The Effect of Oral Simethicone in a Bowel Preparation in a Colorectal Cancer Screening Colonoscopy Setting: A Randomized Controlled Trial.

Introduction: Current guidelines suggest adding oral simethicone to bowel preparation for colonoscopy. However, its effect on key quality indicators for screening colonoscopy remains unclear. The primary aim was to assess the rate of adequate bowel preparation in split-dose high-volume polyethylene glycol (PEG), with or without simethicone. Methods: This is an endoscopist-blinded, randomized controlled trial, including patients scheduled for colonoscopy after a positive faecal immunochemical test. Patients were randomly assigned to 4 L of PEG split dose (PEG) or 4 L of PEG split dose plus 500 mg oral simethicone (PEG + simethicone). The Boston Bowel Preparation Scale (BBPS) score, the preparation quality regarding bubbles using the Colon Endoscopic Bubble Scale (CEBuS), ADR, CIR, and the intraprocedural use of simethicone were recorded. Results: We included 191 and 197 patients in the PEG + simethicone group and the PEG group, respectively. When comparing the PEG + simethicone group versus the PEG group, no significant differences in adequate bowel preparation rates (97% vs. 93%; p = 0.11) were found. However, the bubble scale score was significantly lower in the PEG + simethicone group (0 [0] versus 2 [5], p < 0.01), as well as intraprocedural use of simethicone (7% vs. 37%; p < 0.01). ADR (62% vs. 61%; p = 0.86) and CIR (98% vs. 96%, p = 0.14) did not differ between both groups. Conclusion: Adding oral simethicone to a split-bowel preparation resulted in a lower incidence of bubbles and a lower intraprocedural use of simethicone but no further improvement on the preparation quality or ADR.

Introdução: As normas de orientação atuais sugerem a adição de simeticone oral à preparação intestinal para colonoscopia. Contudo, o seu efeito nos indicadores de qualidade no âmbito da colonoscopia de rastreio não está comprovado. O objetivo principal foi avaliar a taxa de preparação adequada usando polietilenoglicol (PEG) em dose dividida com e sem simeticone oral. Métodos: Estudo randomizado controlado, cego para o endoscopista, incluindo doentes admitidos para colonoscopia após teste fecal imunoquímico positivo. Os doentes foram aleatoriamente alocados para 4 litros de PEG em dose dividida (PEG) ou 4 litros de PEG em dose divida + simeticone oral (PEG + simeticone). Foram avaliados: Boston Bowel Preparation Scale (BBPS), qualidade da preparação relativa às bolhas através da Colon Endoscopic Bubble Scale (CEBuS) scale, ADR, CIR e uso de simeticone durante o procedimento. Resultados: Foram incluídos 191 e 197 doentes nos grupos PEG + simeticone e PEG, respetivamente. Comparando os grupos PEG + simeticone versus PEG, não se registaram diferenças de significado estatístico relativamente à taxa de preparação intestinal adequada (97% vs. 93%; p = 0,01) mas o score da escala de bolhas foi significativamente inferior no grupo PEG + simeticone [0 (0) versus 2 (5), p < 0.01], assim como o uso de simeticone durante o procedimento (7% vs. 37%; p < 0,01). A ADR (62% vs. 61%; p = 0,86) e a CIR (98% vs. 96%, p = 0,14) não diferiram significativamente entre os dois grupos, respetivamente. Discussão/Conclusão: Adicionar simeticone oral à preparação intestinal em dose dividida permitiu menor incidência de bolhas e menor utilização de simeticone durante o procedimento, mas não se associa a melhor preparação intestinal ou melhor ADR.

Combined gastric and colorectal cancer endoscopic screening may be cost-effective in Europe with the implementation of artificial intelligence: an economic evaluation.

BACKGROUND/AIMS: Endoscopic screening for gastric cancer (GC) is not recommended in low-intermediate incidence countries. Artificial intelligence (AI) has high accuracy in GC detection and might increase the cost-effectiveness of screening strategies. We aimed to assess the cost-effectiveness of AI for GC detection in settings with different GC incidence and different accuracies of AI systems. METHODS: Cost-effectiveness analysis (using Markov model) comparing different screening strategies (no screening versus single esophagogastroduodenoscopy (EGD) at 50 years versus stand-alone EGD every 5/10 years versus combined EGD and screening colonoscopy once or twice per decade in Netherlands, Italy and Portugal) with variable AI accuracy settings. The primary outcome was the incremental cost-effectiveness ratio of the different strategies versus no screening. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: Without AI, one single EGD at 50 years (Netherlands, Italy, Portugal), EGD combined with screening colonoscopy once per decade (Italy and Portugal) and EGD combined with screening colonoscopy twice per decade (Portugal) are cost-effective when compared with no screening. If AI increases the accuracy of EGD by at least 1% in comparison to the accuracy of white-light endoscopy accuracy (89%), combined screening twice per decade also becomes cost-effective in Italy. If AI accuracy reaches at least 96%, combined screening once per decade is also cost-effective in the Netherlands. DISCUSSION: In European countries, AI-assisted EGD may improve the cost-effectiveness of GC screening with combined EGD and screening colonoscopy. The actual effect of AI on cost-effectiveness may vary dependent on the accuracy and costs of the AI system.

Cap-Assisted Endoscopic Mucosal Resection for Rectal Neuroendocrine Tumors: An Effective Option.

