A scale to measure the worry level in Gastrointestinal Endoscopy with sedation: Development, reliability, and validity

Objective: This study aims to develop a scale to measure the worry level of patients who will undergo gastrointestinal (GI) endoscopy with deep sedation, and to provide scientific references to alleviate their worries. Method: Based on literature review, panel discussion, patient interview and expert consultation, we developed the first version of the scale. After two pre-investigations, the formal version of the scale was formed, and the reliability and validity were tested on 1389 respondents. Reliability was assessed by Cronbach's alpha. Construct validity was tested by confirmatory factor analysis (CFA) and the Spearman correlations analysis. Results: The scale was composed of four dimensions: financial and time costs, sedation, examination, and psychology. It has 15 items. Reliability and validity were acceptable. The Cronbach's alpha of the whole scale was 0.959 and all the factor loadings were > 0.50. The Spearman correlations of the inter-dimensions ranged from 0.614 to 0.836, and the correlation coefficients between the dimensions and the total score were 0.795 to 0.957. The correlation coefficient between the total scale score and the APAIS was 0.833. Conclusions: This scale has good validity and reliability, which is useful for physicians and medical institutions to take appropriate measures to reduce patients' worries. (AU)

Pre-endoscopy SARS-CoV-2 testing strategy during COVID-19 pandemic: the care must go on.

BACKGROUND: In response to the COVID-19 pandemic, endoscopic societies initially recommended reduction of endoscopic procedures. In particular non-urgent endoscopies should be postponed. However, this might lead to unnecessary delay in diagnosing gastrointestinal conditions. METHODS: Retrospectively we analysed the gastrointestinal endoscopies performed at the Central Endoscopy Unit of Saarland University Medical Center during seven weeks from 23 March to 10 May 2020 and present our real-world single-centre experience with an individualized rtPCR-based pre-endoscopy SARS-CoV-2 testing strategy. We also present our experience with this strategy in 2021. RESULTS: Altogether 359 gastrointestinal endoscopies were performed in the initial period. The testing strategy enabled us to conservatively handle endoscopy programme reduction (44% reduction as compared 2019) during the first wave of the COVID-19 pandemic. The results of COVID-19 rtPCR from nasopharyngeal swabs were available in 89% of patients prior to endoscopies. Apart from six patients with known COVID-19, all other tested patients were negative. The frequencies of endoscopic therapies and clinically significant findings did not differ between patients with or without SARS-CoV-2 tests. In 2021 we were able to unrestrictedly perform all requested endoscopic procedures (> 5000 procedures) by applying the rtPCR-based pre-endoscopy SARS-CoV-2 testing strategy, regardless of next waves of COVID-19. Only two out-patients (1893 out-patient procedures) were tested positive in the year 2021. CONCLUSION: A structured pre-endoscopy SARS-CoV-2 testing strategy is feasible in the clinical routine of an endoscopy unit. rtPCR-based pre-endoscopy SARS-CoV-2 testing safely allowed unrestricted continuation of endoscopic procedures even in the presence of high incidence rates of COVID-19. Given the low frequency of positive tests, the absolute effect of pre-endoscopy testing on viral transmission may be low when FFP-2 masks are regularly used.

White-Light Endoscopic Colorectal Lesion Detection Based on Improved YOLOv5.

As an effective tool for colorectal lesion detection, it is still difficult to avoid the phenomenon of missed and false detection when using white-light endoscopy. In order to improve the lesion detection rate of colorectal cancer patients, this paper proposes a real-time lesion diagnosis model (YOLOv5x-CG) based on YOLOv5 improvement. In this diagnostic model, colorectal lesions were subdivided into three categories: micropolyps, adenomas, and cancer. In the course of convolutional network training, Mosaic data enhancement strategy was used to improve the detection rate of small target polyps. At the same time, coordinate attention (CA) mechanism was introduced to take into account channel and location information in the network, so as to realize the effective extraction of three kinds of pathological features. The Ghost module was also used to generate more feature maps through linear processing, which reduces the stress of learning model parameters and speeds up detection. The experimental results show that the lesion diagnosis model proposed in this paper has a more rapid and accurate lesion detection ability, and the AP value of polyps, adenomas, and cancer is 0.923, 0.955, and 0.87, and mAP@50 is 0.916.

