Preoperative portal vein or portal and hepatic vein embolization: DRAGON collaborative group analysis.

BACKGROUND: The extent of liver resection for tumours is limited by the expected functional reserve of the future liver remnant (FRL), so hypertrophy may be induced by portal vein embolization (PVE), taking 6 weeks or longer for growth. This study assessed the hypothesis that simultaneous embolization of portal and hepatic veins (PVE/HVE) accelerates hypertrophy and improves resectability. METHODS: All centres of the international DRAGON trials study collaborative were asked to provide data on patients who had PVE/HVE or PVE on 2016-2019 (more than 5 PVE/HVE procedures was a requirement). Liver volumetry was performed using OsiriX MD software. Multivariable analysis was performed for the endpoints of resectability rate, FLR hypertrophy and major complications using receiver operating characteristic (ROC) statistics, regression, and Kaplan-Meier analysis. RESULTS: In total, 39 patients had undergone PVE/HVE and 160 had PVE alone. The PVE/HVE group had better hypertrophy than the PVE group (59 versus 48 per cent respectively; P = 0.020) and resectability (90 versus 68 per cent; P = 0.007). Major complications (26 versus 34 per cent; P = 0.550) and 90-day mortality (3 versus 16 per cent respectively, P = 0.065) were comparable. Multivariable analysis confirmed that these effects were independent of confounders. CONCLUSION: PVE/HVE achieved better FLR hypertrophy and resectability than PVE in this collaborative experience.

Immediate and long-term impact of the COVID-19 pandemic on delivery of surgical services.

BACKGROUND: The ongoing pandemic is having a collateral health effect on delivery of surgical care to millions of patients. Very little is known about pandemic management and effects on other services, including delivery of surgery. METHODS: This was a scoping review of all available literature pertaining to COVID-19 and surgery, using electronic databases, society websites, webinars and preprint repositories. RESULTS: Several perioperative guidelines have been issued within a short time. Many suggestions are contradictory and based on anecdotal data at best. As regions with the highest volume of operations per capita are being hit, an unprecedented number of operations are being cancelled or deferred. No major stakeholder seems to have considered how a pandemic deprives patients with a surgical condition of resources, with patients disproportionally affected owing to the nature of treatment (use of anaesthesia, operating rooms, protective equipment, physical invasion and need for perioperative care). No recommendations exist regarding how to reopen surgical delivery. The postpandemic evaluation and future planning should involve surgical services as an essential part to maintain appropriate surgical care for the population during an outbreak. Surgical delivery, owing to its cross-cutting nature and synergistic effects on health systems at large, needs to be built into the WHO agenda for national health planning. CONCLUSION: Patients are being deprived of surgical access, with uncertain loss of function and risk of adverse prognosis as a collateral effect of the pandemic. Surgical services need a contingency plan for maintaining surgical care in an ongoing or postpandemic phase.

ANTECEDENTES: La pandemia en curso tiene un efecto colateral sobre la salud en la prestación de atención quirúrgica a millones de pacientes. Se sabe muy poco sobre el manejo de la pandemia y sus efectos colaterales en otros servicios, incluida la prestación de servicios quirúrgicos. MÉTODOS: Se ha realizado una revisión de alcance de toda la literatura disponible relacionada con COVID-19 y cirugía utilizando bases de datos electrónicas, páginas web de sociedades, seminarios online y repositorios de pre-publicaciones. RESULTADOS: Se han publicado varias guías perioperatorias en un corto período de tiempo. Muchas recomendaciones son contradictorias y, en el mejor de los casos, se basan en datos anecdóticos. A medida que las regiones con el mayor volumen de operaciones per cápita se ven afectadas, se cancela o difiere un número sin precedentes de operaciones. Ninguna de las principales partes interesadas parece haber considerado cómo una pandemia priva de recursos a los pacientes que necesitan una intervención quirúrgica, con pacientes afectados de manera desproporcionada debido a la naturaleza del tratamiento (uso de anestesia, quirófanos, equipo de protección, contacto físico y necesidad de atención perioperatoria). No existen recomendaciones sobre cómo reanudar la actividad quirúrgica. La evaluación tras la pandemia y la planificación futura deben incluir a los servicios quirúrgicos como una parte esencial para mantener la atención quirúrgica adecuada para la población también durante un brote epidémico. La prestación de servicios quirúrgicos, debido a su naturaleza transversal y a sus efectos sinérgicos en los sistemas de salud en general, debe incorporarse a la agenda de la OMS para la planificación nacional de la salud. CONCLUSIÓN: Los pacientes se ven privados de acceso a la cirugía con una pérdida de función incierta y riesgo de un pronóstico adverso como efecto colateral de la pandemia. Los servicios quirúrgicos necesitan un plan de contingencia para mantener la atención quirúrgica durante la pandemia y en la fase post-pandemia.

