2024
Protocol for the development of a core outcome set for clinical trials in primary sclerosing cholangitis
Hussain N, Ma C, Hirschfield G, Walmsley M, Hanford P, Vesterhus M, Kowdley K, Bergquist A, Ponsioen C, Levy C, Assis D, Schramm C, Bowlus C, Trauner M, Aiyegbusi O, Jairath V, Trivedi P. Protocol for the development of a core outcome set for clinical trials in primary sclerosing cholangitis. BMJ Open 2024, 14: e080143. PMID: 38926149, PMCID: PMC11216047, DOI: 10.1136/bmjopen-2023-080143.Peer-Reviewed Original ResearchMeSH KeywordsCholangitis, SclerosingClinical Trials as TopicDelphi TechniqueEndpoint DeterminationHumansOutcome Assessment, Health CareResearch DesignSystematic Reviews as TopicConceptsPrimary sclerosing cholangitisClinical trialsSclerosing cholangitisCore outcome setImmune-mediated liver diseasesPrimary sclerosing cholangitis treatmentOutcome measuresEvaluate novel therapiesSlow disease progressionPatient-reported outcome measuresMedical therapyNovel therapiesLiver fibrosisDisease progressionHistological assessmentLiver diseaseInternational two-round Delphi surveyImaging-based biomarkersIntervention trialsTherapyConsensus meetingHealthcare payersCholangitisSemistructured qualitative interviewsTwo-round Delphi surveyAfrican American race does not confer an increased risk of clinical events in patients with primary sclerosing cholangitis.
Yazdanfar M, Zepeda J, Dean R, Wu J, Levy C, Goldberg D, Lammert C, Prenner S, Reddy K, Pratt D, Forman L, Assis D, Lytvyak E, Montano-Loza A, Gordon S, Carey E, Ahn J, Schlansky B, Korzenik J, Karagozian R, Hameed B, Chandna S, Yu L, Bowlus C. African American race does not confer an increased risk of clinical events in patients with primary sclerosing cholangitis. Hepatology Communications 2024, 8 PMID: 38285883, PMCID: PMC10830082, DOI: 10.1097/hc9.0000000000000366.Peer-Reviewed Original ResearchMeSH KeywordsBlack or African AmericanCholangitis, SclerosingDelayed DiagnosisEnd Stage Liver DiseaseHumansInflammatory Bowel DiseasesRetrospective StudiesSeverity of Illness IndexConceptsPrimary sclerosing cholangitisTransplant-free survivalInflammatory bowel diseaseHepatic decompensationNon-Hispanic whitesSclerosing cholangitisIncreased risk of clinical eventsNatural history of primary sclerosing cholangitisAssociated with transplant-free survivalHistory of primary sclerosing cholangitisAssociated with hepatic decompensationBowel diseaseProgression to hepatic decompensationRisk of clinical eventsDecompensation-free survivalMayo risk scoreAbnormal liver testsPerformance of prognostic modelsAfrican American raceRates of inflammatory bowel diseaseDeath/liver transplantationAA patientsLiver testsDiagnostic delayAA race
2023
Recent Advances in the Management of Primary Sclerosing Cholangitis
Assis D, Bowlus C. Recent Advances in the Management of Primary Sclerosing Cholangitis. Clinical Gastroenterology And Hepatology 2023, 21: 2065-2075. PMID: 37084929, DOI: 10.1016/j.cgh.2023.04.004.Peer-Reviewed Original ResearchMeSH KeywordsBile Duct NeoplasmsBile Ducts, IntrahepaticCholangiocarcinomaCholangitis, SclerosingCholestasisHumansConceptsChronic cholestatic liver diseasePrimary sclerosing cholangitisInflammatory bowel diseasePrognostication of patientsCholestatic liver diseaseSclerosing cholangitisBowel diseaseLiver failureClinical featuresLiver diseaseMedical managementBiliary treeComplex pathophysiologyEffective therapyPharmacologic agentsRare natureCurrent conceptsDiseaseCholangitisFurther studiesCholangiocarcinomaPatientsPathophysiologyTherapyPrognosticationReply: Insurance should cover vancomycin for primary sclerosing cholangitis
