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1.
Gastroenterology Res ; 16(3): 149-156, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37351082

ABSTRACT

Background: Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) represents the most common serious complication after endoscopic retrograde cholangiopancreatography (ERCP). Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and pancreatic duct stenting (PDS) are the prophylactic interventions with more evidence and efficacy; however, PEP still represents a significant source of morbidity, mortality, and economic burden. Chronic statin use has been proposed as a prophylactic method that could be cheap and relatively safe. However, the evidence is conflicting. We aimed to evaluate the impact of endoscopic and pharmacological interventions including chronic statin and aspirin use, on the development of PEP. Methods: A retrospective cohort study evaluated consecutive patients undergoing ERCP at John H. Stroger, Jr. Hospital of Cook County in Chicago from January 2015 to March 2018. Univariate and multivariate analyses were performed using logistic regression. Results: A total of 681 ERCPs were included in the study. Twelve (1.76%) developed PEP. Univariate, multivariate, and subgroup analyses did not show any association between chronic statin or aspirin use and PEP. PDS and rectal indomethacin were protective in patients undergoing pancreatic duct injection. Pancreatic duct injection, female sex, and younger age were associated with a higher risk. History of papillotomy was associated with lower risk only in the univariate analysis (all P values < 0.05). Conclusion: Chronic use of statins and aspirin appears to add no additional benefit to prevent ERCP pancreatitis. Rectal NSAIDs, and PDS after appropriate patient selection continue to be the main prophylactic measures. The lower incidence at our center compared with the reported data can be explained by the high rates of rectal indomethacin and PDS, the use of noninvasive diagnostic modalities for patient selection, and the expertise of the endoscopists.

2.
Article in English | MEDLINE | ID: mdl-35243113

ABSTRACT

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.

3.
J Gastrointest Cancer ; 53(2): 387-393, 2022 Jun.
Article in English | MEDLINE | ID: mdl-33683645

ABSTRACT

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.


Subject(s)
Carcinoma, Hepatocellular , Elasticity Imaging Techniques , Liver Neoplasms , Carcinoma, Hepatocellular/pathology , Elasticity Imaging Techniques/adverse effects , Humans , Liver/diagnostic imaging , Liver/pathology , Liver Cirrhosis/complications , Liver Cirrhosis/diagnosis , Liver Neoplasms/pathology , ROC Curve , Retrospective Studies
4.
Scand J Gastroenterol ; 56(12): 1467-1472, 2021 12.
Article in English | MEDLINE | ID: mdl-34465256

ABSTRACT

BACKGROUND: Emerging evidence suggests an association between acute pancreatitis and COVID-19. Our objective is to conduct a systematic review and meta-analysis to evaluate whether COVID-19 affects the severity and outcomes associated with acute pancreatitis. METHODS: Cochrane guidelines and PRISMA statement were followed for this review. Digital dissertation bases were searched and all studies comparing the outcomes of acute pancreatitis amongst patients with and without COVID-19 were included. We compared the etiology, severity, length of hospital stay and mortality associated with acute pancreatitis in patients with and without COVID-19. RESULTS: Four observational studies with a total of 2,419 patients were included in the review. Presence of COVID-19 significantly increased the odds of mortality (OR 4.10, 95% CI 2.03-8.29) in patients with acute pancreatitis. These patients also had an increased incidence of severe pancreatitis (OR 3.51, 95% CI 1.19-10.32), necrotizing pancreatitis (OR 1.84, 95% CI 1.19-2.85) and a longer length of hospital stay (OR 2.88, 95% CI 1.50-5.52), compared to non-COVID patients. Patients with COVID-19 were more likely to have an unknown or idiopathic etiology of acute pancreatitis (OR 4.02, 95% CI 1.32-12.29), compared to non-COVID-19 patients. CONCLUSION: Current evidence suggests that COVID-19 adversely impacts the morbidity and mortality associated with acute pancreatitis. SARS-CoV-2 may be a causative agent for acute pancreatitis. Further population-based studies are needed to confirm or refute these findings.


