Outcomes of Transoral Incisionless Fundoplication (TIF 2.0): A Prospective, Multicenter Cohort Study in Academic and Community Practices (with video).

BACKGROUND AND AIMS: Transoral incisionless fundoplication (TIF) is an established safe endoscopic technique for the management of GERD but with variable efficacy. In the last decade, the TIF technology and technique have been optimized and more widely accepted but data on outcomes outside clinical trials are limited. We tracked patient-reported and clinical outcomes of GERD patients after TIF 2.0. METHODS: Patients with BMI < 35, hiatal hernia < 2cm, and confirmed GERD with typical and/or atypical symptoms from 9 academic and community medical centers were enrolled in a prospective registry and underwent after TIF 2.0 performed by gastroenterologists and surgeons. The primary outcomes were safety and clinical success (response in >2 of 4 endpoints). Secondary endpoints were symptom improvement, acid exposure time (AET), esophagitis healing, proton pump inhibitor (PPI) use, and satisfaction. Outcomes were assessed at last follow-up within 12 months. RESULTS: 85 patients underwent TIF 2.0, 81 were included in the outcomes analysis. Clinical success was achieved in 94%, GERD-HRQL scores improved in 89%, and elevated RSI score normalized in 85% of patients with elevated baseline. Patient satisfaction improved from 8% to 79% (p <0.0001). At baseline, 81% were taking at least daily PPI, while 80% were on no or occasional PPI after TIF 2.0 (p<0.0001). Esophageal AET was normal in 72%, greater with an optimized TIF 2.0 valve >300 degree circumference, >3cm length (94% vs 57%, p=0.007). There were no TIF 2.0-related serious adverse events. CONCLUSION: TIF 2.0 is a safe and effective endoscopic outpatient treatment option for select patients with GERD.

Wide Variability in Dysplasia Detection Rate and Adherence to Seattle Protocol and Surveillance Recommendations in Barrett's Esophagus: A Population-Based Analysis Using the GIQuIC National Quality Benchmarking Registry.

INTRODUCTION: Variability in adherence rates to the Seattle protocol and to surveillance interval recommendations, established quality indicators (QIs) in Barrett's esophagus (BE), is unknown. METHODS: We evaluated endoscopist and site-based adherence rates to these QIs from January 2018 to May 2021 using the GI Quality Improvement Consortium national registry with matched endoscopy and pathology data. RESULTS: Across 153 practices with 572 endoscopists performing 20,155 endoscopies, adherence to the Seattle protocol varied by endoscopists (median 93.8%, IQR 18.9%) and by site (median 90.0%, IQR 20.1%). Adherence to appropriate surveillance intervals for nondysplastic BE also varied by endoscopist (median 82.4%, IQR 36.3%) and site (median 77.2%, IQR 29.8%). The overall dysplasia detection rate was 3.1% and varied among endoscopists and sites. DISCUSSION: These US population-based results can serve as a benchmark for quality initiatives and intervention trials aimed at improving outcomes for patients with BE.

Patient Knowledge, Risk Perception, and Barriers to Barrett's Esophagus Screening.

INTRODUCTION: Most patients with esophageal adenocarcinoma (EAC) do not have a previous diagnosis of Barrett's esophagus (BE), demonstrating a failure of current screening practices. An understanding of patient attitudes and barriers is essential to develop and implement interventions to improve BE screening adherence. METHODS: We conducted a Web-based survey of patients aged >50 years with chronic gastroesophageal reflux disease at 3 academic medical centers and 1 affiliated safety net health systems. Survey domains included patient characteristics, endoscopy history, familiarity with screening practices, perceived BE/EAC risk, and barriers to screening. RESULTS: We obtained a response rate of 22.6% (472/2,084) (74% men, mean age 67.9 years). Self-identified race and ethnicity of participants was 66.5% non-Hispanic White, 20.0% non-Hispanic Black, 13.4% other race, and 7.1% Hispanic. Screening for BE was recommended in only 13.2%, and only 5.3% reported previous screening. Respondents had notable gaps in knowledge about screening indications; only two-thirds correctly identified BE risk factors and only 19.5% believed BE screening was needed for gastroesophageal reflux disease. More than 1 in 5 respondents believed they would get BE (31.9%) or EAC (20.2%) but reported barriers to screening. Compared with White respondents, more Black respondents were concerned about getting BE/EAC and interested in screening but report higher barriers to screening. DISCUSSION: Patients at risk for BE, particularly racial and ethnic minorities, are worried about developing EAC but rarely undergo screening and have poor understanding of screening recommendations.

