Effectiveness and safety of azathioprine for inflammatory pouch disorders: results from the RESERVO study of GETECCU.

Background: The usefulness of thiopurines has been poorly explored in pouchitis and other pouch disorders. Objective: To evaluate the effectiveness and safety of azathioprine as maintenance therapy in inflammatory pouch disorders. Design: This was a retrospective and multicentre study. Methods: We included patients diagnosed with inflammatory pouch disorders treated with azathioprine in monotherapy. Effectiveness was evaluated at 1 year and in the long term based on normalization of stool frequency, absence of pain, faecal urgency or fistula discharge (clinical remission), or any improvement in these symptoms (clinical response). Endoscopic response was evaluated using the Pouchitis Disease Activity Index (PDAI). Results: In all, 63 patients were included [54% males; median age, 49 (28-77) years]. The therapy was used to treat pouchitis (n = 37) or Crohn's disease of the pouch (n = 26). The rate of clinical response, remission and non-response at 12 months were 52%, 30% and 18%, respectively. After a median follow-up of 23 months (interquartile range 11-55), 19 patients (30%) were in clinical remission, and 45 (66%) stopped therapy. Endoscopic changes were evaluated in 19 cases. PDAI score decreased from 3 (range 2-4) to 1 (range 0-3). In all, 21 patients (33%) presented adverse events and 16 (25%) needed to stop therapy. Conclusion: Azathioprine may be effective in the long term for the treatment of inflammatory pouch disorders and could be included as a therapeutic option.

Evaluation of genetic variants associated with the risk of thiopurine-related pancreatitis: a case control study from ENEIDA registry.

BACKGROUND: Risk factors for developing pancreatitis due to thiopurines in patients with inflammatory bowel disease (IBD) are not clearly identified. AIM: Our aim was to evaluate the predictive pharmacogenetic risk of pancreatitis in IBD patients treated with thiopurines. METHODS: We conducted an observational pharmacogenetic study of acute pancreatitis events in a cohort study of IBD patients treated with thiopurines from the prospectively maintained ENEIDA registry biobank of GETECCU. Samples were obtained and the CASR, CEL, CFTR, CDLN2, CTRC, SPINK1, CPA1, and PRSS1 genes, selected based on their known association with pancreatitis, were fully sequenced. RESULTS: Ninety-five cases and 105 controls were enrolled, 57% were women. Median age at pancreatitis diagnosis was 39 years. We identified 81 benign variants (50 in cases and 67 in controls) and a total of 35 distinct rare pathogenic and unknown significance variants (10 in CEL, 21 in CFTR, 1 in CDLN2, and 3 in CPA1). None of the cases or controls carried pancreatitis-predisposing variants within the CASR, CPA1, PRSS1, and SPINK1 genes, nor a pathogenic CFTR mutation. Four different variants of unknown significance were detected in the CDLN and CPA1 genes; one of them was in the CDLN gene in a single patient with pancreatitis, and 3 in the CPA1 gene in 5 controls. After the analysis of the variants detected, no significant differences were observed between cases and controls. CONCLUSION: In patients with IBD, genes known to cause pancreatitis seem not to be involved in thiopurine-related pancreatitis onset.

Influence of social support and stressful life events on adherence to colorectal cancer screening using faecal occult blood test in Spanish medium risk population.