Subject(s)
COVID-19 , Pancreatitis , Acute Disease , Humans , Length of Stay , Pancreatitis/complications , SARS-CoV-2
5.
Eur J Gastroenterol Hepatol ; 33(1S Suppl 1): e71-e77, 2021 12 01.
Article in English | MEDLINE | ID: mdl-34284413

ABSTRACT

We aimed to conduct a systematic review and meta-analysis on the efficacy and safety of primary needle-knife fistulotomy (NFK) in biliary cannulation. An electronic bibliographic search of digital dissertation databases was performed from inception till March 2020. All prospective studies, including randomized trials evaluating the use of NFK as a primary cannulation technique in biliary cannulation, were analyzed. The primary outcome was a successful cannulation rate and the secondary outcomes were post-ERCP pancreatitis rate and overall post-ERCP complication rate. A total of four prospective studies, including three randomized trials, were included for the analysis. The pooled cannulation success rate for primary NFK was 95.7% (95% CI. 83.1-99.0, P < 0.001). When compared with standard wire-guided cannulation, the analysis did not show any difference between the two techniques in terms of cannulation success (OR, 3.59, 95% CI, 0.34-37.39; P = 0.28; low certainty of evidence). The overall rate of post-ERCP pancreatitis with primary NFK was 1.5 % (95% CI, 0.6-3.9, P < 0.001). When compared with conventional wire-guided technique, the odds of developing post-ERCP pancreatitis with NFK were 0.22 (95% CI, 0.04-1.04, P = 0.06; moderate certainty of evidence). To conclude, NKF seems to be an effective means of biliary cannulation in expert hands. Although it may be associated with a lower rate of post-ERCP pancreatitis, the current strength and quality of evidence to support its use as a primary cannulation strategy is low. It may be considered in ERCPs at higher risk of pancreatitis by experienced endoscopists.


Subject(s)
Pancreatitis , Sphincterotomy, Endoscopic , Catheterization/adverse effects , Catheterization/methods , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Cholangiopancreatography, Endoscopic Retrograde/methods , Humans , Pancreatitis/epidemiology , Pancreatitis/etiology , Prospective Studies , Sphincterotomy, Endoscopic/adverse effects
6.
Pancreas ; 50(5): 667-672, 2021.
Article in English | MEDLINE | ID: mdl-34106575

ABSTRACT

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.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Antibiotic Prophylaxis , Bacterial Infections/prevention & control , Endoscopic Ultrasound-Guided Fine Needle Aspiration/adverse effects , Pancreatic Cyst/pathology , Bacterial Infections/diagnosis , Bacterial Infections/microbiology , Humans , Risk Assessment , Risk Factors , Treatment Outcome
7.
Ann Gastroenterol ; 34(2): 241-246, 2021.
Article in English | MEDLINE | ID: mdl-33654366

ABSTRACT

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.

8.
J Gastrointest Cancer ; 52(2): 523-528, 2021 Jun.
Article in English | MEDLINE | ID: mdl-32405967

ABSTRACT

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.


Subject(s)
Liver Diseases/complications , Neoplasms/complications , Neoplasms/epidemiology , Adult , Aged , Carcinoma, Hepatocellular/pathology , Chicago/epidemiology , Female , Humans , Liver Neoplasms/complications , Liver Neoplasms/pathology , Male , Middle Aged , Neoplasms/pathology , Prognosis , Proportional Hazards Models , Risk Factors
9.
Dig Dis Sci ; 66(1): 247-256, 2021 01.
Article in English | MEDLINE | ID: mdl-32100160

ABSTRACT

BACKGROUND AND AIMS: The nature and outcomes of infection among patients with cirrhosis in safety-net hospitals are not well described. We aimed to characterize the rate of and risk factors for infection, both present on admission and nosocomial, in this unique population. We hypothesized that infections would be associated with adverse outcomes such as short-term mortality. METHODS: We used descriptive statistics to characterize infections within a retrospective cohort characterized previously. We used multivariable logistic regression models to assess potential risk factors for infection and associations with key outcomes such as short-term mortality and length of stay. RESULTS: The study cohort of 1112 patients included 33% women with a mean age of 56 ± 10 years. Infections were common (20%), with respiratory and urinary tract infections the most frequent. We did not observe a difference in the incidence of infection on admission based on patient demographic factors such as race/ethnicity or estimated household income. Infections on admission were associated with greater short-term mortality (12% vs 4% in-hospital and 14% vs 7% 30-day), longer length of stay (6 vs 3 days), intensive care unit admission (28% vs 18%), and acute-on-chronic liver failure (10% vs 2%) (p < 0.01 for all). Nosocomial infections were relatively uncommon (4%), but more frequent among patients admitted to the intensive care unit. Antibiotic resistance was common (38%), but not associated with negative outcomes. CONCLUSION: We did not identify demographic risk factors for infection, but did confirm its morbid effect among patients with cirrhosis in safety-net hospitals.


