Hemospray Versus Conventional Therapy for Non-variceal Upper Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis.

Hemospray (TC-325; Cook Medical, Winston-Salem, NC) has been used effectively in hemostasis in non-variceal upper gastrointestinal (GI) bleeding. Current guidelines suggest using Hemospray as a temporizing measure or adjunct technique. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Hemospray as a modality for primary hemostasis. We searched MEDLINE, CENTRAL, and CINAHL (Cumulative Index of Nursing and Allied Health Literature) databases from inception to August 1, 2022. Three independent reviewers performed a comprehensive review of all original articles describing the application of Hemospray as the primary method of hemostasis in non-variceal upper GI bleeding patients. Three reviewers independently reviewed and abstracted data and assessed study quality using the Cochrane risk of bias tool. Primary outcomes were (1) primary hemostasis rate, (2) rebleeding rate until hospital discharge or death, (3) need for surgery, and (4) overall mortality rate. Of the 211 studies identified, 146 underwent title and abstract review, and four were included in the systematic review. Pooled results from 303 patients showed that compared to standard of care, Hemospray has significantly higher odds of primary hemostasis (OR: 3.48, 95% CI: 1.09-11.18, p = 0.04). There was no statistically significant difference in terms of rebleeding rates (OR: 0.79, 95% CI: 0.24-2.55, p = 0.69), need for surgery (OR: 1.62, 95% CI: 0.35-7.41, p = 0.54), or overall mortality (OR: 1.08, 95% CI: 0.56-2.08, p = 0.83). This systematic review and meta-analysis prove that Hemospray is a better modality of primary hemostasis in non-variceal upper GI bleeding when used as a primary method. At the same time, there is no significant difference in complications, including rebleeding, need for surgical intervention, and all-cause mortality.

A Curious Case of Vanishing Hepatocellular Carcinoma (HCC).

Hepatocellular carcinoma (HCC) is the third most common cause of cancer-related mortality worldwide. Spontaneous regression of HCC is rare with few documented cases in literature. The mechanism of this phenomenon is unknown, but tumor hypoxia and systemic inflammatory response have been suggested as possible etiologies. This article aims to shed more light on this rare phenomenon and provides an opportunity to review the proposed pathophysiology of spontaneous HCC regression. In this case report, we describe an interesting case of a 39-year-old male with HCC who underwent spontaneous regression.

Contrasting Strategies in Bouveret's Syndrome: A Series of Two Cases.

Bouveret's syndrome is a rare complication of cholelithiasis, characterized by gastric outlet obstruction caused by a migrated gallstone. Diagnosis of Bouveret's syndrome necessitates urgent treatment as it carries a high mortality rate. The treatment of Bouveret's syndrome has traditionally been surgical. However, there have been increasing reports of successful endoscopic therapy for Bouveret's syndrome. This case series aims to compare and contrast two cases of Bouveret's syndrome. The gallstone was retrieved via endoscopic access in one case while the other was removed with surgery. For each case, we discuss the various factors that contributed to the decision of which treatment modality to use. In addition, we propose an endoscopic technique that may improve the safety and success rate of endoscopic treatment of Bouveret's syndrome.

Not All Gastric Ulcers Are Malignant.

Eosinophilic granulomatosis with polyangiitis (EGPA) is a small- and medium-vessel vasculitis that majorly involves the respiratory tract but can potentially involve any organ system of the body. Involvement of the gastrointestinal (GI) tract can present on a spectrum. We present an interesting case of a 44-year-old man with a history of asthma and sinusitis who presented with non-specific GI symptoms and weight loss. The patient got diagnosed with EGPA. Endoscopic workup of the GI complaints revealed gastric ulcer and erosions of the upper GI tract. Biopsies of the lesions demonstrated eosinophilic infiltration suggestive of EGPA. This report represents a rare case of GI involvement of EGPA that could be histologically confirmed.

Predictors of poor bowel preparations and colonoscopy cancellations in inpatient colonoscopies, a single center retrospective study.