Dutch, UK and US professionals' perceptions of screening for Barrett's esophagus and esophageal adenocarcinoma: a concept mapping study.

BACKGROUND: Novel, less-invasive technologies to screen for Barrett's esophagus (BE) may enable a paradigm shift in early detection strategies for esophageal adenocarcinoma (EAC). Understanding professionals' perspectives on screening is important to determine how to proceed. We aimed to explore and compare professionals' perceptions of screening for BE and EAC screening in three countries. METHODS: In this study, 29 Dutch, 20 British and 18 American health care professionals (clinicians, researchers and policy makers) participated in concept mapping: a mixed-methods consensus building methodology. Statements on perceived barriers, facilitators, advantages, disadvantages, implications or worries associated with screening for BE and EAC were collected in asynchronous digital brainstorm sessions. Subsequently, participants sorted the statements into groups according to thematic similarity and assessed the relevance of each statement in evaluating the acceptability of BE and EAC screening. Multidimensional scaling and cluster analysis were used to map the associations between generated statements. RESULTS: Professionals across three countries identified eight consistent themes that relate to their perceptions of screening for BE and EAC: (1) Benefits, (2) Harms, (3) Clinical effectiveness concerns, (4) Screening population, (5) Screening modality, (6) Resources, (7) Ownership, and (8) Public communication. Dutch and American professionals prioritized the potential health benefits of screening but also questioned clinical impact. In contrast, British participants prioritized identification of the screening population and suitable test. CONCLUSIONS: Most professionals see potential in less-invasive screening tests for BE and EAC but underline the need to define the target screening population and determine benefits and harms before widely employing them. Successful implementation will require thoughtful consideration of the involvement of general practitioners, readiness of endoscopy and pathology services, balanced public communication, and country-specific regulations.

The status of endoscopic therapies for gastroesophageal reflux disease.

PURPOSE OF REVIEW: Gastroesophageal reflux disease (GERD) is exceedingly common and can significantly impact quality of life through heartburn, troublesome regurgitation, or atypical symptoms. The initial approach is conservative lifestyle changes followed by medications with escalation to antireflux surgery as needed. Endoscopic therapy may represent a bridge between pharmacotherapy and surgery and represents an appropriate option for select individuals. RECENT FINDINGS: Appropriate patient selection for endoscopic antireflux therapies is critical to the success of the intervention. Candidates for endoscopic treatment with trans-oral incisionless fundoplication (TIF) include those with a small (<2 cm) or no hiatal hernia and a Hill valve grade 1 or 2. Transoral incisionless fundoplication with concomitant hiatal hernia repair (cTIF) is a safe and effective option that addresses both the crural diaphragm and gastroesophageal flap valve (GEFV). SUMMARY: Endoscopic interventions for GERD continue to evolve and are not all created equal. Given our current understanding of the mechanisms of GERD, the TIF procedure stands out in its ability to re-create the optimal GEFV. In those patients with altered anatomy, endoscopic approaches may offer at least partial benefit.

Structured training program on confocal laser endomicroscopy for pancreatic cystic lesions: a multicenter prospective study among early-career endosonographers (with video).

