Nonalcoholic Fatty Liver Disease as a Risk Factor for Severe Cholangitis.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is one of the most prevalent chronic liver disorders. Acute cholangitis (AC) is a life-threatening illness. OBJECTIVES: To determine whether NAFLD is a risk factor for the severity of AC. METHODS: We retrospectively studied hospitalized patients with a diagnosis of AC over 5 years. Patients were divided into a NAFLD group and a non-NAFLD group. We compared the two groups with regard to demographic characteristics, co-morbidities, laboratory data, and severity of AC (including Charlson Comorbidity Index [CCI] and Tokyo Consensus meeting criteria). RESULTS: In all, 298 of 419 hospitalized patients diagnosed with AC met the inclusion criteria. Of these, 73/298 (24.5%) were in the NAFLD group. NAFLD group patients were younger and more likely to be diabetic and obese than the non-NAFLD group. Participants in the NAFLD presented with higher serum C-reactive protein and higher liver enzymes (P < 0.05, for each parameter) and with more events of organ dysfunction (P < 0.001) and bacteremia (P < 0.005). Regarding the severity of AC according to Tokyo Consensus, among the NAFLD group more patients presented with Grade II (39.7 vs. 33.3%, P < 0.001) and Grade III (23.3 vs. 18.3, P < 0.001) cholangitis. More Grade I cholangitis was found among the non-NAFLD group (48.4 vs. 37%, P < 0.001). Multivariate logistic regression analysis showed that NAFLD was independently associated with severe AC, Grade III (odds ratio 3.25, 95% confidence interval 1.65-6.45, P = 0.038). CONCLUSIONS: NAFLD is an independent risk factor for the severity of AC.

Elevated lactate/albumin ratio as a novel predictor of in-hospital mortality in hospitalized cirrhotics.

INTRODUCTION AND OBJECTIVES: Novel predictors of prognosis in cirrhotic patients have been emerging in recent years and studies show that the lactate/albumin ratio can serve as an early prognostic marker in different patient groups. We aimed to uncover the clinical significance of the lactate/albumin ratio in hospitalized patients with acutely decompensated cirrhosis. MATERIALS AND METHODS: A retrospective single-center cohort study was conducted in a tertiary medical center. Subjects included had an established diagnosis of liver cirrhosis and were admitted to the ICU or the Internal Medicine department with a clinical picture of acute-on-chronic liver failure between the years 2010 and 2021. The primary outcome was to assess the utility of the lactate/albumin ratio as a prognostic marker to predict mortality in hospitalized cirrhotic patients with acute-on-chronic hepatic failure. RESULTS: Two hundred seventy-nine patients were included in this study. Univariate analysis revealed that mean WBC count, platelet/creatinine ratio, aspartate transaminase (AST), lactate, and MELD score were all significantly associated with the primary outcome. Multivariate analysis showed that the lactate/albumin ratio was the strongest statistically significant (p < 0.001) predictor of death during hospitalization - OR 13.196 (95% CI 3.6-48.3), followed by mean WBC count, MELD score, and serum lactate levels. A ROC curve was constructed, which resulted in an area under the curve (AUC) equal to 0.77. Crosstabs from the ROC showed a sensitivity of 66.7% and a specificity of 76.2% when the lactate/albumin ratio chosen as a cutoff was 0.9061 CONCLUSIONS: Elevated lactate/albumin ratio predicts in-hospital mortality in hospitalized cirrhotics with acute-on-chronic hepatic failure.

Inflammatory bowel disease in families with four or more affected first-degree relatives.

BACKGROUND: Family history increases the risk for inflammatory bowel diseases (IBDs). However, data on differences in phenotypic characteristics among patients with a strong family history of IBD are scarce and controversial. The aim of the study was to compare the phenotypic features of IBD patients with four or more affected first-degree relatives with sporadic cases of IBD. METHODS: Patients with familial and sporadic IBD were identified from the institutional IBD database. IBD patients from families with at least four first-degree affected relatives were selected for analysis and were compared to non-matched sporadic cases with IBD chosen randomly. Comparison for type of IBD (Crohn's disease (CD) vs. ulcerative colitis (UC)), age at onset as well as for disease extent, behavior, extraintestinal manifestations and indicators of severe disease were analyzed. RESULTS: Thirty-five patients with familial IBD (28 CD, seven UC) were compared to 88 sporadic IBD patients (61 CD, 24 UC and three IBDU). Disease duration was 10.3 ± 8.2 in the familial and 8.0 ± 7.2 years in the sporadic cases, p=.13. The familial cases were younger at diagnosis (19.3 ± 8.6 vs. 25.7 ± 11.8, p=.004). Patients with familial compared to sporadic IBD were significantly more likely to require steroid treatment (80% vs. 54.5%, p=.009), biological treatment (94.3%, vs. 63.6%, p<.001) or surgery (25.7%, vs. 11.4%, p=.048). CONCLUSIONS: IBD with a very strong positive family history is associated with younger age at onset and a more adverse IBD phenotype compared to sporadic IBD.