BACKGROUND: An adequate bowel preparation prior to colonoscopy is a major quality-limiting factor that determines both the diagnostic and therapeutic yield of a colonoscopy. Colonoscopy is considered the gold standard for colon cancer screening and it is the primary approach to the workup of hematochezia, diarrhea and iron deficiency anemia (IDA). Several modifiable factors of bowel prep adequacy have been identified, that account for around 25% of inadequate bowel preparations in outpatient colonoscopies. However, the literature is sparse when examining the factors associated with inadequate preparations and procedure cancellations in an inpatient hospital setting. We aim to identify factors that affect bowel preparation adequacy and procedure cancellations among diagnostic colonoscopies performed during hospitalization. METHODS: We retrospectively reviewed the electronic medical records of 1,500 consecutive patients who had a diagnostic colonoscopy as an inpatient at a tertiary level hospital over a 2-year period. All patients were administered a clear liquid diet the day prior to the colonoscopy. Patients were then instructed to drink 4 L of polyethylene glycol (PEG, Golytely) between 5 am to 9 am on the day of the procedure. The clinical course of each case was followed to identify quality of preparations, cancelled procedures and the reasons for cancellations. We applied univariate and multivariate logistic regression analysis to identify variables to predict cancellation and poor preparation. RESULTS: A total of 1,029 patients were included in the study. 194 (18.8%) patients had colonoscopy cancellations and 268 (26.0%) had poor bowel preparations. Multivariate analysis revealed these factors to be associated with colonoscopy cancellations: education at the graduate school level [odds ratio (OR) =1.93, P=0.04], Hispanic ethnicity (OR =0.47, P<0.01), hemoglobin level <10 g/dL (OR =1.41, P=0.05) and if the colonoscopy was done for other indications (OR =0.53, P=0.04). Factors associated with poor bowel preparation on multivariate analysis, were dementia (OR =2.44, P=0.02), gastroparesis (OR =3.97, P=0.01) and inpatient opioids use (OR =1.69, P=0.04). CONCLUSIONS: The rate of colonoscopy cancellations and poor bowel preparations in inpatient colonoscopies were high, and we were able to identify predictors of inadequate colon preparation and procedure cancellations. Exploring more individualized colon preparation regimens based on personal risk factors could reduce the number of inadequate and cancelled colonoscopies in an inpatient setting.

The Cook Score: A Novel Assessment for the Prediction of Liver-Associated Clinical Events in a Diverse Population.

BACKGROUND AND AIMS: Transient elastography (TE) provides accurate quantification of liver fibrosis. Its usefulness could be significantly amplified in terms of predicting liver-associated clinical events (LACE). Our aim was to create a model that accurately predicts LACE by combining the information provided by TE with other variables in patients with chronic liver disease (CLD). METHODS: We retrospectively reviewed the electronic medical records of patients who underwent liver elastography, at John H. Stroger Hospital in Cook County, Chicago, IL. The incidences of LACE were documented including decompensation of CLD, new hepatocellular carcinoma, and liver-associated mortality. Significant predicting factors were identified through a forward stepwise Cox regression model. We used the beta-coefficients of these risk factors to construct the Cook Score for prediction of LACE. Receiver-operating characteristic (ROC) curves were plotted for Cook Score to evaluate its efficiency in prediction, in comparison with MELD-Na Score and FIB-4 Score. RESULTS: A total of 3097 patients underwent liver elastography at our institution. Eighty-eight LACE were identified. Age (hazard ratio (HR) 1.04, p = 0.002), aspartate aminotransferase to alanine aminotransferase ratio (HR 2.61, p < 0.001), platelet count (HR 0.98, p < 0.001), international normalized ration (INR) (HR 17.80, p < 0.001), and liver stiffness measurement (HR1.04, p < 0.001) were identified as significant predictors. The Cook Score was constructed with two optimal cut-off points to stratify patients into low-, intermediate-, and high-risk groups for LACE. The Cook Score proved superior than MELD-Na Score and FIB4 Score in predicting LACE with an area under curve of 0.828. CONCLUSION: This novel score based on a large robust sample would provide accurate prediction of prognosis in patients with chronic liver disease and guide individualized surveillance strategy once validated with future studies.

