The interaction of patients' physical status and time to endoscopy on mortality risk in patients with upper gastrointestinal bleeding: A national prospective cohort study.

BACKGROUND AND AIM: The correct time to perform an upper endoscopy is decisive in acutely GI bleeding patients. However, patients' physical status may affect mortality. We speculated that the physical status and procedural time could be the principal factors accountable for death-risk. The primary aim was to verify the interaction between physical status and time to endoscopy on mortality; the secondary aim was to verify the interaction of the physical status and time to endoscopy on the length of stay (LOS). METHODS: Consecutive patients admitted to 50 Italian hospitals were included. Clinical and endoscopic data were recorded. A multiple logistic regression analysis was performed and the interaction of adjusted clinical physical status and time to endoscopy on mortality was calculated. RESULTS: Complete data were available for 3.190 patients. The time frames did not interfere with outcomes but influenced LOS. Conversely, the ASA score correlated with mortality, LOS, need for transfusions and rebleeding risk. CONCLUSION: Endoscopy time should be tailored to the patient's physical. In our experience, ASA 1-2-3 patients can be safely submitted to endoscopy to reduce the LOS; on the contrary, keen attention should be paid to ASA4 patients, following the 'not too early-not too late' rule (12-24 h from admission).

Upper Gastrointestinal Endoscopy Quality in Italy: A Nationwide Study.

BACKGROUND AND AIMS: International guidelines advise improving esophagogastroduodenoscopy (EGD) quality in Western countries, where gastric cancer is still diagnosed in advanced stages. This nationwide study investigated some indicators for the quality of EGD performed in endoscopic centers in Italy. METHODS: Clinical, endoscopic, and procedural data of consecutive EGDs performed in one month in the participating centers were reviewed and collected in a specific database. Some quality indicators before and during endoscopic procedures were evaluated. RESULTS: A total of 3,219 EGDs performed by 172 endoscopists in 28 centers were reviewed. Data found that some relevant information (family history for GI cancer, smoking habit, use of proton pump inhibitors) were not collected before endoscopy in 58.5-80.7% of patients. Pre-endoscopic preparation for gastric cleaning was routinely performed in only 2 (7.1%) centers. Regarding the procedure, sedation was not performed in 17.6% of patients, and virtual chromoendoscopy was frequently (>75%) used in only one (3.6%) center. An adequate sampling of the gastric mucosa (i.e., antral and gastric body specimens) was heterogeneously performed, and it was routinely performed only by 23% of endoscopists, and in 14.3% centers. CONCLUSIONS: Our analysis showed that the quality of EGD performed in clinical practice in Italy deserves to be urgently improved in different aspects.

Defining Time in Acute Upper Gastrointestinal Bleeding: When Should We Start the Clock?

INTRODUCTION: The execution of upper endoscopy at the proper time is key to correctly managing patients with upper gastrointestinal bleeding (UGIB). Nonetheless, the definition of "time" for endoscopic examinations in UGIB patients is imprecise. The primary aim of this study was to verify whether the different definitions of "time" (i.e., the symptoms-to-endoscopy and presentation-to-endoscopy timeframes) impact mortality. The secondary purpose of this study was to evaluate the similarity between the two timeframes. METHODS: A post-hoc analysis was performed on a prospective multicenter cohort study, which included UGIB patients admitted to 50 Italian hospitals. We collected the timings from symptoms and presentation to endoscopy, together with other demographic, organizational and clinical data and outcomes. RESULTS: Out of the 3324 patients in the cohort, complete time data were available for 3166 patients. A significant difference of 9.2 h (p < 0.001) was found between the symptoms-to-endoscopy vs. presentation-to-endoscopy timeframes. The symptoms-to-endoscopy timeframe demonstrated (1) a different death risk profile and (2) a statistically significant improvement in the prediction of mortality risk compared to the presentation-to-endoscopy timeframe (p < 0.0002). The similarity between the two different timeframes was moderate (K = 0.42 ± 0.01; p < 0.001). CONCLUSIONS: The symptoms-to-endoscopy and presentation-to-endoscopy timeframes referred to different timings during the management of upper endoscopy in bleeding patients, with the former being more accurate in correctly identifying the mortality risk of these patients. We suggest that further studies be conducted to validate our observations, and, if confirmed, a different definition of time should be adopted in endoscopy.