Lower rates of endoscopy and higher mortality in end-stage renal disease patients with gastrointestinal bleeding: A propensity matched national study.

BACKGROUND AND AIM: Patients with end-stage renal disease (ESRD) on hemodialysis are considered to be at higher risk of gastrointestinal bleeding (GIB) as compared with those without renal disease (NRD). We conducted a population-based study using the National Inpatient Sample (NIS) database to study the outcomes of GIB in ESRD. METHODS: Patients admitted with GIB (upper and lower) from 2005 to 2013 were extracted from the NIS database using ICD-9 codes. Patients were divided into NRD and ESRD groups, and a 1:1 propensity matched analysis was performed. Various outcomes were compared in both groups, and subgroup analysis based on the timing of endoscopy was also performed. RESULTS: A total of 218 032 patients were included in the study. There was an increase in inpatient admissions among ESRD patients with GIB with significant reduction in mortality (P < 0.001). In-hospital mortality, length of stay, and total costs were significantly higher in ESRD patients as compared with NRD. ESRD patients were less likely to undergo endoscopic evaluation compared with NRD (P < 0.001). Late endoscopy (> 48 h) was associated with increased need for transfusion and health-care utilization but without a significant difference in mortality as compared with early endoscopy. On multivariate analysis, endoscopy was associated with significantly lower rate of mortality in ESRD patients with GIB (odds ratio 0.28, P < 0.0001). CONCLUSION: End-stage renal disease patients with GIB had a significantly higher rate of mortality and a higher health-care utilization with a lower rate of endoscopic evaluation. Endoscopy was associated with a lower mortality rate on multivariate analysis.

Factors Contributing to Non-Attendance of GI Endoscopic Procedures in a Tertiary Care Center in the Middle East.

INTRODUCTION: The cancer burden in the Middle East is high and growing. Colorectal cancer (CRC) is the second most common cancer for both men and women in the UAE. Although early diagnosis of malignancy reduces morbidity and increases the survival rates, non-attendance of gastroenterology (GI) endoscopic procedures is a significant global problem, which can lead to delay in cancer diagnosis and treatment. Several factors have been found to contribute to non-attendance behavior, including socioeconomic, cultural, and organizational related barriers. The purpose of this study was to identify factors contributing to non-attendance behavior among outpatients scheduled for GI endoscopic procedures in a tertiary hospital in the United Arab Emirates. We conclude with recommendations that can help in reducing the rate of patient no-shows for GI endoscopic procedures in the region. METHODS: In a tertiary medical center in the Middle East, we surveyed patients who did not attend their scheduled GI endoscopic procedures over a period of one year. The questionnaire sought to identify possible reasons for patient's non-attendance. Descriptive measures including means, standard deviation, frequencies, and percentages were used to analyze the demographic characteristics of the study participants. The chi-square test was performed to analyze gender differences. RESULTS: Of 314 outpatients who met study inclusion criteria, 168 agreed to participate (53.5% response rate). The majority of participants were women (n=96, 60.4 %), aged 18 to 73, with a mean of 42 years. The largest age group was between 35 and 44 (n=46, 28.9 %). Approximately equal numbers of non-attendance appointments were scheduled for combined colonoscopy and upper endoscopy (36.3 %), colonoscopy alone (31.3 %), or upper endoscopy alone (31.3 %). The most common causes for cancellation or non-attendance included concerns about the appointment (35.5%), inconvenient timing of the appointment (27.9%) and changes in medical status (26.4%). Gender differences were noted for non-attendance behaviors, with women significantly more likely than men to report feelings of embarrassment (Chi-square 6.261, df=1, p=.012). CONCLUSION: Our study has identified several barriers to patient attendance of endoscopic procedures, as well as opportunities to reduce the rate of patient no-shows, including patient education, scheduling options, and protocols to minimize discomfort and misconceptions around GI endoscopic procedures, particularly accommodating for same gender endoscopists, with the ultimate goal of increasing early cancer screening and prevention.

Safety of Gastrointestinal Endoscopy in Korea: A Nationwide Survey and Population-Based Study.

