each imaging modality. 133 patients were enrolled. 67 patients were randomized to VLE-IRIS and 66 to IRIS-VLE. Total interpretation time did not differ significantly between groups (7.8 min VLE-IRIS vs. 7 min IRIS-VLE, P = 0.1), however unenhanced VLE interpretation time was significantly shorter in the IRIS-VLE group (2.4 min vs. 3.8 min, P < 0.01). When IRIS was used first, 100% of dysplastic areas were identified, compared with 76.9% when VLE was the first interpretation modality (P = 0.06). IRIS-enhanced VLE reduced the time of subsequent unenhanced VLE interpretation, suggesting heightened efficiency and improved dysplasia detection. It was also able to identify all endoscopically non-visible dysplastic areas.

First interobserver agreement of optical coherence tomography in the bile duct: A multicenter collaborative study.

Background and study aims Optical coherence tomography (OCT) is a new technology available for evaluation of indeterminate biliary strictures. It allows under-the-surface visualization and preliminary studies have confirmed standardized characteristics associated with malignancy. The aim of this study is to evaluate the first interobserver agreement in identifying previously agreed upon OCT criteria and diagnosing of malignant versus benign disease. Patients and methods Fourteen endoscopists were asked to review an atlas of reference clips and images of eight criteria derived from expert consensus A total of 35 de-identified video clips were then evaluated for presence of the eight criteria and for final diagnosis of malignant versus benign using the atlas as reference Intraclass correlation (ICC) analysis was done to evaluate interrater agreement. Results Clips of 23 malignant lesions and 12 benign lesions were scored. Excellent interobserver agreement was seen with dilated hypo-reflective structures (0.85) and layering effacement (0.89); hyper-glandular mucosa (0.76), intact layering (0.81), and onion-skin layering (0.77); fair agreement was seen with scalloping (0.58), and thickened epithelium (0.4); poor agreement was seen with hyper-reflective surface (0.36). The diagnostic ICC for both neoplastic (0.8) and non-neoplastic (0.8) was excellent interobserver agreement. The overall diagnostic accuracy was 51 %, ranging from 43 % to 60 %. Conclusions Biliary OCT is a promising new modality for evaluation of indeterminate biliary strictures. Interobserver agreement ranged from fair to almost perfect on eight previously identified criteria. Interobserver agreement for malignancy diagnosis was substantial (0.8). Further studies are needed to validate this data.

Auditing Management of Acute Pancreatitis Using Comprehensive Quality Indicators.

OBJECTIVES: Recently, 40 comprehensive quality indicators in various management domains were created. The aim was to determine if these indicators could be used to audit the management of acute pancreatitis. METHODS: A retrospective study of consecutive patients admitted with acute pancreatitis in 2018 was conducted. Adherence rates with the individual quality indicators were calculated and compared between services. RESULTS: A total of 320 patients were included in this study. Twenty-eight of the 40 quality indicators (70%) could be used to audit management retrospectively. The medical service was found to have lower adherence rates for quality indicators 12 (initial assessment and risk stratification domain; 11% vs 22%, P = 0.009), 14 (initial management domain; 72% vs 88%, P = 0.003), and 33 (surgery domain; 83% vs 100%, P = 0.006). The surgical service was noted to have statistically significant lower adherence rates for quality indicators 4, 5, and 6 of the etiology domain (54% vs 72%, P = 0.002; 86% vs 96%, P = 0.004; and 45% vs 71%, P < 0.0001, respectively), and 21 of the nutrition domain (76% vs 93%, P < 0.0001). CONCLUSIONS: We show that these quality indicators can be used to audit the management of acute pancreatitis in specific management domains.

Comparative outcomes of radiofrequency ablation and cryoballoon ablation in dysplastic Barrett's esophagus: a propensity score-matched cohort study.

BACKGROUND AND AIMS: Strong evidence supports the use of radiofrequency ablation (RFA) in the management of dysplastic/neoplastic Barrett's esophagus (BE). Recently, the efficacy of the cryoballoon ablation (CBA) system was demonstrated in multicenter cohort studies. We aimed to assess the comparative effectiveness and safety of these 2 ablation modalities for endoscopic eradication therapy (EET) in a cohort study. METHODS: Data were abstracted on patients with dysplastic BE or intramucosal carcinoma undergoing EET using RFA or CBA as the primary ablation modality at 2 referral centers. The primary outcome was the rate of complete remission intestinal metaplasia (CRIM). Secondary outcomes were rates of complete remission of dysplasia (CRD) and adverse events. Cox proportional hazards models and propensity scored-matched analyses were conducted to compare outcomes. RESULTS: Three hundred eleven patients (CBA, 85 patients; RFA, 226 patients) with a median follow-up of 1.5 years (interquartile range, .8, 2.5) in the RFA group and 2.0 years (interquartile range, 1.3, 2.5) in the CBA group were studied. On multivariable analyses, the chances of reaching CRD and CRIM were not influenced by ablation modality. Propensity score-matched analysis revealed a comparable chance of achieving CRIM (CBA vs RFA: hazard ratio, 1.24; 95% confidence interval, .79-1.96; P = .35) and CRD (CBA vs RFA: hazard ratio, 1.19; 95% confidence interval, .82-1.73; P = .36). The CBA group had a higher stricture rate compared with the RFA group (10.4% vs 4.4%, P = .04). CONCLUSIONS: Histologic outcomes of EET using CBA and RFA for dysplastic BE appear to be comparable. A randomized trial is needed to definitively compare outcomes between these 2 modalities.