COVID-19 in Patients with Inflammatory Bowel Disease: The Israeli Experience.

BACKGROUND: Crohn's disease (CD) and ulcerative colitis (UC) are chronic, immune-mediated inflammatory bowel diseases (IBD) affecting millions of people worldwide. IBD therapies, designed for continuous immune suppression, often render patients more susceptible to infections. The effect of the immune suppression on the risk of coronavirus disease-19 (COVID-19) is not fully determined yet. OBJECTIVE: To describe COVID-19 characteristics and outcomes and to evaluate the association between IBD phenotypes, infection outcomes and immunomodulatory therapies. METHODS: In this multi-center study, we prospectively followed IBD patients with proven COVID-19. De-identified data from medical charts were collected including age, gender, IBD type, IBD clinical activity, IBD treatments, comorbidities, symptoms and outcomes of COVID-19. A multivariable regression model was used to examine the effect of immunosuppressant drugs on the risk of infection by COVID-19 and the outcomes. RESULTS: Of 144 IBD patients, 104 (72%) were CD and 40 (28%) were UC. Mean age was 32.2 ± 12.6 years. No mortalities were reported. In total, 94 patients (65.3%) received biologic therapy. Of them, 51 (54%) at escalated doses, 10 (11%) in combination with immunomodulators and 9 (10%) with concomitant corticosteroids. Disease location, behavior and activity did not correlate with the severity of COVID-19. Biologics as monotherapy or with immunomodulators or corticosteroids were not associated with more severe infection. On the contrary, patients receiving biologics had significantly milder infection course (p = 0.001) and were less likely to be hospitalized (p = 0.001). Treatment was postponed in 34.7% of patients until recovery from COVID-19, without consequent exacerbation. CONCLUSION: We did not witness aggravated COVID-19 outcomes in patients with IBD. Patients treated with biologics had a favorable outcome.

External kinesiology tape for improvement in fecal incontinence symptom bother in women: a pilot study.

INTRODUCTION AND HYPOTHESIS: Fecal incontinence is a debilitating condition with a devastating impact on quality of life. Using a commercially available kinesiology band we developed an anal tape to be applied to the anus with the aim to determine its impact on symptom bother and quality of life. METHODS: Four-week prospective, self-controlled, pilot study of patients with FI. The primary outcome was improvement in any of the four domains (lifestyle, coping/behavior, depression/self-perception, embarrassment) evaluated by the "Fecal Incontinence Quality of Life Scale." Secondary outcomes included improvement in frequency of incontinence events and safety. Days 0-14 served as control period and days 15-28 as study period. Patients were asked to rate their satisfaction and willingness to use the device in the future using a 10-cm continuous visual analog scale. RESULTS: Twenty patients completed the study. Median age was 64 years; all patients were females. Significant improvements were observed in all domains of the Fecal Incontinence Quality of Life Scale from baseline to day 28 (p < 0.001 for all) and in three of four domains between day 15 and 28 (p < 0.04) but not between days 1 and 14. Five patients (25%) had a ≥ 50% improvement in incontinence events. Patients reported satisfaction and willingness to use the anal tape in the future. Other than mild difficulty to remove the anal tape, no adverse events were reported. CONCLUSIONS: In this small pilot study, the use of the anal tape was safe and effective. The primary outcome of significant improvement in quality of life was achieved ( ClinicalTrials.gov ID:NCT02989545). PUBLIC TRIAL REGISTRY: ClinicalTrials.gov identifier NCT02989545. https://clinicaltrials.gov/ct2/show/NCT02989545.

