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Adverse events associated with the gold probe and the injection gold probe devices used for endoscopic hemostasis:A MAUDE database analysis

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World Journal of Gastrointestinal Endoscopy 2024年第1期16卷 37-43页

作者： Vishnu Charan Suresh Kumar mark aloysius Ganesh Aswath Division of Gastroenterology and Hepatology SUNY Upstate Medical UniversitySyracuseNY 13202United States

BACKGROUND Gastrointestinal(GI)bleeding accounts for over half a million admissions annually and is the most common GI diagnosis requiring hospitalization in the United *** electrocoagulation devices are used for the management of gastrointestinal *** is no data on device-related adverse events for gold probe(GP)and injection gold probe(IGP).AIM To analyze this using the Food and Drug Administration(FDA’s)Manufacturer and User Facility Device Experience(MAUDE)database from 2013 to *** We examined post-marketing surveillance data on GP and IGP from the FDA MAUDE database to report devicerelated and patient-related adverse events between *** MAUDE database is a publicly available resource providing over 4 million records relating to medical device *** analyses were performed using IBM SPSS Statistics V.27.0(IBM Corp.,Armonk,NY,United States).RESULTS Our search elicited 140 reports for GP and 202 reports for IGP,respec-tively,during the study period from January 2013 to August *** reportedly occurred in 130 cases for GP,and actual patient injury or event occurred in 10 patients.A total of 149 patients(74%)reported with Injection GP events suffered no significant consequences due to the device failure,but 53 patients(26%)were affected by an *** GP and IGP are critical in managing gastrointestinal *** study of the FDA MAUDE database revealed the type,number,and trends of reported device-related adverse *** endoscopist and support staff must be aware of these device-related events and be equipped to manage them if they occur.

关键词： Hemostasis Gastrointestinal bleeding Endoscopy Device failure Bipolar coagulation Cautery Risks

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Advances in treatment and prevention of hepatitis B

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World Journal of Gastrointestinal Pharmacology and Therapeutics 2021年第4期12卷 56-78页

作者： Niraj James Shah mark M aloysius Neil Rohit Sharma Kumar Pallav Department of Internal Medicine Digestive DiseaseUniversity of Mississippi Medical CenterJacksonMS 39216United States Department of Internal Medicine The Wright Center for Graduate Medical EducationScrantonPA 18505United States Department of Internal Medicine Interventional Oncology and Surgical EndoscopyParkview Regional Medical CenterParkview Cancer InstituteFort WayneIN 46845United States

Chronic hepatitis B(CHB)continues to contribute to worldwide morbidity and mortality ***,clinicians,pharmaceutical companies,and health organizations have dedicated substantial Intellectual and monetary resources to finding a cure,increasing immunization rates,and reducing the global burden of *** and international health-related organizations including the center for disease control,the national institute of health,the American Association for the study of liver disease(AASLD),The European association for the study of the Liver(EASL),The Asia Pacific association for the study of the Liver(APASL)and the world health organization release periodic recommendations for disease prevention and *** review of the most recent guidelines by EASL,AASLD,APASL,and Taiwan Association for the Study of the Liver revealed that an overwhelming majority of cited studies were published before *** reviewed Hepatitis B-related literature published 2018 onwards to identify recent developments and current barriers that will likely direct future efforts towards eradicating hepatitis *** breakthrough in our understanding of the hepatitis B virus life cycle and resulting drug development is encouraging with significant room for further *** from high-risk populations,most vulnerable to the devastating effects of hepatitis B infection and reactivation remain *** of systems approach,optimization of experimental models,identification and validation of next-generation biomarkers,and precise modulation of the human immune response will be critical for future *** the foreseeable future,new treatments will likely complement conventional therapies rather than replace *** Importantly,pragmatic management of CHB related population health challenges must be prioritized to produce real-world results.