INTRODUCTION: Colorectal cancer (CRC) is the second cause of cancer-related deaths worldwide. Five-year survival rate in Spain is 57%. The most important prognostic factor is the stage of the tumor at the diagnosis. CRC can be early diagnosed, but the adherence to screening programs is low (<50%). This study aims to ascertain the influence of social support and stressful life events on the adherence to the population screening of CRC with fecal occult blood test in Spanish average risk population. METHODS: Multicenter case-control study. We conducted a simple random sampling among individuals invited to participate in the colorectal cancer screening program. We analyzed epidemiological and social variables associated with lifestyle and behavioral factors. We performed a descriptive and a bivariant analyses and a logistic regression analysis. RESULTS: Four hundred and eight patients (237 cases and 171 controls) were included. Multivariant analyses showed independent association between higher adherence to the screening program and older age (OR: 1.06; 95% CI: 1.01-1.10), stable partner (OR: 1.77, 95% CI: 1.08-2.89) and wide social network (OR: 1.68; 95% CI: 1.07-2.66). Otherwise, lower adherence was associated to perceiving barriers to participate in the program (OR: 0.92; 95% CI: 0.88-0.96). We find a statistically significant association between lower adherence and high impact stressful life events in the bivariant analyses, and the tendency was maintained (OR: 0.63, 95% CI: 0.37-1.08) in the multivariant. CONCLUSION: Social variables decisively influence the adherence to colorectal cancer screening. The implementation of social interventions that improve social support, reduce impact of stressful life events and the design of screening programs that decrease the perceived barriers, will contribute to increase the participation on these programs. Secondary, the colorectal cancer diagnosis will be made in early-stages with the consequent mortality reduction.

Effectiveness of Helicobacter pylori Treatments According to Antibiotic Resistance.

INTRODUCTION: Antibiotic resistance is one of the main factors that determine the efficacy of treatments to eradicate Helicobacter pylori infection. Our aim was to evaluate the effectiveness of first-line and rescue treatments against H. pylori in Europe according to antibiotics resistance. METHODS: Prospective, multicenter, international registry on the management of H. pylori (European Registry on H. pylori Management). All infected and culture-diagnosed adult patients registered in the Spanish Association of Gastroenterology-Research Electronic Data Capture from 2013 to 2021 were included. RESULTS: A total of 2,852 naive patients with culture results were analyzed. Resistance to clarithromycin, metronidazole, and quinolones was 22%, 27%, and 18%, respectively. The most effective treatment, regardless of resistance, were the 3-in-1 single capsule with bismuth, metronidazole, and tetracycline (91%) and the quadruple with bismuth, offering optimal cure rates even in the presence of bacterial resistance to clarithromycin or metronidazole. The concomitant regimen with tinidazole achieved an eradication rate of 99% (90/91) vs 84% (90/107) with metronidazole. Triple schedules, sequential, or concomitant regimen with metronidazole did not achieve optimal results. A total of 1,118 non-naive patients were analyzed. Resistance to clarithromycin, metronidazole, and quinolones was 49%, 41%, and 24%, respectively. The 3-in-1 single capsule (87%) and the triple therapy with levofloxacin (85%) were the only ones that provided encouraging results. DISCUSSION: In regions where the antibiotic resistance rate of H. pylori is high, eradication treatment with the 3-in-1 single capsule, the quadruple with bismuth, and concomitant with tinidazole are the best options in naive patients. In non-naive patients, the 3-in-1 single capsule and the triple therapy with levofloxacin provided encouraging results.

Helicobacter pylori Diagnostic Tests Used in Europe: Results of over 34,000 Patients from the European Registry on Helicobacter pylori Management.

BACKGROUND AND AIMS: Several methods are available to diagnose Helicobacter pylori infection. Our objective was to evaluate the tests used for both the initial diagnosis and the confirmation of eradication after treatment in Europe. METHODS: The European Registry on the management of Helicobacter pylori infection is an international, multicentre, prospective, non-interventional registry aiming to evaluate the management of Helicobacter pylori-infected patients in Europe. Countries with at least 100 cases registered from June 2013 to April 2021, and with a validated diagnostic method were analysed. Data were quality reviewed. RESULTS: A total of 34,920 adult patients from 20 countries were included (mean age 51 years; 61% women). To establish the initial diagnosis, invasive tests were performed in 19,801 (71%) patients, non-invasive in 11,369 (41%), and both in 3437 (12%). The most frequent were histology (n = 11,885; 43%), a rapid urease test (n = 10,636; 38%) and an urea breath test (n = 7577; 27%). According to the age, invasive tests were indicated in 11,179 (77%) ≥50 years, and in 8603 (65%) <50 years. Depending on the country, the use of invasive tests ranged from 29-99% in <50 years to 60-99% in ≥50. Most of the tests used to confirm eradication were non-invasive (n = 32,540; 93%), with the urea breath test being the most frequent (n = 32,540; 78%). In 2983 (9%) post-treatment tests, histology (n = 1887; 5%) or a rapid urease test (n = 1223; 4%) were performed. CONCLUSION: A great heterogeneity was observed for the initial diagnosis and confirmation of the eradication. The reasons for the apparent lack of adherence to the clinical guidelines should be further explored.