BACKGROUND: Attention should be paid to endoscopy-related complications and safety-related accidents that may occur in the endoscopy unit. This study investigated the current status of complications associated with diagnostic and therapeutic endoscopy in Korea. METHODS: A questionnaire survey on endoscopy-related complications was conducted in a total of 50 tertiary or general hospitals in Korea. The results were compared to the population-level claims data from the Health Insurance Review & Assessment Service (HIRA), which analyzed endoscopy procedures conducted in 2017 in Korea. RESULTS: The incidences of bleeding associated with diagnostic and therapeutic esophagogastroduodenoscopy (EGD) and with diagnostic and therapeutic colonoscopy were 0.224% and 3.155% and 0.198% and 0.356%, respectively, in the 2017 HIRA claims data, compared to 0.012% and 1.857%, and 0.024% and 0.717%, in the 50 hospitals surveyed. The incidences of perforation associated with diagnostic and therapeutic EGD and with diagnostic and therapeutic colonoscopy were 0.023% and 0.613%, and 0.007% and 0.013%, respectively, in the 2017 HIRA claims data compared to 0.001% and 0.325%, and 0.017% and 0.206%, in the 50 hospitals surveyed. In the HIRA claims data, the incidence of bleeding/perforation after diagnostic colonoscopy in clinics, community hospitals, general hospitals, and tertiary hospitals was 0.129%/0.000%, 0.088%/0.004%, 0.262%/0.009%, and 0.479%/0.030% respectively, and the corresponding incidence of bleeding/perforation after therapeutic colonoscopy was 0.258%/0.004%, 0.401%/0.007%, 0.408%/0.024%, and 0.731%/0.055%. CONCLUSION: The incidences of complications associated with diagnostic and therapeutic EGD or colonoscopy tended to increase with the hospital volume in Korea. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0001728.

The Impact of Night-time Emergency Department Presentation on Upper Gastrointestinal Hemorrhage Outcomes.

GOALS: The aim was to investigate the impact of night-time emergency department (ED) presentation on outcomes of patients admitted for acute upper gastrointestinal hemorrhage (UGIH). BACKGROUND: The relationship between time of ED presentation and outcomes of gastrointestinal hemorrhage is unclear. STUDY: Using the 2016 and 2017 Florida State Inpatient Databases which provide times of ED arrival, we identified and categorized adults hospitalized for UGIH to daytime (07:00 to 18:59 h) and night-time (19:00 to 06:59 h) based on the time of ED presentation. We matched both groups with propensity scores, and assessed their clinical outcomes including all-cause in-hospital mortality, in-hospital endoscopy utilization, length of stay (LOS), total hospitalization costs, and 30-day all-cause readmission rates. RESULTS: Of the identified 38,114 patients with UGIH, 89.4% (n=34,068) had acute nonvariceal hemorrhage (ANVH), while 10.6% (n=4046) had acute variceal hemorrhage (AVH). Compared with daytime patients, ANVH patients admitted at night-time had higher odds of in-hospital mortality (odds ratio: 1.32; 95% confidence interval: 1.06-1.60), lower odds of in-patient endoscopy (odds ratio: 0.83; 95% confidence interval: 0.77-0.90), higher total hospital costs ($9911 vs. $9545, P <0.016), but similar LOS and readmission rates. Night-time AVH patients had a shorter LOS (5.4 vs. 5.8 d, P =0.045) but similar mortality rates, endoscopic utilization, total hospitalization costs, and readmission rates as daytime patients. CONCLUSIONS: Patients arriving in the ED at night-time with ANVH had worse outcomes (mortality, hospitalization costs, and endoscopy utilization) compared with daytime patients. However, those with AVH had comparable outcomes irrespective of ED arrival time.

Acute upper gastrointestinal bleeding due to portal hypertension in children: What is the best timing of endoscopy?