Introduction: The incidence of rectal neuroendocrine tumors (r-NETs) is increasing, and most small r-NETs can be treated endoscopically. The optimal endoscopic approach is still debatable. Conventional endoscopic mucosal resection (EMR) leads to frequent incomplete resection. Endoscopic submucosal dissection (ESD) allows higher complete resection rates but is also associated with higher complication rates. According to some studies, cap-assisted EMR (EMR-C) is an effective and safe alternative for endoscopic resection of r-NETs. Aims: This study aimed to evaluate the efficacy and safety of EMR-C for r-NETs ≤10 mm without muscularis propria invasion or lymphovascular infiltration. Methods: Single-center prospective study including consecutive patients with r-NETs ≤10 mm without muscularis propria invasion or lymphovascular invasion confirmed by endoscopic ultrasound (EUS), submitted to EMR-C between January 2017 and September 2021. Demographic, endoscopic, histopathologic, and follow-up data were retrieved from medical records. Results: A total of 13 patients (male: 54%; n = 7) with a median age of 64 (interquartile range: 54-76) years were included. Most lesions were located at the lower rectum (69.2%, n = 9), and median lesion size was 6 (interquartile range: 4.5-7.5) mm. On EUS evaluation, 69.2% (n = 9) of tumors were limited to muscularis mucosa. EUS accuracy for the depth of invasion was 84.6%. We found a strong correlation between size measurements by histology and EUS (r = 0.83, p < 0.01). Overall, 15.4% (n = 2) were recurrent r-NETs and had been pretreated by conventional EMR. Resection was histologically complete in 92% (n = 12) of cases. Histologic analysis revealed grade 1 tumor in 76.9% (n = 10) of cases. Ki-67 index was inferior to 3% in 84.6% (n = 11) of cases. The median procedure time was 5 (interquartile range: 4-8) min. Only 1 case of intraprocedural bleeding was reported and was successfully controlled endoscopically. Follow-up was available in 92% (n = 12) of cases with a median follow-up of 6 (interquartile range: 12-24) months with no evidence of residual or recurrent lesion on endoscopic or EUS evaluation. Conclusion: EMR-C is fast, safe, and effective for resection of small r-NETs without high-risk features. EUS accurately assesses risk factors. Prospective comparative trials are needed to define the best endoscopic approach.

Introdução: Os tumores neuroendócrinos do reto (r-NETs) apresentam incidência crescente. A maioria dos tumores de pequenas dimensões pode ser excisada endoscopicamente, no entanto, a abordagem ótima é controversa. A mucosectomia convencional associa-se, frequentemente, a resseção endoscópica incompleta. A disseção endoscópica submucosa (ESD) permite elevadas taxas de resseção completa, mas é tecnicamente complexa e associa-se a maior número de complicações. Alguns estudos sugerem a mucosectomia assistida por cap (EMR-C) como uma alternativa eficaz e segura. Objetivo: Este estudo pretendeu avaliar a eficácia e segurança da mucosectomia com cap na resseção de r-NETs com dimensões ≤10 mm, sem invasão da muscularis própria nem infiltração linfovascular. Material e Métodos: Estudo prospetivo unicêntrico incluindo consecutivamente r-NETs com ≤10 mm, sem invasão da muscularis própria ou linfovascular confirmada em ultrassonografia endoscópica (EUS), submetidos a mucosectomia assistida cap entre janeiro de 2017 e setembro de 2021. Colheita de dados demográficos, clínicos e histopatológicos através de registos médicos eletrónicos. Resultados: Incluídos 13 doentes (género masculino: 54%; n = 7) com idade mediana de 64 (intervalo interquartil [IIQ]: 54­76) anos. A maioria das lesões localizava-se no reto inferior (69.2%; n = 9) e apresentava tamanho mediano de 6 (IIQ: 4.5­7.5) mm. Na avaliação por EUS, 69.2% (n = 9) encontravam-se limitados à muscularis mucosa. A acuidade da EUS na avaliação do envolvimento das camadas da parede retal foi de 84.6% e o tamanho avaliado por EUS correlacionou-se fortemente com o medido na histologia (r = 0.83, p < 0.01). Dois casos (15.4%) corresponderam a recorrências de mucosectomias convencionais prévias. A resseção foi macroscópica e histologicamente completa em 92% (n = 12) dos casos. A análise histológica revelou 76.9% (n = 10) tumores de grau 1. O índice Ki-67 foi inferior a 3% em 84.6% (n = 11) dos casos. O tempo mediano de procedimento foi 5 (IIQ: 4­8) minutos. Verificou-se apenas um caso de hemorragia intraprocedimento resolvida endoscopicamente. O seguimento de 92% dos casos (n = 12) com mediana de 6 (IIQ:12­24) meses não revelou lesão residual ou recorrência em avaliações endoscópica e ultrassonográfica. Discussão/Conclusão: A EMR-C é uma técnica endoscópica segura, rápida e efetiva para a resseção de r-TNEs pequenos sem fatores de alto risco. A EUS apresenta elevada acuidade na avaliação dos fatores de risco. Estudos comparativos prospetivos são necessários para estabelecimento da abordagem endoscópica mais profícua.

Can white-light endoscopy or narrow-band imaging avoid biopsy of colorectal endoscopic mucosal resection scars? A multicenter randomized single-blind crossover trial.