关键词： Chronic hepatitis B Hepatitis B virus Hepatitis B prevention Hepatitis B treatment Hepatitis B vaccination Hepatitis B reactivation

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Randomized, Placebo-Controlled Trial of Transdermal Rivastigmine for the Treatment of Encephalopathy in Liver Cirrhosis (TREC Trial)

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Open Journal of Gastroenterology 2014年第6期4卷 255-264页

作者： Patrick P. Basu Niraj James Shah mark M. aloysius Robert S. Brown Columbia University College of Physicians & Surgeons New York USA James J. Peters VA Medical Center New York USA King’s County Hospital New York USA

Objectives: Cognitive dysfunction in patients with hepatic encephalopathy (HE) may be caused by alterations in cholinergic neurotransmission. The objective of the study was to evaluate the efficacy and safety of transdermal rivastigmine in improving cognitive function in patients with overt HE. Design: Randomized, controlled pilot study in which patients with grade 2 or 3 HE were treated with lactulose and randomized to receive either transdermal rivastigmine or placebo for 21 days. The modified encephalopathy scale (MES), object recognition test (ORT), trail test (TT), and serum ammonia were assessed at baseline weekly. Electroencephalography was performed at baseline and the final week of the study. Results: Patients were treated with lactulose (20 g/30 mL three times per day) and either transdermal rivastigmine (4.6 mg/d;n = 15) or placebo (n = 15). Transdermal rivastigmine significantly improved MES, ORT, and TT results compared with placebo (P ≤ 0.0001 at all 3 weeks for all 3 assessments). Serum ammonia improved in both treatment groups, although there was significantly greater improvement with placebo than rivastigmine after 2 weeks of treatment (P What is already known about this subject? ? Current approaches to the management of HE are primarily designed to reduce the levels of ammonia and other gut-derived toxins. ? Traditional strategies for HE treatment have included non-absorbable disaccharides (to decrease bowel transit time) or rifamixin (non-absorbable antibiotics to reduce ammoniogenic flora). ? No transdermal cholinomimetic agents have been used with oral lactulose to date, in HE. What are the new findings? ? Transdermal rivastigmine is safe for use in patients with grade 2 & 3 HE. ? Transdermal rivastigmine in combination with oral lactulose in this study is far superior to lactulose alone in improving cognitive function. How might it impact on clinical practice in the foreseeable future? ? Transdermal rivastigmine in combination with oral lactulo

关键词： Acetylcholinesterase Cholinergic Function Hepatic Encephalopathy Rivastigmine

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The effect of melatonin in functional heartburn: A randomized, placebo-controlled clinical trial

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Open Journal of Gastroenterology 2014年第2期4卷 56-61页

作者： Patrick P. Basu Hemanth Hempole Nitya Krishnaswamy Niraj J. Shah mark M. aloysius Columbia University College of Physicians and Surgeons New York USA James J. Peters VA Medical Center Mount Sinai School of Medicine New York USA King’s County Hospital New York USA North Shore University Hospital at Forest Hills Forest Hills USA

Background: Melatonin is a safe and effective treatment for patients with functional pain and gastrointestinal disorders. Objective: To evaluate the efficacy and safety of melatonin for 3 months in patients with functional heartburn. Methods: In the randomized, placebo-controlled pilot study, patients with functional heartburn were treated with omeprazole 20 mg before breakfast and randomized to receive either melatonin 6 mg (n = 20), nortripty line 25 mg (n = 20), or placebo (n = 20) at bedtime for 3 months. Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQOL) scores were assessed at baseline and at the end of the study. Results: Melatonin improved GERD-HRQOL scores compared with nortriptyline (P = 0.0015) and placebo (P < 0.0001). Fewer adverse events were reported by patients receiving melatonin compared with those receiving nortriptyline or placebo. Conclusions: Melatonin was a safe and effective treatment for functional heartburn.