OBJECTIVE: To compare initial clinical/laboratory parameters and outcomes of mortality/rebleeding of endoscopy performed <12 h(early UGIE) versus endoscopy performed after 12-24h(late UGIE) of ED admission in children with acute upper gastrointestinal bleeding(AUGIB) due to portal hypertension. METHODS: This is a retrospective cohort study. From January 2010 to July 2017, medical records of all children admitted to a tertiary care hospital with AUGIB due to portal hypertension were reviewed until 60 days after ED admission. RESULTS: A total of 98 ED admissions occurred from 73 patients. Rebleeding was identified in 8/98(8%) episodes, and 9 deaths were observed. UGIE was performed in 92(94%) episodes, and 53(58%) of them occurred within 12 h of ED admission. Episodes with early UGIE and late UGIE were similar in terms of history/complaints/laboratory data at admission, chronic liver disease associated, AUGIB duration, and initial management. No statistically significant associations were found between early UGIE and the outcomes of death/rebleeding and prevalence of endoscopic hemostatic treatment (band ligation or sclerotherapy) compared to late UGIE. In the multivariable logistic regression model, the endoscopic hemostatic treatment showed a negative association with early UGIE(OR=0.33;95%CI=0.1-0.9;p = 0.04). CONCLUSIONS: This study suggests that in pediatric patients with AUGIB and portal hypertension, UGIE may be performed after 12-24 h without harm to the patient, facilitating better initial clinical stabilization/treatment and optimization of resources.

Single Shot Multibox Detector Automatic Polyp Detection Network Based on Gastrointestinal Endoscopic Images.

PURPOSE: In order to resolve the situation of high missed diagnosis rate and high misdiagnosis rate of the pathological analysis of the gastrointestinal endoscopic images by experts, we propose an automatic polyp detection algorithm based on Single Shot Multibox Detector (SSD). METHOD: In the paper, SSD is based on VGG-16, the fully connected layer is changed to a convolutional layer, and four convolutional layers with successively decreasing scales are added as a new network structure. In order to verify the practicability, it is not only compared with manual polyp detection but also with Mask R-CNN. RESULTS: Multiple experimental results show that the mean Average Precision (mAP) of the SSD network is 95.74%, which is 12.4% higher than the manual detection and 5.7% higher than the Mask R-CNN. When detecting a single frame of image, the detection speed of SSD is 8.41 times that of manual detection. CONCLUSION: Based on the traditional pattern recognition algorithm and the target detection algorithm using deep learning, we select a variety of algorithms to identify and classify polyps to achieve efficient detection results. Our research demonstrates that deep learning has a lot of room for development in the field of gastrointestinal image recognition.

High Prevalence of Transjugular Intrahepatic Portosystemic Shunt Creation Without Prior Endoscopy During Acute Variceal Bleeding Hospitalization in the United States.

Current clinical guidelines by both American Association for the Study of Liver Disease and European Association for the Study of the Liver recommend endoscopy in all patients admitted with acute variceal bleeding within 12 hours of admission. Transjugular intrahepatic portosystemic shunt (TIPS) creation may be considered in patients at high risk if hemorrhage cannot be controlled endoscopically. We conducted a cross-sectional observational study to assess how frequently TIPS is created for acute variceal bleeding in the United States without preceding endoscopy. Adult patients undergoing TIPS creation for acute variceal bleeding in the United States (n = 6,297) were identified in the last 10 available years (2007-2016) of the National Inpatient Sample. Hierarchical logistic regression was used to examine the relationship between endoscopy nonutilization and hospital characteristics, controlling for patient demographics, income level, insurance type, and disease severity. Of 6,297 discharges following TIPS creation for acute variceal bleeding in the United States, 31% (n = 1,924) did not receive first-line endoscopy during the same encounter. Rates of "no endoscopy" decreased with increasing population density of the hospital county (nonmicropolitan counties 43%, n = 114; mid-size metropolitan county 35%, n = 513; and central county with >1 million population 23%, n = 527) but not by hospital teaching status (n = 1,465, 32% teaching vs. n = 430, 26% nonteaching; P = 0.10). Higher disease mortality risk (odds ratio, 0.42; 95% confidence interval, 0.22-0.80; P = 0.02) was associated with lower odds of noncompliance. Conclusion: One third of all patients undergoing TIPS creation for acute variceal bleeding in the United States do not receive first-line endoscopy during the same encounter. Patients admitted to urban hospitals are more likely to receive guideline-concordant care.

Acute variceal bleeding and out-of-hours endoscopy: Evaluation of an emergency care setting according to Baveno VI guidelines adherence.