BACKGROUND AND AIMS: Data on how to teach endosonographers needle-based confocal laser endomicroscopy (nCLE)-guided histologic diagnosis of pancreatic cystic lesions (PCLs) are limited. Hence, we developed and tested a structured educational program to train early-career endosonographers in nCLE-guided diagnosis of PCLs. METHODS: Twenty-one early-career nCLE-naïve endosonographers watched a teaching module outlining nCLE criteria for diagnosing PCLs. Participants then reviewed 80 high-yield nCLE videos, recorded diagnoses, and received expert feedback (phase 1). Observers were then randomized to a refresher feedback session or self-learning at 4 weeks. Eight weeks after training, participants independently assessed the same 80 nCLE videos without feedback and provided histologic predictions (phase 2). Diagnostic performance of nCLE to differentiate mucinous versus nonmucinous PCLs and to diagnose specific subtypes were analyzed using histopathology as the criterion standard. Learning curves were determined using cumulative sum analysis. RESULTS: Accuracy and diagnostic confidence for differentiating mucinous versus nonmucinous PCLs improved as endosonographers progressed through nCLE videos in phase 1 (P < .001). Similar trends were observed with the diagnosis of PCL subtypes. Most participants achieved competency interpreting nCLE, requiring a median of 38 assessments (range, 9-67). During phase 2, participants independently differentiated PCLs with high accuracy (89%), high confidence (83%), and substantial interobserver agreement (κ = .63). Accuracy for nCLE-guided PCL subtype diagnoses ranged from 82% to 96%. The learned nCLE skills did not deteriorate at 8 weeks and were not impacted by a refresher session. CONCLUSIONS: We developed a practical, effective, and durable educational intervention to train early-career endosonographers in nCLE-guided diagnosis of PCLs.

Role of short interval FLIP panometry in predicting long-term outcomes after per-oral endoscopic myotomy.

BACKGROUND: The Eckardt score (ES) is used to assess symptom response to Per-Oral Endoscopic Myotomy (POEM), but reliable methods to assess physiologic success are needed. Functional lumen imaging probe (FLIP) panometry has a potential role in post-POEM follow-up to predict long-term outcomes. The aim of this study was to assess the correlation between clinical success and FLIP parameters following POEM to determine if short interval FLIP could predict long-term outcomes. METHODS: This was a prospective study of adult patients who underwent POEM with short interval follow-up FLIP between 11/2017 and 3/2020. Clinical success was defined as post-procedure ES ≤ 3. Physiologic success was based on an esophago-gastric junction distensibility index (EGJ-DI) > 2.8 mm2/mmHg on FLIP. RESULTS: 47 patients (55% female, mean age 55 years) were included in the study. Clinical success after POEM was seen in 45 (96%) patients (mean ES 6.5 ± 2.2 pre and 0.83 ± 1.0 post-POEM, p < 0.001). Physiologic success was noted in 43 (91.5%) patients (mean EGJ-DI 6.1 mm2/mmHg ± 2.5). Among 4 patients not meeting criteria for physiologic success, EGJ-DI was 2.5-2.6. There was no correlation between post-POEM EGJ-DI and ES in the short term or long term. Significant reflux esophagitis was seen in 6 (12.8%) patients with no difference in mean EGJ-DI with vs without esophagitis (5.9 vs 6.1, p = 0.44). CONCLUSION: Post-POEM endoscopy with FLIP is useful to both assess EGJ physiology and to examine for reflux esophagitis. Short interval FLIP has limited utility to predict long-term patient outcomes or risk of acid reflux.

Histology, Size, and Number of Advanced Polyps are Associated With Guideline-Discordant Surveillance Recommendations.

Surveillance guidelines following polypectomy promote cost-effective reductions in future colorectal cancer (CRC) risk, but high nonadherence rates1 can have negative consequences on costs and effectiveness. Professional societies recommend a 3-year interval for patients with advanced colorectal polyps (ACPs), although few studies report provider adherence to surveillance intervals.2 This study evaluated rates and predictors of guideline-discordant recommendations for patients with ACPs.