Three-months duration of fully-covered metal stent for refractory dominant extra-hepatic biliary stricture among primary sclerosing cholangitis patients: efficacy and safety.

BACKGROUND: Dominant stricture (DS) is a main cause of complication among patients with Primary Sclerosing Cholangitis (PSC). Endoscopic treatment options include dilation and plastic stenting, each with its own benefits and drawbacks. AIMS: The aim of the current study is to assess the safety and efficacy of fully-covered metal stent (FCMS) in these patients. METHODS: A retrospective study of PSC patients with refractory DS, defined as strictures resistance to conventional therapy (balloon dilatation, plastic biliary stent insertion or both) and who underwent FCMS insertion for 3 months were included. The primary outcome was defined as clinical and laboratory improvement, while secondary outcomes were DS resolution upon stent removal and cholangiographic DS recurrence at 12-months after FCMS extraction. RESULTS: Twenty patients were enrolled from January 2016 through January 2020. Improvement in weakness and pruritus were seen in 80% and 35%, 75% and 65%, 75% and 35% of patients at 1-3 and 6 months following FCMS removal, respectively. Similarly, consistent improvement in all liver enzymes and total bilirubin were seen in up to 6 month following stent removal. Only one patient (5%) needed premature FCMS removal due to cholangitis 1 week after stent placement and 2 cases (10%) of stent related pancreatitis were encountered. At 3-months all remaining stents were softly removed. Cholangiographic DS resolution was demonstrated in 13 patients (65%) after stent removal at 3-months, and DS recurred in 4 patients (4/13 = 30.7%) at 12-months following stent removal. Notably, only proximal biliary DS location showed a trend for DS recurrence (OR 28.6, P = 0.06). CONCLUSION: Temporary 3 months duration FCMS was feasible, safe and effective treatment option among patients with PSC related refractory DS.

Anemia can predict the prognosis of colorectal cancer in the pre-operative stage: a retrospective analysis.

BACKGROUND: Early detection of colorectal cancer (CRC) improves prognosis, yet many CRCs are diagnosed following symptoms. The aim of this study was to determine which CRC-related symptoms or signs can predict an advanced CRC in the pre-operative stage. METHODS: Retrospective analysis of 300 patients who underwent surgery for CRC between the years 2008 and 2019. Patients' symptoms prior to CRC diagnosis were documented. Primary endpoint was the association of signs or/and symptoms with CRC diagnosis at TNM stages of 2-4 (i.e., highly advanced), compared to TNM score of 0-1 (i.e., locally advanced). RESULTS: Three hundred patients, 91 with locally advanced and 209 with highly advanced CRC, were enrolled. There was a significant correlation between highly advanced CRC, compared to locally advanced, regarding tumor size (4.8 vs. 2.6 cm, p<0.001), presentation of any symptom prior to diagnosis (77% vs. 54%, p<0.001), anemia (46% vs. 29%, p=0.004), and severe anemia (17% vs. 4%, p=0.002). Mean hemoglobin was 12.2 ± 2.2 and 13.1 ± 1.8 in the highly advanced compared to locally advanced CRC, respectively, p<0.001. Anemia correlated with the T stage of the tumor: 21% of patients diagnosed at stages 0-1 had anemia, 39% at stage 2, 44% at stage 3, and 66% at stage 4 (p=0.001). CONCLUSIONS: Anemia is the only finding that correlates with highly advanced CRC, in the pre-operative stage. When CRC has been diagnosed, the presence of anemia, at any level, may be considered in determining prognosis at the pre-operative stage. Physicians should be aware that when anemia is present, the risk for highly advanced CRC increases, and therefore should pursue with CRC detection.

Detection of elusive polyps using a large-scale artificial intelligence system (with videos).