Prophylactic Antibiotics Do Not Prevent Infectious Complications of Endoscopic Ultrasound Fine-Needle Aspiration of Pancreatic Cysts: A Systematic Review and Meta-Analysis.

ABSTRACT: Despite limited evidence, endoscopic societies recommend routine use of antibiotic prophylaxis for endoscopic ultrasound fine-needle aspiration of pancreatic cystic lesions. Recent studies suggest lack of benefit in this setting. Our objective is to conduct a systematic review and meta-analysis to assess the efficacy of antibiotics in prevention of infectious complications after ultrasound fine-needle aspiration of pancreatic cystic lesions. A bibliographic search of digital dissertation databases was performed from inception until March 2020. Randomized controlled trials, cohort, and case-control studies that compared prophylactic antibiotics with placebo or no therapy were included in the analysis. The primary outcome was the development of cyst infections. Secondary outcomes were incidence of fever; procedural complications such as bile leak, pancreatitis, or bleeding; and medication-related adverse events. Six studies with a total of 1683 patients were included. The overall incidence of cyst infections was 0.53%. For the primary outcome, there was no significant difference between the 2 groups (odds ratio, 0.54; 95% confidence interval, 0.16-1.82; P = 0.32). No significant difference was noted regarding other complications like fever, pancreatitis, or bile leak. In conclusion, the rate of infectious complications is very low, and antibiotic prophylaxis does not seem to confer any additional benefit in their prevention.

Comparative Effectiveness of Fecal Immunochemical Tests versus Flexible Sigmoidoscopy for Colorectal Cancer Screening: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

BACKGROUND AND AIMS: Fecal immunochemical tests (FITs) and flexible sigmoidoscopies are commonly used modalities for colorectal cancer (CRC) screening. We performed a systematic review and meta-analysis to compare the effectiveness of FIT and sigmoidoscopy in CRC screening. METHODS: PRISMA statement and Cochrane guidelines were followed for this review. Digital dissertation databases were searched from inception till December 1st 2020 and randomized clinical trials comparing the detection rates of CRC for FIT and sigmoidoscopy were included. Outcomes for analysis included participation rates and detection rates of CRC, advanced adenomas and advanced colorectal neoplasia for both screening modalities. RESULTS: Five randomized clinical trials with a total of 261,755 patients were included for the analysis. The participation rate for FIT was significantly higher compared to flexible sigmoidoscopy (OR 2.11, 95% CI 1.29-3.44, p=0.003). In intention-to-screen analysis, the detection rate for advanced colorectal neoplasia was significantly lower with FIT (OR 0.62, 95% CI 0.45-0.84, p=0.002) as compared to flexible sigmoidoscopy but not statistically different for CRC (OR 1.15, 95% CI 0.65-2.02, p=0.63). CONCLUSION: Despite lower participation amongst patients, CRC screening with flexible sigmoidoscopy leads to higher detection of advanced colorectal neoplasia, when compared to a single round of fecal immunochemical testing.

Incidence and risk factors for 30-day readmission in ulcerative colitis: nationwide analysis in biologic era.

BACKGROUND AND STUDY AIM: Ulcerative colitis (UC) is a chronic relapsing and remitting disease requiring frequent hospitalization. Biologics have become the recommended initial therapy for Biologics in patients with moderate to severe UC. Our aim was to estimate the changes in Nationwide Healthcare utilization and assess predictive factors of 30-day readmission, morbidity and mortality of UC. METHODS: This is a retrospective observational study analyzing the Nationwide Readmission database from 2016 to 2017 using ICD-10 codes. The primary outcomes of the study were to assess the predictors of 30-day readmission in patients with UC. RESULTS: Of the 54 138 adult patients with a primary diagnosis of UC, 13.2% were readmitted within 30 days of index hospitalization. The mortality rate (1.4 vs. 0.3%, P < 0.01), length of stay (7 vs. 4.9 days, P < 0.01) and hospital cost ($62 552 vs. $46 971, P < 0.01) were higher on readmission as compared to index hospitalization. We identified multiple patient-related factors (age <65years, men, VTE, protein calorie malnutrition, electrolyte imbalance, anemia, anxiety and alcohol abuse), hospital-related factors (teaching hospitals, high quintile hospitals), as independent predictors of 30-day UC readmission. Colonoscopy, Cannabis use, and colectomy were associated with decreased odds of 30-day readmission. The most common cause of UC was septicemia. CONCLUSIONS: This is the largest nationwide study demonstrating predictors of 30-day readmission, mortality and morbidity associated with UC. Identification and amelioration of these risk factors will decrease readmission rate and mortality amongst UC patients.