关键词： Melatonin Functional Heartburn Nortriptyline HRQOL

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Effect of Vitamin E and Alpha Lipoic Acid in Nonalcoholic Fatty Liver Disease: A Randomized, Placebo-Controlled, Open-Label, Prospective Clinical Trial (VAIN Trial)

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Open Journal of Gastroenterology 2014年第5期4卷 199-207页

作者： Patrick P. Basu Niraj J. Shah mark M. aloysius Robert S. Brown Jr. Columbia University College of Physicians and Surgeons New York USA James J. Peters VA Medical Center Mount Sinai School of Medicine New York USA King’s County Hospital New York USA

Objective: Antioxidants, including alpha lipoic acid (ALA) and vitamin E, are efficacious for the treatment of nonalcoholic fatty liver disease (NAFLD). The objective was to evaluate the effects of ALA and vitamin E alone or combined as therapy for patients with NAFLD and nonalcoholic steatohepatitis (NASH). Design: Placebo-controlled, open-label, prospective study in which patients with NAFLD and NASH were randomized to treatment with ALA 300 mg (n = 40), vitamin E 700 IU (n = 40), ALA 300 mg plus vitamin E 700 IU (n = 40), or placebo (n = 35) daily for 6 months. Body mass index, homeostasis model assessment scores, fibrosis and steatosis markers, and diagnostic laboratory tests were assessed at baseline and at the end of the study. Results: Treatment with ALA and vitamin E alone or in combination, improved inflammatory cytokine levels, steatosis scores, homeostasis model assessment scores, and triglyceride levels after 6 months relative to baseline. Conclusion: Alpha lipoic acid and vitamin E, either alone or in combination, were effective treatments for patients with NAFLD and NASH.

关键词： Antioxidant Liver Disease Vitamin E Alphalipoic Acid

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Effects of Metoclopramide Orally Disintegrating Tablet in Optimizing Late Outpatient Endoscopy: A Randomized Double-Blind Placebo-Controlled Clinical Trial

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Open Journal of Gastroenterology 2014年第4期4卷 187-191页

作者： Patrick P. Basu Niraj J. Shah Hemanth Hampole Nitya Krishnaswamy mark M. aloysius A Columbia University College of Physicians & Surgeons New York USA Forest Hills Hospital Forest Hills New York USA James Peters VA Medical Center New York USA Kings County Hospital Internal Medicine New York USA

Aims: Metoclopramide has been used as a gastro-kinetic agent but the safety and effects of different preparations of metoclopramide on preparation for outpatient endoscopy are largely unknown. The study aimed to evaluate the (1) Safety of using ODT (orally disintegrating tablet) or TT (traditional tablet) metoclopramide pre-endoscopy in non-fasting patients compared with placebo (2) Impact of ODT or TT metoclopramide on sedation and recovery times compared with placebo. Methods: A double blind randomized placebo-controlled trial with 3 arms;Metoclopramide ODT (n = 43), Metoclopramide TT (n = 43) and Placebo (n = 43). Results: Metoclopramide ODT had fewer adverse events compared with TT or placebo. Recovery time was significantly shorter with use of either metoclopramide versus placebo (P < 0.001) & total sedation time was also significantly shorter in the metoclopramide groups versus placebo (P < 0.001). Conclusion: Metoclopramide ODT is safe and beneficial in endoscopic procedures requiring limited access to food and liquid.

关键词： Metoclopramide ODT Endoscopy

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A Study on the Safety of Liver Biopsy Inpatients with Von Willebrand’s Disease

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Open Journal of Gastroenterology 2015年第9期5卷 134-138页

作者： Patrick P. Basu Niraj J. Shah mark M. aloysius K. Rayapudi Robert Brown Division of Digestive and Liver Diseases and Center for Liver Disease and Transplantation Columbia University Medical Center New York USA King’s County Hospital Medical Center New York USA Liver Transplant Center University of North Carolina School of Medicine Carolinas Medical Center Charlotte USA James J Peters VA Medical Center at Icahn School of Medicine at Mount Sinai New York USA