Bowlus C, Arrivé L, Bergquist A, Deneau M, Forman L, Ilyas S, Lunsford K, Martinez M, Sapisochin G, Shroff R, Tabibian J, Assis D. Reply: Insurance should cover vancomycin for primary sclerosing cholangitis. Hepatology 2023, 77: e176-e177. PMID: 36695291, DOI: 10.1097/hep.0000000000000305.Peer-Reviewed Original ResearchOutcomes of immunomodulator and advanced therapies for primary sclerosing cholangitis-associated inflammatory bowel disease
Sayed A, Assis D, Silveira M, Deng Y, Ciarleglio M, Gaidos J, Proctor D, Al-Bawardy B. Outcomes of immunomodulator and advanced therapies for primary sclerosing cholangitis-associated inflammatory bowel disease. European Journal Of Gastroenterology & Hepatology 2023, 35: 270-274. PMID: 36708297, DOI: 10.1097/meg.0000000000002510.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultCholangitisCholangitis, SclerosingFemaleHumansImmunologic FactorsInflammatory Bowel DiseasesMaleMiddle AgedRetrospective StudiesRisk FactorsConceptsPrimary sclerosing cholangitisInflammatory bowel diseasePSC-IBDEndoscopic healingTherapy groupAdvanced therapiesClinical remissionBowel diseaseAcute ascending cholangitisRate of cholangitisSmall bowel involvementThird of patientsAscending cholangitisSclerosing cholangitisAdult patientsBowel involvementSecondary outcomesMedian agePrimary outcomeRetrospective studyHigh riskCholangitisPatientsTherapyLarger studyReply: Living donor liver transplantation for people with PSC
Forman L, Sapisochin G, Assis D, Arrivé L, Bergquist A, Bowlus C, Deneau M, Ilyas S, Lunsford K, Martinez M, Shroff R, Tabibian J. Reply: Living donor liver transplantation for people with PSC. Hepatology 2023, 77: e97-e98. PMID: 36732294, DOI: 10.1097/hep.0000000000000210.Peer-Reviewed Original Research
2022
AASLD practice guidance on primary sclerosing cholangitis and cholangiocarcinoma
Bowlus CL, Arrivé L, Bergquist A, Deneau M, Forman L, Ilyas SI, Lunsford KE, Martinez M, Sapisochin G, Shroff R, Tabibian JH, Assis DN. AASLD practice guidance on primary sclerosing cholangitis and cholangiocarcinoma. Hepatology 2022, 77: 659-702. PMID: 36083140, DOI: 10.1002/hep.32771.Peer-Reviewed Original Research
2021
Oral Vancomycin or Ursodeoxycholic Acid for Pediatric Primary Sclerosing Cholangitis? The Uncontroversial Need for Randomized Controlled Trials
Assis DN, Levy C. Oral Vancomycin or Ursodeoxycholic Acid for Pediatric Primary Sclerosing Cholangitis? The Uncontroversial Need for Randomized Controlled Trials. Hepatology 2021, 73: 887-889. PMID: 33403699, DOI: 10.1002/hep.31702.Peer-Reviewed Original ResearchMeSH KeywordsChildCholagogues and CholereticsCholangitis, SclerosingHumansRandomized Controlled Trials as TopicUrsodeoxycholic AcidVancomycin
2020
Fenofibrate Improves Liver Function and Reduces the Toxicity of the Bile Acid Pool in Patients With Primary Biliary Cholangitis and Primary Sclerosing Cholangitis Who Are Partial Responders to Ursodiol
Ghonem NS, Auclair AM, Hemme CL, Gallucci GM, de la Rosa Rodriguez R, Boyer JL, Assis DN. Fenofibrate Improves Liver Function and Reduces the Toxicity of the Bile Acid Pool in Patients With Primary Biliary Cholangitis and Primary Sclerosing Cholangitis Who Are Partial Responders to Ursodiol. Clinical Pharmacology & Therapeutics 2020, 108: 1213-1223. PMID: 32480421, PMCID: PMC7886378, DOI: 10.1002/cpt.1930.