BACKGROUND AND AIMS: Colorectal cancer is a leading cause of death. Colonoscopy is the criterion standard for detection and removal of precancerous lesions and has been shown to reduce mortality. The polyp miss rate during colonoscopies is 22% to 28%. DEEP DEtection of Elusive Polyps (DEEP2) is a new polyp detection system based on deep learning that alerts the operator in real time to the presence and location of polyps. The primary outcome was the performance of DEEP2 on the detection of elusive polyps. METHODS: The DEEP2 system was trained on 3611 hours of colonoscopy videos derived from 2 sources and was validated on a set comprising 1393 hours from a third unrelated source. Ground truth labeling was provided by offline gastroenterologist annotators who were able to watch the video in slow motion and pause and rewind as required. To assess applicability, stability, and user experience and to obtain some preliminary data on performance in a real-life scenario, a preliminary prospective clinical validation study was performed comprising 100 procedures. RESULTS: DEEP2 achieved a sensitivity of 97.1% at 4.6 false alarms per video for all polyps and of 88.5% and 84.9% for polyps in the field of view for less than 5 and 2 seconds, respectively. DEEP2 was able to detect polyps not seen by live real-time endoscopists or offline annotators in an average of .22 polyps per sequence. In the clinical validation study, the system detected an average of .89 additional polyps per procedure. No adverse events occurred. CONCLUSIONS: DEEP2 has a high sensitivity for polyp detection and was effective in increasing the detection of polyps both in colonoscopy videos and in real procedures with a low number of false alarms. (Clinical trial registration number: NCT04693078.).

Safety of oesophagogastroduodenoscopy in a nonagenarian population.

BACKGROUND: invasive gastrointestinal (GI) procedures are increasingly performed on much older patients but data regarding oesophagogastroduodenoscopy (OGD) in this population are limited. We compared the indications, safety and benefits of OGD for nonagenarians compared to octogenarians. METHODS: an observational retrospective review of patients who underwent OGD between 2013 and 2018 at a gastroenterology institute in one large hospital. Patients aged 90 and above 'nonagenarians' were compared to those aged 80-89 'octogenarians'. RESULTS: 472 patients (231 nonagenarians and 241 octogenarians), median age of 91 for nonagenarians (201 aged 90-94, 30 aged 95 and older) and 82 (174 aged 80-84, 67 aged 85-89) for octogenarians. GI bleeding was a more common and dyspepsia, a less common, indication for nonagenarians compared to octogenarians (55 and 7%, versus 43 and 18%). Significant findings and need for endoscopic treatments were both more commonly found in nonagenarians compared to octogenarians (25 and 24% versus 15 and 8%, respectively). General anaesthesia was more commonly given to nonagenarians (35 versus 10%). Immediate complications and 30-day mortality rate were similar between the groups: (2.6% of nonagenarians versus 1.6% of octogenarians). Of 30 patients aged 95 and older, 13% had late adverse events, compared to 1% of the overall cohort. CONCLUSIONS: OGD appears safe in nonagenarians. Pathological findings and endoscopic interventions are more common. Decisions regarding OGD should not be based on age alone.

Pancreatic and hepatobiliary manifestations of nonalcoholic fatty pancreatic disease: a referral multi-center experience.

BACKGROUND: Nonalcoholic fatty pancreatic disease (NAFPD) is an increasingly recognized disease with accumulating evidence of associated co-morbidities. However, data linked with other pancreatic and hepatobiliary disorders are still being studied. AIMS: To investigate the association of pancreato-hepato-biliary disorders with NAFPD. METHODS: At two Israeli medical centers, a total of 569 patients were analyzed who underwent endoscopic ultrasound for hepatobiliary indications. They were divided into groups depending on the presence or absence of NAFPD. RESULTS: Seventy-eight patients (13.7%) had NAFPD (NAFPD group) vs. 491 patients (86.3%) without (non-NAFPD group). NAFPD was significantly associated with obesity [odds ratio (OR) 4.98, 95% confidence interval (CI) 3.02-8.24, P < 0.0001], hypertension (OR 2.55, 95% CI 1.57-4.15, P = 0.0002), active smoking (OR 2.02, 95% CI 1.04-3.93, P = 0.03), and hyperlipidemia (OR 2.86, 95% CI 1.58-5.18, P = 0.0005). On multivariate regression analysis: fatty liver (OR 5.49, 95% CI 2.88-10.49, P < 0.0001), main duct intraductal papillary mucinous neoplasm (M-IPMN) (OR 2.69, 95% CI 1.05-6.9, P = 0.04), and gallstones (OR 1.93, 95% CI 1.1-3.38, P = 0.02) were the most endoscopically and ultrasonographically detected diseases that significantly correlated with NAFPD. CONCLUSION: NAFPD was associated with several diseases, most importantly the premalignant M-IPMN. Further investigation for these coexisting diseases should be considered.