Objectives: Liver biopsy remains the gold standard for diagnosis of chronic liver diseases. Outpatient percutaneous biopsy is generally safe with a mortality rate of 0.17% and hospitalization rate for bleeding of 3%. Von Willebrand disease (vWD) syndrome is the most common inherited hematological disorder with a prevalence of 1% - 3% globally. We sought to study whether vWD increases the risk of bleeding for liver biopsies. Methods: All patients (n = 120) who underwent outpatient percutaneous liver biopsies from 1997 to 2007 were analyzed. Demographics, PT/INR, platelet count, vW antigen and ristocetin induced platelet aggregation were studied. Results: No vWD patients had major bleeding that required transfusion, hospitalization or surgery but 9 (75%) had minor local bleeding and all had ecchymosis, which resolved spontaneously within 24 hours. Conclusions: Patients with vW factor deficiency can undergo percutaneous liver biopsy without major bleeding. Minor bleeding may occur at a slightly higher rate. vWD is not a contraindication to percutaneous liver biopsy.

关键词： Liver Biopsy vW Disease Safety Complications

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Endoscopic retrograde cholangiopancreatography-related early perforations:A study of effects of procedure duration,complexity,and endoscopist experience

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World Journal of Gastrointestinal Endoscopy 2023年第11期15卷 641-648页

作者： mark aloysius Hemant Goyal Tejas Nikumbh Niraj James Shah Ghassan M Hammoud Pritesh Mutha Mairin Joseph-Talreja Savio John Ganesh Aswath Vaibhav Wadhwa Nirav Thosani Division of Gastroenterology Department of Internal MedicineSUNY Upstate Medical UniversitySyracuseNY13210United States Department of Surgery The University of Texas Health Science CenterHoustonTX 77030United States Department of Internal Medicine The Wright Center for Graduate Medical EducationScrantonPA 18510United States Department of Medicine Division of Digestive DiseasesThe University of Missouri at ColumbiaColumbiaMO 65211United States Division of Gastroenterology Department of Internal MedicineSUNY Upstate Medical UniversitySyracuseNY 13210United States

BACKGROUND Perforations(Perf)during endoscopic retrograde cholangiopancreatography(ERCP)are rare(<1%)but potentially fatal events(up to 20%mortality).Given its rarity,most data is through case series studies from centers or analysis of large *** a meta-analysis has shown fewer adverse events as a composite(bleeding,pancreatitis,Perf)during ERCP performed at high-volume centers,there is very little real-world data on endoscopist and center procedural volumes,ERCP duration and complexity on the occurrence of *** To study the profile of Perf related to ERCP by center and endoscopist procedure volume,ERCP time,and complexity from a national endoscopic *** from clinical outcomes research initiative-national endoscopic database(2000-2012)who underwent ERCP were stratified based on the endoscopist and center volume(quartiles),and total procedure duration and complexity grade of the ERCP based on procedure *** effects of these variables on the Perf that occurred were *** variables were compared between Perf and no perforations(NoPerf)using the Mann-Whitney U test as the data demonstrated significant skewness and *** A total of 14153 ERCPs were performed by 258 endoscopists,with 20 reported Perf(0.14%)among 16 *** patient age in years 61.6±14.8 vs 58.1±18.8(Perf ***,P=NS).The cannulation rate was 100%and 91.5%for Perf and NoPerf groups,respectively.13/20(65%)of endoscopists were high-volume performers in the 4th quartile,and 11/20(55%)of Perf occurred in centers with the highest volumes(4th quartile).Total procedure duration in minutes was 60.1±29.9 vs 40.33±23.5(Perf vs NoPerf,P<0.001).Fluoroscopy duration in minutes was 3.3±2.3 vs 3.3±2.6(Perf vs NoPerf P=NS).50%of the procedures were complex and greater than grade 1 difficulty.3/20(15%)patients had prior biliary surgery.13/20(65%)had sphincterotomies performed with stent *** occurred in only 1/20(0.5%).CONCLUSION

关键词： Endoscopic retrograde cholangiopancreatography Endoscopy complications Perforations

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Prehospital transdermal glyceryl trinitrate for ultra- acute ischaemic stroke: data from the RIGHT- 2 randomised sham- controlled ambulance trial

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Stroke & Vascular Neurology 2024年第1期9卷 38-49,I0035-I0046页