Schistosoma japonicum Associated With Colorectal Cancer.

Colorectal cancer (CRC) is one of the most common cancers worldwide, with increasing prevalence in Asian countries with a crude incidence of 21.1 per 100,000. Schistosoma is a genus of trematodes that infect millions of humans, affecting multiple organs, notably the intestines, liver, and bladder. Those trematodes may cause chronic inflammation in the affected organ leading to long-term complications such as fibrosis and neoplasia. There is rising evidence that infection with Schistosoma japonicum is correlated with the liver and CRC in endemic Asian countries. It is reported that chronic infection with Schistosomiasis raises the risk of CRC by 3 times. Less commonly seen outside of endemic areas, we present a case of S. japonicum-associated CRC in the United States in a woman with sigmoid adenocarcinoma and Schistosoma japonicum infection.

Identifying predictors and evaluating the role of steroids in the prevention of post-embolization syndrome after transarterial chemoembolization and bland embolization.

BACKGROUND: Transarterial chemoembolization (TACE) and bland embolization (TAE), performed for hepatocellular carcinoma (HCC), are often complicated by post-embolization syndrome (PES). There are limited data regarding the incidence of PES after TAE and the role of steroids in PES. We report the incidence of PES post TACE and TAE, identify predictors, and evaluate the role of steroids in PES. METHODS: Demographic and clinical variables of patients who underwent embolization were collected and PES was identified. Risk factors for PES, TACE and TAE were derived by logistic regression. We compared patients who received dexamethasone to those who did not, regarding baseline characteristics, occurrence of PES, and hospital stay. RESULTS: A total of 171 patients, average age 60.5 years, underwent the procedure, 77.8% were male, and 87.7% had cirrhosis. Of these 171, 107 underwent TACE and 64 TAE. Dexamethasone was given to 106 (61.9%) patients, of whom 85 had TACE and 21 TAE. One hundred twenty-four patients (72.5%) developed PES. PES occurred in more patients who underwent TACE, 80 (74.7%) vs. 44 (68.7%), and resulted in a longer hospital stay (1.47 vs. 1.12 days, P=0.034). Predictive factors for PES included female sex (odds ratio [OR] 2.76, 95% confidence interval [CI] 1.04-7.34; P=0.041), and alcohol-related HCC (OR 3.14, 95%CI 1.42-6.95; P=0.005). Dexamethasone did not affect the length of hospital stay (1.43 vs. 1.29 days, P=0.422) or the rate of prolonged hospitalization (18.8% vs. 15.4%, P=0.561). CONCLUSION: There was no difference in the incidence of PES following TACE or TAE and the use of dexamethasone did not reduce the incidence of PES or the duration of hospital stay.

A delay in colonoscopy after positive fecal tests leads to higher incidence of colorectal cancer: A systematic review and meta-analysis.