BACKGROUND : Current guidelines suggest that routine biopsy of post-endoscopic mucosal resection (EMR) scars can be abandoned, provided that a standardized imaging protocol with virtual chromoendoscopy is used. However, few studies have examined the accuracy of advanced endoscopic imaging, such as narrow-band imaging (NBI) vs. white-light endoscopy (WLE) for prediction of histological recurrence. We aimed to assess whether NBI accuracy is superior to that of WLE and whether one or both techniques can replace biopsies. METHODS : The study was a multicenter, randomized, pathologist-blind, crossover trial, with consecutive patients undergoing first colonoscopy after EMR of lesions ≥ 20 mm. Computer-generated randomization and opaque envelope concealed allocation. Patients were randomly assigned to scar examination with NBI followed by WLE (NBI + WLE), or WLE followed by NBI (WLE + NBI). Histology was the reference method, with biopsies being performed for all tissues. RESULTS : The study included 203 scars (103 in the NBI + WLE group, 100 in the WLE + NBI group). Recurrence was confirmed histologically in 29.6 % of the scars. The diagnostic accuracy of NBI was not statistically different from that of WLE (95 % [95 %CI 92 %-98 %] vs. 94 % [95 %CI 90 %-97 %]; P = 0.48). The negative predictive values (NPVs) were 96 % (95 %CI 93 %-99 %) for NBI and 93 % (95 %CI 89 %-97 %) for WLE (P = 0.06). CONCLUSIONS : The accuracy of NBI for the diagnosis of recurrence was not superior to that of WLE. Endoscopic assessment of EMR scars with WLE and NBI achieved an NPV that would allow routine biopsy to be avoided in cases of negative optical diagnosis.

The Impact of a Structured Virtual Reality Simulation Training Curriculum for Novice Endoscopists.

Background: Current evidence supports the use of virtual reality (VR) simulation-based training for novice endoscopists. However, there is still a need for a standardized induction programme which ensures sufficient preparation, with knowledge and basic skills, before their approach to patient-based training. We designed a structured progressive programme in upper endoscopy and colonoscopy and aimed to determine its impact on cognitive and technical performance. Methods: Prospective, multicentre study, focused on "Endoscopy I, 2018," a course with a theoretical and a hands-on module (20 h) in the GI Mentor II®. Gastroenterology residents of the 1st year were enrolled. A pre-test and test were applied to evaluate the cognitive component, and a pre-training and post-training esophagogastroduodenoscopy (EGD) and colonoscopy VR cases were used to evaluate the technical component. The hands-on training included psychomotor exercises (Navigation I, Endobubble I), 4 EGD, and 4 colonoscopy VR cases. The metrics applied for technical skills evaluation were time to reach the second portion of duodenum (D2)/cecum (seconds), efficiency of screening (%), and time the patient was in pain (%). Results: Twenty-three participants were included, majority female (67%), 26 ± 0.7 years old. Comparing the pre-test versus test, the cognitive score significantly improved (11/15 vs. 14/15; p < 0.001). Considering the technical assessment after training: in EGD, the time to D2 was significantly lower (193 vs. 63 s; p < 0.001), and the efficiency of screening significantly better (64 vs. 91%; p < 0.001); in colonoscopy, the time to reach the cecum was significantly lower (599 vs. 294 s; p = 0.001), the time the patient was in pain was significantly lower (27 vs. 10%; p = 0.005), and the efficiency of screening had a tendency towards improvement (50 vs. 68%; p = 0.062). Conclusion: The proposed training curriculum in basic endoscopy for novices is aligned with international recommendations and demonstrated a significant impact on cognitive and technical skills learning achievements.

Introdução: A evidência científica suporta o uso de simuladores de realidade virtual na fase inicial da formação. Contudo, persiste a necessidade de um programa padronizado, que garanta uma preparação adequada dos formandos, com conhecimento e competências básicas, antes de transitarem para o treino em pacientes. Desenhámos um programa de treino estruturado e progressivo em endoscopia digestiva alta (EDA) e colonoscopia, pretendendo este estudo avaliar o seu impacto no desempenho cognitivo e técnico. Métodos: Estudo prospetivo e multicêntrico, focado no programa de treino "Endoscopia I, 2018." Este curso incluiu um módulo teórico e um módulo prático (20 h) no simulador GI Mentor II®. Foram recrutados internos de Gastrenterologia do 1° ano. Realizou-se um pré-teste e um teste para avaliar o componente cognitivo e foram usados casos virtuais selecionados, de EDA e colonoscopia, para avaliar o componente técnico pré e pós-treino. A prática incluiu exercícios psicomotores (Navigation I, Endobubble I), 4 casos virtuais de EDA e 4 de colonoscopia. As métricas aplicadas na avaliação foram o tempo até à segunda porção duodenal (D2)/cego (segundos), a eficiência da inspeção (%) e o tempo que o paciente teve dor (%). Resultados: Vinte e três participantes incluídos, a maioria do género feminino (67%), com idade média de 26 ± 0.7 anos. Comparando o pré-teste versus (vs.) teste, o resultado da avaliação cognitiva melhorou (11/15 vs. 14/15; p < 0.001). Relativamente à avaliação técnica após o treino: na EDA, o tempo para alcançar D2 foi significativamente menor (193 vs. 63 s; p < 0.001) e a eficiência da inspeção foi significativamente melhor (64 vs. 91%; p < 0.001); na colonoscopia, o tempo até ao cego foi significativamente menor (599 vs. 294 s; p = 0.001), o tempo em que o paciente teve dor foi significativamente menor (27 vs. 10%; p = 0.005) e a eficiência da inspeção revelou uma tendência de melhoria (50 vs. 68%; p = 0.062). Conclusão: O presente programa de treino em endoscopia básica para iniciados está alinhado com as recomendações internacionais e demonstrou um impacto significativo na aquisição de capacidades cognitivas e técnicas.