New insight of human-IgH 3'regulatory regions in immunoglobulins switch.

BACKGROUND: Several studies in animal models have demonstrated the role of the 3' Regulatory Region (3'RR) in the B cell maturation in mammals. In healthy humans, the concentration of each class of circulating immunoglobulins (Igs) has stable but different levels, due to several control mechanisms that also involve a duplicated version of the 3'RR on the chromosome 14 (chr14). The classes' equilibrium can be altered during infections and in other pathological conditions. MATERIAL AND METHODS: We studied the concentrations of IgA, IgM, IgG classes and IgG subclasses in a cohort of 1235 people having immunoglobulin concentrations within normal range to determine the presence of any correlation between the Igs serum concentrations, age and ratio among Ig classes and IgG subclasses in healthy humans. Furthermore, we assessed the concentrations of IgE and the allelic frequency of 3'RR1 hs1.2 enhancer in a group of 115 subjects with high levels of circulating IgE due to acute exacerbation of allergic asthma and in a control group of 118 healthy subjects. RESULTS: In both children and adult subjects, the concentrations of the four IgG subclasses decreased from IgG1 to IgG4. Furthermore, the 3'RR1 enhancer hs1.2 alleles contribute to the control of the IgG subclasses levels, but it does not affect the IgE levels. CONCLUSION: The 3'RR1 controls IgG and IgE through different mechanisms, only in the IgG case involving the hs1.2 alleles. Thus, considering the IgH constant genes loci on the chromosome 14 and the multiple steps of switch that rearrange the whole region, we found that in humans the classes of Igs are modulated by mechanisms involving a complex interaction and transition between 3'RR1 and 3'RR2, also in physiological conditions.

Comparison of assessment tools in acute upper gastrointestinal bleeding: Which one at which time point?

BACKGROUND: Decisions on managing bleeders remain a critical issue due to the high death risk. The Glasgow-Blatchford score (GBS) correctly identifies low-risk patients but none of the existing scores precisely assess the high risk patients. AIMS: To evaluate bleeding scores' prognostic performances in predicting mortality risk. SECONDARY OUTCOMES: To compare the scores in low and high-risk patients and identify the "best performing cut-off" (if different from the standard one) in discriminating survivors from deceased. METHODS: prospective multicenter cohort study including consecutive UGIB patients admitted to 50 Italian hospitals. We collected information to calculate Rockall, PNED, AIMS65, GB, and ABC scores, together with demographic and clinical data, and outcomes. RESULTS: for low-risk patients, the GB and the ABC are the best performing scores; for high-risk patients, all scores showed weak results, with the PNED score having the higher PPV. Searching for the "best performing cut-off", we found different points that determined a relevant numerical gain in terms of patients correctly assessed. CONCLUSIONS: we suggest using the GBS and the ABC score at admission, while the PNED appears to be more useful for high-risk. We also suggest using a new decisional cut-offs that, if validated, may increase the accuracy of current scores.

Improved Survival for Patients With Acute Upper Gastrointestinal Bleeding While on Antithrombotic Therapy: A Multicenter Prospective Cohort Study.

