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.

Red Flag Signs and Symptoms for Patients With Early-Onset Colorectal Cancer: A Systematic Review and Meta-Analysis.

Importance: Early-onset colorectal cancer (EOCRC), defined as a diagnosis at younger than age 50 years, is increasing, and so-called red flag signs and symptoms among these individuals are often missed, leading to diagnostic delays. Improved recognition of presenting signs and symptoms associated with EOCRC could facilitate more timely diagnosis and impact clinical outcomes. Objective: To report the frequency of presenting red flag signs and symptoms among individuals with EOCRC, to examine their association with EOCRC risk, and to measure variation in time to diagnosis from sign or symptom presentation. Data Sources: PubMed/MEDLINE, Embase, CINAHL, and Web of Science were searched from database inception through May 2023. Study Selection: Studies that reported on sign and symptom presentation or time from sign and symptom presentation to diagnosis for patients younger than age 50 years diagnosed with nonhereditary CRC were included. Data Extraction and Synthesis: Data extraction and quality assessment were performed independently in duplicate for all included studies using Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guidelines. Joanna Briggs Institute Critical Appraisal tools were used to measure risk of bias. Data on frequency of signs and symptoms were pooled using a random-effects model. Main Outcomes and Measures: Outcomes of interest were pooled proportions of signs and symptoms in patients with EOCRC, estimates for association of signs and symptoms with EOCRC risk, and time from sign or symptom presentation to EOCRC diagnosis. Results: Of the 12 859 unique articles initially retrieved, 81 studies with 24 908 126 patients younger than 50 years were included. The most common presenting signs and symptoms, reported by 78 included studies, were hematochezia (pooled prevalence, 45% [95% CI, 40%-50%]), abdominal pain (pooled prevalence, 40% [95% CI, 35%-45%]), and altered bowel habits (pooled prevalence, 27% [95% CI, 22%-33%]). Hematochezia (estimate range, 5.2-54.0), abdominal pain (estimate range, 1.3-6.0), and anemia (estimate range, 2.1-10.8) were associated with higher EOCRC likelihood. Time from signs and symptoms presentation to EOCRC diagnosis was a mean (range) of 6.4 (1.8-13.7) months (23 studies) and a median (range) of 4 (2.0-8.7) months (16 studies). Conclusions and Relevance: In this systematic review and meta-analysis of patients with EOCRC, nearly half of individuals presented with hematochezia and abdominal pain and one-quarter with altered bowel habits. Hematochezia was associated with at least 5-fold increased EOCRC risk. Delays in diagnosis of 4 to 6 months were common. These findings highlight the need to identify concerning EOCRC signs and symptoms and complete timely diagnostic workup, particularly for individuals without an alternative diagnosis or sign or symptom resolution.

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.

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.

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.

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.

Management of Post Ablative Barrett's Esophagus: a Review of Current Practices and Look at Emerging Technologies.

Purpose of review: Endoscopic eradication therapy is an effective and durable treatment for Barrett's esophagus (BE) related neoplasia, but even after achieving successful eradication, these patients remain at risk for recurrence and require ongoing routine examinations. The optimal surveillance protocol including endoscopic technique, sampling strategy, and timing are still being refined. The aim of this review is to discuss current management principles for the post ablation patient and emerging technologies to guide clinical practice. Recent findings: There is increasing evidence to support less frequent surveillance exams in the first year after complete eradication of intestinal metaplasia and a move towards targeted biopsies of visible lesions and sampling high-risk locations such as the gastroesophageal junction. Promising technologies on the horizon that could impact management include novel biomarkers, personalized surveillance intervals, and non-endoscopic approaches. Summary: Ongoing high-quality examinations after endoscopic eradication therapy are key to limiting recurrent BE. Surveillance intervals should be based on the pretreatment grade of dysplasia. Future research should focus on technologies and surveillance practices that are most efficient for patients and the healthcare system.

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.

Prognostic Impact of the Presence of Barrett's Esophagus and Intestinal Metaplasia on Esophageal Adenocarcinoma Survival.

