ABSTRACT
ABSTRACT Background: Common bile duct (CBD) stones are known to complicate 10-15% of gallstone diseases. Endoscopic retrograde cholangiopancreatography (ERCP) is the therapeutic modality of choice for bile duct clearance in CBD stones but may fail to achieve stone clearance. This prospective study was done to identify the predictors of failure of CBD clearance with ERCP. Objective: This prospective study was done to identify the predictors of failure of CBD clearance with ERCP. Methods: All consecutive patients with bile duct stones undergoing ERCP at a tertiary care center were prospectively included from October 2020 to October 2021. The study's primary outcome was to identify and analyze factors that could predict the failure of complete CBD clearance. Results: A total of 120 patients (50.8% males, median age: 53.5 years) were included in the final analysis. Successful clearance of CBD stones during the index procedure was achieved in 70% of patients. At a cut-off stone diameter of >10.5 mm and CBD diameter of >12.5 mm, the AUC was 0.890 and 0.884, respectively, to predict failed clearance of CBD. On multivariate analysis, stone diameter ≥15 mm [odds ratio (OR) 16.97, 95% confidence interval (CI): 1.629-176.785], location of stones in hepatic ducts (OR 7.74, 95%CI: 2.041-29.332), presence of stricture distal to stone (OR 6.99, 95%CI: 1.402-34.726) and impacted stone (OR 21.61, 95%CI: 1.84-253.058) were independent predictors of failed bile duct clearance. Conclusion: Stone size and location are independent predictors of failed bile duct clearance. The endoscopist should consider these factors while subjecting a patient to biliary ductal clearance to plan additional intervention.
RESUMO Contexto: Cálculos do ducto biliar comum (CDC) são conhecidos por complicar 10-15% das doenças de cálculos biliares. A colangiopancreatografia retrógrada endoscópica (CPRE) é a modalidade terapêutica de escolha para a limpeza do CDC, mas pode falhar na sua remoção. Objetivo: Este estudo prospectivo foi realizado para identificar os previsores de falha na limpeza do CDC com CPRE. Métodos: Pacientes consecutivos com cálculos no ducto biliar submetidos a CPRE em um centro de atendimento terciário foram incluídos prospectivamente de outubro de 2020 a outubro de 2021. O principal resultado do estudo foi identificar e analisar fatores que poderiam prever a falha na limpeza completa do CDC. Resultados: Um total de 120 pacientes (50,8% homens, idade média: 53,5 anos) foram incluídos na análise final. A limpeza bem-sucedida dos cálculos de CDC durante o procedimento inicial foi alcançada em 70% dos pacientes. Com um diâmetro de corte de cálculos >10,5 mm e de diâmetro de CDC de >12,5 mm, a AUC foi de 0,890 e 0,884, respectivamente, para prever a falha na limpeza do CDC. Na análise multivariada, diâmetro da cálculos ≥15 mm [razão de chances (OR) 16,97, intervalo de confiança de 95% (IC): 1,629-176,785], localização dos cálculos nos ductos hepáticos (OR 7,74, IC95%: 2,041-29,332), presença de estreitamento distal ao cálculo (OR 6,99, IC95%: 1,402-34,726) e cálculo impactado (OR 21,61, IC95%: 1,84-253,058) foram previsores independentes de falha na limpeza do ducto biliar. Conclusão: O tamanho e a localização dos cálculos são previsores independentes de falha na limpeza do ducto biliar. O endoscopista deve considerar esses fatores ao submeter um paciente à limpeza ductal biliar para planejar intervenção adicional.