Gastroenterologists' Attitude Regarding Medical Cannabis for Inflammatory Bowel Diseases in Israel.

BACKGROUND: The use of medical cannabis (MC) for inflammatory bowel diseases (IBDs) is expanding. Current evidence does not support the efficacy of MC for reducing inflammation in IBD patients. Even so, many gastroenterologists encounter the issue of recommending use of MC to IBD patients. METHODS: A Web-based survey was completed by 84 (34%) gastroenterologists in Israel. RESULTS: Out of 84 physicians whom completed the questionnaire, 59 (70%) were male, 34 (40%) were under age 50 years, 71 (85%) were adult gastroenterologists, and 53 (63%) work mainly in a hospital. Of them, 15, 41, and 44% of physicians think that MC is very effective, mildly effective, and not effective at all, respectively. Physicians will commonly, rarely, and never recommend MC in 31, 47, and 22%, respectively. Older physicians (above age 50 years) were significantly more likely to have a positive attitude towards MC in both questions. When presented with a clinical scenario of a patient in deep remission, requesting to increase the dose, 32% would increase, 49% would maintain, and only 18% would stop prescribing MC altogether; 48% of physicians did not know the recommended initial dose for MC. Only 2 (2.5%) physicians initiated the use of MC to all patients. Female gastroenterologists were significantly more likely to initiate MC, p = 0.048. CONCLUSION: The use of MC for IBD patients is commonly encountered. Completely different attitudes regarding this treatment were seen. Age above 50 years and female physicians generally had a more positive attitude towards the use of MC. Guidelines and clear recommendations are needed.

Nonalcoholic fatty liver disease and the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis: the hidden danger.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) has been identified as risk factor for several diseases; however, its association with post endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been studied. AIMS: To assess whether NAFLD is a risk factor for the development of PEP. METHODS: We performed a retrospective multicenter study. All patients who underwent ERCP during 2013-2016 at either the Shaare Zedek Medical Center in Jerusalem or EMMS Nazareth hospital and who had a diagnosis of NAFLD by abdominal imaging were eligible for inclusion. Four hundred and one patients were included, among them, 38 (9.5%) were diagnosed with PEP according to clinical, laboratory and radiological criteria. RESULTS: In univariate analysis, the following risk factors were associated with increased risk for PEP; Fatty liver (OR 2.363, p = .01), elevated levels of aspartate transaminase (OR 1.008, p = .04), ALT (OR 0.979, p = .0007), alkaline phosphatase (OR 1.008, p = .01), gamma-glutamyl transferase (OR 1.014, p = .0005) and total bilirubin (OR 1.141, p = .005). In multivariate logistic regression analysis, only NAFLD showed statistically significant association with PEP (OR 3.224, 95% CI 1.548-6.713, p = .001) with receiver operator characteristics (ROC) area under the curve (AUC) of 0.8156. CONCLUSION: NAFLD was shown to be a risk factor for PEP. Therefore, we suggest considering prophylactic pancreatic stenting and/or NSAID's suppositories among these patients.

Pancreatobiliary manifestations of nonalcoholic fatty liver disease: a retrospective case-control multicenter study.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) has become a major cause of chronic liver disease. Several extrahepatic manifestations have been reported in relation to NAFLD. However, data regarding pancreatobiliary manifestation are scarce. AIM: We aimed to explore the association of pancreatobiliary manifestation with NAFLD. METHODS: A retrospective multicenter study that included all patients who underwent an endoscopic ultrasound performed for hepatobiliary indications and for whom the endosonographer reported on the presence or absence of fatty liver. The endoscopic ultrasound reports were reviewed and all pathological findings were reported. RESULTS: Overall, 545 patients were included in the study, among them, 278 patients had fatty liver (group A) as compared to 267 who did not have (group B). The average age in group A was 64.5 ± 13.5 years vs. 61.2 ± 14.7 years in group B. Male sex constituted 49.6 and 58% in groups A and B, respectively. On multivariate analysis, fatty pancreas [odds ratio (OR) 4.02; P = 0.001], serous cystadenoma (SCA) (OR 5.1; P = 0.0009), mucinous cystadenoma (MCA) (OR 9.7; P = 0.005), side-branch intraductal papillary mucinous neoplasm (IPMN) (OR 2.76; P < 0.0001), mixed-type IPMN (OR 16.4; P = 0.0004), pancreatic neuroendocrine tumor (NET) (OR 8.76; P < 0.0001), gallbladder stones (OR 1.9; P = 0.02) and hilar lymphadenopathy (OR 6.8; P < 0.0001) were significantly higher among patients with NAFLD. After adjustment for fatty pancreas, the association remained significant for SCA (OR 3; P = 0.01), MCA (OR 4.6; P = 0.03), side-branch IPMN (OR 1.7; P = 0.02), mixed-type IPMN (OR 5.5; P = 0.01) and pancreatic NET (OR 4.5; P = 0.001). CONCLUSION: Pancreatobiliary manifestations are common among patients with NAFLD. Assessment of these coexistent manifestations should be considered in the setting of patients with NAFLD.

