Aims Hospitalization is a strong predictor for inadequate colon cleansing before colonoscopy, increasing missed pathology and costs for healthcare system. We aimed to identify factors associated to inadequate colon cleansing among inpatients, and to derive and validate a predictive model.
Introduction: Outbreak of the novel SARS-CoV-2 infection, leading to coronavirus disease 2019 (COVID-19) has been declared an official pandemic by WHO on March 11, 2020 COVID-19 patients have an increased susceptibility to develop thrombotic complications, and therefore thromboprophylaxis is routinely administered The widespread of anticoagulant treatment and the exposure to stress ulcer risk may increase the occurrence of upper gastrointestinal bleeding (UGIB) Timing of upper GI endoscopy should be carefully evaluated given the risk of respiratory worsening in non-intensive care unit (ICU) patients Aims \u0026 Methods: To retrospectively evaluate the medical and endoscopic management of UGIB in non-ICU COVID-19 patients referred to eight COVID Hub Centers from Northern Italy COVID-19 inpatients (positive nasopharyngeal swab or bronchoalveolar lavage) older than 18 yrs with overt sign of UGIB were enrolled in the study in the period from March 5th to April 30th Demographic and clinical characteristics at admission were evaluated Type of anticoagulant and/or antiplatelet therapy were acquired Severity of COVID- 19 pneumonia was classified according to the type of oxygen support Glasgow Blatchford score was calculated at onset of signs of GI bleeding Timing between onset of signs of GI bleeding and execution, if performed, of upper GI endoscopy was evaluated Endoscopic characteristics and outcome of patients were evaluated overall or according to the execution or not of an upper GI endoscopy before and after 24 hr Chi-square test with Fisher test and Mann-Whitney test were used when appropriate Results: 23 patients (18 male;75 yrs;IQR 64-78) were included in the study Antiplatelet therapy was present in 7/23 patients whereas 18/23 (78%) were on anticoagulant therapy before or during hospital stay (35% on prophylactic therapy and 44% in full dose anticoagulant) and 65% of them had two or more comorbidities (78% hypertension or chronic heart disease, 48% diabetes and 9% cirrhosis) 69% of patients had a significant respiratory involvement (high flow oxygen or non-invasive positive pressure support) Signs of upper GI bleeding appeared in a median time of 4 days (0 6-7) during hospital stay being presence of tarry stool the most common finding (52%) In 11 patients (48%) upper GI endoscopy was performed within 24 hr (4 had haematemesis), whereas it was not performed because of complete resolution of bleeding with medical management in 4 patients, and because of severe respiratory worsening in one Peptic ulcer was the most common finding (8/18) followed by erosive or haemorragic gastritis (4/18), Mallory-Weiss or Dieulafoy lesion (4/18) and variceal bleeding (1/18) Endoscopic treatment (adrenaline injection + clips in 5 and cyanoacrylate injection in one) was necessary in 6/18 patients Mortality rate was 21 7% Mortality (2 vs 3 patients) and rebleeding (2 vs 1 episodes) were not different between patients having upper GI endoscopy before or after 24 hr/not performed Need of endoscopic treatment was more common in patients in which upper GI endoscopy was performed before 24 hr (6 vs 1 patients, p=0 02) although Glasgow Blatchford score was similar between the two groups (13;12-16 vs 12;9-15) Conclusion: Upper GI bleeding is not a common complication in COVID-19 patients although the widespread of thromboprophylactic therapy, and peptic ulcer disease is the most common finding Conservative management with optimization of medical therapy and delay of endoscopy could be an option in patients that are at risk of respiratory complications
Aims The inpatient status is one of the strongest independent predictors for inadequate colon cleansing. The best strategy for bowel preparation among inpatients is yet unknown. Based on experts’ opinion, high-volume, 4L polyethilene glycol (PEG) solution should be the standard-of-care in this setting. We aimed to determine whether the novel 1L-PEG plus ascorbate prep is associated with increased colon cleansing among inpatients.