Surgical technique for placement of the automated low flow ascites pump (Alfapump).

Approximately 10% of patients with ascites associated with cirrhosis fail to respond to dietary rules and diuretic treatment and therefore present with refractory ascites. In order to avoid iterative large-volume paracentesis in patients with contraindication to TIPS, the automated low flow ascites pump system (Alfapump) was developed to pump ascites from the peritoneal cavity into the urinary bladder, where it is eliminated spontaneously by normal micturition. This manuscript reports the surgical technique for placement of the Alfapump.

Mortality after liver surgery in Germany.

BACKGROUND: Mortality rates after liver surgery are not well documented in Germany. More than 1000 hospitals offer liver resection, but there is no central regulation of infrastructure requirements or outcome quality. METHODS: Hospital mortality rates after liver resection were analysed using the standardized hospital discharge data (Diagnosis-Related Groups, ICD-10 and German operations and procedure key codes) provided by the Research Data Centre of the Federal Statistical Office and Statistical Offices of the Länder in Wiesbaden, Germany. RESULTS: A total of 110 332 liver procedures carried out between 2010 and 2015 were identified. The overall hospital mortality rate for all resections was 5·8 per cent. The mortality rate among 17 574 major hepatic procedures was 10·4 per cent. Patients who had surgery for colorectal liver metastases (CRLMs) had the lowest mortality rate among those with malignancy (5·5 per cent), followed by patients with gallbladder cancer (7·1 per cent), hepatocellular carcinoma (9·3 per cent) and intrahepatic cholangiocarcinoma (11·0 per cent). Patients with extrahepatic cholangiocarcinoma had the highest mortality rate (14·6 per cent). The mortality rate for extended hepatectomy was 16·2 per cent and the need for a biliodigestive anastomosis increased this to 25·5 per cent. Failure to rescue after complications led to mortality rates of more than 30 per cent in some subgroups. There was a significant volume-outcome relationship for CRLM surgery in very high-volume centres (mean 26-60 major resections for CRLMs per year). The mortality rate was 4·6 per cent in very high-volume centres compared with 7·5 per cent in very low-volume hospitals (odds ratio 0·60, 95 per cent c.i. 0·42 to 0·77; P < 0·001). CONCLUSION: This analysis of outcome data after liver resection in Germany suggests that hospital mortality remains high. There should be more focused research to understand, improve or justify factors leading to this result, and consideration of centralization of liver surgery.