BACKGROUND AND AIM: A delay in performing colonoscopies after positive fecal tests in a screening program may risk neoplastic progression. Our objective is to conduct a systematic review and meta-analysis to evaluate the effects of timing of a colonoscopy after a positive fecal test on the detection of colorectal cancer. METHODS: Cochrane guidelines and PRISMA statement were followed for this review. Digital dissertation databases were searched from inception to June 1, 2020, and all studies reporting the detection rates of colorectal cancer on the basis of different time intervals between a positive fecal test and the post-test colonoscopy were included. We compared the detection rates of colorectal cancer (overall and advanced-stage) and advanced adenoma based on different time intervals. RESULTS: A total of 361 637 patients from six observational studies were included for the analysis. The odds of detecting any colorectal cancer (odds ratio [OR] 1.58, 95% confidence interval [CI] 1.23-2.03, P < 0.001), advanced-stage colorectal cancer (OR 2.16, 95% CI 1.47-3.16, P < 0.001), or advanced adenomas (OR 1.17, 95% CI 1.06-1.28, P = 0.001) are significantly higher if the colonoscopies are performed after 6 months from a positive fecal test, compared with within 6 months. There was no significant difference in the detection rates based on a 1-month, a 2-month, or a 3-month cut-off. CONCLUSIONS: A delay of colonoscopies beyond 6 months after positive fecal tests is associated with a higher odds of detecting colorectal cancer. A timely follow up of patients with positive fecal tests is warranted.

Non-hepatic Cancers Independently Predict Liver Decompensation Events.

BACKGROUND: Advanced liver fibrosis and cirrhosis represent independent risk factors for hepatocellular carcinoma (HCC). There is also evidence suggesting that several etiologies of chronic liver disease elevate the risk for non-hepatic cancers, including nonalcoholic fatty liver disease (NAFLD), alcohol abuse, and hepatitis C infection. In the present study, we aim to characterize the cancer incidence in patients with chronic liver disease and assess the prognostic value of non-hepatic cancer on the decompensation events of this population. METHODS: We retrospectively reviewed the electronic medical records of patients who underwent transient elastography (TE) of liver, at John H. Stroger Hospital in Cook County, Chicago, IL. We identified patients who had decompensation of cirrhosis. We also extracted their cancer history. The cancer profiles of the cohort were compared by the presence or absence of advanced liver fibrosis. We then performed univariate and multivariate forward stepwise Cox regression analysis to identify the significant risk factors for the decompensation events and plotted Kaplan-Meier curve to demonstrate the significance of cancer in the prediction of decompensation events. RESULTS: We identified a total of 3097 patients who underwent TE. A total of 45 liver decompensation events were documented. In the univariate Cox regression model, MELD-Na score (hazard ratio (HR) 1.25, p < 0.001), liver stiffness measurement (HR 1.05, p = 0.004), and history of any cancer (HR 3.81, p = 0.001) emerged as predictors of decompensation. Non-hepatic cancer proved to be a significant predictor of decompensation (HR 3.57, p = 0.002). CONCLUSION: The present study represents the first attempt to the best of our knowledge to describe the cancer incidence in this high-risk population. We found that non-HCC cancers independently predict hepatic decompensation events, which is an intriguing finding. We propose that physicians should be more vigilant to cancer history of patients with chronic liver disease as it might provide valuable prognostic information and guide individualized treatment and surveillance plans.

Evaluation of Ferritin and Transferrin Ratio as a Prognostic Marker for Hepatocellular Carcinoma.

PURPOSE OF THE STUDY: Hepatocellular carcinoma (HCC) has tripled in incidence over the past 20 years and now ranks as the third leading cause of mortality attributed to cancer. Underlying pathophysiology is sustained hepatic inflammation which results in hepatocellular dysplasia and thus an environment prone to HCC. Considering the essential role of inflammation in the pathogenesis of HCC, we evaluated the prognostic utility of ferritin-transferrin ratio (FTR) in HCC. METHODS: We retrospectively reviewed the electronic medical records of patients with HCC (diagnosed on radiographic criteria and/or biopsy) from 2000 through 2015. We collected data regarding the patient demographics, laboratory investigations at the time of HCC diagnosis and prior to the initiation of treatment. Overall survival was calculated from the time of diagnosis, cases were censored at the date of last follow-up, if date of death was not known. Kaplan-Meier curves were estimated to evaluate the prognostic significance of FTR. Receiver operating characteristics (ROC) curve was plotted for FTR to predict mortality and identify cut-off value by optimized Youden's index. RESULTS: Among the 176 patients identified by initial screening, 116 patients were eventually included for analysis. Overall median survival was 11.9 months. FTR, of note, was significantly lower in alive (6.9, p < 0.001). In univariate analysis, alfa-fetoprotein (AFP), aspartate aminotransferase (AST), serum ferritin (SF), transferrin (TFS), and FTR were significantly associated with mortality. On multivariate analysis for mortality, FTR, AFP, and epidemiologic factors predictive of mortality including male gender and advanced HCC were significant. CONCLUSION: The ferritin-transferrin ratio (FTR), calculated at the time of HCC diagnosis could predict mortality in our cohort of patients. With an optimal cut-off of 7.7 for FTR were stratified into high- and low-risk groups. The hazard ratio between the two groups was 2.36 (p < 0.003). Future studies with longitudinal follow-up of FTR at intervals and important time points (e.g., perioperative) might provide more insights to its prognostic value.

