Good outcome of liver transplantation in patients with pre-existing renal cell carcinoma.

The presence of a pre-existing or recent extra-hepatic solid tumor was considered for a long time as an absolute contraindication to liver transplantation, by fear of futility with an unacceptable increase in non-liver-related mortality. However, cancer-related mortality in solid malignancies is heterogeneous, and experts suggest that case-by-case multidisciplinary decisions should be made. Here, we report the cases of 3 patients with favorable oncological and liver outcome in patients with renal cell carcinoma detected during pre-transplant evaluation that nonetheless underwent liver transplantation.

High incidence of postoperative infections after pancreaticoduodenectomy: A need for perioperative anti-infectious strategies.

OBJECTIVES: Postoperative infections occur frequently after pancreaticoduodenectomy, especially in patients with bile colonization. Recommendations for perioperative anti-infectious treatment are lacking, and clinical practice is heterogenous. We have analyzed the effects of bile colonization and antibiotic prophylaxis on postoperative infection rates, types and therapeutic consequences. METHODS: Retrospective observational study in patients undergoing pancreaticoduodenectomy with intraoperative bile culture. Data on postoperative infections and non-infectious complications, bile cultures and antibiotic prophylaxis adequacy to biliary bacteria were collected. RESULTS: Among 129 patients, 53% had a positive bile culture and 23% had received appropriate antibiotic prophylaxis. Postoperative documented infection rate was over 40% in patients with or without bile colonization, but antibiotic therapy was more frequent in positive bile culture patients (77% vs. 57%, P=0,008). The median duration of antibiotic therapy was 11 days and included a broad-spectrum molecule in 42% of cases. Two-thirds of documented postoperative infections involved one or more bacteria isolated in bile cultures, which was associated with a higher complication rate. While bile culture yielded Gram-negative bacilli (57%) and Gram-positive cocci (43%), fungal microorganisms were scarce. Adequate preoperative antibiotic prophylaxis according to bile culture was not associated with reduced infectious or non-infectious complication rates. CONCLUSION: Patients undergoing pancreaticoduodenectomy experience a high rate of postoperative infections, often involving bacteria from perioperative bile culture when positive, with no preventive effect of an adequate preoperative antibiotic prophylaxis. Increased postoperative complications in patients with bile colonization may render necessary a perioperative antibiotic treatment targeting bile microorganisms. Further prospective studies are needed to improve the anti-infectious strategy in these patients.

Management of pancreatic ascites complicating alcoholic chronic pancreatitis.

INTRODUCTION: Pancreatic ascites (PA) is an unusual and little studied complication of chronic alcoholic pancreatitis. Management is complex and is based mainly on empirical data. The aim of this retrospective work was to analyse the management of PA at our centre. PATIENTS AND METHODS: A total of 24 patients with PA complicating chronic alcoholic pancreatitis were managed at the Lille University Hospital between 2004 and 2018. Treatment was initially medical and then, in case of failure, interventional (endoscopic, radiological and/or surgical). Data regarding epidemiology, therapeutic and follow-up data were collected retrospectively. RESULTS: Twenty-four patients were analysed; median follow-up was 18.5 months [6.75-34.25]. Exclusively medical treatment was effective in three of four patients, but, based on intention to treat, medical therapy alone was effective in only two out of 24 patients. Of 17 patients treated endoscopically, treatment was successful in 15 of them. Of the 15 who underwent surgery, external surgical drainage was effective in 13. Multimodal treatment, initiated after 6.5 days [4-13.5] of medical treatment, was effective in 12 out of 14 patients. In total, 21 patients were successfully treated (87%) with a morbidity rate of 79% and a mortality rate of 12.5% (n=3). CONCLUSION: PA gives rise to significant morbidity and mortality. Conservative medical treatment has only a limited role. If medical treatment fails, endoscopic and then surgical treatment allow a favourable outcome in more than 80% of patients.

Predictive factors for utilization of a low-volume center in pancreatic surgery: A nationwide study.