Subject(s)
Communicable Diseases/epidemiology , End Stage Liver Disease/epidemiology , Length of Stay/trends , Liver Cirrhosis/epidemiology , Safety-net Providers/trends , Aged , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/therapeutic use , Cohort Studies , Communicable Diseases/diagnosis , Communicable Diseases/drug therapy , Cross Infection/diagnosis , Cross Infection/drug therapy , Cross Infection/epidemiology , Drug Resistance, Multiple, Bacterial/drug effects , Drug Resistance, Multiple, Bacterial/physiology , End Stage Liver Disease/diagnosis , End Stage Liver Disease/drug therapy , Female , Hospital Mortality/trends , Hospitals, Urban/trends , Humans , Liver Cirrhosis/diagnosis , Liver Cirrhosis/drug therapy , Male , Middle Aged , Retrospective Studies , Risk Factors , Treatment Outcome
10.
J Gastroenterol Hepatol ; 36(6): 1479-1486, 2021 Jun.
Article in English | MEDLINE | ID: mdl-33351959

ABSTRACT

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.


Subject(s)
Adenoma/diagnosis , Adenoma/epidemiology , Colonoscopy , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/epidemiology , Delayed Diagnosis/adverse effects , Occult Blood , Adenoma/etiology , Colorectal Neoplasms/etiology , Female , Humans , Incidence , Male , Time Factors
11.
J Gastrointestin Liver Dis ; 29(1): 69-76, 2020 Mar 13.
Article in English | MEDLINE | ID: mdl-32176745

ABSTRACT

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.


Subject(s)
Gastrointestinal Hemorrhage/therapy , Hemostasis, Endoscopic/methods , Minerals/pharmacology , Upper Gastrointestinal Tract/pathology , Hemostatics/pharmacology , Humans , Treatment Outcome
12.
Clin Liver Dis (Hoboken) ; 15(1): 25-30, 2020 Jan.
Article in English | MEDLINE | ID: mdl-32104574

ABSTRACT

http://aasldpubs.onlinelibrary.wiley.com/hub/journal/10.1002/(ISSN)2046-2484/video/15-1-reading-attar a video presentation of this article.

13.
Dig Dis Sci ; 65(5): 1529-1538, 2020 05.
Article in English | MEDLINE | ID: mdl-31559551

ABSTRACT

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.


Subject(s)
Hospitalization/statistics & numerical data , Liver Abscess, Pyogenic/mortality , Liver Abscess, Pyogenic/therapy , Patient Acceptance of Health Care/statistics & numerical data , Safety-net Providers/statistics & numerical data , Adult , Aged , Aged, 80 and over , Databases, Factual , Drainage/mortality , Female , Hospital Mortality , Humans , Laparotomy/mortality , Liver Abscess, Pyogenic/etiology , Male , Middle Aged , Retrospective Studies , Risk Factors , Treatment Outcome , United States/epidemiology , Young Adult
14.
Eur J Gastroenterol Hepatol ; 32(2): 193-198, 2020 02.
Article in English | MEDLINE | ID: mdl-31851082

ABSTRACT

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.


Subject(s)
Crohn Disease , Gastroenterology , Adult , Crohn Disease/diagnosis , Crohn Disease/therapy , Educational Status , Evidence-Based Medicine , Humans , Sample Size , United States
15.
Ann Gastroenterol ; 32(6): 642-649, 2019.
Article in English | MEDLINE | ID: mdl-31700243