Background/Aims: Barrett's esophagus (BE), defined by the presence of intestinal metaplasia (IM) on histology, is thought to be the only identifiable precursor lesion for esophageal adenocarcinoma (EAC). Recent studies have suggested the possibility of an alternate, non-IM associated EAC that is a more aggressive form of EAC with worse survival. Among EAC patients, we aimed to compare survival of patients with and without IM at the time of diagnosis. Methods: This was a retrospective cohort study of all patients with histologic confirmed EAC evaluated at a tertiary care center from 2013 to 2019. Cases were categorized according to the presence or absence of IM on histologic specimens (Group I-IM-EAC and Group II-non-IM-EAC). We compared demographic characteristics, clinical stage, therapy, and survival between the 2 groups using the Chi-square and ANOVA tests (for categorical and continuous variables, respectively). We used Cox proportional hazards regression to determine the association of IM with overall survival, adjusting for sex, age at diagnosis, tumor location, histologic grade, and clinical stage. Results: A total of 475 patients were included in this analysis (mean age 64.8 years [SD 10.8], 89% white) and 109 (23.0%) had no evidence of IM. Compared with IM-EAC (Group I), individuals in the non-IM-EAC group were younger (P = .01) and had a greater proportion of patients diagnosed with advanced disease (49.5 vs 20.2% for stage 4, P < .001). These patients were less likely to undergo endoscopic therapy alone (0.92% vs 29.78%, P < .001) or surgery alone (0 vs 9.84%, P = .001). On multivariable analysis, the presence of IM-EAC was associated with improved overall survival compared to non-IM-EAC (HR 0.69, 95% CI 0.49-0.96). Additional factors associated with poor survival was increasing stage of diagnosis (HR 6.49: 95% CI 3.77-11.15 for stage 4, HR 2.19: 95% CI 1.25-3.84 for stage 3, HR 2.04: 95% CI 0.98-4.25 for stage 2 compared to stage 1) and more advanced histologic stage (HR 2.00, 95% CI 1.26-3.19) for poorly/undifferentiated compared to well differentiated). Conclusions: EAC without the presence of IM on histology was associated with worse survival compared to those with IM. Future prospective studies with detailed molecular sequencing are required to clarify if 2 separate phenotypes of EAC exist (IM-EAC and non-IM-EAC). If confirmed, this may have significant implications for screening and management strategies.

Navigational tunnel technique for gastric peroral endoscopic pyloromyotomy: getting straight to the point (pylorus).

BACKGROUND AND AIMS: Gastric peroral endoscopic pyloromyotomy (G-POEM) is emerging as a treatment option for patients with gastroparesis. The most technically difficult part of the procedure is creating a submucosal tunnel in the gastric antrum, which can be directionally challenging. We describe a novel navigational tunneling method that guides submucosal dissection in the direction of the pylorus and helps to identify the pyloric landmarks. METHODS: Consecutive patients from September to December 2020 who underwent G-POEM for symptomatic gastroparesis were included. All cases were confirmed by prolonged gastric emptying study. The navigational tunnel technique was performed as follows: (1) mucosal cautery markings were made to outline the tunnel starting 3 to 4 cm proximal to the pylorus, (2) submucosal injection was done at the level of the pylorus and extended backward to the incision point, and (3) submucosal dissection was carried out after the prior submucosal injection straight to the pylorus. RESULTS: Six patients with gastroparesis underwent G-POEM with the navigational tunneling technique. The average time for submucosal injection was 2 minutes and 42 seconds, and the average tunnel time was 15 minutes and 36 seconds. There were no adverse events. All patients reported significant improvement (50%-85%) in symptoms. CONCLUSIONS: This novel navigational tunneling technique appears to guide and facilitate G-POEM by providing a visual path for submucosal dissection straight to the pylorus. It may increase efficiency, decreasing the need to repeatedly exit the tunnel to check direction and preventing nonproductive wandering. It may also help identify the pyloric ring within the tunnel.

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.