ANTECEDENTES: En Alemania, los datos de mortalidad después de la cirugía no están bien documentados. En más de 1.000 hospitales se realizan resecciones hepáticas, pero no existe una regulación central de los prerrequisitos estructurales necesarios y de la calidad de los resultados. MÉTODOS: Las tasas de mortalidad hospitalaria relacionadas con las resecciones hepáticas se analizaron utilizando los datos estandarizados del alta hospitalaria (Diagnóstico de grupos relacionados, DRG), la clasificación internacional de enfermedades 10 (ICD10) y la clave de procedimientos y operaciones (códigos OPS) proporcionados por el RDC de la Oficina Federal de Estadística y Oficinas de Estadística de Länder en Wiesbaden, Alemania. RESULTADOS: Se identificaron un total de 110.332 procedimientos hepáticos (de 2010 a 2015). La tasa global de mortalidad hospitalaria para todas las resecciones fue del 5,8%. Las resecciones hepáticas mayores (n = 15.333) presentaron una mortalidad del 10,4%. Los pacientes con metástasis hepáticas colorrectales (colorectal liver metastases, CRLM) tuvieron la mortalidad más baja de entre los pacientes con neoplasias malignas (5,5%), seguidos de los pacientes con cáncer de vesícula biliar (7,1%), colangiocarcinoma intrahepático (intrahepatic colangiocarcinoma, iCC) (11,0%) y carcinoma hepatocelular (hepatocellular carcinoma, HCC) (9,3%). Los pacientes con colangiocarcinoma extrahepático (extrahepatic cholangiocarcinoma, eCC) presentaron la mortalidad más alta (14,6%). Las hepatectomías extendidas (16,2%) y la necesidad de una anastomosis biliodigestiva (biliodigestive anastomosis, BDA) aumentaron la mortalidad a un 25,5%. La falta de solución de algunas complicaciones llevó a tasas de mortalidad de más del 30% en algunos subgrupos. Hubo una relación significativa volumen-resultado para las CRLM en centros de alto volumen (25,3 a 59,7 resecciones mayores/año; razón de oportunidades, odds ratio, OR 0,60, i.c. del 95%: 0,42-0,77; P < 0,001), lo que resultó en una disminución en las tasas de mortalidad de 7,5/6,4/7,5/6,5% a 4,6%. CONCLUSIÓN: El análisis de los resultados después de la resección hepática en Alemania muestra una alta mortalidad hospitalaria inesperada. Este análisis indica la necesidad de efectuar una investigación más específica para comprender, mejorar o justificar los factores que determinan estos hallazgos.

A randomized, controlled study to assess the conversion from calcineurin-inhibitors to everolimus after liver transplantation--PROTECT.

Posttransplant immunosuppression with calcineurin inhibitors (CNIs) is associated with impaired renal function, while mTor inhibitors such as everolimus may provide a renal-sparing alternative. In this randomized 1-year study in patients with liver transplantation (LTx), we sought to assess the effects of everolimus on glomerular filtration rate (GFR) after conversion from CNIs compared to continued CNI treatment. Eligible study patients received basiliximab induction, CNI with/without corticosteroids for 4 weeks post-LTx, and were then randomized (if GFR > 50 mL/min) to continued CNIs (N = 102) or subsequent conversion to EVR (N = 101). Mean calculated GFR 11 months postrandomization (ITT population) revealed no significant difference between treatments using the Cockcroft-Gault formula (-2.9 mL/min in favor of EVR, 95%-CI: [-10.659; 4.814], p = 0.46), whereas use of the MDRD formula showed superiority for EVR (-7.8 mL/min, 95%-CI: [-14.366; -1.191], p = 0.021). Rates of mortality (EVR: 4.2% vs. CNI: 4.1%), biopsy-proven acute rejection (17.7% vs. 15.3%), and efficacy failure (20.8% vs. 20.4%) were similar. Infections, leukocytopenia, hyperlipidemia and treatment discontinuations occurred more frequently in the EVR group. No hepatic artery thrombosis and no excess of wound healing impairment were noted. Conversion from CNI-based to EVR-based immunosuppression proved to be a safe alternative post-LTx that deserves further investigation in terms of nephroprotection.

Hepatocellular carcinoma progression during bridging before liver transplantation.