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBile Acids and SaltsBiomarkersCholangitis, SclerosingCytokinesDrug Therapy, CombinationFemaleFenofibrateHumansInflammation MediatorsLiverLiver Cirrhosis, BiliaryLiver Function TestsMaleMiddle AgedPPAR alphaPrincipal Component AnalysisRetrospective StudiesTreatment OutcomeUrsodeoxycholic AcidYoung AdultConceptsPrimary sclerosing cholangitisPrimary biliary cholangitisBile acid metabolismSclerosing cholangitisBiliary cholangitisBile acidsAcid metabolismPeroxisome proliferator-activated receptor alphaProliferator-activated receptor alphaRetrospective observational studyBeneficial clinical effectsCholestatic liver diseasePro-inflammatory cytokinesBile acid metabolitesHealthy control subjectsBile acid poolSerum alkaline phosphataseAminotransferase abnormalitiesUrsodiol therapyFenofibrate therapyPartial respondersBile acid precursorsClinical effectsFenofibrate treatmentLiver diseaseMachine Learning in a Complex Disease: PREsTo Improves the Prognostication of Primary Sclerosing Cholangitis
Shung DL, Assis DN. Machine Learning in a Complex Disease: PREsTo Improves the Prognostication of Primary Sclerosing Cholangitis. Hepatology 2020, 71: 8-10. PMID: 31850533, DOI: 10.1002/hep.31069.Commentaries, Editorials and Letters
2019
Bile‐Derived Organoids From Patients With Primary Sclerosing Cholangitis Recapitulate Their Inflammatory Immune Profile
Soroka CJ, Assis DN, Alrabadi LS, Roberts S, Cusack L, Jaffe AB, Boyer JL. Bile‐Derived Organoids From Patients With Primary Sclerosing Cholangitis Recapitulate Their Inflammatory Immune Profile. Hepatology 2019, 70: 871-882. PMID: 30561836, DOI: 10.1002/hep.30470.Peer-Reviewed Original ResearchMeSH KeywordsAdultBileCholangiopancreatography, Endoscopic RetrogradeCholangitis, SclerosingCytokinesFemaleFluorescent Antibody TechniqueGene Expression RegulationGenome-Wide Association StudyHumansImaging, Three-DimensionalMaleMiddle AgedOrganoidsRegistriesSensitivity and SpecificitySignal TransductionStem CellsTissue Culture TechniquesConceptsPSC patientsTumor necrosis factor alphaEpithelial cellular adhesion moleculePrimary sclerosing cholangitisChemokine ligand 20End-stage diseaseEndoscopic retrograde cholangiopancreatographyHuman leukocyte antigenT cell chemoattractantNecrosis factor alphaCellular adhesion moleculesGamma-glutamyl transferaseImmune-related genesSclerosing cholangitisClinical courseImmune profileInterleukin-17AProinflammatory mediatorsRetrograde cholangiopancreatographyLeukocyte antigenAnion exchanger 2Factor alphaInflammatory stimuliEffective treatmentBiliary-like cellsThe Contribution of B Cells in Autoimmune Liver Diseases
Taylor SA, Assis DN, Mack CL. The Contribution of B Cells in Autoimmune Liver Diseases. Seminars In Liver Disease 2019, 39: 422-431. PMID: 31226726, PMCID: PMC6800599, DOI: 10.1055/s-0039-1688751.BooksConceptsAutoimmune liver diseaseT cell activationB cellsLiver diseaseT cellsCell activationB-cell mechanismsRegulatory T cellsProduction of autoantibodiesAutoreactive T cellsAutoreactive B cellsGeneration of cytokinesAutoimmune hepatitisCell mechanismsAntigen presentationDisease pathogenesisAutoantibodiesDiseaseCellsActivationVast majorityHepatitisCholangiopathyAutoimmunityCytokinesEffects of Vedolizumab in Patients With Primary Sclerosing Cholangitis and Inflammatory Bowel Diseases
Lynch KD, Chapman RW, Keshav S, Montano-Loza AJ, Mason AL, Kremer AE, Vetter M, de Krijger M, Ponsioen CY, Trivedi P, Hirschfield G, Schramm C, Liu CH, Bowlus CL, Estes DJ, Pratt D, Hedin C, Bergquist A, de Vries AC, van der Woude CJ, Yu L, Assis DN, Boyer J, Ytting H, Hallibasic E, Trauner M, Marschall HU, Daretti LM, Marzioni M, Yimam KK, Perin N, Floreani A, Beretta-Piccoli BT, Rogers JK, Group I, Levy C. Effects of Vedolizumab in Patients With Primary Sclerosing Cholangitis and Inflammatory Bowel Diseases. Clinical Gastroenterology And Hepatology 2019, 