Bismuth quadruple three-in-one single capsule three times a day increases effectiveness compared with the usual four times a day schedule: results from the European Registry on Helicobacter pylori Management (Hp-EuReg).

BACKGROUND: The recommended schedule for single capsule bismuth quadruple therapy (scBQT, Pylera) includes a proton pump inhibitor (PPI) two times a day and three scBQT capsules four times a day. Four times a day treatments are inconvenient and reduce adherence. In contrast, adherence improves with three times a day schedules. In clinical practice, many gastroenterologists use four capsule scBQT three times a day. However, the effectiveness and safety of this latter approach remain uncertain. AIM: To assess the effectiveness and safety of scBQT administered three times a day in the patients included in the European Registry on Helicobacter pylori Management (Hp-EuReg). METHODS: All Spanish adult patients registered in the Asociación Española de Gastroenterología Research Electronic Data Capture (REDCap) database from June 2013 to March 2021 receiving 10-day scBQT were analysed. Modified intention-to-treat effectiveness, adherence and the safety of scBQT given three times a day were calculated and compared with the four times a day schedule. A multivariate analysis was performed to determine independent factors predicting cure of the infection. RESULTS: Of the 3712 cases, 2516 (68%) were four times a day and 1196 (32%) three times a day. Mean age was 51 years, 63% were women and 15% had a peptic ulcer. The three times a day schedule showed significantly better overall cure rates than four times a day (1047/1112, 94%; 95% CI 92.7 to 95.6 vs 2207/2423, 91%; 95% CI 89.9 to 92.2, respectively, p=0.002). Adherence and safety data were similar for both regimens. In the multivariate analysis, three times a day dosage, first-line therapy, use of standard or high-dose PPIs and adherence over 90% were significantly associated with cure of the infection. CONCLUSIONS: ScBQT prescribed three times a day was more effective than the traditional four times a day schedule. No differences were observed in treatment adherence or safety.

Differences between childhood- and adulthood-onset eosinophilic esophagitis: An analysis from the EoE connect registry.

BACKGROUND: Direct comparisons of childhood- and adulthood-onset eosinophilic esophagitis (EoE) are scarce. AIM: To compare disease characteristics, endoscopic and histological features, allergic concomitances and therapeutic choices across ages. METHODS: Cross-sectional analysis of the EoE CONNECT registry. RESULTS: The adulthood-onset cohort (those diagnosed at ≥18y) comprised 1044 patients and the childhood-onset cohort (patients diagnosed at <18 y), 254. Vomiting, nausea, chest and abdominal pain, weight loss, slow eating and food aversion were significantly more frequent in children; dysphagia, food bolus impaction and heartburn predominated in adults. A family history of EoE was present in 16% of pediatric and 8.2% of adult patients (p<0.001). Concomitant atopic diseases did not vary across ages. Median±IQR diagnostic delay (years) from symptom onset was higher in adults (2.7 ± 6.1) than in children (1 ± 2.1; p<0.001). Esophageal strictures and rings predominated in adults (p<0.001), who underwent esophageal dilation more commonly (p = 0.011). Inflammatory EoE phenotypes were more common in children (p = 0.001), who also presented higher eosinophil counts in biopsies (p = 0.015) and EREFS scores (p = 0.017). Despite PPI predominating as initial therapy in all cohorts, dietary therapy and swallowed topical corticosteroids were more frequently prescribed in children (p<0.001). CONCLUSIONS: Childhood-onset EoE has differential characteristics compared with adulthood-onset, but similar response to treatment.

Perceived barriers and benefits in the participation in faecal occult blood test colorectal cancer screening programme.