Expected value of artificial intelligence in gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

This ESGE Position Statement defines the expected value of artificial intelligence (AI) for the diagnosis and management of gastrointestinal neoplasia within the framework of the performance measures already defined by ESGE. This is based on the clinical relevance of the expected task and the preliminary evidence regarding artificial intelligence in artificial or clinical settings. MAIN RECOMMENDATIONS:: (1) For acceptance of AI in assessment of completeness of upper GI endoscopy, the adequate level of mucosal inspection with AI should be comparable to that assessed by experienced endoscopists. (2) For acceptance of AI in assessment of completeness of upper GI endoscopy, automated recognition and photodocumentation of relevant anatomical landmarks should be obtained in ≥90% of the procedures. (3) For acceptance of AI in the detection of Barrett's high grade intraepithelial neoplasia or cancer, the AI-assisted detection rate for suspicious lesions for targeted biopsies should be comparable to that of experienced endoscopists with or without advanced imaging techniques. (4) For acceptance of AI in the management of Barrett's neoplasia, AI-assisted selection of lesions amenable to endoscopic resection should be comparable to that of experienced endoscopists. (5) For acceptance of AI in the diagnosis of gastric precancerous conditions, AI-assisted diagnosis of atrophy and intestinal metaplasia should be comparable to that provided by the established biopsy protocol, including the estimation of extent, and consequent allocation to the correct endoscopic surveillance interval. (6) For acceptance of artificial intelligence for automated lesion detection in small-bowel capsule endoscopy (SBCE), the performance of AI-assisted reading should be comparable to that of experienced endoscopists for lesion detection, without increasing but possibly reducing the reading time of the operator. (7) For acceptance of AI in the detection of colorectal polyps, the AI-assisted adenoma detection rate should be comparable to that of experienced endoscopists. (8) For acceptance of AI optical diagnosis (computer-aided diagnosis [CADx]) of diminutive polyps (≤5 mm), AI-assisted characterization should match performance standards for implementing resect-and-discard and diagnose-and-leave strategies. (9) For acceptance of AI in the management of polyps ≥ 6 mm, AI-assisted characterization should be comparable to that of experienced endoscopists in selecting lesions amenable to endoscopic resection.

Endoscopic submucosal dissection: a country dissemination experience and outcomes.

OBJECTIVE: An increasing use of endoscopic submucosal dissection (ESD) has been reported in Western countries, although some differences in training schemes and outcomes have been described. We aimed to report the training model, implementation, and outcomes of ESD in Portugal. METHODS: All endoscopists trained at our center from our country (n = 9) were invited to a survey regarding: (a) training period; (b) ESD outcomes and (c) implementation of ESD in each respective center. RESULTS: All endoscopists completed the survey. Learning ESD was centered on human ESD assistance in a high-volume center during a median time of 6 months and complemented mainly by hands-on courses (89%). During the surveyed period, a total of 1229 ESD were performed, mostly in gastric locations (74%). Median complete R0 and curative resection rate were 92% (IQR, 81-96.8) and 87% (IQR, 74-93.3), respectively, and median perforation rate was 0.89% (IQR, 0.25-6.22). The main limitations encountered during the implementation of ESD were related to the lack of initial mentoring or insufficient expertise to progress to more difficult lesions. CONCLUSION: Learning ESD through participation in hands-on courses and visiting high-volume centers seems to be adequate to achieve a good competence at the initial stage of ESD, which in fact is in consonance with the European Society of Gastrointestinal Endoscopy recommendations. However, mentoring is essential for technical progression, and this represents the fundamental barrier during the adoption of ESD, which may be overcome by increasing hands-on training in animal or artificial simulators, but preferably with the implementation of a structured training program.

Cost-effectiveness of artificial intelligence for screening colonoscopy: a modelling study.

BACKGROUND: Artificial intelligence (AI) tools increase detection of precancerous polyps during colonoscopy and might contribute to long-term colorectal cancer prevention. The aim of the study was to investigate the incremental effect of the implementation of AI detection tools in screening colonoscopy on colorectal cancer incidence and mortality, and the cost-effectiveness of such tools. METHODS: We conducted Markov model microsimulation of using colonoscopy with and without AI for colorectal cancer screening for individuals at average risk (no personal or family history of colorectal cancer, adenomas, inflammatory bowel disease, or hereditary colorectal cancer syndrome). We ran the microsimulation in a hypothetical cohort of 100 000 individuals in the USA aged 50-100 years. The primary analysis investigated screening colonoscopy with versus without AI every 10 years starting at age 50 years and finishing at age 80 years, with follow-up until age 100 years, assuming 60% screening population uptake. In secondary analyses, we modelled once-in-life screening colonoscopy at age 65 years in adults aged 50-79 years at average risk for colorectal cancer. Post-polypectomy surveillance followed the simplified current guideline. Costs of AI tools and cost for downstream treatment of screening detected disease were estimated with 3% annual discount rates. The main outcome measures included the incremental effect of AI-assisted colonoscopy versus standard (no-AI) colonoscopy on colorectal cancer incidence and mortality, and cost-effectiveness of screening projected for the average risk screening US population. FINDINGS: In the primary analyses, compared with no screening, the relative reduction of colorectal cancer incidence with screening colonoscopy without AI tools was 44·2% and with screening colonoscopy with AI tools was 48·9% (4·8% incremental gain). Compared with no screening, the relative reduction in colorectal cancer mortality with screening colonoscopy with no AI was 48·7% and with screening colonoscopy with AI was 52·3% (3·6% incremental gain). AI detection tools decreased the discounted costs per screened individual from $3400 to $3343 (a saving of $57 per individual). Results were similar in the secondary analyses modelling once-in-life colonoscopy. At the US population level, the implementation of AI detection during screening colonoscopy resulted in yearly additional prevention of 7194 colorectal cancer cases and 2089 related deaths, and a yearly saving of US$290 million. INTERPRETATION: Our findings suggest that implementation of AI detection tools in screening colonoscopy is a cost-saving strategy to further prevent colorectal cancer incidence and mortality. FUNDING: European Commission and Japan Society of Promotion of Science.

Empirical rescue treatment of Helicobacter pylori infection in third and subsequent lines: 8-year experience in 2144 patients from the European Registry on H. pylori management (Hp-EuReg).