GOALS: Aim of the study was to determine if patients with acute upper gastrointestinal bleeding (AUGIB) while on antithrombotic agents (ATs) are at higher risk for worse outcomes. BACKGROUND: ATs are risk factors of AUGIB, but their impact on clinical outcomes is uncertain. STUDY: Patients with AUGIB (nonvariceal, NV-AUGIB or variceal, V-AUGIB) in 50 Italian hospitals were prospectively enrolled from January 1, 2014 to December 31, 2015. Clinical data, laboratory tests, comorbidities, prognostic scores, received therapies, and outcomes (death, rebleeding, surgery/radiology, transfusions, length of hospitalization) were analyzed. RESULTS: A total of 3324 patients (2764 NV-AUGIB, 83.2% and 560 V-AUGIB, 16.8%) were enrolled, 1399 (42.1%) on ATs. Patients taking ATs were older (75.4 vs. 62.8 y, P <0.001), had higher American Society of Anesthesiologists (ASA), Rockall and Glasgow-Blatchford scores ( P <0.001). At multivariate analysis considering comorbidities, ATs use resulted an independent protective factor against death [odds ratio (OR): 0.63, 95% confidence interval (CI): 0.45-0.87, P =0.006]. Rebleeding (5.5% vs. 5.8%, P =0.71) and need for salvage surgery/radiology (4.2% vs. 4.8%, P =0.41) were similar in the 2 groups. Considering specific ATs, low-dose aspirin was the most powerful factor lowering the death risk (OR: 0.51, 95% CI: 0.33-0.81, P =0.004). While the generic use of AT therapy did not emerge as a statistically significant independent protective factor considering separately NV-AUGIB (OR: 0.80, 95% CI: 0.56-1.13, P =0.21) and V-AUGIB (OR: 0.40, 95% CI: 0.15-1.07, P =0.068), the protective effect of low-dose aspirin was confirmed for NV-AUGIB (OR: 0.62, 95% CI: 0.41-0.94, P =0.025). CONCLUSIONS: ATs use is an independent protective factor against death in AUGIB. The protective effect is mainly derived from low-dose aspirin.

Enteroscopy in diagnosis and treatment of small bowel bleeding: A Delphi expert consensus.

BACKGROUND: Enteroscopy plays an important role in the management of small bowel bleeding. However, current guidelines are not specifically designed for small bowel bleeding and recommendations from different international societies do not always align. Consequently, there is heterogeneity in the definitions of clinical entities, clinical practice policies, and adherence to guidelines among clinicians. This represents an obstacle to providing the best patient care and to obtain homogeneous data for clinical research. AIMS: The aims of the study were to establish a consensus on the definitions of bleeding entities and on the role of enteroscopy in the management of small bowel bleeding using a Delphi process. METHODS: A core group of eight experts in enteroscopy identified five main topics of small bowel bleeding management and drafted statements on each topic. An expert panel of nine gastroenterologists participated in three rounds of the Delphi process, together with the core group. RESULTS: A total of 33 statements were approved after three rounds of Delphi voting. CONCLUSION: This Delphi consensus proposes clear definitions and a unifying strategy to standardize the management of small bowel bleeding. Furthermore, it provides a useful guide in daily practice for both clinical and technical issues of enteroscopy.

Sustainability in gastroenterology and digestive endoscopy: Position Paper from the Italian Association of Hospital Gastroenterologists and Digestive Endoscopists (AIGO).

Climate crisis is dramatically changing life on earth. Environmental sustainability and waste management are rapidly gaining centrality in quality improvement strategies of healthcare, especially in procedure-dominant fields such as gastroenterology and digestive endoscopy. Therefore, healthcare interventions and endoscopic procedures must be evaluated through the 'triple bottom line' of financial, social, and environmental impact. The purpose of the paper is to provide information on the carbon footprint of gastroenterology and digestive endoscopy and outline a set of measures that the sector can take to reduce the emission of greenhouse gases while improving patient outcomes. Scientific societies, hospital executives, single endoscopic units can structure health policies and investment to build a "green endoscopy". The AIGO study group reinforces the role of gastrointestinal endoscopy professionals as advocates of sustainability in digestive endoscopy. The "green endoscopy" can shape a more sustainable health service and lead to an equitable, climate-smart, and healthier future.

Efficacy of Helicobater pylori eradication in patients with diffuse large B-cell lymphoma of the stomach: A systematic review.