STUDY OBJECTIVE: It has been demonstrated that mortality following pancreatectomy is correlated with surgical volume. However, up until now, no French study has focused on predictive factors to undergo pancreatectomy in low-volume centers. The objective of this study is to analyze the clinical characteristics, socio-economic status and medical density according to surgical volume and to analyze predictive factors for undergoing pancreatectomy in low-volume centers. PATIENTS AND METHODS: All patients who underwent pancreatectomy in France from 2012 to 2015 were identified fromthe PMSI database. Hopsitals were classified as low, intermediate and high volume (<10, 11-19, ≥20 resections/year, respectively). Clinical and socioeconomic data, travel distance and rurality were assesed to identify factors associated with undergoing pancreatectomy at low-volume hospitals. RESULTS: In overall, 12,333 patients were included. Those who underwent pancreatectomy in low-volume centers were more likely older, had high Charlson comorbidity index (CCI), had low socioeconomic status, and resided in rural locations.distance traveled by patients operated on in low-volume centers was significantly shorter (23 vs. 61km, P<0.001). In multivariable analysis, older age (P=0.04), CCI≥4 (P=0.008), short travel distance (P<0.001), low socio-economic status (P<0.001) and rurality (P<0.001) were associated withundergoing pancreatectomy in low-volume centers. CONCLUSION: Patients continue to undergo pancreatectomy at low-volume hospitals is due not only to clinical parameters, but also to socioeconomic and environmental factors. These factors should be taken into account in process of pancreatic surgery centralization.

The management of gallbladder polyps.

Neoplastic gallbladder polyps (NGP) are rare; the prevalence in the overall population is less than 10%. NGP are associated with a risk of malignant degeneration and must be distinguished from other benign gallbladder polypoid lesions that occur more frequently. NGP are adenomas and the main risk associated with their management is to fail to detect their progression to gallbladder cancer, which is associated with a particular poor prognosis. The conclusions of the recent European recommendations have a low level of evidence, based essentially on retrospective small-volume studies. Abdominal sonography is the first line study for diagnosis and follow-up for NGP. To prevent the onset of gallbladder cancer, or treat malignant degeneration in its early phases, all NGP larger than 10mm, or symptomatic, or larger than 6mm with associated risk factors for cancer (age over 50, sessile polyp, Indian ethnicity, or patient with primary sclerosing cholangitis) are indications for cholecystectomy. Apart from these situations, simple sonographic surveillance is recommended for at least five years; if the NGP increases in size by more than 2mm in size, cholecystectomy is indicated. Laparoscopic cholecystectomy is possible but if the surgeon feels that the risk of intra-operative gallbladder perforation is high, conversion to laparotomy should be preferred to avoid potential intra-abdominal tumoral dissemination. When malignant NGP is suspected (size greater than 15mm, signs of locoregional extension on imaging), a comprehensive imaging workup should be performed to search for liver extension: in this setting, radical surgery should be considered.

BRAF mutation is not associated with an increased risk of recurrence in patients undergoing resection of colorectal liver metastases.

BACKGROUND: BRAF mutation is associated with a poor prognosis in patients with metastatic colorectal cancer. For patients with resectable colorectal liver metastases (CRLMs), the prognostic impact of BRAF mutation is unknown and the benefit of surgery debated. This nationwide intergroup (ACHBT, FRENCH, AGEO) study aimed to evaluate the oncological outcome of patients undergoing liver resection for BRAF-mutated CRLMs. METHODS: The study included patients who underwent resection for BRAF-mutated CRLMs in 24 centres between 2012 and 2016. A case-matched comparison was made with 183 patients who underwent resection of CRLMs with wild-type BRAF during the same interval. RESULTS: Sixty-six patients who underwent resection for BRAF-mutated CRLMs in 24 centres were compared with 183 patients with wild-type BRAF. The 1- and 3-year disease-free survival (DFS) rates were 46 and 19 per cent for the BRAF-mutated group, and 55·4 and 27·8 per cent for the group with wild-type BRAF (P = 0·430). In multivariable analysis, BRAF mutation was not associated with worse DFS (hazard ratio 1·16, 95 per cent c.i. 0·72 to 1·85; P = 0·547). The 1- and 3-year overall survival rates after surgery were 94 and 54 per cent respectively among patients with BRAF mutation, and 95·8 and 82·9 per cent in those with wild-type BRAF (P = 0·004). Median survival after disease progression was 23·0 (95 per cent c.i. 11·0 to 35·0) months among patients with mutated BRAF and 44·3 (35·9 to 52·6) months in those with wild-type BRAF (P = 0·050). Multisite disease progression was more common in the BRAF-mutated group (48 versus 29·8 per cent; P = 0·034). CONCLUSION: These results support surgical treatment for resectable BRAF-mutated CRLM, as BRAF mutation by itself does not increase the risk of relapse after resection. BRAF mutation is associated with worse survival in patients whose disease relapses after resection of CRLM, as for non-metastatic colorectal cancer.

Early removal of intraperitoneal drainage after pancreatoduodenectomy in patients without postoperative fistula at POD3: Results of a randomized clinical trial.