ABSTRACT
Resumen Introducción: cerca del 10% al 15% de los pacientes con coledocolitiasis presentan cálculos gigantes, definidos como aquellos que miden más de 10 mm a 15 mm. La extracción de estos puede ser problemática, aun para endoscopistas experimentados. Casi todos los pacientes con esta patología pueden ser tratados endoscópicamente, y la mayoría de los cálculos son removidos con la realización de esfinterotomía (EFT), litotripsia mecánica (LM) o dilatación papilar con balón grande (DPBG). La DPBG ha demostrado ser efectiva en el manejo del cálculo gigante y disminuye la necesidad de LM. Objetivos: determinar la prevalencia de coledocolitiasis gigante en el Hospital Universitario de la Samaritana (HUS) entre el 2009 y el 2014, la frecuencia de éxito endoscópico y la necesidad de manejo quirúrgico, además de evaluar los factores asociados con el uso de litotripsia en casos de cálculos gigantes de la vía biliar. Materiales y métodos: el presente es un estudio de casos y controles de pacientes con cálculos gigantes, definidos como cálculos mayores de 10 mm en pacientes llevados a colangiopancreatografía retrógrada endoscópica (CPRE) en el HUS entre 2009 y 2014. Los casos fueron los pacientes a quienes se les realizó litotripsia y, los controles, quienes no requirieron este procedimiento. Los resultados se presentan como medias o medianas, y se indican sus respectivas medidas de dispersión para las variables continuas, según pruebas de normalidad o como frecuencias y porcentajes para las variables categóricas. Se realizó un análisis de regresión logística con el principal objetivo de determinar los factores asociados con litotripsia, en el que se incluyeron las variables biológicamente plausibles o que, estadísticamente, mostraron diferencias en el análisis bivariado (p<0,200). Los resultados se presentan como odds ratios (oportunidad relativa) ajustados (ORA). Resultados: entre 2009 y 2014, se realizaron un total de 1403 CPRE, de las cuales 198 (14,1%) tuvieron presencia de cálculos gigantes. Fue más frecuente la coledocolitiasis gigante en el sexo femenino que en el masculino. La edad promedio de los pacientes fue de 66,6 años. El diámetro promedio del colédoco fue de 18 mm, y el diámetro promedio de los cálculos fue de 18 mm. Al 99% de los pacientes se les realizo EFT, el 28% requirió LM, al 48% se les realizo DPBG, el 5,5% requirió LM y DPBG, y el 30,8% requirió el avance de prótesis biliar y más de una CPRE para la resolución de la coledocolitiasis. En el 89,9% de los casos, el manejo endoscópico fue exitoso. El 10,1% requirió cirugía. En el 9,0% de los casos, se presentaron complicaciones (6 pancreatitis, 7 sangrados, 2 impactaciones de canastilla y 1 perforación). En el análisis bivariado, la DPBG fue un factor protector del requerimiento de LM (ORA 0,07-IC del 95% 0,025-0,194), y el tamaño del colédoco es un predictor del requerimiento de LM (p<0,05). Conclusiones: en nuestra serie, la prevalencia de coledocolitiasis gigante y el éxito del manejo endoscópico es similar a la reportada en la literatura. La EFT, la LM y la DPBG fueron efectivas en el manejo de los cálculos gigantes. El tamaño del colédoco es un predictor de requerimiento de LM y la DPBG disminuyó el requerimiento de LM.
Abstract Introduction: About 10% to 15% of patients with choledocholithiasis develop a giant calculus, defined as one that measures more than 10 mm to 15 mm. Removal of these stones can be problematic even for experienced endoscopists. Almost all patients with this pathology can be treated endoscopically: most are removed with sphincterotomies, mechanical lithotripsy (ML) or large balloon papillary dilatation (LBPD). LBPD has been shown to be effective in handling giant calculi and decreases the need for ML. Objectives: The aim of this study was to determine the prevalence of giant choledocholithiasis at HUS between 2009 and 2014, the frequency of successful endoscopic treatment, and the frequency of surgery in these cases. We also evaluated factors associated with the use of lithotripsy to remove giant biliary calculi. Materials and Methods: This study is a case-control study of patients who had giant calculi and underwent ERCP at the HUS between 2009 and 2014. Calculi larger than 10 mm were defined as giant. Cases were patients who underwent lithotripsy while controls were those who did not require lithotripsy. The results for continuous variables are presented as means or medians and their respective measures of dispersion while results for categorical variables are presented according to tests of normality or as frequencies and percentages. A logistic regression analysis was used to determine factors associated with lithotripsy. Biologically plausible variables and those that had statistically significant differences in the bivariate analysis (p <0.200) were included. The results are presented as adjusted odds ratios (ORA). Results: Between 2009 and 2014, a total of 1403 ERCPs were performed. Giant calculi were found in 198 (14.1%) of these procedures. Giant choledocholithiasis was more common in female patients than in male patients. The patients' mean age was 66.6 years. The average diameter of the common bile duct was 18 mm, and the average diameter of the stones was 18 mm. Ninety-nine percent of these patients underwent sphincterotomies, 28% required ML, 48% underwent LBPD, 5.5% required ML and LBPD, and 30.8% required biliary stents and more than one ERCP for the resolution of choledocholithiasis. In 89.9% of cases, endoscopic management was successful. Only 10.1% of the total number of patients required surgery. Complications occurred in 9.0% of the cases: 6 cases of pancreatitis, 7 cases of bleeding, 2 impacted cannula and 1 perforation. In the bivariate analysis, LBPD was a protective factor against the need for ML (ORA 0.07-IC 95% 0.025-0.194) and choledochal size was a predictor a need for MM (p <0.05). Conclusions: In our series the prevalence of giant choledocholithiasis and the success of endoscopic management are similar to those reported in the literature. Sphincterotomies, ML and LBPD were effective for managing giant calculi. Choledochal size is a predictor of a need for ML while performance of LBPD decreased the need for ML.