ABSTRACT

BACKGROUND: In 2012, the American Association for the Study of Liver Diseases published practice guidelines for the management of patients with ascites caused by cirrhosis, using data from randomized controlled trials (RCTs) and observational studies. We reexamined the strength of these RCTs by calculating the fragility index (FI), a novel metric proposed for evaluating the robustness of RCTs. METHODS: We screened all RCTs referenced in the guidelines for specific criteria. We calculated the FI and fragility quotient (FQ), and analyzed the correlation between FI and several variables. RESULTS: Twenty-one RCTs were included. The median (25th, 75th) FI and FQ were 1 (interquartile range [IQR] 0.5-6) and 0.070 (IQR 0.008-0.166), respectively. For studies that reported the number of patients lost to follow up (12 RCTs), the median of patients lost was 2 (IQR 0-6.5). There was no significant correlation between FI and sample size (rs=0.357), P-value (rs=-0.299), number lost to follow up (rs=0.355), Science Citation Index (rs=0.347), year of publication (rs=-0.085), blinding (rpb=-0.18) or number of centers (rpb=0.10). However, a significant correlation was seen between FI and number needed to treat (rs=-0.549; P=0.015). CONCLUSIONS: RCTs in the field of cirrhosis-related ascites are fragile. Of the 21 trials analyzed, 13 had an FI of 3 or below and these trials influenced 13 of the 49 recommendations in the guidelines. We recommend the incorporation of FI and FQ in addition to P-value to better understand the meaning of the results in gastroenterological studies.

16.
Cureus ; 11(7): e5082, 2019 Jul 04.
Article in English | MEDLINE | ID: mdl-31516791

ABSTRACT

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.

17.
Ann Gastroenterol ; 32(5): 489-497, 2019.
Article in English | MEDLINE | ID: mdl-31474796

ABSTRACT

BACKGROUND: Ursodeoxycholic acid (UDCA) and obeticholic acid are currently approved treatments for primary biliary cholangitis (PBC). Since some patients do not respond adequately to UDCA, other therapies, such as bezafibrate, have been developed. In this meta-analysis we evaluated the efficacy and safety of using both UDCA and bezafibrate in patients with an inadequate response to UDCA. METHODS: We evaluated all randomized controlled trials comparing the combination of UDCA and bezafibrate with UDCA monotherapy. Standardized mean difference (SMD) was used to assess the treatment effect of combination therapy compared with UDCA alone. RESULTS: Ten trials with a total of 369 patients were analyzed. UDCA and bezafibrate combination therapy was more effective than UDCA monotherapy in improving alanine aminotransferase (SMD -2.04, 95% confidence interval [CI] -3.30 to -0.79), alkaline phosphatase at both less than 12 months (SMD -3.63, 95%CI -6.43 to -0.84) and more than 12 months (SMD -2.33, 95%CI -4.03 to -0.63), gamma-glutamyltransferase (SMD -1.29, 95%CI -2.67 to 0.08), triglyceride (SMD -0.80, 95%CI -1.41 to -0.19), immunoglobulin M (SMD -1.48, 95%CI -2.39 to -0.56), and cholesterol (SMD -4.61, 95%CI -7.34 to -1.89). There was no difference between the 2 groups in bilirubin, aspartate aminotransferase or albumin. None of the adverse effects differed statistically between the 2 groups. CONCLUSION: UDCA and bezafibrate combined treatment is superior to UDCA alone in UDCA non-responders with regard to decreasing liver biochemistry markers, without any significant increase in side effects in patients with PBC.

18.
Dig Dis Sci ; 64(12): 3610-3615, 2019 12.
Article in English | MEDLINE | ID: mdl-31286346

ABSTRACT

BACKGROUND: Modified Marshall Score is one of the severity scores for acute pancreatitis (AP) and is included in the Revised Atlanta Classification, but given its utilization of a set serum creatinine level (sCr), it may misclassify stable patients with chronic kidney disease (CKD) to a more severe class just due to their elevated sCr. AIMS: Our study aims to evaluate the role of CKD in AP and the possibility of utilizing acute kidney injury (AKI) into developing a new scoring system. METHODS: We retrospectively reviewed the electronic medical records of three hundred consecutive patients who were diagnosed with AP during hospitalization. Multiple demographic variables and clinical course indices were collected. Univariate logistic regression was then applied to predict mortality and ICU admission. Finally, receiver operating curve was utilized to compare original versus New Revised Marshall Score. RESULTS: Two hundred and eight-four (284) patients had a definitive diagnosis of AP. When comparing patients who had AKI on admission to those without AKI, the AKI group showed statistically significant higher mortality rate (5.6% vs. 1.1%, p = 0.04). Finally, we substituted the renal part of Marshall Score with our AKIN and we plotted the New "Revised" Marshall Score, which showed a higher AUROC compared to the original modified version (C-statistics 0.93 vs. 0.89, p < 0.05). CONCLUSION: We found that AKI predicts mortality and outperforms the use of a fixed sCr value alone. The use of our New Revised Marshall Score can accurately classify AP severity, avoiding misclassification of AP severity and providing better patient care.


