Pure Cut or Endocut for Biliary Sphincterotomy? A Multicenter Randomized Clinical Trial

dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorFUNARI, Mateus Pereira
dc.contributor.authorBRUNALDI, Vitor Ottoboni
dc.contributor.authorPROENCA, Igor Mendonca
dc.contributor.authorGOMES, Pedro Victor Aniz
dc.contributor.authorQUEIROZ, Lucas Tobias Almeida
dc.contributor.authorVIEIRA, Yuri Zamban
dc.contributor.authorMATUGUMA, Sergio Eiji
dc.contributor.authorIDE, Edson
dc.contributor.authorFRANZINI, Tomazo Antonio Prince
dc.contributor.authorSANTOS, Marcos Eduardo Lera dos
dc.contributor.authorCHENG, Spencer
dc.contributor.authorMINATA, Mauricio Kazuyoshi
dc.contributor.authorSANTOS, Jose Sebastio dos
dc.contributor.authorMOURA, Diogo Turiani Hourneaux de
dc.contributor.authorKEMP, Rafael
dc.contributor.authorMOURA, Eduardo Guimares Hourneaux de
dc.date.accessioned2024-04-05T19:39:31Z
dc.date.available2024-04-05T19:39:31Z
dc.date.issued2023
dc.description.abstractINTRODUCTION: Adverse events (AE) after endoscopic retrograde cholangiopancreatography (ERCP) are not uncommon and post-ERCP acute pancreatitis (PEP) is the most important one. Thermal injury from biliary sphincterotomy may play an important role and trigger PEP or bleeding. Therefore, this study evaluated the outcomes of 2 electric current modes used during biliary sphincterotomy. METHODS: From October 2019 to August 2021, consecutive patients with native papilla undergoing ERCP with biliary sphincterotomy were randomized to either the pure cut or endocut after cannulation. The primary outcome was PEP incidence. Secondary outcomes included intraprocedural and delayed bleeding, infection, and perforation. RESULTS: A total of 550 patients were randomized (272 pure cut and 278 endocut). The overall PEP rate was 4.0% and significantly higher in the endocut group (5.8% vs 2.2%, P = 0.034). Univariate analysis revealed >5 attempts (P = 0.004) and endocut mode (P = 0.034) as risk factors for PEP. Multivariate analysis revealed >5 attempts (P = 0.005) and a trend for endocut mode as risk factors for PEP (P = 0.052). Intraprocedural bleeding occurred more often with pure cut (P = 0.018), but all cases were controlled endoscopically during the ERCP. Delayed bleeding was more frequent with endocut (P = 0.047). There was no difference in perforation (P = 1.0) or infection (P = 0.4999) between the groups. DISCUSSION: Endocut mode may increase thermal injury leading to higher rates of PEP and delayed bleeding, whereas pure cut is associated with increased intraprocedural bleeding without clinical repercussion. The electric current mode is not related to perforation or infection. Further RCT assessing the impact of electric current on AE with overlapping preventive measures such as rectal nonsteroidal anti-inflammatory drugs and hyperhydration are needed. The study was submitted to the Brazilian Clinical Trials Platform (http://www.ensaiosclinicos.gov.br) under the registry number RBR-5d27tn.eng
dc.description.indexMEDLINE
dc.description.indexPubMed
dc.description.indexScopus
dc.description.indexDimensions
dc.description.indexWoS
dc.identifier.citationAMERICAN JOURNAL OF GASTROENTEROLOGY, v.118, n.10, p.1871-1879, 2023
dc.identifier.doi10.14309/ajg.0000000000002458
dc.identifier.eissn1572-0241
dc.identifier.issn0002-9270
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/59200
dc.language.isoeng
dc.publisherLIPPINCOTT WILLIAMS & WILKINSeng
dc.relation.ispartofAmerican Journal of Gastroenterology
dc.rightsrestrictedAccesseng
dc.rights.holderCopyright LIPPINCOTT WILLIAMS & WILKINSeng
dc.subjectERCPeng
dc.subjectelectric currenteng
dc.subjectendocuteng
dc.subjectpancreatitis/PEPeng
dc.subjectpure cuteng
dc.subject.otherendoscopic retrograde cholangiopancreatographyeng
dc.subject.otherrisk-factorseng
dc.subject.othereuropean-societyeng
dc.subject.otherercpeng
dc.subject.othercomplicationseng
dc.subject.othermodeeng
dc.subject.othermanagementeng
dc.subject.otherelectrosurgeryeng
dc.subject.otherpancreatitiseng
dc.subject.otherperforationseng
dc.subject.wosGastroenterology & Hepatologyeng
dc.titlePure Cut or Endocut for Biliary Sphincterotomy? A Multicenter Randomized Clinical Trialeng
dc.typearticleeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng
dspace.entity.typePublication
hcfmusp.author.externalBRUNALDI, Vitor Ottoboni:Fac Med Ribeirao Preto, Div Gastrointestinal Surg, Surg & Anat Dept, Ribeirao Preto, Brazil
hcfmusp.author.externalQUEIROZ, Lucas Tobias Almeida:Fac Med Ribeirao Preto, Div Gastrointestinal Surg, Surg & Anat Dept, Ribeirao Preto, Brazil
hcfmusp.author.externalVIEIRA, Yuri Zamban:Fac Med Ribeirao Preto, Div Gastrointestinal Surg, Surg & Anat Dept, Ribeirao Preto, Brazil
hcfmusp.author.externalSANTOS, Jose Sebastio dos:Fac Med Ribeirao Preto, Div Gastrointestinal Surg, Surg & Anat Dept, Ribeirao Preto, Brazil
hcfmusp.author.externalKEMP, Rafael:Fac Med Ribeirao Preto, Div Gastrointestinal Surg, Surg & Anat Dept, Ribeirao Preto, Brazil
hcfmusp.citation.scopus1
hcfmusp.contributor.author-fmusphcMATEUS PEREIRA FUNARI
hcfmusp.contributor.author-fmusphcIGOR MENDONCA PROENCA
hcfmusp.contributor.author-fmusphcPEDRO VICTOR ANIZ GOMES DE OLIVEIRA
hcfmusp.contributor.author-fmusphcSERGIO EIJI MATUGUMA
hcfmusp.contributor.author-fmusphcEDSON IDE
hcfmusp.contributor.author-fmusphcTOMAZO ANTONIO PRINCE FRANZINI
hcfmusp.contributor.author-fmusphcMARCOS EDUARDO LERA DOS SANTOS
hcfmusp.contributor.author-fmusphcSPENCER CHENG
hcfmusp.contributor.author-fmusphcMAURICIO KAZUYOSHI MINATA
hcfmusp.contributor.author-fmusphcDIOGO TURIANI HOURNEAUX DE MOURA
hcfmusp.contributor.author-fmusphcEDUARDO GUIMARAES HOURNEAUX DE MOURA
hcfmusp.description.beginpage1871
hcfmusp.description.endpage1879
hcfmusp.description.issue10
hcfmusp.description.volume118
hcfmusp.origemWOS
hcfmusp.origem.dimensionspub.1163075716
hcfmusp.origem.scopus2-s2.0-85173568348
hcfmusp.origem.wosWOS:001141819600032
hcfmusp.publisher.cityPHILADELPHIAeng
hcfmusp.publisher.countryUSAeng
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