BACKGROUND: Colorectal cancer is the second cancer-related cause of death in the world. Tumour stage at diagnosis is the principal prognosis factor of survival. However, the participation in the programme is around 50%. The aim of the study was to identify the benefits and barriers perceived by the population when participating in a colorectal cancer screening programme with faecal occult blood test. METHODS: We carried out a cases-controls study with 408 participants. We analyzed epidemiological and social variables associated with lifestyle and behavioural factors based in the Health Belief Model. We conducted a descriptive analysis, and identified variables associated to adherence by a logistic regression. RESULTS: Variables independently associated with the participation in a colorectal cancer screening programme were age (OR 1.06; 95% CI: 1.01-1.11), having a stable partner (OR 1.96; 95% CI: 1.20-3.18), the level of education (OR 1.59; 95% CI: 1.02-2.47) and two of the barriers to participate in the faecal occult blood test screening: "you don't know how to do one" (OR=0.46; 95% CI: 0.23-0.93) and "it is not that important right now" (OR=0.43; 95% CI: 0.24-0.78). CONCLUSION: The existing barriers for screening with faecal occult blood test are the best factor predicting. This is relevant when designing the intervention programmes, as they should focus on reducing perceived barriers to increase the participation in colorectal cancer screening, thereby reducing colorectal cancer mortality.

Inadequate social support decreases survival in decompensated liver cirrhosis patients.

INTRODUCTION: Inadequate social support is associated with higher mortality both in the general population and in patients with chronic diseases. There are no studies that have described social support in liver cirrhosis and its impact on prognosis. OBJECTIVES: To analyze the impact social support has in the survival of patients with decompensated cirrhosis. METHODS: Prospective multicentric cohort study (2016-2019). Patients with decompensated liver cirrhosis were included. Epidemiological, clinical and social variables were collected, using the validated Medical Outcomes Study Social Support Survey, with a 12-month follow-up. RESULTS: A total of 127 patients were included, of which 79.5% were men. The most common etiology of cirrhosis was alcohol (74.8%), mean age was 60 years (SD 10.29), mean MELD was 15.6 (SD 6.3) and most of the patients had a Child-Pugh B (53.5%) or C (35.4%). In the assessment of social support, we observed that most of the patients (92.2%) had adequate global support. At the end of the follow-up (median 314 days), 70.1% of the patients survived. The 1-year survival rate in patients with inadequate global social support was 30%, compared to 73.5% in the presence of social support. In multivariate Cox regression analysis, inadequate social support predicted survival with an adjusted HR of 5.5 (95% CI 2,3-13,4) independently of MELD (HR 1.1, 95% CI 1-1.2), age (HR 1, 95% CI 1-1.1) and hepatocarcinoma (HR 10.6, 95% CI 4.1-27.4). CONCLUSION: Adequate social support improves survival in liver cirrhosis, independently of clinical variables. Social intervention strategies should be considered for their management.

International on-line questionnaire about severe lower gastrointestinal bleeding management: Do we have it clear? / Encuesta internacional on-line sobre el manejo de la hemorragia digestiva baja grave. ¿Lo tenemos claro?

BACKGROUND AND AIMS: The diagnostic and therapeutic strategy in severe lower gastrointestinal bleeding (LGIB) varies depending on the patient's clinical situation. Actual clinical practice guidelines propose different management strategies. We aim to know the attitude of the gastroenterologists from different hospitalary centers in the management of this entity. METHODS: Descriptive and observational study using an on-line questionnaire, addressed to gastroenterologists in Spain and Latin America, in December 2021. RESULTS: We included 281 anonymous questionnaires of gastroenterologists from Spain and Latin America. Diagnostic and therapeutic management of severe LGIB was heterogeneous among the participants. Regarding to the first diagnostic modalities they showed variability between performing computed tomography angiography (CTA) (44.5%), gastroscopy (33.1%), colonoscopy (20.6%) and arteriography (1.1%). The therapeutic attitude after a positive CTA mostly varied between performing arteriography (38.1%) and colonoscopy (44.1%). If negative CTA, in the majority of cases a gastroscopy was performed. If the patient needed intensive critical unit (ICU) care and to undergo colonoscopy, most participants performed an urgent colonoscopy (<24h) (31% always, 43.4% in most cases); while if the patient did not require ICU admission this percentage was lower (10% always, 33.8% in most cases). The 40.9% of the participants admitted having doubts about the management of this patients and the 98.2% considered the need for a creation of an action protocol. CONCLUSIONS: There is a high interhospitalary variability on the management of severe lower gastrointestinal bleeding among gastroenterologists. It is necessary to unify the diagnostic and therapeutic management of this pathology.