BACKGROUND: Recipient selection for liver transplantation in hepatocellular carcinoma (HCC) is based primarily on criteria affecting the chance of long-term success. Here, the relationship between pretransplant bridging therapy and long-term survival was investigated in a subgroup analysis of the SiLVER Study. METHODS: Response to bridging, as defined by comparison of imaging at the time of listing and post-transplant pathology report, was categorized into controlled versus progressive disease (more than 20 per cent tumour growth or development of new lesions). RESULTS: Of 525 patients with HCC who had liver transplantation, 350 recipients underwent pretransplant bridging therapy. Tumour progression despite bridging was an independent risk factor affecting overall survival (hazard ratio 1.80; P = 0.005). For patients within the Milan criteria (MC) at listing, mean overall survival was longer for those with controlled versus progressive disease (6.8 versus 5.8 years; P < 0.001). Importantly, patients with HCCs outside the MC that were downsized to within the MC before liver transplantation had poor outcomes compared with patients who never exceeded the MC (mean overall survival 6.2 versus 6.6 years respectively; P = 0.030). CONCLUSION: Patients with HCCs within the MC that did not show tumour progression under locoregional therapy had the best outcomes after liver transplantation. Downstaging into the limits of the MC did not improve the probability of survival.Prognostic factors determining the long-term success of liver transplantation in patients with hepatocellular carcinoma are still under discussion. A subgroup analysis of the SiLVER trial showed that disease control under bridging therapy is strongly associated with improved prognosis in terms of overall survival. However, in tumours exceeding the limits of the Milan criteria, downstaging did not restore the probability of survival compared with that of patients within the Milan criteria.

Pre-existent portal vein thrombosis in liver transplantation: influence of pre-operative disease severity.

BACKGROUND: Portal vein thrombosis (PVT) is a surgical challenge in liver transplantation (LTx). In contrast to LTx in decompensated liver disease, which are associated with a higher morbidity and mortality, PVT influence on outcome is still under debate. To evaluate this influence at different stages of liver decompensation, we compared the outcome of patients suffering from PVT to patients with patent portal vein within different score ranges. METHODS: We included 193 LTx (24 with PVT) in our study, transplanted between 2004 and 2007 at our institution. Patients were divided into four Model of End-Stage Liver Disease (MELD) score groups, and outcome was compared between PVT- and non-PVT patients. RESULTS: In non-decompensated liver disease (MELD <15), we found a significantly decreased survival in patients suffering from PVT (one-yr survival 57% vs. 89%). By contrast, MELD score >15 (decompensated liver disease) leads to an equal or even better survival in PVT-patients compared with patients without PVT (one-yr survival 91% vs.75%), with an only slightly increased morbidity. CONCLUSION: Outcome in patients with PVT seems to be dependent on pre-operative disease severity. In contrast to compensated liver disease, no influence of PVT on outcome could be found in decompensated liver disease, and should therefore not be considered as a contraindication in LTx.

Giant cell hepatitis: an unusual cause of fulminant liver failure.

Giant cell hepatitis is a very rare disease of unknown origin. It has been hypothesized that drugs, viral infections, or autoimmune reactions may play a pathogenetic role. Here, we describe a 33 year old patient with bacterial bronchitis who was treated with doxycycline (100 mg/d) for one week. Furthermore the patient complained of malaise and a distinct jaundice. Liver parameters increased dramatically (AST 4670 U/l, ALT 5350 U/l, bilirubin 226 µmol/l) and liver function was impaired (INR = 1,45). The ultrasound scan showed a hepatomegaly with no signs of cirrhosis, normal spleen size and normal bile ducts; liver perfusion was normal. No evidence of Wilson's disease, hemochromatosis, autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cirrhosis, hepatitis A, B, C and E, HIV, CMV, VZV, adenoviral infections, or paracetamol intoxication was found. Subsequently, the patient developed acute liver failure (AST 2134 U/l, ALT 2820 U/l, bilirubin 380 µmol/l, INR 3.0) and a beginning renal failure. Therefore, he was transferred to our transplant center. Due to increasing confusion and somnolence due to cerebral edema mechanical ventilation was needed. Because of an acute renal failure and severe hepatic encephalopathia MARS-hemodialysis was performed. Three weeks after the appearance of the jaundice he underwent liver transplantation (MELD 40). Surprisingly, in the explanted liver the diagnosis of giant cell hepatitis was made. Today--2 years after successful liver transplantation--the patient is in very good condition with normal liver function. In conclusion, giant cell hepatitis is a rare cause of acute liver failure that is often recognized only histologically.