BACKGROUND: The extent to which patients with acute variceal bleeding (AVB) receive recommended care is largely unknown. AIM: to evaluate the adherence of the 4 major Baveno VI recommendations [vasoactive agents, prophylactic antibiotic, esophagogastroduodenoscopy (EGD) within 12 hours, endoscopic variceal ligation (EVL)] as a marker of quality of an emergency model. METHODS: Retrospective evaluation of AVB admissions to a tertiary centre in which endoscopy was available 24hours-a-day, with a regional out-of-hours service at night (the furthest hospital is 200Km away). Patients were divided in directly admitted or transferred from other centres. RESULTS: 210 AVB patients were included; 101 (48.1%) were directly admitted. The majority of patients were submitted to vasoactive agents (85.7%) and prophylactic antibiotics (79%) before EGD. In 178 patients (84.8%) endoscopy was performed within 12h and EVL was the procedure of choice in 116 (74.8%) (only oesophageal varices). No significant differences were observed between directly admitted and transferred patients in adherence rates. Overall rebleeding rate was 8.6%, in-hospital mortality 11.4% and 6-week mortality 20%. CONCLUSION: Adherence to quality metrics was high which might have played a vital role for reported outcomes. These results suggest that this model of care, provides accessibility and equity in access to urgent endoscopy.

Real-World Data on the Impact of COVID-19 on Endoscopic Procedural Delays.

INTRODUCTION: The initial surge of the coronavirus disease 2019 (COVID-19) pandemic prompted national recommendations to delay nonurgent endoscopic procedures. The objective of this study was to provide real-world data on the impact of COVID-19 on endoscopic procedures in a safety-net healthcare system and cancer center affiliated with a tertiary academic center. METHODS: This retrospective cohort study used a combination of electronic health record data and a prospective data tool created to track endoscopy procedures throughout COVID-19 to describe patient and procedural characteristics of endoscopic procedures delayed during the initial COVID-19 surge. RESULTS: Of the 480 patients identified, the median age was 57 years (interquartile range 46-66), 55% (n = 262) were male, and 59% self-identified as white. Colonoscopy was the most common type of delayed procedure (49%), followed by combined esophagogastroduodenoscopy (EGD) and colonoscopy (22%), and EGD alone (20%). Colorectal cancer screening was the most common indication for delayed colonoscopy (35%), and evaluation of suspected bleeding (30%) was the most common indication for delayed combined EGD and colonoscopy. To date, 46% (223/480) of delayed cases have been completed with 12 colorectal, pancreatic, and stomach cancers diagnosed. Sociodemographic factors, procedure type, and sedation type were not significantly associated with endoscopy completion. The median time to endoscopy after delayed procedure was 88 days (interquartile range 63-119) with no differences by procedure type. DISCUSSION: To minimize potential losses to follow-up, delayed, or missed diagnoses and to reduce progression of gastrointestinal diseases, all efforts should be used to ensure follow-up in those whose endoscopic procedures were delayed because of COVID-19.

Association between time to stent dysfunction and the anti-tumour effect of systemic chemotherapy following stent placement in patients with pancreaticobiliary cancers and malignant gastric outlet obstruction: a retrospective cohort study.

BACKGROUND: Malignant gastric outlet obstruction (MGOO) occasionally occurs due to pancreaticobiliary cancer. Endoscopic duodenal stenting (DS) is a common treatment for MGOO. However, it has been reported that DS does not have sufficient patency time for it to be used in patients who have a potentially increased lifespan. Nowadays, systemic chemotherapy for pancreaticobiliary cancer has developed, and its anti-tumour effect would make time to stent dysfunction longer. Therefore, we retrospectively evaluated the association between objective response to systemic chemotherapy, followed by DS and time to stent dysfunction in patients with advanced pancreaticobiliary cancer. METHODS: This retrospective study included 109 patients with advanced pancreaticobiliary cancer who received systemic chemotherapy after DS. Patients who showed complete or partial response were defined as responders. The rest were defined as non-responders. Time to stent dysfunction was compared between responders and non-responders using the landmark analysis at 2 months after DS. Death without recurrence of MGOO was considered as a competing risk for time to stent dysfunction. RESULTS: Combination and monotherapy regimens were adopted for 46 and 63 patients, respectively. Median progression-free survival and overall survival were 3.2 months (95% confidence interval [CI], 2.4-4.0) and 6.0 months (95% CI, 4.6-7.3). Objective response was observed in 21 patients (19.3%). Median time to stent dysfunction was 12.5 months (95% CI, 8.4-16.5) in the entire cohort. In 89 patients, responders had a lower cumulative incidence of stent dysfunction than non-responders: 9.5 and 19.1% at 6 months, and 19.0 and 27.9% at 1-year, respectively. There was difference of time to stent dysfunction between responders and non-responders among patients who received combination regimen as the first-line treatment with p-value of 0.009: cumulative incidence was 0 and 42.9% at 6 months, and 9.3 and 57.1% at 1-year, respectively. CONCLUSIONS: Longer time to stent dysfunction is expected when systemic chemotherapy following DS suppresses tumour progression; DS is slated to be a standard treatment for MGOO even in patients with pancreaticobiliary cancer and a long lifespan.