OBJECTIVE: To evaluate the use, effectiveness and safety of Helicobacter pylori empirical rescue therapy in third and subsequent treatment lines in Europe. DESIGN: International, prospective, non-interventional registry of the clinical practice of European gastroenterologists. Data were collected and quality reviewed until October 2021 at Asociación Española de Gastroenterología-Research Electronic Data Capture. All cases with three or more empirical eradication attempts were assessed for effectiveness by modified intention-to-treat and per-protocol analysis. RESULTS: Overall, 2144 treatments were included: 1519, 439, 145 and 41 cases from third, fourth, fifth and sixth treatment lines, respectively. Sixty different therapies were used; the 15 most frequently prescribed encompassed >90% of cases. Overall effectiveness remained <90% in all therapies. Optimised treatments achieved a higher eradication rate than non-optimised (78% vs 67%, p<0.0001). From 2017 to 2021, only 44% of treatments other than 10-day single-capsule therapy used high proton-pump inhibitor doses and lasted ≥14 days. Quadruple therapy containing metronidazole, tetracycline and bismuth achieved optimal eradication rates only when prescribed as third-line treatment, either as 10-day single-capsule therapy (87%) or as 14-day traditional therapy with tetracycline hydrochloride (95%). Triple amoxicillin-levofloxacin therapy achieved 90% effectiveness in Eastern Europe only or when optimised. The overall incidence of adverse events was 31%. CONCLUSION: Empirical rescue treatment in third and subsequent lines achieved suboptimal effectiveness in most European regions. Only quadruple bismuth-metronidazole-tetracycline (10-day single-capsule or 14-day traditional scheme) and triple amoxicillin-levofloxacin therapies reached acceptable outcomes in some settings. Compliance with empirical therapy optimisation principles is still poor 5 years after clinical practice guidelines update. TRIAL REGISTRATION NUMBER: NCT02328131.

Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg).

BACKGROUND & AIMS: After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain infected. The aim of the current study was to assess the effectiveness and safety of second-line empiric treatment in Europe. METHODS: This international, multicenter, prospective, non-interventional registry aimed to evaluate the decisions and outcomes of H pylori management by European gastroenterologists. All infected adult cases with a previous eradication treatment attempt were registered with the Spanish Association of Gastroenterology-Research Electronic Data Capture until February 2021. Patients allergic to penicillin and those who received susceptibility-guided therapy were excluded. Data monitoring was performed to ensure data quality. RESULTS: Overall, 5055 patients received empiric second-line treatment. Triple therapy with amoxicillin and levofloxacin was prescribed most commonly (33%). The overall effectiveness was 82% by modified intention-to-treat analysis and 83% in the per-protocol population. After failure of first-line clarithromycin-containing treatment, optimal eradication (>90%) was obtained with moxifloxacin-containing triple therapy or levofloxacin-containing quadruple therapy (with bismuth). In patients receiving triple therapy containing levofloxacin or moxifloxacin, and levofloxacin-bismuth quadruple treatment, cure rates were optimized with 14-day regimens using high doses of proton pump inhibitors. However, 3-in-1 single capsule or levofloxacin-bismuth quadruple therapy produced reliable eradication rates regardless of proton pump inhibitor dose, duration of therapy, or previous first-line treatment. The overall incidence of adverse events was 28%, and most (85%) were mild. Three patients developed serious adverse events (0.3%) requiring hospitalization. CONCLUSIONS: Empiric second-line regimens including 14-day quinolone triple therapies, 14-day levofloxacin-bismuth quadruple therapy, 14-day tetracycline-bismuth classic quadruple therapy, and 10-day bismuth quadruple therapy (as a single capsule) provided optimal effectiveness. However, many other second-line treatments evaluated reported low eradication rates. ClincialTrials.gov number: NCT02328131.

The Colon Endoscopic Bubble Scale (CEBuS): a two-phase evaluation study.

BACKGROUND: To date, no scale has been validated to assess bubbles associated with bowel preparation. This study aimed to develop and assess the reliability of a novel scale - the Colon Endoscopic Bubble Scale (CEBuS). METHODS: This was a multicenter, prospective, observational study with two online evaluation phases of 45 randomly distributed still colonoscopy images (15 per scale grade). Observers assessed images twice, 2 weeks apart, using CEBuS (CEBuS-0 - no or minimal bubbles, covering < 5 % of the surface; CEBuS-1 - bubbles covering 5 %-50 %; CEBuS-2 - bubbles covering > 50 %) and reporting the clinical action (do nothing; wash with water; wash with simethicone). RESULTS: CEBuS provided high levels of agreement both in evaluation Phase 1 (4 experts) and Phase 2 (6 experts and 13 non-experts), with almost perfect intraobserver reliability: kappa 0.82 (95 % confidence interval 0.75-0.88) and 0.86 (0.85-0.88); interobserver agreement - intraclass correlation coefficient (ICC) 0.83 (0.73-0.89) and 0.90 (0.86-0.94). Previous endoscopic experience had no influence on agreement among experts vs. non-experts: kappa 0.86 (0.80-0.91) vs. 0.87 (0.84-0.89) and ICC 0.91 (0.87-0.94) vs. 0.90 (0.86-0.94), respectively. Interobserver agreement on clinical action was ICC 0.63 (0.43-0.78) in Phase 1 and 0.77 (0.68-0.84) in Phase 2. Absolute agreement on clinical action per scale grade was 85 % (82-88) for CEBuS-0, 21 % (16-26) for CEBuS-1, and 74 % (70-78) for CEBuS-2. CONCLUSION: CEBuS proved to be a reliable instrument to standardize the evaluation of colonic bubbles during colonoscopy. Assessment in daily practice is warranted.