[Preoperative iron deficiency with/without anemia-an underestimated risk factor?] / Präoperativer Eisenmangel mit/ohne Anämie ­ ein unterschätzter Risikofaktor?

BACKGROUND: Every third surgical patient already suffers from anemia before surgery. The main cause is iron deficiency. OBJECTIVE: This article describes the perioperative risk of iron deficiency with/without anemia and summarizes potential preventive measures. MATERIAL AND METHODS: Presentation of various current original papers, guidelines and own experiences from the German patient blood management network. RESULTS AND CONCLUSION: Preoperative iron deficiency with/without anemia is an underestimated risk factor for perioperative complications. The implementation of preoperative diagnostics and treatment as part of a comprehensive patient blood management reduces complications and increases patient safety.

Prognostic value of the monoethylglycinexylidide (MEGX)-test prior to liver resection.

BACKGROUND/AIMS: The critical issue before major hepatic resection is to evaluate and detect patients with a potentially increased risk of hepatic failure. In this study the prognostic value of the monoethylglycinexylidide (MEGX)- liver function test was evaluated with regards to clinical course and survival after partial liver resection. METHODOLOGY: Between 1995 and 2000 a total of 55 patients (29 male, 26 female) underwent a partial liver resection at the Georg-August University of Göttingen. Forty-two patients were treated for malignant, and 13 for benign, disease. MEGX-testing was performed 15 and 30 minutes after a single-dose of 1mg/kg BW Lidocaine i.v. was applied. RESULTS: MEGX-test results after 30 minutes had significant influence on hospital mortality. Patients who died during the hospital stay showed median MEGX-30 minutes results of 32 microg/L in (4-107 microg/L) in comparison to the surviving patients with a median 68 microg/L (16-176 microg/L) (p = 0.026). Furthermore, patients with MEGX scaled categories of 3 and 4 had a significantly lower surivial at 150 days (p = 0.008) and overall (p = 0.0002). There was an indirect impact of MEGX on hospital stay, costs and mortality reflecting high fluid loss: patients with lower loss of fluid over drainages had a significantly lower mortality at 150 days (p = 0.00046) and overall (p = 0.00008), than did patients with higher fluid loss. Low MEGX-values significantly influenced long hospital stay (p = 0.00001) and high costs (p = 0.00001). Pathologic MEGX in combination with increased age, increased BMI and extensive surgical procedures including resection of over 50% volume of the liver had a significant influence on complications (p = 0.015). CONCLUSION: The preoperative MEGX-test, especially the 30 minutes value, is a useful medium to estimate the liver reserve in non-cirrhotic patients prior to liver resection. In combination with the resection volume it may be very useful to identify patients with a high risk of developing a postoperative liver failure.

Early experience shows rapid shrinking of abdominal aortic aneurysms after endovascular treatment with Anaconda device.