OBJECTIVES: The role of Helicobater pylori eradication in the treatment of high-grade diffuse large B-cell lymphoma (DLBCL) of the stomach is unclear. METHODS: We performed a systematic review and meta-analysis of currently available data. DLBCL-remission rate after eradication therapy, post-remission maintenance, and response rate in the case of additional oncological therapy were extracted. RESULTS: By considering data of seven studies, the DLBCL remission was achieved in 81 (53.3%; 95% CI = 45.3-61.2) out of 152 H. pylori eradicated patients. The regression rate did not differ between pure DLCBL and DLCBL with MALT component, between stage I and stage II disease, and between Caucasians and Asians. Disease regression was maintained in all patients after at a median of 63 months (range: 46-29) follow-up. In those non-responders, DLBLC remission after additional chemo-immunotherapy was achieved in 63 (98.4%; 95% CI = 95.4-100) out of 64 patients. CONCLUSIONS: Data this systematic review suggest considering H. pylori eradication as first-line therapy to treat infected patients with early-stage, high-grade gastric lymphoma.

Derivation and validation of Re.Co.De death score risk in patients with acute nonvariceal upper GI bleeding.

BACKGROUND AND AIMS: Scores in upper GI bleeding (UGIB) are used to stratify death risk and need for hospitalization at admission, but a tool that incorporates dynamic changes during the hospital stay is lacking. We aimed to develop a death risk score that considers changes in clinical status during hospitalization and compare its performance with existing ones. METHODS: A multicenter cohort study enrolling patients with UGIB in 50 Italian hospitals from January 2014 to December 2015 was conducted. Data were collected and used to develop a risk score using logistic regression analyses. Performance curves (area under the receiver-operating characteristic [AUROC] curves), sensitivities, specificities, positive and negative predictive values, and outcomes classified as low, intermediate, and high death risk were calculated. The score's performance was externally validated and then compared with other scores. RESULTS: We included 1852 patients with nonvariceal UGIB in the development cohort and 912 in the validation cohorts. The new score, which we named the Re.Co.De (rebleeding-comorbidities-deteriorating) score, included 10 variables depicting the changes in clinical conditions while in the hospital. The mortality AUROC curves were .93 (95% confidence interval, .91-.96) in the derivation cohort and .94 (95% confidence interval, .91-.98) in validation cohort. In a comparison of AUROC curves with other scores, the new score showed a significant performance compared with pre- and postendoscopy scores. Patients with low and high scores had 30-day mortality rates of .001% and 48.2%, respectively. CONCLUSIONS: The Re.Co.De score has a higher performance for predicting mortality in patients with UGIB compared with other scores, correctly identifying patients at low and high death risk while in the hospital through a dynamic re-evaluation of clinical status.

No evidence of "weekend effect" in upper gastrointestinal bleeding in Italy: data from a nationwide prospective registry.

OBJECTIVES: The literature offers conflicting information about 'weekend effect' in acute upper gastrointestinal bleeding (AUGIB). Aim of our study was to compare clinical outcomes of patients admitted for AUGIB during the weekend or on weekdays in Italy. METHODS: We analyzed data from a prospective registry of AUGIB (either nonvariceal, NV-AUGIB or variceal, V-AUGIB) from 50 Italian hospitals from January 2014 to December 2015. Mortality, rebleeding, need for salvage procedures and length of hospitalization were compared among patients admitted during the weekend or on weekdays. RESULTS: In total 2599 patients (mean age 67.4 ± 15.0 years, 69.2% males) were included, 2119 (81.5%) with NV-AUGIB and 480 (18.5%) with V-AUGIB. Totally 494 patients with NV-AUGIB (23.3%) and 129 patients with V-AUGIB (20.7%) were admitted during the weekend. The two study groups were similar in terms of physical status (American Society of Anesthesiologists score, comorbidities) and bleeding-specific prognostic scores. We did not find differences in terms of mortality (5.6 vs. 4.9%; P = 0.48), rebleeding (5.9 vs. 5.1%; P = 0.39), need for salvage procedures (4.0 vs. 3.6%; P = 0.67) or duration of hospitalization (8.5 ± 6.9 vs. 8.3 ± 7.2 days; P = 0.58) between patients admitted during weekend or weekdays. Considering separately NV-AUGIB and V-AUGIB, the only difference found in clinical outcomes was a higher rebleeding risk in patients with V-AUGIB admitted during the weekend (13.2 vs. 7.4%; P = 0.05). CONCLUSIONS: Data from our large, prospective multicenter registry shows that in Italy there is no significant 'weekend effect' for either NV- or V-AUGIB. Our results show that the Italian hospital network is efficient and able to provide adequate care and an effective therapeutic endoscopy even during the weekend.