Should Colorectal Cancer Screening in Portugal Start at the Age of 45 Years? A Cost-Utility Analysis.

BACKGROUND AND OBJECTIVE: Colorectal cancer (CRC) is one of the most common cancers in Europe. Recently, new data from the USA and Europe revealed an increase in the incidence of CRC in individuals aged <55 years and a reduction in those aged >65 years. Mortality rate was stable in patients aged <55 years and decreased after the age of 55 years. Based on the USA data, the American Cancer Society (ACS) published a qualified recommendation advocating the start of CRC screening at the age of 45 years. We aimed to evaluate if the changes in the CRC incidence/mortality observed in the USA and the rest of Europe also occur in Portugal, and then perform a cost-utility analysis of CRC screening that starts at 45 years of age. METHODS: We evaluated the incidence of CRC by age group using data from the National Cancer Registry, and the mortality rate according to the National Statistics Institute in the periods 1993-2010 and 2003-2016. A cost-utility analysis was performed with a decision tree from a societal perspective comparing biennial fecal immunochemical test (FIT) or a single colonoscopy screening versus nonscreening at the age of 45 years in Portugal. RESULTS: In Portugal, in 1993-2010, there was an increase in CRC incidence of 17% (from 25 to 30/100,000), 35% (from 39 to 54/100,000), and 71% (from 52 to 97/100,000) in patients aged 45-49 years, 50-54 years, and 55-59 years, respectively. The mortality rate of patients aged 45-54 years remained stable between 2003 and 2016 (12/100,000) as a counterpoint to a moderate decrease in those aged 55-64 years (from 38 to 35/100,000) and a sharp reduction in those aged 65-75 years (from 93 to 75/100,000). Screening for CRC at the age of 45 years has no cost utility with the current incidence. FIT screening provided an ICUR of EUR 84,304/quality-adjusted life years (QALY) while colonoscopy provided an ICUR of EUR 3,112,244/QALY. On one-way sensitivity analysis, FIT screening would only have cost utility at the present cost of colonoscopy under sedation (EUR 150) and acceptance rates if the incidence rate rises above 47.5/100,000; colonoscopy at this age would have no cost utility despite changes in costs and/or incidence rates. CONCLUSION: In Portugal, the incidence of CRC in patients aged 45-55 years has been increasing with a stable mortality rate, in contrast to the decrease in mortality in the age groups covered by the current CRC screening program. However, at present, CRC screening in Portugal at the age of 45 years has no cost utility and will only have this if the incidence rate rises above 47.5/100,000 (vs. the actual incidence of 30/100,000).

INTRODUÇÃO E OBJETIVOS: O cancro colorretal (CCR) é uma das neoplasias mais comuns na Europa. Recentemente, temos observado um aumento da incidencia de cancro colorretal (CCR) em individuos <50 anos (não abrangidos pelos programas de rastreio), tanto na europa como nos Estados Unidos da América (EUA). Simultaneamente, a taxa de mortalidade (TM) permaneceu estável em doentes <55 anos e diminuiu >55 anos. Baseado nestes dados, a American Cancer Society (ACS) publicou uma recomendação qualificada advogando o inicio do rastreio aos 45 anos. Avaliar se as alterações na incidência/mortalidade de CCR observadas nos EUA/Europa também ocorrem em Portugal e realizar uma análise de custo-utilidade do início do rastreio de CCR aos 45 anos. MÉTODOS: Avaliamos a incidencia de CCR por faixa etária usando dados do Registro Oncológico Nacional (1993­2010) e TM de acordo com o Instituto Nacional de Estatística (2003­2016). A análise de custo-utilidade foi realizada com uma árvore de decisão sob uma perspetiva social, comparando o teste imunoquímico fecal bienal (FIT) com a realização de uma colonoscopia total aos 45 anos. RESULTADOS: Em Portugal (1993­2010) observou-se um aumento na incidencia de CRC de 17% (25/100.000 vs. 30/100.000), 35% (39/100.000 vs. 54/100.000) e 71% (52/100.000 vs. 97/100.000) em doentes com 45­49 anos, 50­54 anos e 55­59 anos, respetivamente. A TM de indivíduos com 45­54 anos permaneceu estável (12/100.000) ao contrário da diminuição moderada em indivíduos com 55­64 (38/100.000 vs. 35/100.000) e uma acentuada redudo em 65­75 (93/100.000 vs. 75/100.000). O rastreio de CCR aos 45 anos não teve custo-utilidade na presente incidencia (FIT/colonoscopia total). O rastreio com FIT forneceu um RCEI de € 84.304/QALY, enquanto a colonoscopia forneceu um RCEI de € 3.112.244/OALY. Em análise de sensibilidade unilateral, o rastreio com FIT apresentaria custo-utilidade com o custo atual da colonoscopia sob sedação (€ 150) e taxas de aceitado apenas se a incidencia subir acima de 47,5/100.000; o rastreio com colonoscopia nesta idade nunca teria custo-utilidade, apesar das mudanças nos custos e/ou taxas de incidencia. CONCLUSÃO: Em Portugal, a incidencia de CCR em doentes com idades entre 45­55 anos tem aumentado (TM estável). Este cenário é semelhante ao descrito nos EUA/restante europa. No entanto, o inicio do rastreio do CCR aos 45 anos em Portugal apenas terá custo-utilidade se incidencia for >47.5/100.000 (vs. 30/100.000).

Gastric Hyperplastic Polyps: A Benign Entity? Analysis of Recurrence and Neoplastic Transformation in a Cohort Study.