BACKGROUND: The Anaconda prosthesis is a new endovascular device for abdominal aortic aneurysms repair. AIM: of the study was to evaluate successful access to the arterial site, safety and efficacy of stent placement and fixation, assessment of endoleaks, patency of the graft due to twists, kinks or obstruction within the first 30 days after the procedure. Secondary objectives were the assessment of clinical success after 6 months due to graft patency and aneurysm exclusion without endoleak as well as the continuing clinical success without showing aneurysm expansion or any graft failure. PATIENTS AND METHODS: Between 2003 and 2006 a total of 14 patients with infrarenal aortic aneurysm (median diameter prior to endovascular treatment: 56.7 mm (range: 50 to 70 mm) were treated with the Anaconda endovascular device. 8 of these patients were treated in accordance to a prospective Phase II clinical study protocol (Anaconda ANA 004). 6 more patients received the same endovascular device after CE-certification. RESULTS: Primary and secondary objectives were achieved in 12 of 14 patients after 6 months. In one patient insertion of the graft system was impossible due to kinking and circular calcification of the iliac arteries. Iliac access utilizing an alternative stent graft system (Cook, Zenith) was also unsuccessful. This patient underwent a conversion to open surgery and died. Another patient died 6 months after treatment unrelated to the procedure. A significant reduction of the median aneurysm diameter from 56.7 to 49.0 mm (range: 45 to 54 mm) was achieved after 6 months (p = 0.05). No endoleak was seen in the follow up. CONCLUSIONS: Early results show that he Anaconda endovascular device for aneurysm repair is a safe and effective device for patients with suitable abdominal aortic aneurysms and proper distal access vessels which results in significant aneurysm diameter decrease and a low complication rate after 6 months of follow-up.

Pretransplant calcium levels have no predictive value for delayed graft function, long-term graft function, cardiovascular events, or graft and patient survival in renal transplantation.

BACKGROUND: Disorders of calcium homeostasis are one of the most common problems in patients with end-stage renal disease (ESRD). Elevated calcium levels increase the incidence of cardiovascular mortality in ESRD patients, and appear to be a risk factor for the occurrence of delayed graft function (DGF) after kidney transplantation. Therefore, we investigated the impact of pretransplant serum calcium levels on outcomes after kidney transplantation: DGF, acute rejection, graft function, and survival, as well as the incidence of cardiovascular events. METHODS: We studied 285 patients (96.9% of all transplanted patients) who underwent their first transplantation between 1995 and 2004. Demographic data were extracted from hospital records or were documented during follow-up; serum samples were collected at the time of transplantation. RESULTS: In our cohort the incidence of DGF was 16.5% and 35.4% of acute rejection episodes (ARE). However, pretransplant calcium levels were not related to DGF or ARE in our patient cohort. Furthermore, there was no correlation between pretransplant serum calcium level with the incidence of cardiovascular events or mortality, as well as graft function or survival. CONCLUSION: In our study population pretransplant calcium levels showed no effect on DGF, ARE rate, the occurrence of cardiovascular events or death, renal graft function, or survival. Therefore, pretransplant calcium level is not a helpful marker for risk stratification at the time of transplantation.

[Pararectal mini-incision for strictly retroperitoneal nephrectomy in living kidney donation]. / Pararektale Miniinzision zur streng retroperitonealen Nephrektomie in der Lebendspende.

PURPOSE: In this study we present the technique of a strictly retroperitoneal donor nephrectomy via a pararectal mini-incision. MATERIAL AND METHODS: Data of 34 living kidney donations were analyzed. All donors underwent a pararectal mini-incision and strictly retroperitoneal nephrectomy (MIDN). RESULTS: Total operation time, perioperative use of pain medication, length of hospital stay after successful mobilization, and return to full enteral nutrition and regular digestion were evaluated retrospectively. Total operation time for MIDN was 132+/-26 min. The total average application was 22.2+/-19.4 mg of opioid in morphine equivalent dosage (MED), 7.7+/-6.1 g metamizol, and 512+/-325 mg NSAR during hospital stay, which was 4.9+/-1.4 days. Patients were mobilized primarily 2.9+/-8.0 h after surgery. Mobility was achieved 33.8+/-15.8 h after surgery. Enteral nutrition with fluids was started after 1.9+/-7.0 h, full enteral nutrition was accomplished after 37.4+/-19.0 h, and normal digestion returned 58.6+/-23.0 h after the procedure. CONCLUSIONS: The strictly retroperitoneal nephrectomy via a mini-incision is an elegant, minimally traumatic, safe, and quickly learnable method, resulting in short hospital stays, good cosmetic results, and a low grade of complications.

[Sigmoid colon diverticulitis : Treatment modalities 2011-2013]. / Sigmadivertikulitis : Behandlungsmodalitäten 2011 bis 2013.

INTRODUCTION: Diverticulosis is a relevant disease in Germany with a prevalence of over 60 % in patients aged ≥70 years. The S2k guidelines for the treatment of diverticulosis were recently published. Systematic epidemiological data on treatment modalities do not exist. METHODS: Analysis of in-hospital treatment modalities for diverticulosis based on data from the Federal Office of Statistics. RESULTS: Approximately 130,000 inpatient cases of diverticulosis are treated in Germany per year. Approximately 25 % undergo surgery and of these slightly under 50 % (12,000 procedures) are carried out by laparoscopy. The complication rates are 18 % in a best case scenario and up to 85 % in a worst case scenario. A stage-adjusted classification of treatment modalities based on data from the Federal Office of Statistics is currently practically impossible. CONCLUSION: To enable stage-adjusted epidemiological analysis of diverticulosis, a standardized and transparent documentation system enabling systematic analysis is necessary, which does not currently exist (e. g. ICD 10 coding); moreover, information on conservative and interventional treatment options are not included in the operations and procedures key (OPS) coding system.

[Patient blood management: Current state of the literature]. / Patient-blood-Management : Stand der aktuellen Literatur.

BACKGROUND: Preoperative anemia has a prevalence of approximately 30% and is one of the strongest predictors of perioperative red blood cell (RBC) transfusion. It is rarely treated although it is an independent risk factor for the occurrence of postoperative complications. Additionally, the high variability in the worldwide usage of RBC transfusions is alarming. Due to these serious deficits in patient care, in 2011 the World Health Organization recommended the implementation of a patient blood management (PBM). OBJECTIVES: This article provides information about PBM as a multidimensional and interdisciplinary approach. MATERIAL AND METHODS: A selective literature search was carried out in the Medline and Cochrane library databases including consideration of national and international guidelines. RESULTS: A PBM promotes the medically and ethically appropriate use of all available resources, techniques and materials in favor of an optimized perioperative patient care. Patients' own resources should be specifically protected, strengthened and used and include (i) diagnosis and therapy of preoperative anemia, (ii) minimizing perioperative blood loss, (iii) blood-conserving surgical techniques, (iv) restriction of diagnostic blood sampling, (v) utilization of individual anemia tolerance, (vi) optimal coagulation and hemotherapy concepts and (vii) guideline-based, rational indications for the use of RBC transfusions. CONCLUSION: A PBM should be advocated as an incentive to evaluate and critically optimize local conditions. An individual, interdisciplinarily structured bundle of different PBM measures has great potential to optimize the quality of patient care and to make it safer.

[Incidence of posthepatectomy liver failure and biliary leakage : A cohort study]. / Inzidenz von Leberversagen und Galleleckagen nach Leberteilresektion : Eine Kohortenstudie.

BACKGROUND: The International Study Group of Liver Surgery (ISGLS) defined posthepatectomy liver failure as pathological values for the international normalized ratio (INR) and bilirubin 5 days after liver resection. The occurrence of biliary leakage was defined as a drainage bilirubin to serum bilirubin ratio > 3 at day 3 or later after resection or interventional surgical revision due to biliary peritonitis. A confirmatory explorative analysis was carried out. PATIENTS AND METHODS: The study involved an evaluation of primary liver resection from the years 2009 and 2010. Primary endpoints were the incidence of posthepatectomy liver failure and biliary leakage in accordance with the ISGLS definition. Secondary endpoints were complications and 90-day mortality. Results are displayed as median values (minimum and maximum). RESULTS: A total of 214 liver resections were included from the years 2009 and 2010. Patients were an average of 61.5 years old (min. 18, max. 83 years). The incidence of liver failure was 7.4 % (16 out of 214) and fatal in 7 patients. In 31 % (65 out of 214) a biliary leakage occurred, 14 (23 %) patients developed a type B, 1 patient(5 %) a type C leakage and 50 leakages were clinically inapparent. The incidence of clinically relevant biliary leakages was 7 % (15 out of 214). The sensitivity of the definition was 100 % and the specificity 75 %. The incidence of Dindo-Calvien complications > 3b was 10.2 %, of sepsis 5.6 % and the 90-day mortality was 6.5 %. Multivariate analysis did not reveal independent predictive factors for biliary leakage or liver failure. CONCLUSION: The definition for posthepatectomy liver failure was found to be valid in this cohort. The incidence of postoperative biliary leakage is over-estimated with the current definition and delivers a large number of false positive results without clinical relevance.

[Technique of liver procurement in postmortem donation]. / Technik der Leberentnahme bei postmortaler Spende.

BACKGROUND: The procurement of the liver is a standardized surgical procedure in the hands of qualified transplantation and organ procurement surgeons which is defined in the German guidelines. METHODS: Literature review and discussion of critical aspects concerning the procurement of liver allografts. The procurement of livers should be performed by qualified transplantation and organ procurement surgeons (certification). The technique is standardized in German guidelines. A thoracotomy can help to optimize exposition which is essential to avoid technical complications and injuries to the graft especially in a training situation. Dissection in the cold is recommended. Knowledge of the anatomic variations of the hepatic artery is essential in procuring liver allografts. Documentation of errors and anatomic variations, packing of organs and a standardized closure of the thorax and abdomen are obligations of the responsible leading organ procurement surgeon.

[Biliodigestive anastomosis: indications, complications and interdisciplinary management]. / Biliodigestive Anastomosen: Indikationen, Komplikationen und interdisziplinäres Management.

Techniques for biliodigestive anastomoses are a frequent indication in primary surgical interventions. Moreover, they are required to manage secondary complications of hepatobiliary surgery. Evidence for the management of complications following biliodigestive anastomoses is low. Biliodigestive anastomoses can be performed as hepaticojejunostomy, hepatojejunostomy/portoenterostomy and hepaticoduodenostomy using running or single stitch suture techniques. Complication management in the hands of experienced hepatopancreatobiliary surgeons should consider a time delay to the primary operation and an interdisciplinary surgical and/or endoscopic or radiologic interventional approach. The therapy may be protracted and requires repeated critical reflection of the particular complication.

[Challenges in the organization of investigator initiated trials: in transplantation medicine]. / Herausforderungen in der Organisation "investigator initiated trials": Am Beispiel der Transplantationsmedizin.

INTRODUCTION: Transplantation medicine offers multiple translational questions which should preferably be transferred to clinical evidence. The current gold standard for testing such questions and hypotheses is by prospective randomized controlled trials (RCT). The trials should be performed independently from the medical industry to avoid conflicts of interests and to guarantee a strict scientific approach. A good model is an investigator initiated trial (IIT) in which academic institutions function as the sponsor and in which normally a scientific idea stands before marketing interests of a certain medical product. METHODS: We present a model for an IIT which is sponsored and coordinated by Regensburg University Hospital at 45 sites in 13 nations (SiLVER study), highlight special pitfalls of this study and offer alternatives to this approach. RESULTS: Finances: financial support in clinical trials can be obtained from the medical industry. Alternatively in Germany the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) offers annual grants. The expansion of financial support through foundations is desirable. Infrastructure: sponsorship within the pharmaceutics act (Arzneimittelgesetz) demands excellent infrastructural conditions and a professional team to accomplish clinical, logistic, regulatory, legal and ethical challenges in a RCT. If a large trial has sufficient financial support certain tasks can be outsourced and delegated to contract research organizations, coordinating centers for clinical trials or partners in the medical industry. CONCLUSIONS: Clinical scientific advances to improve evidence are an enormous challenge when performed as an IIT. However, academic sponsors can perform (international) IITs when certain rules are followed and should be defined as the gold standard when scientific findings have to be established clinically.