Emerging Endoscopic Interventions in Bariatric Surgery.

Although obesity rates are growing across the world, endoscopic modalities to treat obesity and its metabolic consequences are advancing rapidly. Multiple devices and techniques dedicated to weight management are being developed and have either been approved for use or are undergoing clinical trial. This article reviews many of these endoscopic interventions in bariatric surgery, including gastric aspiration devices, incisionless magnetic anastomotic systems, endoluminal bypass barrier sleeves, primary surgery obesity endoluminal, endoscopic sleeve gastroplasty, and duodenal mucosal resurfacing. These effective techniques may serve either as a primary therapy or as a bridge to bariatric surgery.

COVID-19 Disruptions to Endoscopic Surveillance in Lynch Syndrome.

Disruptions in cancer screening due to the COVID-19 pandemic may disproportionally affect patients with inherited cancer predisposition syndromes, including Lynch syndrome. Herein, we study the effect of the COVID-19 pandemic on endoscopic surveillance in Lynch syndrome through a prospective study of patients with Lynch syndrome at a tertiary referral center who were scheduled for endoscopic surveillance during the COVID-19 pandemic shutdown between March 16, 2020 and June 4, 2020. Of our cohort of 302 individuals with Lynch syndrome, 34 (11%) had endoscopic procedures scheduled during the COVID-19 pandemic shutdown. Of the 27 patients whose endoscopic surveillance was canceled during this period, 85% rescheduled procedures within 6 months with a median delay of 72 days [interquartile range (IQR), 55-84 days], with identification of an advanced adenoma or gastrointestinal cancer in 13%. Individuals who did not have a rescheduled endoscopic procedure were significantly younger than those with a rescheduled procedure [age 35 (IQR, 26-43) vs. age 55 (IQR, 43-63), P = 0.018]. Male sex was also suggestive of increasing likelihood of not having a rescheduled procedure. Taken together, our study demonstrates that the COVID-19 pandemic shutdown led to delayed endoscopic surveillance in Lynch syndrome, with potentially impactful delays among young patients. These data also emphasize the importance of timely surveillance in Lynch syndrome during this current, as well as potential future, global pandemics. PREVENTION RELEVANCE: The COVID-19 pandemic has led to unprecedented disruptions in cancer screening, which may have disproportionate effects on individuals at increased cancer risk, including those with Lynch syndrome. Herein, we show that the COVID-19 pandemic led to significant disruptions in Lynch syndrome surveillance with potentially impactful delays, thus highlighting the importance of ensuring timely surveillance among this high-risk cohort.

Long-term Safety and Efficacy of the Anti-MAdCAM-1 Monoclonal Antibody Ontamalimab [SHP647] for the Treatment of Ulcerative Colitis: The Open-label Study TURANDOT II.

