Risk Factors for Hemorrhagic Adverse Events in Percutaneous Transhepatic Biliary Drainage: A Prospective Multicenter Study.

PURPOSE: To determine risk factors (RFs) for hemorrhagic adverse events (AEs) associated with percutaneous transhepatic biliary drainage (PTBD) and to develop a risk assessment model. MATERIALS AND METHODS: This was a multicenter, prospective, case control study between 2015 and 2020. Adults with an indication for PTBD were included. Patients who had undergone recent previous drainage procedures were excluded. Multiple variables were controlled. The exposure variables were the number of capsular punctures and passes (using the same puncture). A multivariate analysis was performed (logistic regression analysis). RESULTS: A total of 304 patients (mean age, 63 years ± 14 [range, 23-87 years]; female, 53.5%) were included. Hemorrhagic AEs occurred in 13.5% (n = 41) of the patients, and 3.0% (n = 9) of the cases were severe. Univariate analysis showed that the following variables were not associated with hemorrhagic AEs: age, sex, bilirubin and hemoglobin levels, type of pathology, portal hypertension, location of vascular punctures, ascites, nondilated bile duct, intrahepatic tumors, catheter features, blood pressure, antiplatelet drug use, and tract embolization. Multivariate analysis showed that number of punctures (odds ratio [OR], 2.5; P = .055), vascular punctures (OR, 4.1; P = .007), fatty liver or cirrhosis (OR, 3.7; P = .021), and intrahepatic tumor obstruction (Bismuth ≥ 2; OR, 2.4; P = .064) were associated with hemorrhagic AEs. Patients with corrected coagulopathies had fewer hemorrhagic AEs (OR, -5.5; P = .026). The predictability was 88.2%. The area under the curve was 0.56 (95% confidence interval, 0.50-0.61). CONCLUSIONS: Preprocedural and intraprocedural RFs were identified in relation to hemorrhage with PTBD. AE risk assessment information may be valuable for prediction and management of hemorrhagic AEs.

Image-Guided Surgical Training in Percutaneous Hepatobiliary Procedures: Development of a Realistic and Meaningful Bile Duct Dilatation Porcine Model.

Background: Malignant or benign biliary obstructions can be successfully managed with minimally invasive percutaneous interventions. Since percutaneous approaches are challenging, extensive training using relevant models is fundamental to improve the proficiency of percutaneous physicians. The aim of this experimental study was to develop an in vivo training model in pigs to simulate bile duct dilatation to be used during percutaneous biliary interventions. Materials and Methods: Twenty-eight large white pigs were involved and procedures were performed in an experimental hybrid operating room. Under general anesthesia, animals underwent a preoperative magnetic resonance cholangiography (MRC). Afterward, the common bile duct was isolated and ligated laparoscopically. A postoperative MRC was performed 72 hours after the procedure to evaluate bile duct dilatation. The In vivo models presenting an effective dilatation model were included in the hands-on part of a percutaneous surgery training course. Animals were euthanized at the end of the training session. Results: Postoperative MRC confirmed the presence of bile duct dilatation in the survival pigs (n = 25). No intraoperative complications occurred and mean operative time was 15.8 ± 5.27 minutes. During the course, 27 trainees could effectively perform percutaneous transhepatic cholangiography, bile duct drainage, biliary duct dilatation, and stent placement, with a > 90% success rate, thereby validating the experimental model. All animals survived during the training procedures and complications occurred in 28.3% of cases. Conclusion: The creation of an in vivo bile duct dilatation animal model is feasible with a low short-term mortality. It provides a realistic and meaningful training model in percutaneous biliary procedures.

RISK OF BLEEDING COMPLICATIONS IN PERCUTANEOUS BILIARY DRAINAGE: THE PARADOX OF THE NORMAL HEMOSTASIS.

BACKGROUND: Percutaneous biliary drainage is a safe procedure. The risk of bleeding complications is acceptable. Frequently, patients with biliary obstructions usually have coagulation disorders thus increasing risk of bleeding. For this reason, patients should always fit the parameters of hemostasis. AIM: To determine whether the percentage of bleeding complications in percutaneous biliary drainage is greater in adults with corrected hemostasis prior to the procedure regarding those who did not require any. METHODS: : Prospective, observational, transversal, comparative by independent samples (unpaired comparison). Eighty-two patients with percutaneous biliary drainage were included. The average age was 64±16 years (20-92) being 38 male and 44 female. Patients who presented altered hemostasis were corrected and the presence of bleeding complications was evaluated with laboratory and ultrasound. RESULTS: Of 82 patients, 23 needed correction of hemostasis. The approaches performed were: 41 right, 30 left and 11 bilateral. The amount of punctures on average was 3±2. There were 13 (15.8%) bleeding complications, 12 (20%) in uncorrected and only one (4.34%) in the corrected group with no statistical difference. There were no differences in side, number of punctures and type of drainage, but number of passes and the size of drainage on the right side were different. There was no related mortality. CONCLUSION: Bleeding complications in patients requiring hemostasis correction for a percutaneous biliary drainage was not greater than in those who did not require any.

STAGES AND FACTORS OF THE "PERIOPERATIVE PROCESS": POINTS IN COMMON WITH THE AERONAUTICAL INDUSTRY.

BACKGROUND: The aeronautical industry is one of the disciplines that most use control systems. Its purpose is to avoid accidents and return safer flights. The flight of an airplane, from its takeoff to its landing is a process divided into stages under strict control. A surgical procedure has the same characteristics. We try to identify and develop the stages of the surgical process using the experience of the aviation industry in order to optimize the results and reduce surgical complications. AIM: To identify and develop the stages of the surgical process so that they could be applied to surgery departments. METHODS: A search, review and bibliographic analysis of the application of aeronautical control and safety to medical practice in general and to surgery, in particular, were carried out. RESULTS: Surgical process comprises the perioperative period. It is composed of Preoperative Stage (it is divided into 2 "sub-steps": hospital admission and control of preoperative studies) Operative Stage (it is divided into 3 "sub-steps": anesthetic induction, surgery, and anesthetic recovery) and Postoperative Stage (it is divided into 2 "sub-steps": control during hospitalization and ambulatory control). Two checkpoints must be developed. Checkpoint #1 would be located between the preoperative and operative stages, and checkpoint #2 would be located between the operative and postoperative stages. Surgical factors are surgeons, instrumental and technology, anesthesiology and operating room environment. CONCLUSION: It is possible and necessary to develop a systematic surgical procedure. Its application in the department of surgery could optimize the results and reduce the complications and errors related to daily practice.

Risk of bleeding complications in percutaneous biliary drainage: the paradox of the normal hemostasis / Risco de complicações de sangramento na drenagem biliar percutânea: o paradoxo da hemostase normal

ABSTRACT Background: Percutaneous biliary drainage is a safe procedure. The risk of bleeding complications is acceptable. Frequently, patients with biliary obstructions usually have coagulation disorders thus increasing risk of bleeding. For this reason, patients should always fit the parameters of hemostasis. Aim: To determine whether the percentage of bleeding complications in percutaneous biliary drainage is greater in adults with corrected hemostasis prior to the procedure regarding those who did not require any. Methods : Prospective, observational, transversal, comparative by independent samples (unpaired comparison). Eighty-two patients with percutaneous biliary drainage were included. The average age was 64±16 years (20-92) being 38 male and 44 female. Patients who presented altered hemostasis were corrected and the presence of bleeding complications was evaluated with laboratory and ultrasound. Results: Of 82 patients, 23 needed correction of hemostasis. The approaches performed were: 41 right, 30 left and 11 bilateral. The amount of punctures on average was 3±2. There were 13 (15.8%) bleeding complications, 12 (20%) in uncorrected and only one (4.34%) in the corrected group with no statistical difference. There were no differences in side, number of punctures and type of drainage, but number of passes and the size of drainage on the right side were different. There was no related mortality. Conclusion: Bleeding complications in patients requiring hemostasis correction for a percutaneous biliary drainage was not greater than in those who did not require any.

RESUMO Racional: A drenagem biliar percutânea é procedimento seguro. O risco de complicações hemorrágicas é aceitável. Frequentemente, os pacientes com obstruções biliares apresentam distúrbios de coagulação, aumentando o risco de sangramento. Por esse motivo, eles devem sempre ser adequados aos parâmetros da hemostasia. Objetivo: Determinar se a porcentagem de complicações hemorrágicas na drenagem biliar percutânea é maior em adultos com hemostasia corrigida antes do procedimento em relação àqueles que necessitaram nenhuma. Métodos: Estudo prospectivo, observacional, transversal, comparativo por amostras independentes (comparação não pareada). Oitenta e dois pacientes foram submetidos à drenagem biliar percutânea. A idade média foi de 64±16 anos (20-92), 38 eram homens e 44 mulheres. Os pacientes que apresentaram hemostasia alterada foram corrigidos, e a presença de complicações hemorrágicas foi avaliada com exames laboratoriais e ultrassonográficos. Resultados: Dos 82 pacientes, 23 necessitaram de correção da hemostasia. O acesso à direita foi em 41 casos, 30 à esquerda e 11 bilaterais. A quantidade de punções em média foi de 3±2. Houve 13 (15,8%) complicações hemorrágicas, 12 (20%) no grupo não corrigido e apenas uma (4,34%) no corrigido sem diferença estatística. Não houve diferenças no lado, no número de perfurações e no tipo de drenagem, mas o número de passagens e o tamanho da drenagem no lado direito foram diferentes. Não houve mortalidade. Conclusão: As complicações hemorrágicas em pacientes que necessitam de correção da hemostasia antes da drenagem biliar percutânea não são maiores do que naqueles que não a requerem.

Stages and factors of the "perioperative process": points in common with the aeronautical industry / Etapas e fatores do "processo perioperatório": pontos em comum com a indústria aeronáutica

ABSTRACT Background: The aeronautical industry is one of the disciplines that most use control systems. Its purpose is to avoid accidents and return safer flights. The flight of an airplane, from its takeoff to its landing is a process divided into stages under strict control. A surgical procedure has the same characteristics. We try to identify and develop the stages of the surgical process using the experience of the aviation industry in order to optimize the results and reduce surgical complications. Aim: To identify and develop the stages of the surgical process so that they could be applied to surgery departments. Methods: A search, review and bibliographic analysis of the application of aeronautical control and safety to medical practice in general and to surgery, in particular, were carried out. Results: Surgical process comprises the perioperative period. It is composed of Preoperative Stage (it is divided into 2 "sub-steps": hospital admission and control of preoperative studies) Operative Stage (it is divided into 3 "sub-steps": anesthetic induction, surgery, and anesthetic recovery) and Postoperative Stage (it is divided into 2 "sub-steps": control during hospitalization and ambulatory control). Two checkpoints must be developed. Checkpoint #1 would be located between the preoperative and operative stages, and checkpoint #2 would be located between the operative and postoperative stages. Surgical factors are surgeons, instrumental and technology, anesthesiology and operating room environment. Conclusion: It is possible and necessary to develop a systematic surgical procedure. Its application in the department of surgery could optimize the results and reduce the complications and errors related to daily practice.

RESUMO Racional: A indústria aeronáutica é uma das disciplinas que mais utiliza sistemas de controle. Sua finalidade é evitar acidentes e retornar voos mais seguros. O voo de um avião, desde a decolagem até a aterrissagem, é processo dividido em etapas com estrito controle. Um procedimento cirúrgico tem as mesmas características. Tentar identificar e desenvolver etapas no processo cirúrgico, utilizando a experiência da indústria aeronáutica, poderá otimizar os resultados e reduzir as complicações cirúrgicas. Objetivo: Identificar e desenvolver etapas no processo cirúrgico para que possam ser aplicadas nos serviços de cirurgia. Métodos: Foram realizadas pesquisas, revisão e análise bibliográfica sobre o controle e segurança aeronáutica e aplicando-as na prática médica em geral e à cirurgia em particular. Resultados: O processo cirúrgico compreende o período perioperatório. É composto de pré-operatório (dividido em duas sub-etapas: admissão hospitalar e controle de estudos pré-operatórios); fase operatória (dividida em três sub-etapas: indução anestésica, operação e recuperação anestésica) e fase pós-operatória (dividida em duas "sub-etapas": controle durante a hospitalização e controle ambulatorial). Dois pontos de verificação devem ser desenvolvidos. O ponto de checagem nº 1 estaria localizado entre os estágios pré-operatório e operatório, e o ponto de checagem nº 2 entre os estágios operatório e pós-operatório. Fatores cirúrgicos são cirurgiões, instrumental e tecnologia, anestesiologia e ambiente de sala de cirurgia. Conclusão: É possível e necessário desenvolver um procedimento cirúrgico sistemático. Sua aplicação no departamento de cirurgia poderia otimizar os resultados e reduzir as complicações e erros relacionados à prática diária.

THE CRITICAL VIEW OF SAFETY PREVENTS THE APPEARANCE OF BILIARY INJURIES? ANALYSIS OF A SURVEY.

BACKGROUND: The risk of bile duct injury (BDI) during cholecystectomy remains a concern, despite efforts proposed for increasing safety. The Critical View of Safety (CVS) has been adopted promoting to reduce its risk. AIM: To perform a survey to assess the awareness of the CVS, estimating the proportion of surgeons that correctly identified its elements and its relationship with BDI. METHODS: An anonymous online survey was sent to 2096 surgeons inquiring on their common practices during cholecystectomy and their knowledge of the CVS. RESULTS: A total of 446 surgeons responded the survey (21%). The percentage of surgeons that correctly identified the elements of CVS was 21.8% and 24.8% among surgeons claiming to know the CVS. The percentage of surgeons that reported BDI was higher among those that incorrectly identified the elements of the CVS (p=0.03). In the multivariate analysis, career length was the most significant factor related to BDI (p=0.002). CONCLUSIONS: The percentage of surgeons that correctly identified the Critical View of Safety was low, even among those who claimed to know the CVS. The percentage of surgeons that reported BDI was higher among those that incorrectly identified the elements of the CVS.

Percutaneous Image-guided Surgery Training: Model IHU-DAICIM.

The evolution of guided imaging surgery is well known in recent years. As the field of action becomes more specific, learning and teaching are also more specific. State-of-the-art medical training should be mandatory in the field of general medicine and surgery in particular. In this work, we report on how to create a model for the formation of guided surgery by images in a simple and fast way, and its implementation by young surgeons. Pig models have been used in which collections made by bovine small intestine and simulated tumor lesions have been placed. Several types of image-guided procedures have been performed. No major complications were found during the development of the model or during its use. It is possible to develop a quick, simple, and safe living training model that can be used immediately after preparation.

The critical view of safety prevents the appearance of biliary injuries? analysis of a survey / Visão crítica de segurança previne lesões biliares? análise de um levantamento

ABSTRACT Background: The risk of bile duct injury (BDI) during cholecystectomy remains a concern, despite efforts proposed for increasing safety. The Critical View of Safety (CVS) has been adopted promoting to reduce its risk. Aim: To perform a survey to assess the awareness of the CVS, estimating the proportion of surgeons that correctly identified its elements and its relationship with BDI. Methods: An anonymous online survey was sent to 2096 surgeons inquiring on their common practices during cholecystectomy and their knowledge of the CVS. Results: A total of 446 surgeons responded the survey (21%). The percentage of surgeons that correctly identified the elements of CVS was 21.8% and 24.8% among surgeons claiming to know the CVS. The percentage of surgeons that reported BDI was higher among those that incorrectly identified the elements of the CVS (p=0.03). In the multivariate analysis, career length was the most significant factor related to BDI (p=0.002). Conclusions: The percentage of surgeons that correctly identified the Critical View of Safety was low, even among those who claimed to know the CVS. The percentage of surgeons that reported BDI was higher among those that incorrectly identified the elements of the CVS.

RESUMO Racional: O risco de lesão do ducto biliar (BDI) durante a colecistectomia continua a ser preocupante, apesar dos esforços propostos para aumentar a segurança. A Visão Crítica da Segurança (CVS) foi adotada e proposta para redução de seu risco. Objetivo: Realizar levantamento para avaliar a conscientização da CVS, e estimando a proporção de cirurgiões que identificaram corretamente seus elementos e sua relação com BDI. Métodos: Pesquisa online anônima foi enviada para 2096 cirurgiões perguntando sobre suas práticas comuns durante a colecistectomia e seu conhecimento da CVS. Resultados: Um total de 446 cirurgiões responderam a pesquisa (21%). A porcentagem que identificou corretamente os elementos da CVS foi de 21,8% e 24,8% entre os cirurgiões que afirmam conhecê-la. A porcentagem dos que relataram BDI foi maior entre os que incorretamente identificaram os elementos da CVS (p=0,03). Na análise multivariada, o tempo na carreira foi o fator mais significativo relacionado à BDI (p=0,002). Conclusões: A porcentagem de cirurgiões que identificaram corretamente a CVS foi baixa, mesmo entre aqueles que alegaram conhecê-la. A porcentagem de cirurgiões que relataram BDI foi maior entre aqueles que incorretamente identificaram os elementos da CVS.

[Transfistular treatment of the retained bile duct stones: analysis on complications and therapeutic success according to technologies]. / Tratamiento tranfistular de la litiasis residual coledociana: análisis sobre complicaciones y éxito terapéutico según técnicas.

BACKGROUND: The retained bile duct stones with distant fistulous tract has been treated by the transfistular route as the first line of treatment since the publications of Dr Mazzariello. Several techniques have been developed and several studies have been published, but little has been assessed about the relationship between complications and differences in extraction techniques. OBJECTIVE: This study aimed to determine the percentage of therapeutic success and determine which variables influence the occurrence of complications. METHODS: Retrospective, observational, descriptive and comparative study. RESULTS: We included in the study 59 patients with residual bile duct stones. The treatment success rate in our sample was 96.6% [95% confidence interval (95% CI) 88.2- 99.6%]. The complication rate was 10% (95% CI 4%-21%). These complications were mild, being the highest magnitude STROC III A (abscess of the peri-fistular tract). There was not mortality during the development of research. Statistically significant differences were found in the number of sessions required to achieve therapeutic success and in the occurrence of complications. The remaining variables did not show differences. The age and the amount of stones needed a larger sample size to show statistical differences. CONCLUSIONS: Our series showed results and complication rates similar to other national and international series. There was no relationship between the different techniques and the complications.

Tratamiento tranfistular de la litiasis residual coledociana: análisis sobre complicaciones y éxito terapéutico según técnicas / [Transfistular treatment of the retained bile duct stones: analysis on complications and therapeutic success according to technologies].

BACKGROUND: The retained bile duct stones with distant fistulous tract has been treated by the transfistular route as the first line of treatment since the publications of Dr Mazzariello. Several techniques have been developed and several studies have been published, but little has been assessed about the relationship between complications and differences in extraction techniques. OBJECTIVE: This study aimed to determine the percentage of therapeutic success and determine which variables influence the occurrence of complications. METHODS: Retrospective, observational, descriptive and comparative study. RESULTS: We included in the study 59 patients with residual bile duct stones. The treatment success rate in our sample was 96.6

). These complications were mild, being the highest magnitude STROC III A (abscess of the peri-fistular tract). There was not mortality during the development of research. Statistically significant differences were found in the number of sessions required to achieve therapeutic success and in the occurrence of complications. The remaining variables did not show differences. The age and the amount of stones needed a larger sample size to show statistical differences. CONCLUSIONS: Our series showed results and complication rates similar to other national and international series. There was no relationship between the different techniques and the complications.

Tratamiento tranfistular de la litiasis residual coledociana: análisis sobre complicaciones y éxito terapéutico según técnicas. / [Transfistular treatment of the retained bile duct stones: analysis on complications and therapeutic success according to technologies].

BACKGROUND: The retained bile duct stones with distant fistulous tract has been treated by the transfistular route as the first line of treatment since the publications of Dr Mazzariello. Several techniques have been developed and several studies have been published, but little has been assessed about the relationship between complications and differences in extraction techniques. OBJECTIVE: This study aimed to determine the percentage of therapeutic success and determine which variables influence the occurrence of complications. METHODS: Retrospective, observational, descriptive and comparative study. RESULTS: We included in the study 59 patients with residual bile duct stones. The treatment success rate in our sample was 96.6

[95

confidence interval (95

CI) 88.2- 99.6

]. The complication rate was 10

(95

CI 4

-21

). These complications were mild, being the highest magnitude STROC III A (abscess of the peri-fistular tract). There was not mortality during the development of research. Statistically significant differences were found in the number of sessions required to achieve therapeutic success and in the occurrence of complications. The remaining variables did not show differences. The age and the amount of stones needed a larger sample size to show statistical differences. CONCLUSIONS: Our series showed results and complication rates similar to other national and international series. There was no relationship between the different techniques and the complications.

Cephalic vein: detail of its anatomy in the deltopectoral triangle / Vena cefálica: detalle de su anatomía en el trígono deltopectoral

The cephalic vein shows a scarce description, especially in the deltopectoral triangle, and its ending in the axillary vein. Some established considerations such as "superficial vein, located in the deltopectoral groove, accompanied by braches of the thoraco-acromial artery, which ends in the deltopectoral triangle in the shape of fan arch" should be reevaluated. Procedures difficulties in the la catheterization deserve for a more accurate description. A descriptive, prospective study is performed. The goal is to determine the anatomy of the cephalic vein in the deltopectoral triangle, with a special focus on the characteristics concerning its path and type of termination. Findings show that the cephalic vein is deeply placed and has a different path than that of an arch (circumference segment on a level) with a retro pectoral path and an acceptable diameter, thus useful and safe in the catheterization processes.

La vena cefálica ha sido poco descrita en el triángulo deltopectoral y su terminación en la vena axilar. Algunas consideraciones la señalan como "la vena superficial, situada en el surco deltopectoral, acompañada de ramas de la arteria toraco-acromial, que termina en el trígono deltopectoral en forma de arco de ventilador" por lo que debe ser reevaluado. Debido a las dificultades en los procedimientos de cateterización la vena cefálica merece una descripción más exacta. Se realizó un estudio descriptivo prospectivo con el objetivo de determinar la anatomía de la vena cefálica en el trígono deltopectoral, dando especial atención a sus trayecto y tipo de terminación. Los resultados demostraron que la vena cefálica está localizada profundamente en el surco deltopectoral, presenta un trayecto distinto a un arco (segmento de la circunferencia de un nivel) siendo este trayecto retropectoral y un diámetro aceptable, por lo tanto, útil y seguro para los procesos de cateterización.