Drug-Induced Liver Injury Caused by "Khat," an Herbal Stimulant.

We describe a case of Catha edulis (Khat) drug-induced liver injury in a 28-year-old man from Yemen. The patient presented with jaundice, fatigue, and anorexia. Extensive workup, including liver biopsy, was performed. This is the first reported case in the United States without definite autoimmune hepatitis. Diagnosis requires high clinical suspicion and extensive workup. Increasing migration and differences in cultural practices lead to the need for an increased awareness of this type of cases, which is underreported.

Efficacy of Hemospray in Upper Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis.

BACKGROUND AND AIMS: Hemospray is a non-contact modality of endoscopic hemostasis that has been used in the management of upper gastrointestinal bleeding (UGIB) with varying success. Our aim was to evaluate the efficacy of Hemospray in the management of UGIB. METHODS: An electronic bibliographic search of digital dissertation databases was performed from inception till October 2019. All prospective studies, including randomized controlled trials evaluating the efficacy of Hemospray in the management of UGIB were analysed. The primary outcome was immediate haemostasis and the secondary outcome was rebleeding rate. Subgroup analyses based on etiology of UGIB (tumour-related, variceal, etc) were also performed. RESULTS: A total of 11 prospective studies, including 4 randomized trials were included for the analysis. The pooled immediate haemostasis rate with Hemospray was 93% (95% CI 90.3-95%, p<0.001). Rebleeding occurred in 14.4% (95% CI 8.8-22.8%, p<0.001) of patients. For the subgroup of tumour-related bleeding, the immediate haemostasis rate was 95.3% (95% CI 89.6-97.3%; p <0.001) and rebleeding rate was 21.9% (95% CI 13.9-32.7%, p <0.001). In patients with variceal bleeding, immediate haemostasis was achieved in 92.7% (95% CI 83.6-96.9%; p<0.001) of patients, with a rebleeding rate of 3.1% (95% CI 0.9-10.2%, p <0.001). CONCLUSION: Hemospray shows high immediate haemostasis and low bleeding percentages. The odds were in its favour compared to conventional endoscopic modalities, but not statistically significant. The results are undermined by the risk of bias in the studies. Nevertheless, it is an easy technique that should be further investigated with better studies.

Risk Factors, Management, and Outcomes of Pyogenic Liver Abscess in a US Safety Net Hospital.

BACKGROUND: The causes and management of pyogenic liver abscess (PLA) have undergone multiple changes over the past decades. It is a relatively rare disease in the USA, and its incidence rate in the USA is increasing. The last US community hospital experience of PLA was published in 2005. We performed a retrospective study of patients admitted with PLA to an urban safety net hospital. AIMS: To ascertain risk factors, management approaches, and outcomes of PLA. METHODS: Electronic medical record was queried for diagnosis codes related to PLA during the years 2009-2018. Clinical information was compiled in an electronic database which was later analyzed. Main study outcomes were in-hospital mortality, 30-day readmission rate, and intensive care utilization rate. RESULTS: A total of 77 patients with PLA were admitted in the study period. Most common risk factors were diabetes mellitus (23.4%), previous liver surgery (20.7%), and hepatic malignancy (16.9%). 89% of patients were treated with percutaneous drainage or aspiration, and surgical drainage was reserved for other with other indications for laparotomy. In-hospital mortality, 30-day readmission, and intensive care utilization rates were 2.6%, 7% and 22%, respectively. Median length of stay was 11 days (inter-quartile range 7). Rate of antimicrobial resistance in abscess fluid cultures was 40%; 13 cases of Klebsiella pneumoniae liver abscess were noted in our cohort, most of whom were Hispanic or Asian. CONCLUSIONS: PLA was principally managed by percutaneous drainage or aspiration with good outcomes. Further studies investigating the racial predilection of K. pneumoniae liver abscesses could reveal clues to its pathogenesis.

