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Master's Dissertation
DOI
https://doi.org/10.11606/D.5.2021.tde-27082021-113651
Document
Author
Full name
Cesar Capel de Clemente Junior
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2021
Supervisor
Committee
Moura, Eduardo Guimarães Hourneaux de (President)
Figueira, Estela Regina Ramos
Franzini, Tomazo Antonio Prince
Torrez, Franz Robert Apodaca
Title in Portuguese
Comparação entre papilotomia endoscópica isolada versus associada à dilatação balonada da papila para remoção de cálculos do ducto biliar comum: revisão sistemática e metanálise baseada em ensaios clínicos randomizados
Keywords in Portuguese
Colangiopancreatografia retrógrada endoscópica
Coledocolitíase
Dilatação balonada da papila
Eventos adversos
Litotripsia/métodos
Metanálise
Revisão
Abstract in Portuguese
Introdução: coledocolitíase apresenta incidência estimada entre 5 a 10 % nos pacientes com colecistolitíase. A abordagem endoscópica tornouse a via terapêutica de escolha nesses casos. Porém cerca de 10% dos casos não alcançam eficácia plena pelos métodos convencionais, além disso, não é um procedimento isento de eventos adversos. Objetivo: comparar, a partir de revisão sistemática da literatura e subsequente metanálise de ensaios clínicos randomizados, a taxa de remoção de cálculos biliares e as incidências de sangramento, pancreatite, colangite, perfuração, necessidade de litotripsia mecânica e recorrência de coledocolitíase entre as modalidades: papilotomia isolada (PE) versus papilotomia associada à dilatação balonada da papila (P-DBP) na coledocolitíase. Métodos: realizou-se uma revisão sistemática a partir das bases de dados MedLine/PUBMED, Scopus, Biblioteca Cochrane, LILACS, banco de dados EMBASE e pesquisa manual através das referências dos artigos recuperados até fevereiro de 2020. A pesquisa de literatura foi restrita a ensaios clínicos randomizados. Os dados de eficácia e incidências de eventos adversos foram extraídos para a subsequente metanálise. A avaliação do efeito de tratamento e da heterogeneidade entre os estudos foi realizada através do método proposto por Higgins et al. (I²), com efeitos fixo e randômico, usando o software Review Manager 5.3. A diferença entre os desfechos foi calculada pela diferença de risco com efeito fixo para as variáveis dicotômicas. Resultados: doze ensaios clínicos randomizados com 2115 pacientes foram incluídos. P-DBP foi superior quanto às taxas de remoção completa de cálculos tanto na análise geral (p=0,005) quanto na análise de subgrupo com cálculos maiores que 10 mm (p=0,03). PE foi associada a maior taxa de sangramento pós-CPRE (p=0,05) e a maiores necessidades de litotripsia mecânica em geral (p=0,0005) e em subgrupos com cálculos maiores que 10 mm (p=0,005) e 15 mm (p=0.03). As incidências de pancreatite (p=0,51), colangite (p=0,97) e perfuração (p=0,23) foram estatisticamente similares entre os grupos. Conclusões: obteve-se que a papilotomia associada à dilatação ampla da papila apresentou maior taxa de remoção completa dos cálculos da via biliar comum tanto na análise geral quanto em subgrupo com cálculos maiores que 10 mm, além de apresentar menores taxas de sangramento pós-CPRE e menor necessidade de litotripsia mecânica em comparação à papilotomia isolada. As incidências de pancreatite, perfuração, colangite e recorrência de coledocolitíase foram similares entre os grupos
Title in English
Comparison between endoscopic sphincterotomy vs endoscopic sphincterotomy associated with balloon dilation for removal of common bile duct stones: systematic review and meta-analysis based on randomized controlled trial
Keywords in English
Adverse events
Cholangiopancreatography endoscopic retrograde
Choledocholithiasis
Large balloon dilation
Lithotripsy/methods
Meta-analysis
Review
Abstract in English
Background: choledocholithiasis has an estimated incidence of between 5 and 10% in patients with cholecystolithiasis. The endoscopic approach has become the therapeutic pathway of choice in these cases. However, about 10% of the cases do not reach full efficacy by conventional methods, moreover, it is not an adverse event-free procedure. Aim: to compare gallstones removal rate and incidence of bleeding, pancreatitis, cholangitis, perforation, use of mechanical lithotripsy and choledocholithiasis recurrence between isolated sphincterotomy (EST) versus sphincterotomy plus large balloon dilation of the papilla (ESBD) in choledocholithiasis through the meta-analysis of randomized clinical trials (RCT). Methods: a systematic review was conducted from the databases MedLine via PUBMED, Cochrane Library, Scopus, LILACS, EMBASE database and manual search through references of articles retrieved until February 2020. Literature research was restricted to randomized clinical trials. Efficacy data and incidences of adverse events were extracted for the subsequent meta-analysis. Treatment effect and heterogeneity of the studies were analyzed by the method proposed by Higgins et al., called I2 , with fixed (FE) and random effects (RE), using Review Manager software version 5.3. The difference between the outcomes was calculated by the risk difference with fixed effect for the dichotomous variables. Results: twelve RCTs with 2,115 patients were included. ESBD obtained higher rates for the complete removal of gallstones in general (p=0.005) and in subgroup analysis of stones greater than 10 mm (p=0.03). EST was associated with more post-ERCP bleeding (p=0.05) and more need of mechanical lithotripsy in general (p=0.0005) and in subgroup analysis of stones greater than 10 mm (p=0,005) and 15 mm (p=0.03). Incidence of pancreatitis (p=0.51), cholangitis (p=0.97) and perforation (p=0.23) was similar between the groups. Conclusion: ESBD presented better results regarding the primary outcome: complete removal of the common bile duct stones in general and in subgroup analysis with gallstones greater than 10 mm, in addition to presenting itself with lower rates of post-ERCP bleeding and less need for mechanical lithotripsy when compared to EST in the approach to remove gallstones. Incidence of pancreatitis, cholangitis, perforation and gallstones recurrence was similar between the groups
 
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Publishing Date
2021-08-27
 
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