Abstract Background Recently, comparative trials among biologics in ulcerative colitis (UC) provided conflicting results on their reciprocal superiority or equivalence. Therefore, in patients naive to biologics, the first-choice biological drug is uncertain. Methods In a retrospective, real-life, multicentre inception cohort study involving 11 Italian IBD tertiary centres, all consecutive patients, naive to biologics, treated with adalimumab (ADA), infliximab biosimilar (CTP-13), golimumab (GOL) or vedolizumab (VDZ) after their postmarketing approval (2014–2018) for moderate–severe active UC, were followed up for 1 year or until relapse. All drugs were compared with each other and to naive patients treated with IFX-originator (IFX-O, Remicade) in 2013–2014 as a reference group. A propensity score analysis was performed. The primary endpoint was the 1 year relapse-free, optimisation-free, steroid-free remission, defined as Mayo score ≤2, with bleeding subscore = 0, no relapse after first clinical remission and no optimisation with dose intensification or steroids courses. Multiple further secondary endpoints were analysed (Table 1). Results Two hundred ninety-six naive patients (ADA = 56, CTP-13 = 73, GOL = 60, VDZ = 34, IFX-O = 73) were included. The primary end-point was achieved in similar percentages in all groups, irrespective of optimisation. IFX-O and ADA had similar rates of clinical remission achieved once during the follow-up but higher rates than GOL and VDZ. The 1-year relapse rate, however, was lower with VDZ than ADA, GOL and IFX-O. Treatment failure for primary/secondary no response was higher with GOL than IFX-O and ADA. Treatment failures for intolerance were similar among all drugs. CTP-13 performed differently than the originator for some secondary end-points. Conclusion Based on a strict definition of clinical remission, all biologics appear equally effective at 1 year in patients naive to these drugs. IFX originator and ADA appear more effective in the induction phase, while patients responders to VDZ had more prolonged clinical remission. Some differences on secondary questionable outcomes between IFX biosimilar and originator have been observed.
Abstract Background Until 2014, infliximab originator (Remicade, IFX-O) was the only biological treatment approved in Italy for ulcerative colitis (UC), followed by the sequential approval of adalimumab (ADA), infliximab biosimilar (CTP-13), golimumab (GOL) and vedolizumab (VDZ). Recently, comparative trials among these drugs provided conflicting results on their reciprocal superiority or equivalence. Methods In a retrospective, real-life, multicenter inception cohort study involving 11 Italian IBD tertiary centres, all consecutive patients with moderate-to-severe active UC, treated with ADA, CTP-13, GOL or VDZ after their post-marketing approval (2014–2018) were followed-up for 1 year or until relapse. All drugs were compared with each other and to patients treated with Remicade in 2013–2014 (reference group). The 80% power calculation of the study required at least 75 patients in each arm. A propensity score analysis was performed. The primary endpoint was the 1 year relapse-free, optimisation-free, steroid-free remission, defined as Mayo partial score ≤2, with bleeding subscore = 0, no relapse after first clinical remission and no optimisation with dose intensification or steroids courses. Multiple further secondary endpoints were analysed (Table 1). Results 492 patients (ADA=90, CTP-13=105, GOL=79, VDZ=142, IFX-O=76) were included. Overall, 65% achieved clinical remission once during the follow-up, with IFX-O performing better than GOL and VDZ. The relapse rate was 24%, with the lowest rates with VDZ. The primary end-point was achieved in similar percentages in all groups, except for lower rates with GOL than IFX-O. IFX-O performed better than each other drug for other clinical outcomes (Table 1). Discontinuation for intolerance was similar among the drugs, but CTP-13 had more frequent adverse events (mainly infusion reactions) than ADA, VDZ and IFX-O. Conclusion Based on a strict definition of clinical remission, all biologics appear equally effective at 1 year, except for GOL vs. IFX originator. IFX-O appears more effective in multiple questionable clinical outcomes. IFX biosimilar had more adverse events than the other drugs. IFX originator should be used as the reference drug in head to head, controlled, comparison trials for current and future biologics in UC.
Endoscopic resection of large colonic lesions (LCLs, > 20 mm) is effective and associated with low rate of complications when performed by trained endoscopists in resourced centers. Aim of present study is to evaluate the reproducibility of good performance of endoscopic resection of LCLs outside referral centers.
Endoscopic ultrasound-guided biopsy (EUS-biopsy) is safe and effective technique for obtaining samples from pancreatic masses. The aim of the present study was to evaluate the presence of a histological sample using 25G SharkCore Needles (Medtronic, Dublin, Ireland).
Background: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease.Methods: A prospective, multicenter, cohort study using a structured database.Results: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 6 14 infusions of infliximab. The mean follow-up was 4.3 6 +/- 2.8 months, and the total follow-up time was 195 patient-years. After 2061 infusions, 66 serious adverse events were reported (12.1%), 38 (6.9%) of them were infusion-related reactions. The biosimilar had to be stopped in 29 (5.3%) cases for severe infusion reactions (8 naive, 19 previous exposed, and 2 switch), and in further 16 patients (2.9%) for other serious adverse events. Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti-tumor necrosis factor alpha (incidence rate ratio = 2.82, 95% CI: 1.05-7.9). The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks, using time-to-event methods for censored observations: 35 patients were primary failures (8.1%). After further 8, 16, and 24 weeks, the efficacy estimations were 95.7%, 86.4%, and 73.7% for naive, 97.2%, 85.2%, and 62.2% for pre-exposed, and 94.5%, 90.8%, and 78.9% for switch, respectively (log-rank P = 0.64).Conclusions: Although no direct comparison was performed, preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab.