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C Arnaud - One of the best experts on this subject based on the ideXlab platform.
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Prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage: randomized clinical trial.
British journal of surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Buc, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C ArnaudAbstract:Biliary Fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic Biliary drainage during hepatectomy on the occurrence of postoperative Biliary Fistula.
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Prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage: randomized clinical trial
The British journal of surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Buc, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C ArnaudAbstract:BACKGROUND Biliary Fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic Biliary drainage during hepatectomy on the occurrence of postoperative Biliary Fistula. METHODS This multicentre RCT was carried out from 2009 to 2016 in nine centres. Patients were randomized to transcystic Biliary drainage or no transcystic drainage (control). Patients underwent hepatectomy (more than 2 segments) of non-cirrhotic livers. The primary endpoint was the occurrence of Biliary Fistula after surgery. Secondary endpoints were morbidity, postoperative mortality, duration of hospital stay, reoperation, readmission to hospital, and complications caused by catheters. Intention-to-treat and per-protocol analyses were performed. RESULTS A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The Biliary Fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The Biliary Fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing Biliary Fistula. The use of transcystic drainage during hepatectomy to prevent postoperative Biliary Fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).
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prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage randomized clinical trial
British Journal of Surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C Arnaud, Patrick PessauxAbstract:ANTECEDENTES: La Fistula biliar es una de las complicaciones mas comunes despues de la hepatectomia. Este estudio evalua el efecto del drenaje biliar transcistico durante la hepatectomia en la aparicion de una Fistula biliar postoperatoria. METODOS: Este ensayo prospectivo aleatorizado y multicentrico (Clinical Trial NCT01469442) con dos grupos de estudio (grupo transcistico versus grupo control) se llevo a cabo de 2009 a 2016 en 9 centros. Los pacientes fueron sometidos a una hepatectomia (≥ 2 segmentos) en higados no cirroticos. El resultado principal fue la aparicion de una Fistula biliar despues de la cirugia. Los resultados secundarios fueron la morbilidad, la mortalidad postoperatoria, la duracion de la estancia hospitalaria, la reintervencion, la necesidad de reingreso y las complicaciones causadas por los cateteres. Se realizaron analisis por intencion de tratamiento y por protocolo. RESULTADOS: Un total de 310 pacientes fueron randomizados. Por intencion de tratamiento, 158 pacientes fueron aleatorizados al grupo transcistico y 149 al grupo control. Siete pacientes fueron excluidos del analisis por protocolo por desviaciones del protocolo. La tasa de Fistula biliar fue del 5,9% en el analisis por intencion de tratamiento y del 6,0% en el analisis por protocolo. Esta tasa fue similar para el grupo transcistico y para el grupo control: 5,7% versus 6,0% (P = 1). No hubo diferencias en terminos de morbilidad (49,4% versus 46,9%, P = 0,731), mortalidad (2,5% versus 4,7%, P = 0,367) y reintervenciones (4,4% versus 10,1%, P = 1). La mediana de la duracion de la estancia hospitalaria fue mayor para el grupo transcistico (11 versus 10 dias, P = 0,042). El riesgo de Fistula biliar se correlaciono con el grosor y la longitud de la transeccion hepatica. CONCLUSION: Este ensayo aleatorizado no demuestra la superioridad del drenaje transcistico durante la hepatectomia para prevenir la Fistula biliar. No se recomienda el uso de drenaje transcistico durante la hepatectomia para prevenir la Fistula biliar postoperatoria. RESULTS: A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The Biliary Fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The Biliary Fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION: This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing Biliary Fistula. The use of transcystic drainage during hepatectomy to prevent postoperative Biliary Fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).
C Maulat - One of the best experts on this subject based on the ideXlab platform.
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Prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage: randomized clinical trial.
British journal of surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Buc, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C ArnaudAbstract:Biliary Fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic Biliary drainage during hepatectomy on the occurrence of postoperative Biliary Fistula.
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Prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage: randomized clinical trial
The British journal of surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Buc, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C ArnaudAbstract:BACKGROUND Biliary Fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic Biliary drainage during hepatectomy on the occurrence of postoperative Biliary Fistula. METHODS This multicentre RCT was carried out from 2009 to 2016 in nine centres. Patients were randomized to transcystic Biliary drainage or no transcystic drainage (control). Patients underwent hepatectomy (more than 2 segments) of non-cirrhotic livers. The primary endpoint was the occurrence of Biliary Fistula after surgery. Secondary endpoints were morbidity, postoperative mortality, duration of hospital stay, reoperation, readmission to hospital, and complications caused by catheters. Intention-to-treat and per-protocol analyses were performed. RESULTS A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The Biliary Fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The Biliary Fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing Biliary Fistula. The use of transcystic drainage during hepatectomy to prevent postoperative Biliary Fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).
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prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage randomized clinical trial
British Journal of Surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C Arnaud, Patrick PessauxAbstract:ANTECEDENTES: La Fistula biliar es una de las complicaciones mas comunes despues de la hepatectomia. Este estudio evalua el efecto del drenaje biliar transcistico durante la hepatectomia en la aparicion de una Fistula biliar postoperatoria. METODOS: Este ensayo prospectivo aleatorizado y multicentrico (Clinical Trial NCT01469442) con dos grupos de estudio (grupo transcistico versus grupo control) se llevo a cabo de 2009 a 2016 en 9 centros. Los pacientes fueron sometidos a una hepatectomia (≥ 2 segmentos) en higados no cirroticos. El resultado principal fue la aparicion de una Fistula biliar despues de la cirugia. Los resultados secundarios fueron la morbilidad, la mortalidad postoperatoria, la duracion de la estancia hospitalaria, la reintervencion, la necesidad de reingreso y las complicaciones causadas por los cateteres. Se realizaron analisis por intencion de tratamiento y por protocolo. RESULTADOS: Un total de 310 pacientes fueron randomizados. Por intencion de tratamiento, 158 pacientes fueron aleatorizados al grupo transcistico y 149 al grupo control. Siete pacientes fueron excluidos del analisis por protocolo por desviaciones del protocolo. La tasa de Fistula biliar fue del 5,9% en el analisis por intencion de tratamiento y del 6,0% en el analisis por protocolo. Esta tasa fue similar para el grupo transcistico y para el grupo control: 5,7% versus 6,0% (P = 1). No hubo diferencias en terminos de morbilidad (49,4% versus 46,9%, P = 0,731), mortalidad (2,5% versus 4,7%, P = 0,367) y reintervenciones (4,4% versus 10,1%, P = 1). La mediana de la duracion de la estancia hospitalaria fue mayor para el grupo transcistico (11 versus 10 dias, P = 0,042). El riesgo de Fistula biliar se correlaciono con el grosor y la longitud de la transeccion hepatica. CONCLUSION: Este ensayo aleatorizado no demuestra la superioridad del drenaje transcistico durante la hepatectomia para prevenir la Fistula biliar. No se recomienda el uso de drenaje transcistico durante la hepatectomia para prevenir la Fistula biliar postoperatoria. RESULTS: A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The Biliary Fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The Biliary Fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION: This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing Biliary Fistula. The use of transcystic drainage during hepatectomy to prevent postoperative Biliary Fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).
J-m Regimbeau - One of the best experts on this subject based on the ideXlab platform.
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Prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage: randomized clinical trial.
British journal of surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Buc, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C ArnaudAbstract:Biliary Fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic Biliary drainage during hepatectomy on the occurrence of postoperative Biliary Fistula.
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Prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage: randomized clinical trial
The British journal of surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Buc, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C ArnaudAbstract:BACKGROUND Biliary Fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic Biliary drainage during hepatectomy on the occurrence of postoperative Biliary Fistula. METHODS This multicentre RCT was carried out from 2009 to 2016 in nine centres. Patients were randomized to transcystic Biliary drainage or no transcystic drainage (control). Patients underwent hepatectomy (more than 2 segments) of non-cirrhotic livers. The primary endpoint was the occurrence of Biliary Fistula after surgery. Secondary endpoints were morbidity, postoperative mortality, duration of hospital stay, reoperation, readmission to hospital, and complications caused by catheters. Intention-to-treat and per-protocol analyses were performed. RESULTS A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The Biliary Fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The Biliary Fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing Biliary Fistula. The use of transcystic drainage during hepatectomy to prevent postoperative Biliary Fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).
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prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage randomized clinical trial
British Journal of Surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C Arnaud, Patrick PessauxAbstract:ANTECEDENTES: La Fistula biliar es una de las complicaciones mas comunes despues de la hepatectomia. Este estudio evalua el efecto del drenaje biliar transcistico durante la hepatectomia en la aparicion de una Fistula biliar postoperatoria. METODOS: Este ensayo prospectivo aleatorizado y multicentrico (Clinical Trial NCT01469442) con dos grupos de estudio (grupo transcistico versus grupo control) se llevo a cabo de 2009 a 2016 en 9 centros. Los pacientes fueron sometidos a una hepatectomia (≥ 2 segmentos) en higados no cirroticos. El resultado principal fue la aparicion de una Fistula biliar despues de la cirugia. Los resultados secundarios fueron la morbilidad, la mortalidad postoperatoria, la duracion de la estancia hospitalaria, la reintervencion, la necesidad de reingreso y las complicaciones causadas por los cateteres. Se realizaron analisis por intencion de tratamiento y por protocolo. RESULTADOS: Un total de 310 pacientes fueron randomizados. Por intencion de tratamiento, 158 pacientes fueron aleatorizados al grupo transcistico y 149 al grupo control. Siete pacientes fueron excluidos del analisis por protocolo por desviaciones del protocolo. La tasa de Fistula biliar fue del 5,9% en el analisis por intencion de tratamiento y del 6,0% en el analisis por protocolo. Esta tasa fue similar para el grupo transcistico y para el grupo control: 5,7% versus 6,0% (P = 1). No hubo diferencias en terminos de morbilidad (49,4% versus 46,9%, P = 0,731), mortalidad (2,5% versus 4,7%, P = 0,367) y reintervenciones (4,4% versus 10,1%, P = 1). La mediana de la duracion de la estancia hospitalaria fue mayor para el grupo transcistico (11 versus 10 dias, P = 0,042). El riesgo de Fistula biliar se correlaciono con el grosor y la longitud de la transeccion hepatica. CONCLUSION: Este ensayo aleatorizado no demuestra la superioridad del drenaje transcistico durante la hepatectomia para prevenir la Fistula biliar. No se recomienda el uso de drenaje transcistico durante la hepatectomia para prevenir la Fistula biliar postoperatoria. RESULTS: A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The Biliary Fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The Biliary Fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION: This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing Biliary Fistula. The use of transcystic drainage during hepatectomy to prevent postoperative Biliary Fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).
E Boleslawski - One of the best experts on this subject based on the ideXlab platform.
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Prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage: randomized clinical trial.
British journal of surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Buc, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C ArnaudAbstract:Biliary Fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic Biliary drainage during hepatectomy on the occurrence of postoperative Biliary Fistula.
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Prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage: randomized clinical trial
The British journal of surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Buc, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C ArnaudAbstract:BACKGROUND Biliary Fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic Biliary drainage during hepatectomy on the occurrence of postoperative Biliary Fistula. METHODS This multicentre RCT was carried out from 2009 to 2016 in nine centres. Patients were randomized to transcystic Biliary drainage or no transcystic drainage (control). Patients underwent hepatectomy (more than 2 segments) of non-cirrhotic livers. The primary endpoint was the occurrence of Biliary Fistula after surgery. Secondary endpoints were morbidity, postoperative mortality, duration of hospital stay, reoperation, readmission to hospital, and complications caused by catheters. Intention-to-treat and per-protocol analyses were performed. RESULTS A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The Biliary Fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The Biliary Fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing Biliary Fistula. The use of transcystic drainage during hepatectomy to prevent postoperative Biliary Fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).