Early-Age Onset Colorectal Neoplasia in Average-Risk Individuals Undergoing Screening Colonoscopy: A Systematic Review and Meta-Analysis.

BACKGROUND & AIMS: Incidence and mortality associated with early-age onset colorectal cancer (EAO-CRC) is increasing, prompting professional society recommendations to lower the screening age in average-risk individuals. The yield of screening individuals younger than 50 years is not known. METHODS: A systematic review of 3 databases from inception through July 2020 was performed in all languages that reported colonoscopy findings in average-risk individuals younger than 50 years. The primary outcomes were EAO colorectal neoplasia (CRN) and advanced colorectal neoplasia (aCRN) prevalence. Subgroup analyses were performed based on sex, geographic location, time period, and age, including comparison with those aged 50-59 years. Generalized linear mixed model with random intercept logistic regression and fixed subgroup effects were performed. RESULTS: Of 10,123 unique articles, 17 studies published between 2002 and 2020, including 51,811 average-risk individuals from 4 continents, were included. The pooled rate of EAO-CRN was 13.7% (95% confidence interval [CI], 0.112%-0.168%) and EAO-aCRN was 2.2% (95% CI, 0.016%-0.031%). Prevalence of CRC was 0.05% (95% CI, 0.00029%-0.0008%). Rates of EAO-CRN were higher in men compared with women (relative risk, 1.71%; 95% CI, 1.49%-1.98%), and highest in the United States (15.6%; 95% CI, 12.2%-19.7%) compared with Europe (14.9%; 95% CI, 6.9%-29.3%), East Asia (13.4%; 95% CI, 10.3%-17.2%), and the Middle East (9.8%; 95% CI, 7.8%-12.2%) (P = .04) The rate of EAO-CRN in age groups 45-49 years and 50-59 years was 17.8% (95% CI, 14.5%-21.6%) and 24.8% (95% CI, 19.5%-30.8%), respectively (P = .04). The rate of EAO-aCRN in age group 45-49 years was 3.6% (95% CI, 1.9%-6.7%) and 4.2% (95% CI, 3.2%-5.7%), respectively (P = .69). CONCLUSIONS: The rate of aCRN in individuals aged 45-49 years was similar to the rate observed in individual aged 50-59 years, suggesting that expanding screening to this population could yield a similar impact on colorectal cancer risk reduction.

Characterization of Prevalent, Post-Endoscopy, and Incident Esophageal Cancer in the United States: A Large Retrospective Cohort Study.

BACKGROUND & AIMS: Efforts to assess and improve the effectiveness of Barrett's esophagus (BE) screening and surveillance are ongoing in the United States. Currently, there are limited population-based data in the United States to guide these efforts. METHODS: We performed a retrospective cohort study using data from large commercial and Medicare Advantage health plans in the United States from 2004 - 2019. We identified individuals with BE and analyzed the proportion who developed EAC. EACs were classified as prevalent EAC (diagnosed within 30 days of index endoscopy), post-endoscopy esophageal adenocarcinoma (PEEC, diagnosed 30 - 365 days after index endoscopy), and incident EAC (diagnosed 365 days or more after index endoscopy). Using this cohort, we performed a nested case-control study to identify factors associated with prevalent EAC at BE diagnosis and study healthcare utilization prior to BE diagnosis. RESULTS: We identified 50,817 individuals with incident BE. Of the 366 who developed EAC, 67.2%, 13.7%, and 19.1% were diagnosed with prevalent EAC, PEEC, and incident EAC respectively. Factors positively associated with prevalent EAC versus BE without prevalent EAC included male sex, dysphagia, weight loss, and Charlson-Deyo comorbidity score. In those with prevalent EAC, most patients with dysphagia or weight loss had their symptoms first recorded within three months of EAC diagnosis. Healthcare utilization rates were similar between those with and without prevalent EAC. CONCLUSIONS: Two-thirds of EACs among individuals with BE are diagnosed at the time of BE diagnosis. Additionally, PEEC accounts for 14% of these EACs. These results may guide future research studies that investigate novel BE diagnostic strategies that reduce the morbidity and mortality of EAC.