Nonalcoholic fatty liver disease is associated with COVID-19 severity independently of metabolic syndrome: a retrospective case-control study.

AIM: Coronavirus disease 2019 (COVID-19) is a recently encountered disease that was declared a pandemic by WHO in 2020. Obesity and other components of the metabolic syndrome may aggravate the severity of COVID-19. Nonalcoholic fatty liver disease (NAFLD) represents the hepatic manifestation of metabolic syndrome. The aim of this study was to investigate a possible association between MAFLD and COVID-19 severity. METHODS: We performed a retrospective, case-control study, enrolling 71 consecutive COVID-19 patients who were divided into two groups according to the presence or absence of fatty liver by computed tomography scan. All medical records of eligible patients were reviewed including demographic, clinical, laboratory parameters and data regarding the presence of NAFLD and COVID-19 severity. RESULTS: NAFLD was identified in 22/71 (31%) of the study group. Out of 71, thirteen suffered from severe COVID-19. NAFLD patients had more severe COVID-19 compared with non-NAFLD subjects, 8/22 (36.3%) vs. 5/49(10.2%), (P < 0.005), respectively. Multiple logistic regression analysis showed that NAFLD subjects were more likely to have severe COVID-19 disease (odds ratio 3.57, 95% confidence interval: 1.22, 14.48, P = 0.0031). CONCLUSION: NAFLD represents a high risk for severe COVID-19 irrespective to gender, and independent of metabolic syndrome specifically in male gender. Moreover, obesity, hypertension and metabolic syndrome were also significantly associated with severe COVID-19.

Long-Term Safety of Endoscopic Biliary Stents for Cholangitis Complicating Choledocholithiasis: A Multi-Center Study.

BACKGROUND: Treatment of cholangitis complicating choledocholithiasis includes biliary sphincterotomy and stone extraction. In certain cases of elderly comorbid patients with high risk for definitive endoscopic treatment, biliary stenting is the only measure for relieving biliary obstruction. AIM: We aimed to report the safety of retained biliary stone. METHODS: a multi-center, retrospective case-control study conducted at two Israeli medical centers from January 2013 to December 2018 including all patients 18 years of age or older who underwent ERCP and biliary stent insertion for the treatment of acute cholangitis due to choledocholithiasis. RESULTS: Three-hundred and eight patients were identified. Eighty-three patients had retained long-term biliary stents of more than 6 months (group A) from insertion compared to 225 patients whose biliary stents were removed within a 6-month period (group B). The mean follow-up in group A was 66.1± 16.3 vs. 11.1 ± 2.7 weeks in group B. Overall complications during the follow-up were similar between groups A and B (6% vs. 4.9%, OR 1.24, Chi square 0.69). Similarly, the rate of each complication alone was not different when comparing group A to group B (3.6%, 1.2% and 1.2% vs. 2.7%, 0.44% and 1.8%) for cholangitis, stent related pancreatitis and biliary colic, respectively (Chi square 0.85). Even after 12 months, the rates of overall complications and each complication alone were not higher compared to less than 12 months (Chi square 0.72 and 0.8, respectively). CONCLUSION: endoscopic biliary stenting for cholangitis complicating choledocholithiasis is safe for the long-term period without increase in stent related complications.

Vedolizumab is effective and safe in elderly inflammatory bowel disease patients: a binational, multicenter, retrospective cohort study.