作者： Jason Philip Appleton Lisa J Woodhouse Craig S Anderson Sandeep Ankolekar Lesley Cala mark Dixon Timothy J England Kailash Krishnan Grant Mair Keith W Muir John Potter Christopher I Price Marc Randall Thompson G Robinson Christine Roffe Else C Sandset Jeffrey L Saver Angela Shone aloysius Niroshan Siriwardena Joanna M Wardlaw Nikola Sprigg Philip M Bath Stroke University Hospitals Birmingham NHS Foundation TrustBirminghamUK Institute of Applied HealthResearch University of Birmingham College of Medical and Dental SciencesBirminghamUK Stroke Trials Unit Mental Health and Clinical NeurosciencesUniversity of NottinghamNottinghamUK Faculty of Medicine The George Institute for Global HealthSydneyNew South WalesAustralia The George Institute China at Peking University Health Science Center BeijingChina Neurology Royal Prince Alfred HospitalSydney Health PartnersSydneyNew South WalesAustralia Department of Neurology King's College Hospital NHS Foundation TrustLondonUK Faculty of Health and Medical Sciences University of Western AustraliaCrawleyWestern AustraliaAustralia East Midlands Ambulance Service NHS Trust NottinghamUK Stroke Queen's Medical CentreNottingham University Hospitals NHS TrustNottinghamUK Centre for Clinical Brain Sciences Dementia Research InstituteUniveristy of EdinburghEdinburghUK Institute of Neurology and Psychology University of GlasgowGlasgowUK Bob Champion Research and Education Building University of East AngliaNorwichUK Institute of Neuroscience Newcastle UniversityNewcastle upon TyneUK Department of Neurology Leeds Teaching Hospitals NHS TrustLeedsUK Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre University of LeicesterLeicesterUK Stroke Research in Stoke Institute for Science and Technology in MedicineKeele UniversityStoke-on TrentUK Department of Neurology Oslo University HospitalOsloNorway Research and Development Norwegian Air Ambulance FoundationOsloNorway Department of Neurology and Comprehensive Stroke Center David Geffen School of MedicineUCLALos AngelesCaliforniaUSA Research and Graduate Services University of NottinghamNottinghamUK Community and Health Research Unit University of LincolnLincolnUK

Background The effect of transdermal glyceryl trinitrate(GTN,a nitrovasodilator)on clinical outcome when administered before hospital admission in suspected stroke patients is ***,we assess the safety and efficacy of GTN in the prespecified subgroup of patients who had an ischaemic stroke within the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2(RIGHT-2).Methods RIGHT-2 was an ambulance-based multicentre sham-controlled blinded-endpoint study with patients randomised within 4hours of *** primary outcome was a shift in scores on the modified Rankin scale(mRS)at day *** outcomes included death;a global analysis(Wei-Lachin test)containing Barthel Index,EuroQol-5D,mRS,telephone interview for cognitive status-modified and Zung depression scale;and neuroimaging-determined‘brain frailty’*** were reported as n(%),mean(SD),median[IQR],adjusted common OR(acOR),mean difference or Mann-Whitney difference(MWD)with 95%*** 597 of 1149(52%)patients had a final diagnosis of ischaemic stroke;age 75(12)years,premorbid mRS>2107(18%),Glasgow Coma Scale 14(2)and time from onset to randomisation 67[45,108]***‘brain frailty’was common:median score 2[2,3](range 0–3).At day 90,GTN did not influence the primary outcome(acOR for increased disability 1.15,95%CI 0.85 to 1.54),death or global analysis(MWD 0.00,95%CI-0.10 to 0.09).In subgroup analyses,there were non-significant interactions suggesting GTN may be associated with more death and dependency in participants randomised within 1hour of symptom onset and in those with more severe *** In patients who had an ischaemic stroke,ultra-acute administration of transdermal GTN in the ambulance did not improve clinical outcomes in a population with more clinical and radiological frailty than seen in previous in-hospital *** IS ALREADY KNOWN ON THIS TOPIC⇒Transdermal glyceryl trinitrate(GTN)was associat-ed with less death and dependency in those w

关键词： Glasgow nitrate random

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