Digestive Manifestations in Patients Hospitalized With Coronavirus Disease 2019.

BACKGROUND & AIMS: The prevalence and significance of digestive manifestations in coronavirus disease 2019 (COVID-19) remain uncertain. We aimed to assess the prevalence, spectrum, severity, and significance of digestive manifestations in patients hospitalized with COVID-19. METHODS: Consecutive patients hospitalized with COVID-19 were identified across a geographically diverse alliance of medical centers in North America. Data pertaining to baseline characteristics, symptomatology, laboratory assessment, imaging, and endoscopic findings from the time of symptom onset until discharge or death were abstracted manually from electronic health records to characterize the prevalence, spectrum, and severity of digestive manifestations. Regression analyses were performed to evaluate the association between digestive manifestations and severe outcomes related to COVID-19. RESULTS: A total of 1992 patients across 36 centers met eligibility criteria and were included. Overall, 53% of patients experienced at least 1 gastrointestinal symptom at any time during their illness, most commonly diarrhea (34%), nausea (27%), vomiting (16%), and abdominal pain (11%). In 74% of cases, gastrointestinal symptoms were judged to be mild. In total, 35% of patients developed an abnormal alanine aminotransferase or total bilirubin level; these were increased to less than 5 times the upper limit of normal in 77% of cases. After adjusting for potential confounders, the presence of gastrointestinal symptoms at any time (odds ratio, 0.93; 95% CI, 0.76-1.15) or liver test abnormalities on admission (odds ratio, 1.31; 95% CI, 0.80-2.12) were not associated independently with mechanical ventilation or death. CONCLUSIONS: Among patients hospitalized with COVID-19, gastrointestinal symptoms and liver test abnormalities were common, but the majority were mild and their presence was not associated with a more severe clinical course.

The Volume-Outcome Effect Calls for Centralization of Care in Esophageal Adenocarcinoma: Results From a Large National Cancer Registry.

INTRODUCTION: Using the National Cancer Database, we assessed the relationship between facility overall esophageal adenocarcinoma (EAC) case volume and survival. METHODS: We categorized facilities into volume quintiles based on annual EAC patient volume and performed a multivariable Cox proportional hazards regression between facility patient volume and survival. RESULTS: In a cohort of 116,675 patients, facilities with higher vs lower (≥25 vs 1-4 cases) annual EAC patient volume demonstrated improved survival (adjusted hazard ratio: 0.80. 95% confidence interval: 0.70-0.91). DISCUSSION: This robust volume-outcome effect calls for centralization of care for EAC patients at high annual case volume facilities.

Increased Risk of Colorectal Cancer Tied to Advanced Colorectal Polyps: An Untapped Opportunity to Screen First-Degree Relatives and Decrease Cancer Burden.

Advanced adenomas represent a subset of colorectal polyps that are known to confer an increased risk of colorectal neoplasia to the affected individual and their first-degree relatives (FDRs). Accordingly, professional guidelines suggest earlier and more intensive screening for FDRs of those with advanced adenomas similar to FDRs of those with colorectal cancer (CRC). Although the risk to family members is less clear among patients with advanced serrated polyps, they are often considered in the same category. Unfortunately, there is a growing concern that patients, endoscopists, and primary care providers are unaware of the familial risk associated with these polyps, leaving a wide gap in screening these high-risk individuals. Herein, we propose a standardized language around advanced colorectal polyps and present a detailed review of the literature on associated familial risk. We outline the challenges to implementing the current screening recommendations and suggest approaches to overcome these limitations, including a proposed new colonoscopy quality metric to capture communication of familial CRC risk. Improving screening in these high-risk groups has the potential to substantially reduce the burden of CRC.

Endoscopic eradication therapy for Barrett's oesophagus: state of the art.