BACKGROUND: Immune modulating therapies are associated with an increased risk of infections and malignancies. This is of particular concern in elderly inflammatory bowel disease patients. This study aims to compare the safety and efficacy of vedolizumab between young and elderly inflammatory bowel disease patients. METHODS: A binational, multicentre, retrospective, cohort study was performed from 2015 to 2019. Patients who underwent treatment with vedolizumab and were followed for at least 14 weeks were studied. They were divided according to age into groups: 40 years or less or 60 years or older. Clinical and endoscopic responses at weeks 14 and 52 and infection development were compared between young and elderly inflammatory bowel disease patient groups. RESULTS: There were 144 patients (82 Crohn's disease and 62 ulcerative colitis) in the elderly cohort and 140 patients (83 Crohn's disease and 57 ulcerative colitis) in the young cohort. The average age was 70.2 ± 7.3 years and 29.6 ± 5.7 years, respectively. Clinical and endoscopic responses were comparable between the groups (week 52 remission of Crohn's disease: 40% vs. 35%, P = 0.7; week 52 remission of ulcerative colitis: 48% vs. 51%, P = 0.84). Previous anti-tumour necrosis factor biological therapy was independently associated with poor clinical remission rates at week 52 (Crohn's disease: odds ratio 0.23, 95% confidence interval 0.06-0.79; P = 0.02 and ulcerative colitis: odds ratio 0.10 95% confidence interval 0.01-0.74; P = 0.024). There were significantly more infections in the elderly cohort (2% vs. 12%, P = 0.002), none of which were fatal. CONCLUSIONS: Vedolizumab is equally effective in elderly and young inflammatory bowel disease patients. The findings of this study demonstrate an increased risk of infections among the elderly treated with vedolizumab, which may be related to their age and underlying diseases.

The severity of anemia does not correlate with the risk of gastrointestinal cancer in subsequent evaluation.

Introduction: Iron deficiency anemia (IDA) is a risk factor for gastrointestinal (GI) malignancies. Little is known regarding the correlation between the depth of anemia and the risk for GI malignancy. The aim of this study was to test the hypothesis that very low hemoglobin levels pose an additional risk compared to low hemoglobin levels.Methods: Patients 40-70 years old, presenting to the ER with IDA during years 2016-2017 were retrospectively analyzed. Comparison was performed between two groups, one with a very low hemoglobin level (below 8 g/dL) and the other a low hemoglobin level (between 8-10 g/dL).Results: 1020 patients were analyzed, and 107 fulfilled the inclusion criteria. Seventy-five patients (70%) were in the very low hemoglobin group and 21 patients (19.6%) were diagnosed with a new GI malignancy. Mean age was 56, 49 (45%) were females, and 68 (63%) underwent esophagogastroduodenoscopy (EGD) or/and colonoscopy during the index hospitalization. The median hemoglobin and MCV were 7.3 G/dL, and 73 fL, respectively. New malignancies were found in 15/75 (20%) and 6/32 (19%) of patients with very low and low hemoglobin levels, respectively (p = .88). GI malignancies were more commonly found in females compared to males, 14 (29%) vs. 7 (12%), p = .032, respectively. The right colon was the most common site for malignancy. Active GI bleeding was not a risk factor for GI malignancy.Conclusions: Very low hemoglobin levels and overt GI bleeding do not pose an additional risk factor for GI malignancy, compared to low hemoglobin levels and no overt GI bleeding.

Disease flare at prior pregnancy and disease activity at conception are important determinants of disease relapse at subsequent pregnancy in women with inflammatory bowel diseases.

PURPOSE: Disease flare throughout gestation are not uncommon among women with inflammatory bowel diseases (IBD), and can substantially affect pregnancy outcomes. We aimed to evaluate the effect of prior pregnancy outcome on the risk of disease flare at subsequent pregnancy in women with IBD. METHODS: Women with IBD attending a multidisciplinary clinic for the preconception, antenatal and postnatal treatment were prospectively recruited during 2011-2018. RESULTS: Overall, 476 IBD women were followed during the study period. Of them, 69 (14.5%) had two pregnancies throughout follow-up period and constituted the study cohort. Among these 69 women, 48 (69.6%) had Crohn's disease and 21 (30.4%) ulcerative colitis. The median interpregnancy interval was 20 [11-32] months. Overall, 34 (49.3%) women experienced disease flare at the subsequent pregnancy. In multivariate analysis, active disease at conception (odds ratio [95% CI]: 25.65 (3.05, 25.52), P < 0.001) and history of disease flare at the previous pregnancy (odds ratio [95% CI]: 4.21 (1.10, 16.58), P < 0.001) were the only independent predictors of disease relapse in current gestation. Rates of hospitalization during pregnancy (14.7% vs. 0, P = 0.02) and preterm delivery (32.4% vs. 5.7%, P = 0.006) were higher, and neonatal birth weight was lower (median 3039 vs. 3300 g, P = 0.03), in those with disease flare as compared to those with maintained remission. CONCLUSION: History of disease relapse at previous gestation and periconception disease activity were found as important predictors of disease flare among IBD women. These data would facilitate adequate counseling and informed management decisions among reproductive-aged IBD women and their treating physicians.