Comparison of assessment tools in acute upper gastrointestinal bleeding: which one for which decision.

BACKGROUND: Upper GI bleeding (UGIB) remains a common emergency with significant mortality. Scores help triage patients, but it is still unclear which score should be used in the different decision-making moments to identify patients at high or low death risk. We aimed to compare the overall performances of the most validated scores and their cut-off performance to identify patients at low and high death risk. The secondary outcome was to compare the scores' performance for predicting therapeutic endoscopy, the need for transfusion(s), rebleeding, and surgery/interventional radiology. METHODS: We conducted a prospective multicenter cohort study, including consecutive UGIB patients admitted to 50 Italian hospitals. We collected information to calculate the Rockall, the Progetto Nazionale Endoscopia Digestiva (PNED), the AIMS65, the Glasgow-Blatchford (GBS), and the Age, Blood tests, Comorbidities (ABC) scores, together with demographic figures, clinical data, and outcomes. RESULTS: We obtained complete data of 2307 outpatients, including 1887 non-variceal and 420 variceal bleeders. Our cohort's mean age was 67.5 years, with a prevalence of male gender (69%). The GBS has the best overall performance (ROC 0.74) compared to the other scores in identifying low-risk patients (p < .001). At the cut-off 0-1, both GBS and ABC scores provide the highest PPV (100%) for low-risk patients. ABC and PNED scores are the most useful ones (for AUC >80) to assess the high-risk patients for mortality. CONCLUSIONS: At admission, GBS and ABC scores identify low-risk patients suitable for outpatient management, while PNED and ABC scores identify high-risk patients. During hospitalization, the PNED score should be used to re-assess the mortality risk if a modification of clinical status occurs.

Correct use of telemedicine in gastroenterology, hepatology, and endoscopy during and after the COVID-19 pandemic: Recommendations from the Italian association of hospital gastroenterologists and endoscopists (AIGO).

The purpose of the present document is to provide detailed information on the correct and optimal use of digital media to ensure continuity of care for gastroenterological patients in everyday clinical practice, in health emergencies and/or when the patient cannot reach the hospital for other reasons. During the recent COVID-19 pandemic, telemedicine has allowed many patients with chronic diseases to access remote care worldwide, proving to be the ideal solution to overcome restrictions and carry out non-urgent routine follow-ups on chronic patients. The COVID-19 pandemic has therefore made organizational and cultural renewal essential for the reorganization of healthcare in order to ensure greater continuity of care with a minimum risk of spreading the virus to users, practitioners and their families. These AIGO recommendations are intended to provide Italian gastroenterologists with a tool to use this method appropriately, in compliance with current legislation, in particular the proper approach and procedures for conducting a remote examination using a video conferencing tool, the so-called televisit. In the near future, telemedicine may contribute to a possible reorganization of healthcare systems, through innovative care models focusing on the citizen and facilitating access to services throughout the entire Country.

Clinical outcomes in cirrhotics with variceal or nonvariceal gastrointestinal bleeding: A prospective, multicenter cohort study.