PURPOSE OF REVIEW: Barrett's oesophagus is the only identifiable precursor lesion to oesophageal adenocarcinoma. The stepwise progression of Barrett's oesophagus to dysplasia and invasive carcinoma provides the opportunity to intervene and reduce the morbidity and mortality associated with this lethal cancer. Several studies have demonstrated the efficacy and safety of endoscopic eradication therapy (EET) for the management of Barrett's oesophagus related neoplasia. The primary goal of EET is to achieve complete eradication of intestinal metaplasia (CE-IM) followed by enrolment of patients in surveillance protocols to detect recurrence of Barrett's oesophagus and Barrett's oesophagus related neoplasia. RECENT FINDINGS: EET depends on early and accurate detection and diagnosis of Barrett's oesophagus related neoplasia. All visible lesions should be resected followed by ablation of the remaining Barrett's epithelium. After treatment, patients should be enrolled in endoscopic surveillance programmes. For nondysplastic Barrett's oesophagus, surveillance alone is recommended. For low-grade dysplasia, both surveillance and ablation are reasonable options and should be decided on an individual basis according to patient risk factors and preferences. EET is preferred for high-grade dysplasia and intramucosal carcinoma. For T1b oesophageal adenocarcinoma, esophagectomy remains the standard of care, but endoscopic therapy can be considered in select cases. SUMMARY: EET is now standard of care and endorsed by societal guidelines for the treatment of Barrett's oesophagus related neoplasia. Future studies should focus on risk stratification models using a combination of clinical data and biomarkers to identify ideal candidates for EET, and to predict recurrence. Optimal therapy for T1b cancer and surveillance strategy after CE-IM are topics that require further study.

Higher Growth Rate of Branch Duct Intraductal Papillary Mucinous Neoplasms Associates With Worrisome Features.

BACKGROUND & AIMS: For patients with branch duct intraductal papillary mucinous neoplasms (BD-IPMNs, cysts), it is a challenge to identify those at high risk for malignant lesions. We sought to identify factors associated with development of pancreatic cancer, focusing on neoplasm growth rate. METHODS: We performed a retrospective study of 189 patients with BD-IPMNs who underwent at least 2 contrast-enhanced cross-sectional imaging studies, 1 year or more apart, at a tertiary referral center from January 2003 through 2013. Patients with cysts that had Fukuoka worrisome or high-risk features were excluded. Two radiologists reviewed all images. Cyst size was recorded at the initial and final imaging studies and growth rate was calculated. We collected patient demographic data, cyst characteristics, and clinical outcomes; univariate logistic regression models were used to determine the odds of developing worrisome features. The primary outcomes were to determine growth rate of low-risk BD-IPMNs and to assess whether cyst growth rate correlates high-risk features of IPMNs. RESULTS: Based on image analyses, cysts were initially a median 11 mm (range, 3-31 mm) and their final size was 12.5 mm (range, 3-42 mm). After a median follow-up time of 56 months (range, 12-163 months), the median cyst growth rate was 0.29 mm/year. Twelve patients developed worrisome features, no patients developed high-risk features, 4 patients had surgical resection, and no cancers developed. The rate of BD-IPMN growth was greater in patients who developed worrisome features than those who did not (2.84 mm/year vs 0.23 mm/year; P < .001). The odds of developing worrisome features increased for each unit (mm) increase in cyst size (odds ratio, 1.149; 95% CI, 1.035-1.276, P = .009). CONCLUSION: In a retrospective analysis of images from patients with BD-IPMN, we found low-risk BD-IPMNs to grow at an extremely low rate (less than 0.3 mm/year). BD-IPMNs in only about 6% of patients developed worrisome features, and none developed high-risk features or invasive cancers. BD-IPMNs that developed worrisome features were associated with a significantly higher rate of growth than lesions with low-risk features. Low risk BD-IPMNs that grow more than 2.5 mm/year might require surveillance.