Safety and effectiveness of ustekinumab for induction of remission in patients with Crohn's disease: A multicenter Israeli study.

INTRODUCTION: Ustekinumab is an effective treatment of Crohn's disease (CD). Real-world data addressing the efficacy and safety of ustekinumab are scarce. AIM: Our aim was to assess the safety and efficacy of ustekinumab in a large national patient cohort. METHODS: A prospective multicenter study, in which we followed patients with active CD treated with ustekinumab for 24 weeks. Induction dose was intravenous ranging from 260 to 520 mg, according to body weight, followed by 90 mg doses given subcutaneously every 8 weeks. Clinical response was defined as a reduction of at least 1 severity category, as defined by Harvey-Bradshaw index (HBI). Patients with HBI < 5 were considered to be in clinical remission. Patients who stopped needing steroids at week 24 were defined as being in steroid-free clinical remission. RESULTS: A total of 106 CD patients from eight Israeli centers were included. All patients were previously exposed to at least one biological agent. Our cohort consisted of 65 (61.3%) females. Mean age was 41 ± 14 years with an average disease duration of 12.2 ± 8 years. A total of 96 (90.5%) patients continued treatment throughout week 24. Clinical response was observed in 52% of these patients with mean HBI reduction from 8.34 ± 3.8 to 6.8 ± 4.4 at week 24 (p = 0.001). Clinical remission was achieved in 33 patients (31.1%). Moreover, the number of patients requiring steroid treatment was reduced by 66% at week 24. Out of 106 patients, 11 patients (10.4%) discontinued treatment: 3 due to adverse events (2.8%), 7 due to a lack of response, and 1 who was lost to follow-up. Following 24 weeks of treatment, 15 patients reported minor adverse events. CONCLUSIONS: In a large real-world Israeli cohort of non-naïve-to-biological-treatment CD patients, ustekinumab was effective and safe in induction of clinical remission with a significant reduction in the number of patients requiring steroid treatment.

Clinical utility of fecal calprotectin in monitoring disease activity and predicting relapse in pregnant patients with inflammatory bowel diseases.

OBJECTIVES: Inflammatory bowel diseases (IBDs) are commonly diagnosed in reproductive-aged women and can substantially affect pregnancy outcomes. Non-invasive monitoring of IBD during the prenatal course is particularly challenging as traditional laboratory biomarkers are often affected by pregnancy-related physiologic changes. We aimed to evaluate the role of fecal calprotectin (FC) in monitoring disease activity and predicting relapse among IBD women throughout gestation. METHODS: Women with IBD attending a multidisciplinary clinic for the preconception, antenatal and postnatal treatment were prospectively recruited during 2014-2018. FC levels were determined with an enzyme-linked immunoassay. RESULTS: A total of 265 FC (preconception, n = 41; 1st trimester, n = 48; 2nd trimester, n = 84; 3rd trimester, n = 76; postpartum, n = 16) measurements were obtained in 157 pregnancies. Higher FC concentrations were found in all time points in those with active disease than those in remission as assessed by either physician global assessment or disease clinical scores. FC levels were significantly correlated with physician global assessment and disease activity indices in all 5 periods of investigation. Excluding those with disease flare at the time of conception, disease relapse was encountered during the prenatal course in 40 (31.5%) of the remaining 127 pregnancies. FC levels were significantly higher in those who experienced a disease flare later in the course of gestation as compared to those who maintained clinical remission (median 341 vs. 224 µg/g, P = 0.04). CONCLUSION: FC appears to be a reliable marker of ongoing disease activity throughout the prenatal course as well as a predictor of imminent disease flare among IBD pregnant patients.