INTRODUCTION: Hyperplastic polyps represent 30-93% of all gastric epithelial polyps. They are generally detected as innocuous incidental findings; however, they have a risk of neoplastic transformation and recurrence. Frequency and risk factors for neoplastic transformation and recurrence are not well established and are fields of ongoing interest. This study aims to evaluate the frequency of and identify the risk factors for recurrence and neoplastic change of gastric hyperplastic polyps (GHP). METHODS: A single-centre retrospective cohort study including consecutive patients who underwent endoscopic resection of GHP from January 2009 to June 2020. Demographic, endoscopic, and histopathologic data was retrieved from the electronic medical records. RESULTS: A total of 195 patients were included (56% women; median age 67 [35-87] years). The median size of GHP was 10 (3-50) mm, 62% (n = 120) were sessile, 61% (n = 119) were located in the antrum, and 36% (n = 71) had synchronous lesions. Recurrence rate after endoscopic resection was 23% (n = 26). In multivariate analysis, antrum location was the only risk factor for recurrence (odds ratio [OR] 3.0; 95% confidence interval [CI] 1.1-8.1). Overall, 5.1% (n = 10) GHP showed neoplastic transformation, with low-grade dysplasia in 5, high-grade dysplasia in 4, and adenocarcinoma in 1. In multivariate analysis, a size >25 mm (OR 84; 95% CI 7.4-954) and the presence of intestinal metaplasia (OR 7.6; 95% CI 1.0-55) and dysplasia (OR 86; 95% CI 10-741) in adjacent mucosa were associated with an increased risk of neoplastic transformation. Recurrence was not associated with neoplastic transformation (OR 1.1; 95% CI 0.2-5.9). DISCUSSION: Our results confirmed the risk of recurrence and neoplastic transformation of GHP. Antrum location was a predictor of recurrence. The risk of neoplastic change was increased in large lesions and with intestinal metaplasia and dysplasia in adjacent mucosa. More frequent endoscopic surveillance may be required in these subgroups of GHP.

INTRODUÇÃO E OBJETIVOS: Os pólipos hiperplásicos constituem 30­93% das lesões gástricas epiteliais benignas. Apresentam-se frequentemente como achados endoscópicos incidentais inocuos, no entanto, apresentam risco de recorrência e transformação neoplásica. A frequência e fatores associados à recorrência e transformação neoplásica não estão bem estabelecidos e são áreas de interesse crescente. Este estudo pretende avaliar a frequência e identificar fatores associados à recorrência e transformado maligna dos pólipos gástricos hiperplásicos (PGH). MÉTODOS: Estudo de coorte retrospectivo unicèntrico incluindo consecutivamente doentes com PGH submetidos a ressedo endoscópica entre janeiro de 2009 e junho de 2020. Efetuada análise das características demográficas, endoscópicas e anatomopatológicas através dos registos clínicos eletrónicos. SUMARIOS DOS RESULTADOS: Incluídos 195 doentes género feminino: 56%, idade mediana: 67 (35­87) anos. Os pólipos apresentavam tamanho mediano de 10 (3­50) mm, 61.5% (n = 120) eram sésseis, 61% (n = 119) apresentavam localização antral e 36% (n = 71) tinham lesões síncronas. A frequência de recorrência foi 23% (n = 26). Na análise multivariada, apenas a localização no antro se associou significativamente a recorrência odds ratio (OR): 3.0; intervalo de confiança (IC) 95%: 1.1­8.1). Em 5.1% (n = 10) dos casos verificou-se transformação neoplásica, correspondendo a 5 casos de displasia de baixo grau, 4 casos de displasia de alto grau e 1 caso de carcinoma. Na análise multivariada, dimensão superior a 25 mm (OR: 84; IC95%: 7.4­954), presença de metaplasia (OR: 7.6; IC95%: 1.0­55) e displasia (OR: 86; IC95%: 10­741) na mucosa adjacente associaram-se a transformação neoplásica. A recorrência não se associou a transformação neoplásica (OR: 1.1; IC95%: 0.2­5.9). DISCUSSÃO/CONCLUSÃO: Estes resultados corroboraram os riscos de recorrência e transformado neoplásica associados aos PGH. A localização antral foi preditor de recorrência. O risco de transformado neoplásica foi superior em lesões maiores e coexistência de metaplasia e displasia na mucosa adjacente. Poderá justificar-se uma estratégia de vigilancia mais frequente nestes subgrupos.

The Role of Statins on Helicobacter pylori Eradication: Results from the European Registry on the Management of H. pylori (Hp-EuReg).

Statins could increase the effectiveness of Helicobacter pylori eradication therapies due to their anti-inflammatory effect. The aim of this study was to analyze the impact of this therapeutic association in real life. This is a multicenter, prospective, non-interventional study aimed at evaluating the management of H. pylori by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap from 2013 to 2020. The association between statin use and H. pylori eradication effectiveness was evaluated through multivariate analysis. Overall, 9988 and 705 patients received empirical and culture-guided treatment, respectively. Overall, statin use was associated with higher effectiveness in the empirical group (OR = 1.3; 95%CI = 1.1-1.5), but no association was found with first-line treatment effectiveness (N = 7738); as an exception, statin use was specifically associated with lower effectiveness of standard triple therapy (OR = 0.76; 95%CI = 0.59-0.99). In the rescue therapy empirical group (N = 2228), statins were associated with higher overall effectiveness (OR = 1.9; 95%CI = 1.4-2.6). However, sub-analyses by treatment schemes only confirmed this association for the single-capsule bismuth quadruple therapy (OR = 2.8; 95%CI = 1.3-5.7). No consistent association was found between statin use and H. pylori therapy effectiveness. Therefore, the addition of statins to the usual H. pylori treatment cannot be currently recommended to improve cure rates.