BACKGROUND AND AIMS: Ontamalimab, a fully-human monoclonal antibody targeting MAdCAM-1, induced remission in patients with moderate-to-severe ulcerative colitis [UC] in the TURANDOT study. We aimed to assess long-term safety, tolerability, and efficacy of ontamalimab in TURANDOT II. METHODS: TURANDOT II was a phase 2, multicentre, open-label [OL] study in patients with moderate-to-severe UC who completed TURANDOT on placebo or ontamalimab (NCT01771809). Patients were randomised to 75 mg or 225 mg ontamalimab every 4 weeks for 72 weeks [OL1]. The dosage could be increased to 225 mg from Week 8 at the investigator's discretion. All patients then received 75 mg every 4 weeks for 72 weeks [OL2], followed by 6-month safety follow-up. The primary objective was safety, measured by adverse events [AEs], serious AEs [SAEs], and AEs leading to withdrawal. Mucosal healing [MH; centrally read endoscopy] was assessed. RESULTS: Of 330 patients, 180 completed OL1; 94 escalated to 225 mg; 127 completed OL2. Overall, 36.1% experienced drug-related AEs. The most common SAE [10.0%] was worsening/ongoing UC; 5.5% of patients had serious infections, the most common being gastroenteritis [0.9%]. One death and four cancers [all unrelated to ontamalimab] occurred. No PML [progressive multifocal leukoencephalopathy]/lymphoproliferative disorders occurred. Geometric mean high-sensitivity C-reactive protein [hsCRP] and faecal calprotectin decreased across OL1 in both dose groups. The proportion of patients assigned to placebo in TURANDOT achieving MH increased from 8.8% [6/68] at baseline to 35.3% at Week 16 [24/68; non-responder imputation]. The corresponding increase in the ontamalimab group was from 23.3% [61/262] to 26.7% [70/262]. CONCLUSIONS: Ontamalimab was well tolerated up to 144 weeks in patients with moderate-to-severe UC, with good safety and efficacy.

Optimal timing of endoscopy for acute upper gastrointestinal bleeding: a systematic review and meta-analysis.

Acute upper gastrointestinal bleeding (UGIB) is the most common indication for urgent endoscopy, but the correct timing of endoscopy in these patients is still debated. Our systematic review with meta-analysis was aimed at investigating the potential clinical benefit of very early endoscopy for UGIB patients. We performed an electronic literature search of PubMed, Scopus, Web of Science and the Cochrane Library up to 23rd May 2020 and considered only randomised controlled trials (RCTs) comparing management of UGIB patients by very early vs early endoscopy. Only five RCTs were considered eligible for quantitative analysis, with a total population of 926 cases (468 in the very early endoscopy arm and 458 in the early). The meta-analysis showed no statistically significant benefit for very early endoscopy compared to early endoscopy in terms of risk of rebleeding, mortality, ICU admission, blood transfusion, surgery and length of hospital stay. However, our results showed a significantly higher need for haemostatic treatment when very early endoscopy was performed (RR 1.23, 95% CI 1.06-1.42, p < 0.01) in comparison to early endoscopy.

Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from the Open-label Extension of the OASIS Study.

BACKGROUND AND AIMS: Etrasimod is an oral, selective, sphingosine 1-phosphate receptor modulator. In a phase 2, randomised, double-blind, placebo-controlled trial in adults with moderately-to-severely active ulcerative colitis [OASIS], etrasimod 2 mg provided significant benefit versus placebo and was generally well tolerated. This open-label extension [OLE] evaluated safety and efficacy of etrasimod for up to 52 weeks. METHODS: In OASIS, 156 patients received etrasimod 1 mg, etrasimod 2 mg, or placebo, once daily for 12 weeks. After completing OASIS, patients could enrol in the OLE and receive etrasimod 2 mg for an additional 34-40 weeks. RESULTS: In all, 118 patients enrolled in the OLE; 112 patients received etrasimod 2 mg at any point and were evaluated for safety and efficacy. A total of 92 [82%] patients who received etrasimod 2 mg in the OLE completed the study. Treatment-emergent adverse events occurred in 60% [67/112] of patients receiving etrasimod 2 mg at any time, most commonly worsening ulcerative colitis and anaemia; 94% of adverse events were mild/moderate. At end of treatment, 64% of patients met the criteria for clinical response, 33% for clinical remission, and 43% for endoscopic improvement. Week 12 clinical response, clinical remission, or endoscopic improvement was maintained to end of treatment in 85%, 60%, or 69% of patients, respectively. Steroid-free clinical remission occurred in 22% of overall patients. CONCLUSIONS: In this long-term extension study, etrasimod 2 mg demonstrated a favourable safety profile. Most patients with clinical response, clinical remission, or endoscopic improvement at Week 12 maintained that status to end of treatment.