Accurate and timely diagnosis of Eosinophilic Esophagitis improves over time in Europe. An analysis of the EoE CONNECT Registry.

BACKGROUND: Poor adherence to clinical practice guidelines for eosinophilic esophagitis (EoE) has been described and the diagnostic delay of the disease continues to be unacceptable in many settings. OBJECTIVE: To analyze the impact of improved knowledge provided by the successive international clinical practice guidelines on reducing diagnostic delay and improving the diagnostic process for European patients with EoE. METHODS: Cross-sectional analysis of the EoE CONNECT registry based on clinical practice. Time periods defined by the publication dates of four major sets of guidelines over 10 years were considered. Patients were grouped per time period according to date of symptom onset. RESULTS: Data from 1,132 patients was analyzed and median (IQR) diagnostic delay in the whole series was 2.1 (0.7-6.2) years. This gradually decreased over time with subsequent release of new guidelines (p < 0.001), from 12.7 years up to 2007 to 0.7 years after 2017. The proportion of patients with stricturing of mixed phenotypes at the point of EoE diagnosis also decreased over time (41.3% vs. 16%; p < 0.001), as did EREFS scores. The fibrotic sub-score decreased from a median (IQR) of 2 (1-2) to 0 (0-1) when patients whose symptoms started up to 2007 and after 2017 were compared (p < 0.001). In parallel, symptoms measured with the Dysphagia Symptoms Score reduced significantly when patients with symptoms starting before 2007 and after 2012 were compared. A reduction in the number of endoscopies patients underwent before the one that achieved an EoE diagnosis, and the use of allergy testing as part of the diagnostic workout of EoE, also reduced significantly over time (p = 0.010 and p < 0.001, respectively). CONCLUSION: The diagnostic work-up of EoE patients improved substantially over time at the European sites contributing to EoE CONNECT, with a dramatic reduction in diagnostic delay.

EoE CONNECT, the European Registry of Clinical, Environmental, and Genetic Determinants in Eosinophilic Esophagitis: rationale, design, and study protocol of a large-scale epidemiological study in Europe.

BACKGROUND: The growing prevalence of eosinophilic esophagitis (EoE) represents a considerable burden to patients and health care systems. Optimizing cost-effective management and identifying mechanisms for disease onset and progression are required. However, the paucity of large patient cohorts and heterogeneity of practice hinder the defining of optimal management of EoE. METHODS: EoE CONNECT is an ongoing, prospective registry study initiated in 2016 and currently managed by EUREOS, the European Consortium for Eosinophilic Diseases of the Gastrointestinal Tract. Patients are managed and treated by their responsible specialists independently. Data recorded using a web-based system include demographic and clinical variables; patient allergies; environmental, intrapartum, and early life exposures; and family background. Symptoms are structurally assessed at every visit; endoscopic features and histological findings are recorded for each examination. Prospective treatment data are registered sequentially, with new sequences created each time a different treatment (active principle, formulation, or dose) is administered to a patient. EoE CONNECT database is actively monitored to ensure the highest data accuracy and the highest scientific and ethical standards. RESULTS: EoE CONNECT is currently being conducted at 39 centers in Europe and enrolls patients of all ages with EoE. In its aim to increase knowledge, to date EoE CONNECT has provided evidence on the effectiveness of first- and second-line therapies for EoE in clinical practice, the ability of proton pump inhibitors to induce disease remission, and factors associated with improved response. Drug effects to reverse fibrous remodeling and endoscopic features of fibrosis in EoE have also been assessed. CONCLUSION: This prospective registry study will provide important information on the epidemiological and clinical aspects of EoE and evidence as to the real-world and long-term effectiveness and safety of therapy. These data will potentially be a vital benchmark for planning future EoE health care services in Europe.

Rawl's questionnaire spanish validation for colorectal cancer screening with faecal occult blood testing. / Validación al castellano del cuestionario Rawl de cribado de cáncer colorrectal con sangre oculta en heces.

INTRODUCTION: Colorectal cancer 5-years-survival is 57%, partway due to a low rate of participation in screening programmes. Instruments analyzing causes of low adherence are needed. OBJECTIVE: To evaluate the validity and internal consistency of the Spanish version of Rawl's Questionnaire for the screening of colorectal cancer by faecal occult blood testing. TYPE OF STUDY: Questionnaire validation methodology. LOCATION: Three Primary Care Centres in Valencia. VARIABLES: Age, sex, civil status, educational level, social class, smoking, alcohol consumption, body mass index, personal and family history of cancer. RESULTS: We analyzed 408 individuals (237 cases and 171 controls). Mean age was 59.45 years (SD 5.17). Internal consistency of all variables reached a Cronbach's alfa of 0.796. The Cronbach's alfa benefit dimension of the screening was 0.871 and for the barrier dimension of the screening it was 0.817. Intraclass correlation coefficients of the test-retest for the benefit dimension of the screening was 0.809 (CI 95% 0.606-0.913) and 0.499 (CI 95% 0.126-0.750) for the barrier dimension. CONCLUSION: The Spanish version of Rawl's Questionnaire is valid, reliable and reproducible, so we have this validated instrument with which to identify barriers and benefits in a colorectal screening programme in Spain.

Predictive Value of Carcinoembryonic Antigen in Symptomatic Patients without Colorectal Cancer: A Post-Hoc Analysis within the COLONPREDICT Cohort.

We aimed to assess the risk of cancer in patients with abdominal symptoms after a complete colonoscopy without colorectal cancer (CRC), according to the carcinoembryonic antigen (CEA) concentration, as well as its diagnostic accuracy. For this purpose, we performed a post-hoc analysis within a cohort of 1431 patients from the COLONPREDICT study, prospectively designed to assess the fecal immunochemical test accuracy in detecting CRC. Over 36.5 ± 8.4 months, cancer was detected in 115 (8%) patients. Patients with CEA values higher than 3 ng/mL revealed an increased risk of cancer (HR 2.0, 95% CI 1.3-3.1), CRC (HR 4.4, 95% CI 1.1-17.7) and non-gastrointestinal cancer (HR 1.7, 95% CI 1.0-2.8). A new malignancy was detected in 51 (3.6%) patients during the first year and three variables were independently associated: anemia (OR 2.8, 95% CI 1.3-5.8), rectal bleeding (OR 0.3, 95% CI 0.1-0.7) and CEA level >3 ng/mL (OR 3.4, 95% CI 1.7-7.1). However, CEA was increased only in 31.8% (95% CI, 16.4-52.7%) and 50% (95% CI, 25.4-74.6%) of patients with and without anemia, respectively, who would be diagnosed with cancer during the first year of follow-up. On the basis of this information, CEA should not be used to assist in the triage of patients presenting with lower bowel symptoms who have recently been ruled out a CRC.

Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients.

Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. Observational multicentre study including adult patients with ulcerative colitis treated with golimumab and with at least twelve months of follow-up. We included 190 patients, 105 (55.26%) naive to anti-TNF, with mean disease duration of 9.32 ± 8.09 years. Probability of persistence was 63%, 46%, 39% and 27% at 1, 2, 3 and 4 years, respectively. Persistence was lower in patients with primary failure to previous anti-TNF. Eighty-two (43.16%) patients needed dose intensification during follow-up, with a mean time until intensification of 8.03 ± 8.64 months. Dose intensification and lower disease duration predicted higher persistence with golimumab (p = 0.037 and p = 0.008, respectively). During a follow-up of 17.25 ± 15.83 months, 32 (16.5%) patients needed hospitalisation and 11 (6%) underwent colectomy. No unexpected adverse events were reported. Golimumab has demonstrated good persistence and safety profile for long treatment in ulcerative colitis patients.