Subject(s)
Acute Kidney Injury/epidemiology , Pancreatitis/mortality , Renal Insufficiency, Chronic/epidemiology , Acute Kidney Injury/metabolism , Adult , Creatinine/metabolism , Female , Gallstones/complications , Humans , Hypertriglyceridemia/complications , Intensive Care Units/statistics & numerical data , Logistic Models , Male , Middle Aged , Mortality , Pancreatitis/etiology , Pancreatitis/metabolism , Pancreatitis, Alcoholic/metabolism , Pancreatitis, Alcoholic/mortality , Prognosis , ROC Curve , Renal Insufficiency, Chronic/metabolism , Retrospective Studies , Risk Assessment , Severity of Illness Index
19.
Cureus ; 11(2): e4139, 2019 Feb 26.
Article in English | MEDLINE | ID: mdl-31058022

ABSTRACT

A 49-year-old lady with no past medical history presented with dysphagia and 40-pound weight loss, which occurred over eight months. On physical examination, she had proximal muscle weakness and crackles in basilar regions of the lungs. Labs were significant for low albumin, elevated transaminases, and high aldolase. Imaging suggested aspiration pneumonitis in both lungs and hepatic steatosis. A swallow evaluation revealed oropharyngeal dysphagia and muscle biopsy confirmed a rare form of myositis. A liver biopsy showed steatohepatitis and a diagnosis of starvation-induced steatohepatitis was made. The patient succumbed to hypoxic respiratory failure from aspiration pneumonitis before the treatment for myositis could be initiated. We report the first case of starvation-induced steatohepatitis in a patient with dysphagia from myositis affecting the oropharyngeal musculature.

20.
PLoS One ; 14(3): e0211811, 2019.
Article in English | MEDLINE | ID: mdl-30840670

ABSTRACT

BACKGROUND: Safety-net hospitals provide care for racially/ethnically diverse and disadvantaged urban populations. Their hospitalized patients with cirrhosis are relatively understudied and may be vulnerable to poor outcomes and racial/ethnic disparities. AIMS: To examine the outcomes of patients with cirrhosis hospitalized at regionally diverse safety-net hospitals and the impact of race/ethnicity. METHODS: A study of patients with cirrhosis hospitalized at 4 safety-net hospitals in 2012 was conducted. Demographic, clinical factors, and outcomes were compared between centers and racial/ethnic groups. Study endpoints included mortality and 30-day readmission. RESULTS: In 2012, 733 of 1,212 patients with cirrhosis were hospitalized for liver-related indications (median age 55 years, 65% male). The cohort was racially diverse (43% White, 25% black, 22% Hispanic, 3% Asian) with cirrhosis related to alcohol and viral hepatitis in 635 (87%) patients. Patients were hospitalized mainly for ascites (35%), hepatic encephalopathy (20%) and gastrointestinal bleeding (GIB) (17%). Fifty-four (7%) patients died during hospitalization and 145 (21%) survivors were readmitted within 30 days. Mortality rates ranged from 4 to 15% by center (p = .007) and from 3 to 10% by race/ethnicity (p = .03), but 30-day readmission rates were similar. Mortality was associated with Model for End-stage Liver Disease (MELD), acute-on-chronic liver failure, hepatocellular carcinoma, sodium and white blood cell count. Thirty-day readmission was associated with MELD and Charlson Comorbidity Index >4, with lower risk for GIB. We did not observe geographic or racial/ethnic differences in hospital outcomes in the risk-adjusted analysis. CONCLUSIONS: Hospital mortality and 30-day readmission in patients with cirrhosis at safety-net hospitals are associated with disease severity and comorbidities, with lower readmissions in patients admitted for GIB. Despite geographic and racial/ethnic differences in hospital mortality, these factors were not independently associated with mortality.


Subject(s)
Ethnicity/statistics & numerical data , Hospitalization/statistics & numerical data , Liver Cirrhosis/pathology , Comorbidity , Female , Hospitals/statistics & numerical data , Humans , Male , Middle Aged , Patient Readmission/statistics & numerical data , Retrospective Studies , Safety-net Providers/statistics & numerical data
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