18: 179-187.e6. PMID: 31100458, PMCID: PMC6941216, DOI: 10.1016/j.cgh.2019.05.013.Peer-Reviewed Original ResearchConceptsPrimary sclerosing cholangitisInflammatory bowel diseaseEffect of vedolizumabSerum levelsLast followSclerosing cholangitisBowel diseaseStudy groupInternational PSC Study GroupAlkaline phosphataseLiver-related eventsLiver-related outcomesPresence of cirrhosisProportion of patientsSubset of patientsMedian serum levelsAnalysis of patientsInternational Study GroupLarge international cohortNorth American centersBacterial cholangitisCirrhosis decompensationEntire cohortClinical dataIntegrin α4β7Patient-Derived Organoids from Human Bile: An In Vitro Method to Study Cholangiopathies
Soroka CJ, Assis DN, Boyer JL. Patient-Derived Organoids from Human Bile: An In Vitro Method to Study Cholangiopathies. Methods In Molecular Biology 2019, 1981: 363-372. PMID: 31016667, DOI: 10.1007/978-1-4939-9420-5_24.BooksConceptsPrimary sclerosing cholangitisPrimary sclerosing cholangitis patientsEndoscopic retrograde cholangiopancreatographySclerosing cholangitisCholangitis patientsRetrograde cholangiopancreatographyExtrahepatic bile duct epitheliumTherapeutic endoscopic retrograde cholangiopancreatographyChemo/cytokinesEnd-stage diseaseBile duct epitheliumPatient-derived organoidsPharmacotherapeutic treatmentClinical indicationsIndividual patientsInflammatory stimuliHeterogeneous diseaseBiliary phenotypeDuct epitheliumDisease statusCholangitisCholangiopathyHuman bileBiliary cellsPatients
2017
Primary Sclerosing Cholangitis Is Not Rare Among Blacks in a Multicenter North American Consortium
Goldberg DS, Levy C, Yimam K, Gordon SC, Forman L, Verna E, Yu L, Rahimi R, Schwarz K, Eksteen B, Pratt D, Boyer JL, Assis D, Bowlus C. Primary Sclerosing Cholangitis Is Not Rare Among Blacks in a Multicenter North American Consortium. Clinical Gastroenterology And Hepatology 2017, 16: 591-593. PMID: 29102704, PMCID: PMC5860952, DOI: 10.1016/j.cgh.2017.10.028.Peer-Reviewed Original ResearchCombination Therapy of All-Trans Retinoic Acid With Ursodeoxycholic Acid in Patients With Primary Sclerosing Cholangitis
Assis DN, Abdelghany O, Cai SY, Gossard AA, Eaton JE, Keach JC, Deng Y, Setchell KD, Ciarleglio M, Lindor KD, Boyer JL. Combination Therapy of All-Trans Retinoic Acid With Ursodeoxycholic Acid in Patients With Primary Sclerosing Cholangitis. Journal Of Clinical Gastroenterology 2017, 51: e11-e16. PMID: 27428727, PMCID: PMC5218875, DOI: 10.1097/mcg.0000000000000591.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAlanine TransaminaseAlkaline PhosphataseBile Acids and SaltsCholagogues and CholereticsCholangitis, SclerosingCholestenonesDrug Therapy, CombinationFemaleHumansLiverLiver Function TestsMaleMiddle AgedPilot ProjectsTreatment OutcomeTretinoinUrsodeoxycholic AcidYoung AdultConceptsPrimary sclerosing cholangitisUrsodeoxycholic acidAlanine aminotransferaseUDCA monotherapyPrimary endpointSclerosing cholangitisMedian serum alanine aminotransferasePilot studyWeeks of therapyMarkers of inflammationSerum alanine aminotransferaseRetinoic acidAlkaline phosphataseAll-Trans Retinoic AcidSerum ALP levelsHuman pilot studyCombination of ATRAAddition of ATRABile acid synthesisTrans retinoic acidExploratory pilot studyALT levelsAccepted therapyWeek 12C4 levels
2015
Editorial: environmental risk factors for PSC with and without IBD – the story unfolds
Assis DN, Levy C. Editorial: environmental risk factors for PSC with and without IBD – the story unfolds. Alimentary Pharmacology & Therapeutics 2015, 41: 1214-1216. PMID: 25939466, DOI: 10.1111/apt.13186.Commentaries, Editorials and Letters