BACKGROUND AND AIM: Upper gastrointestinal bleeding (UGIB) is associated with a distinct mortality in cirrhotics. We evaluated whether the rate of mortality and other outcomes differs between variceal and nonvariceal UGIB. METHODS: This was a prospective, multicenter, cohort study on UGIB cirrhotics observed in 50 hospitals. Variceal or nonvariceal UGIB were diagnosed at endoscopy. The 6-week mortality rate, need of blood transfusion, intensive care unit (ICU) admission, radiologic or surgical intervention, rebleeding rate, and length of stay in hospital were the main clinical outcomes compared. Data were analyzed at univariate and multivariate analysis, and odds ratio (OR) with their 95% confidence interval (CI) was calculated. RESULTS: The study enrolled 706 cirrhotics, including 516 (73%) variceal and 190 (27%) nonvariceal UGIB. There were 78 (11%; 95% CI = 8.7-13.4) deceases, without any difference between variceal (11.0%) and nonvariceal (11.0%) groups. Child-Pugh score C (OR: 6.99; 95% CI = 2.58-18.95), and development of either hepatorenal syndrome (OR: 16.5; 95% CI = 7.02-38.9) or hepatic encephalopathy (OR: 2.38; 95% CI = 1.25-4.5) were independent predictors of mortality. Transfusions and onset of hepatic encephalopathy were significantly more frequent in variceal, whereas ICU admission rate was higher in nonvariceal bleedings. Overall, antibiotic prophylaxis was eventually administered in only 392 (55.5%) patients. CONCLUSIONS: Data found that the overall mortality rate in cirrhotics with UGIB seems to be reducing and that the value did not differ between variceal and nonvariceal types. Prevention of both hepatorenal syndrome and hepatic encephalopathy and implementation of antibiotic prophylaxis could improve survival in these patients.

The "Hub and Spoke" model has no effect on mortality in acute upper gastrointestinal bleeding: A prospective multicenter cohort study.

BACKGROUND: the lack of standardized pathways for patients with gastrointestinal bleeding may have led to differences in their management and inequity to medical care access. The "Hub & Spoke" model was adopted to fill this gap in many disciplines, but, to our knowledge, no data exist on its efficacy on mortality in GI bleeding. We aimed to evaluate if the "Hub & Spoke" organizational model has an impact on mortality risk from UGIB. METHODS: from January 2014 to December 2015, 3324 consecutive patients admitted for UGIB in 50 Italian hospitals were enrolled (1977 patients in hospitals within the "Hub & Spoke" network for digestive hemorrhagic emergency and 1347 in hospitals outside the "Hub & Spoke" network). Clinical, endoscopic and organizational data were recorded. RESULTS: we observed no differences in mortality between patients admitted to hospitals included or not included in the "Hub & Spoke" network (5.2% vs 6.1%, p = 0.3). On multivariate analysis, admission in gastroenterology wards (OR 0.61, p = 0.001) or an academic hospital (OR 0.65, p < 0.056) were independent protective factors while being in "Hub & Spoke" organization system did not affect mortality (OR 1.09, p = 0.57). CONCLUSION: the "Hub & Spoke" model per sé does not impact on mortality while being treated in academic hospital or gastroenterology wards improved survival.

Quality performance measures for small capsule endoscopy: Are the ESGE quality standards met?

Background and study aims The European Society of Gastrointestinal Endoscopy (ESGE) recently issued a quality performance measures document for small bowel capsule endoscopy (SBCE). The aim of this nationwide survey was to explore SBCE practice with ESGE quality measures as a benchmark. Patients and methods A dedicated per-center semi-quantitative questionnaire based on ESGE performance measures for SBCE was created by a group of SBCE experts. One-hundred-eighty-one centers were invited to participate and were asked to calculate performance measures for SBCE performed in 2018. Data were compared with 10 ESGE quality standards for both key and minor performance measures. Results Ninety-one centers (50.3 %) participated in the data collection. Overall in the last 5 years (2014-2018), 26,615 SBCEs were performed, 5917 of which were done in 2018. Eighty percent or more of the participating centers reached the minimum standard established by the ESGE Small Bowel Working Group (ESBWG) for four performance measures (indications for SBCE, complete small bowel evaluation, diagnostic yield and retention rate). Conversely, compliance with six minimum standards established by ESBWG concerning adequate bowel preparation, patient selection, timing of SBCE in overt bleeding, appropriate reporting, reading protocols and referral to device-assisted enteroscopy was met by only 15.5 %, 10.9 %, 31.1 %, 67.7 %, 53.4 %, and 32.2 % of centers, respectively. Conclusions The present survey shows significant variability across SBCE centers; only four (4/10: 40 %) SBCE procedural minimum standards were met by a relevant proportion of the centers ( ≥ 80 %). Our data should help in identifying target areas for quality improvement programs in SBCE.