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prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage randomized clinical trial
British Journal of Surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C Arnaud, Patrick PessauxAbstract:ANTECEDENTES: La Fistula biliar es una de las complicaciones mas comunes despues de la hepatectomia. Este estudio evalua el efecto del drenaje biliar transcistico durante la hepatectomia en la aparicion de una Fistula biliar postoperatoria. METODOS: Este ensayo prospectivo aleatorizado y multicentrico (Clinical Trial NCT01469442) con dos grupos de estudio (grupo transcistico versus grupo control) se llevo a cabo de 2009 a 2016 en 9 centros. Los pacientes fueron sometidos a una hepatectomia (≥ 2 segmentos) en higados no cirroticos. El resultado principal fue la aparicion de una Fistula biliar despues de la cirugia. Los resultados secundarios fueron la morbilidad, la mortalidad postoperatoria, la duracion de la estancia hospitalaria, la reintervencion, la necesidad de reingreso y las complicaciones causadas por los cateteres. Se realizaron analisis por intencion de tratamiento y por protocolo. RESULTADOS: Un total de 310 pacientes fueron randomizados. Por intencion de tratamiento, 158 pacientes fueron aleatorizados al grupo transcistico y 149 al grupo control. Siete pacientes fueron excluidos del analisis por protocolo por desviaciones del protocolo. La tasa de Fistula biliar fue del 5,9% en el analisis por intencion de tratamiento y del 6,0% en el analisis por protocolo. Esta tasa fue similar para el grupo transcistico y para el grupo control: 5,7% versus 6,0% (P = 1). No hubo diferencias en terminos de morbilidad (49,4% versus 46,9%, P = 0,731), mortalidad (2,5% versus 4,7%, P = 0,367) y reintervenciones (4,4% versus 10,1%, P = 1). La mediana de la duracion de la estancia hospitalaria fue mayor para el grupo transcistico (11 versus 10 dias, P = 0,042). El riesgo de Fistula biliar se correlaciono con el grosor y la longitud de la transeccion hepatica. CONCLUSION: Este ensayo aleatorizado no demuestra la superioridad del drenaje transcistico durante la hepatectomia para prevenir la Fistula biliar. No se recomienda el uso de drenaje transcistico durante la hepatectomia para prevenir la Fistula biliar postoperatoria. RESULTS: A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The Biliary Fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The Biliary Fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION: This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing Biliary Fistula. The use of transcystic drainage during hepatectomy to prevent postoperative Biliary Fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).
J Belghiti - One of the best experts on this subject based on the ideXlab platform.
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Prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage: randomized clinical trial.
British journal of surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Buc, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C ArnaudAbstract:Biliary Fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic Biliary drainage during hepatectomy on the occurrence of postoperative Biliary Fistula.
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Prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage: randomized clinical trial
The British journal of surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Buc, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C ArnaudAbstract:BACKGROUND Biliary Fistula is one of the most common complications after hepatectomy. This study evaluated the effect of transcystic Biliary drainage during hepatectomy on the occurrence of postoperative Biliary Fistula. METHODS This multicentre RCT was carried out from 2009 to 2016 in nine centres. Patients were randomized to transcystic Biliary drainage or no transcystic drainage (control). Patients underwent hepatectomy (more than 2 segments) of non-cirrhotic livers. The primary endpoint was the occurrence of Biliary Fistula after surgery. Secondary endpoints were morbidity, postoperative mortality, duration of hospital stay, reoperation, readmission to hospital, and complications caused by catheters. Intention-to-treat and per-protocol analyses were performed. RESULTS A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The Biliary Fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The Biliary Fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing Biliary Fistula. The use of transcystic drainage during hepatectomy to prevent postoperative Biliary Fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).