Adverse Event Profile During the Treatment of Helicobacter pylori: A Real-World Experience of 22,000 Patients From the European Registry on H. pylori Management (Hp-EuReg).

INTRODUCTION: The safety of Helicobacter pylori eradication treatments and to what extent adverse events (AEs) influence therapeutic compliance in clinical practice are hardly known. Our aim was to assess the frequency, type, intensity, and duration of AEs, and their impact on compliance, for the most frequently used treatments in the "European Registry on Helicobacter pylori management." METHODS: Systematic prospective noninterventional registry of the clinical practice of European gastroenterologists (27 countries, 300 investigators) on the management of H. pylori infection in routine clinical practice. All prescribed eradication treatments and their corresponding safety profile were recorded. AEs were classified depending on the intensity of symptoms as mild/moderate/severe and as serious AEs. All data were subject to quality control. RESULTS: The different treatments prescribed to 22,492 patients caused at least 1 AE in 23% of the cases; the classic bismuth-based quadruple therapy was the worst tolerated (37% of AEs). Taste disturbance (7%), diarrhea (7%), nausea (6%), and abdominal pain (3%) were the most frequent AEs. The majority of AEs were mild (57%), 6% were severe, and only 0.08% were serious, with an average duration of 7 days. The treatment compliance rate was 97%. Only 1.3% of the patients discontinued treatment due to AEs. Longer treatment durations were significantly associated with a higher incidence of AEs in standard triple, concomitant, bismuth quadruple, and levofloxacin triple or quadruple therapies. DISCUSSION: Helicobacter pylori eradication treatment frequently induces AEs, although they are usually mild and of limited duration. Their appearance does not interfere significantly with treatment compliance.

Overcoming the barriers to dissemination and implementation of quality measures for gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) and United European Gastroenterology (UEG) position statement.

The European Society of Gastrointestinal Endoscopy (ESGE) has developed performance measures and established a framework for quality assessment for gastrointestinal endoscopy in Europe. Most national societies actively undertake initiatives to implement and explicitly endorse these quality indicators. Given this, ESGE proposes that, at a national level, strong leadership should exist to disseminate and implement quality parameters. Thus, understanding the potential barriers that may vary locally is of paramount importance. ESGE suggests that each national society should prioritize quality and standards of care in gastrointestinal endoscopy in their activities and should survey/understand which measures are a local priority to their members and make measuring quality intrinsic to daily endoscopy practice.

European Registry on Helicobacter pylori management: Single-capsule bismuth quadruple therapy is effective in real-world clinical practice.

BACKGROUND: There has been resurgence in the use of bismuth quadruple therapy (proton pump inhibitor, bismuth, tetracycline and metronidazole) for treating Helicobacter pylori infection thanks to a three-in-one single-capsule formulation. OBJECTIVE: To evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy. METHODS: Data were collected in a multicentre, prospective registry of the clinical practice of gastroenterologists on the management of H. pylori infection, where patients were registered at the Asociación Española de Gastroenterologia REDCap database on an electronic case report form until January 2020. Effectiveness by modified intention-to-treat and per-protocol as well as multivariable analysis were performed. Independent factors evaluated were: age, gender, indication, compliance, proton pump inhibitor dose and treatment line. RESULTS: Finally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e., three capsules every 6 h for 10 days). The majority of these patients were naive (64%), with an average age of 50 years, 64% women and 16% with peptic ulcer. An overall modified intention-to-treat effectiveness of 92% was achieved. Eradication was over 90% in first-line treatment (95% modified intention-to-treat, n = 1166), and this was maintained as a rescue therapy, both in second (89% modified intention-to-treat, n = 375) and subsequent lines of therapy (third to sixth line: 92% modified intention-to-treat, n = 236). Compliance was the factor most closely associated with treatment effectiveness. Adverse events were generally mild to moderate, and 3% of patients reported a severe adverse event, leading to discontinuation of treatment in 1.7% of cases. CONCLUSIONS: Single-capsule bismuth quadruple therapy achieved H. pylori eradication in approximately 90% of patients in real-world clinical practice, both as a first-line and rescue treatment, with good compliance and a favourable safety profile.

Procalcitonin in preterm rupture of membranes: a systematic review and meta-analysis.

PURPOSE: Early detection of infection is of supreme importance in obstetrics; however, during pregnancy it is not reliably predicted by standard laboratory tests. We aimed to determine if procalcitonin (PCT) is a reliable predictor of chorioamnionitis (CA) in women with premature rupture of membranes (PPROM). METHODS: An electronic search of Scopus, ISI, Medline, Embase, ClinicalTrials.gov and the Cochrane Library databases was performed using specified key words. We examined all English and French reports on PCT measurement after admission for PPROM and considered: human studies published between 1990 and 2019; observational studies; and randomized controlled trials. A protocol was determined previously, registered at PROSPERO as CRD42019145464. The eligibility was independently assessed by two researchers and literature search yielded 590 studies; after revision of the titles and abstracts, 46 articles were identified as potentially eligible; eight studies were included in the meta-analysis. Primary data synthesis was performed in Review Manager Version 5.3 and average sensitivity and specificity was calculated using Midas, Stata. RESULTS: From the eight studies included, 335 participants with PPROM were enrolled. Our meta-analysis disclosed that PCT has a poor sensitivity (0.50; 95% CI 0.28-0.73) and a modest specificity (0.72; 95% CI 0.51-0.87) in diagnosing CA. C-reactive protein (CRP) not only has better sensitivity (0.71; 95% CI 0.53-0.84), but also better specificity (0.75; 95% CI 0.55-0.88), compared with the other inflammatory parameters analyzed. Procalcitonin does not seems to be better than CRP in preterm rupture of membranes for chorioamnionitis diagnosis.