Non-guided self-learning program for high-proficiency optical diagnosis of diminutive and small colorectal lesions: A single-endoscopist pilot study.

BACKGROUND: The implementation of optical diagnosis (OD) of diminutive colorectal lesions in clinical practice has been hampered by differences in performance between community and academic settings. One possible cause is the lack of a standardized learning tool. Since the factors related to better learning are not well described, strong evidence upon which a consistent learning tool could be designed is lacking. We hypothesized that a self-designed learning program may be enough to achieve competency in OD of diminutive lesions of the colon. AIM: To assess the accuracy of OD of diminutive lesions in real colonoscopies after application of a self-administered learning program. METHODS: This was a single-endoscopist prospective pilot study, in which an experienced endoscopist followed a self-designed, self-administered learning program in OD of colorectal lesions. An assessment phase divided in two halves with a 6-mo period in between without performance of OD was developed in a population-based colorectal cancer screening program. The accomplishment of the Preservation and Incorporation of Valuable Endoscopic Innovations criteria and performance measures were calculated overall and in the two halves of the assessment phase, assessing their response to the 6-mo stopping period. The evolution of performance through blocks of 50 lesions was also assessed. RESULTS: Overall, 152 patients and 522 lesions (≤ 5 mm: 399, and 6-9 mm: 123) were included. The negative predictive value for the OD of adenoma in rectosigmoid lesions diagnosed with high confidence was 91.7% [95% confidence interval (CI): 87.3-96.6]. The proportion of agreement on surveillance interval between OD and pathological diagnosis was higher than 95%. Overall accuracy for diminutive lesions diagnosed with high confidence was 89.5% (95%CI: 86.3-92.7). The overall accuracy of OD was similar in the two halves of the assessment phase [90.1 (95%CI: 85.6-94.7) vs 88.2 (95%CI: 87.9-95.9)]. All the other performance parameters were also equivalent, except for specificity. Specificity, negative predictive value and accuracy were the parameters most affected by the stopping period between the two halves. Upon analyzing trends on blocks of 50 lesions, an improvement on sensitivity (P = 0.02) was detected only in the first half and an improvement on accuracy (P = 0.01) was detected only in the second half. CONCLUSION: A self-administered learning program is sufficient to achieve expert-level OD. To maintain performance, continuous practice is needed, with a refresher course following any long non-practice period.

A long-term prospective study of the efficacy and safety of endoscopic septotomy using the LigaSure® system for the treatment of Zenker's diverticulum.

BACKGROUND AND OBJECTIVES: endoscopic septotomy of the cricopharyngeal muscle (ESCM) is a technique used for the treatment of Zenker's diverticulum (ZD). The experience with computerized vascular sealing systems (LigaSure® type) is limited. The objective of this study was to evaluate the efficacy and safety of ESCM using LigaSure®. METHODS: this was a long-term prospective study of 18 patients with ZD, who were referred to our hospital due to ESCM between 2010 and 2016. The severity of the symptoms was determined using the Dakkak-Bennett validated scale for dysphagia and the rest with numerical scales. The rates of relapse and retreatment were evaluated. RESULTS: ESCM with LigaSure® was performed in 17 cases, one case was excluded due to technical difficulties. The median age was 72 years and regurgitation, dysphagia and respiratory symptoms were found in 100%, 89% and 56% of cases, respectively. The median size of the diverticulum was 28 mm (20-60 mm). The median time of the procedure was 35 minutes (25-45 minutes). There were four complications, two hemorrhages and two perforations. The median follow-up was 13 months (range: 12-82 months). Clinical improvements were observed for all symptoms and were maintained 12 months after treatment (p < 0.05). There was no relapse during follow-up in 13 patients. A complete section was not achieved and clinical relapse occurred after a median time of seven months that required retreatment in the remaining patients. CONCLUSIONS: ESCM with LigaSure® may be a safe and effective technique in long-term follow-up situations, with low rates of relapse.