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prevention of Biliary Fistula after partial hepatectomy by transcystic Biliary drainage randomized clinical trial
British Journal of Surgery, 2020Co-Authors: C Maulat, J-m Regimbeau, E Boleslawski, J Belghiti, J Hardwigsen, E Vibert, J-r Delpero, E Tournay, C Arnaud, Patrick PessauxAbstract:ANTECEDENTES: La Fistula biliar es una de las complicaciones mas comunes despues de la hepatectomia. Este estudio evalua el efecto del drenaje biliar transcistico durante la hepatectomia en la aparicion de una Fistula biliar postoperatoria. METODOS: Este ensayo prospectivo aleatorizado y multicentrico (Clinical Trial NCT01469442) con dos grupos de estudio (grupo transcistico versus grupo control) se llevo a cabo de 2009 a 2016 en 9 centros. Los pacientes fueron sometidos a una hepatectomia (≥ 2 segmentos) en higados no cirroticos. El resultado principal fue la aparicion de una Fistula biliar despues de la cirugia. Los resultados secundarios fueron la morbilidad, la mortalidad postoperatoria, la duracion de la estancia hospitalaria, la reintervencion, la necesidad de reingreso y las complicaciones causadas por los cateteres. Se realizaron analisis por intencion de tratamiento y por protocolo. RESULTADOS: Un total de 310 pacientes fueron randomizados. Por intencion de tratamiento, 158 pacientes fueron aleatorizados al grupo transcistico y 149 al grupo control. Siete pacientes fueron excluidos del analisis por protocolo por desviaciones del protocolo. La tasa de Fistula biliar fue del 5,9% en el analisis por intencion de tratamiento y del 6,0% en el analisis por protocolo. Esta tasa fue similar para el grupo transcistico y para el grupo control: 5,7% versus 6,0% (P = 1). No hubo diferencias en terminos de morbilidad (49,4% versus 46,9%, P = 0,731), mortalidad (2,5% versus 4,7%, P = 0,367) y reintervenciones (4,4% versus 10,1%, P = 1). La mediana de la duracion de la estancia hospitalaria fue mayor para el grupo transcistico (11 versus 10 dias, P = 0,042). El riesgo de Fistula biliar se correlaciono con el grosor y la longitud de la transeccion hepatica. CONCLUSION: Este ensayo aleatorizado no demuestra la superioridad del drenaje transcistico durante la hepatectomia para prevenir la Fistula biliar. No se recomienda el uso de drenaje transcistico durante la hepatectomia para prevenir la Fistula biliar postoperatoria. RESULTS: A total of 310 patients were randomized. In intention-to-treat analysis, there were 158 patients in the transcystic group and 149 in the control group. Seven patients were removed from the per-protocol analysis owing to protocol deviations. The Biliary Fistula rate was 5·9 per cent in intention-to-treat and 6·0 per cent in per-protocol analyses. The rate was similar in the transcystic and control groups (5·7 versus 6·0 per cent; P = 1·000). There were no differences in terms of morbidity (49·4 versus 46·3 per cent; P = 0·731), mortality (2·5 versus 4·7 per cent; P = 0·367) and reoperations (4·4 versus 10·1 per cent; P = 1·000). Median duration of hospital stay was longer in the transcystic group (11 versus 10 days; P = 0·042). The Biliary Fistula risk was associated with the width and length of the hepatic cut surface. CONCLUSION: This randomized trial did not demonstrate superiority of transcystic drainage during hepatectomy in preventing Biliary Fistula. The use of transcystic drainage during hepatectomy to prevent postoperative Biliary Fistula is not recommended. Registration number: NCT01469442 ( http://www.clinicaltrials.gov).