Fragility index: how fragile is the data that support the American College of Gastroenterology guidelines for the management of Crohn's disease?

Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine. However, recent literature has drawn attention to the limitations of using P-value to report statistical significance of outcomes in the clinical trials. We performed this analysis to analyze the strength of the data that supported the American College of Gastroenterology (ACG) guidelines for 'Management of Crohn's disease in adults' using fragility index (FI). We screened all the RCTs referenced in the 2018 ACG guidelines 'Management of Crohn's disease in adults'. We calculated the FI and the fragility quotient (FQ) and its correlation with P-value. Data were also collected on the patients lost to follow up, year of publication, sample size, number needed to treat (NNT), science citation index (SCI), presence of blinding and the number of centers in these studies. Of the 91 RCTs cited in this guideline, 32 RCTs met the inclusion criteria. The median values for FI for 32 trials were 3 [interquartile range (IQR) 2-6], FQ 0.026 (IQR 0.012-0.413), P-value 0.010 (IQR 0.001-0.03), lost to follow up 17 (IQR 10-39.5) and sample size 133 (IQR 74.5-281.5). There was statistically significant correlation between FI and P-value (rs -0.86, P <0.001) and sample size (rs 0.56, P = 0.002). There was no correlation found with number lost to follow up, NNT, SCI, year of publication, blinding and number of centers. The majority of the RCTs conducted in the field of Crohn's disease rely on small number of superior events for statistical significance, thus rendering the validity of their conclusion questionable. At least 18 out of 60 ACG recommendations are based on RCTs in which, number of patients lost to follow up exceeds FI, thus making reported outcomes of the trial weak. We suggest that FI and FQ should be included in clinical trials to better understand if the data are meaningful, beyond a P-value.

Safety and Efficacy of Infliximab in Severe Alcoholic Hepatitis: A Systematic Review.

Severe alcoholic hepatitis (SAH) is associated with significant morbidity and mortality, yet the treatment options available are very limited. Past studies have evaluated the efficacy of infliximab in such patients; however, they were limited by sample size. Our aim was to perform a systematic review of these studies to assess the role of infliximab in patients with SAH. We conducted a literature search using electronic database engines including Ovid, PubMed, Scopus, MEDLINE and Cochrane Library from inception to October 2018 to identify published articles addressing outcomes in patients treated for alcoholic hepatitis with infliximab. The primary outcome reviewed was one-month mortality. Secondary outcomes included rate and type of infection; cause of mortality; levels of aspartate aminotransferase, alanine aminotransferase, bilirubin and tumor necrosis factor-α; and Maddrey discriminant function. Five studies including two randomized controlled trials and three case series were included in our analysis with a total sample size of 70 patients. One-month mortality ranged from 10% to 17% in patients who received a single dose of infliximab with or without prednisone compared to 38% in patients who received three doses of infliximab in combination with prednisone. A single dose of infliximab was associated with an infection rate of 10% to 26% in contrast to an 89% rate with three doses of infliximab. Infliximab, when used in a single dose, could potentially be an alternative agent for the management of SAH in a large group of patients who have contraindications such as gastrointestinal bleeding, uncontrolled diabetes or an active hepatitis infection. It might also have a role in the prevention of hepatorenal syndrome. There is a need for larger trials to evaluate the role of infliximab in a cohort of patients who are not candidates for prednisolone therapy.