BACKGROUND: To determine whether the timing of removal of abdominal drainage (AD) after pancreatoduodenectomy (PD) influences the 30-day surgical site infection (30-day SSI) rate. METHODS: A multicenter randomized, intention-to-treat trial with two parallel arms (superiority of early vs. standard AD removal on SSI) was performed between 2011 and 2015 in patients with no pancreatic fistula (PF) on POD3 after PD (NCT01368094). The primary endpoint was the 30-day SSI rate. The secondary endpoints were specific post-PD complications (grade BC PF), postoperative morbidity and risk factor of SSI, reoperation rate, 30-day mortality, length of drainage, length of stay and postoperative infectious complications. RESULTS: One hundred and forty-one patients were randomized: 71 in the early arm, 70 in the standard arm (70.2% of pancreatic adenocarcinomas; 91.5% of pancreatojejunostomies; 66.0% of bilateral drainages; feasibility: 39.9%). Early removal of drains was not associated with a significant decrease of 30-day SSI (14.1% vs. 24.3%, P=0.12). A lower rate of deep SSI was observed in the early arm (2.8% vs. 17.1%, P=0.03), leading to a shorter length of stay (17.8±6.8 vs. 21.0±6.1, P=0.01). Grade BC PF rate (5.6%), severe morbidity (17.7%), reoperation rate (7.8%), 30-day mortality (1.4%) and wound-SSI rate (7.8%) were similar between arms. After multivariate analysis, the timing of AD removal was not associated with an increase of 30-day SSI (OR=0.74 [95% CI 0.35-1.13, P=0.38]). CONCLUSION: In selected patients with no PF on POD3, early removal of abdominal drainage does not seem to increase or decrease surgical site infection's occurrence.

Do complications following pancreatic resections impact hospital costs in France: Medico-economic study on 127 patients.

OBJECTIVE: To define the cost of pancreatectomies and to identify factors associated with increased hospital costs after pancreatic resection. METHODS: All patients undergoing pancreatic surgery in our department between January 2008 and December 2014 were included. All complications occurring during hospitalization or in the 90-day period after discharge were documented. The hospital costs were analyzed and predictive factors of increased hospital costs were determined. RESULTS: One hundred and twenty seven patients were identified. Most patients underwent pancreatectomy for malignant tumors (70%). Median hospital costs were 21,392 [15,998-29,667] euros. Age (P=0.011) and preoperative jaundice (P<0.001) were associated with higher hospital costs. Intraoperative surgical time and blood loss were correlated with increased costs (P=0.001 and P=0.002, respectively). Pancreatoduodenectomy was associated with statistically significantly higher costs compared to distal pancreatectomy (21,770 vs. 15,422 euros, P=0.001). Severe postoperative complications (Clavien-Dindo grade≥3) (P=0.001), septic complications (P=0.002) and hemorrhage (P=0.001) statistically significantly increased costs. In multivariate analysis, septic (P=0.003) and severe complications (P=0.01) were statistically significantly associated with increased hospital costs. CONCLUSION: Pancreatic surgery is associated with high hospital costs, essentially related to postoperative complications.

Conversion to resection of liver metastases from colorectal cancer with hepatic artery infusion of combined chemotherapy and systemic cetuximab in multicenter trial OPTILIV.

BACKGROUND: Systemic chemotherapy typically converts previously unresectable liver metastases (LM) from colorectal cancer to curative intent resection in ∼15% of patients. This European multicenter phase II trial tested whether hepatic artery infusion (HAI) with triplet chemotherapy and systemic cetuximab could increase this rate to 30% in previously treated patients. PATIENTS AND METHODS: Participants had unresectable LM from wt KRAS colorectal cancer. Main non-inclusion criteria were advanced extra hepatic disease, prior HAI and grade 3 neuropathy. Irinotecan (180 mg/m(2)), oxaliplatin (85 mg/m(2)) and 5-fluorouracil (2800 mg/m(2)) were delivered via an implanted HAI access port and combined with i.v. cetuximab (500 mg/m(2)) every 14 days. Multidisciplinary decisions to resect LM were taken after every three courses. The rate of macroscopic complete resections (R0 + R1) of LM, progression-free survival (PFS) and overall survival (OS) were computed according to intent to treat. RESULTS: The patient population consisted of 42 men and 22 women, aged 33-76 years, with a median of 10 LM involving a median of six segments. Up to 3 extrahepatic lesions of <1 cm were found in 41% of the patients. A median of six courses was delivered. The primary end point was met, with R0-R1 hepatectomy for 19 of the 64 previously treated patients, 29.7% (95% confidence interval 18.5-40.9). Grade 3-4 neutropenia (42.6%), abdominal pain (26.2%), fatigue (18%) and diarrhea (16.4%) were frequent. Objective response rate was 40.6% (28.6-52.3). Median PFS and OS reached 9.3 (7.8-10.9) and 25.5 months (18.8-32.1) respectively. Those with R0-R1 hepatectomy had a median OS of 35.2 months (32.6-37.8), with 37.4% (23.6-51.2) alive at 4 years. CONCLUSION: The coordination of liver-specific intensive chemotherapy and surgery had a high curative intent potential that deserves upfront randomized testing. PROTOCOL NUMBERS: EUDRACT 2007-004632-24, NCT00852228.

Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS): impact of the inter-stages course on morbi-mortality and implications for management.

BACKGROUND: Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) was recently developed to induce rapid hypertrophy and reduce post-hepatectomy liver failure in patients with insufficient remnant liver volume (RLV). However, mortality rates >12% have been reported. This study aimed to analyze the perioperative course of ALPPS and to identify factors associated with morbi-mortality. METHODS: Between April 2011 and September 2013, 62 patients operated in 9 Franco-Belgian hepatobiliary centres underwent ALPPS for colorectal metastases (N = 50) or primary tumors, following chemotherapy (N = 50) and/or portal vein embolization (PVE; N = 9). RESULTS: Most patients had right (N = 31) or right extended hepatectomy (N = 25) (median RLV/body weight ratio of 0.54% [0.21-0.77%]). RLV increased by 48.6% [-15.3 to 192%] 7.8 ± 4.5 days after stage1, but the hypertrophy decelerated beyond 7 days. Stage2 was cancelled in 3 patients (4.8%) for insufficient hypertrophy, portal vein thrombosis or death and delayed to ≥9 days in 32 (54.2%). Overall, 25 patients (40.3%) had major complication(s) and 8 (12.9%) died. Fourteen patients (22.6%) had post-stage1 complication of whom 5 (35.7%) died after stage2. Factors associated with major morbi-mortality were obesity, post-stage1 biliary fistula or ascites, and infected and/or bilious peritoneal fluid at stage2. The latter was the only predictor of Clavien ≥3 by multivariate analysis (OR: 4.9; 95% CI: 1.227-19.97; p = 0.025). PVE did not impact the morbi-mortality rates but prevented major cytolysis that was associated with poor outcome. CONCLUSIONS: The inter-stages course was crucial in determining ALPPS outcome. The factors of high morbi-mortality rates associated with ALPPS are linked to the technique complexity.

Outcome in porcine acellular dermal matrix reinforcement of infected abdominal wall defects: a prospective study.

PURPOSE: Management of infected abdominal wall defects is a subject of debate, and the use of prosthetic mesh repair is not recommended due to the dramatic rate of mesh infection. The aim of this prospective study was to determine the recurrence rate and long-term outcomes of repairing infected abdominal wall defects using the Strattice porcine acellular dermal matrix reinforcement through a single-stage surgical approach. METHODS: From August 2010 to May 2012, consecutive patients treated for infected abdominal wall defects using Strattice, a biologic prosthesis, were enrolled. All data were collected prospectively and all patients were followed for physical examination and CT scan evaluation. The primary outcome measure was the recurrence rate. RESULTS: Eighteen patients were enrolled and 14 were evaluable. Of these, eight patients had mesh infections and six had enterocutaneous fistulas. Median follow-up was 13 months (range, 3-22) and median length of hospitalization was 13 days (range, 4-56). The Strattice was placed in the intraperitoneal underlay position in 12 patients, and in the retro-rectus position for two. Post-operative complications included skin dehiscence (n = 3), wound infection (n = 2), skin necrosis (n = 1), and seroma (n = 2). At the end of follow-up, six patients (43 %) experienced abdominal wall defect recurrence. CONCLUSIONS: The utility of biologic prostheses to repair infected abdominal wall defects is controversial; however, currently, they remain the only alternative to a two-staged surgery. Prospective, randomized studies in larger populations of patients are necessary to fully determine the usefulness of biologic prostheses in this setting.

FOLFOX4 versus sequential dose-dense FOLFOX7 followed by FOLFIRI in patients with resectable metastatic colorectal cancer (MIROX): a pragmatic approach to chemotherapy timing with perioperative or postoperative chemotherapy from an open-label, randomized phase III trial.

BACKGROUND: Perioperative FOLFOX4 (oxaliplatin plus 5-fluorouracil/leucovorin) chemotherapy is the current standard in patients with resectable metastases from colorectal cancer (CRC). We aimed to determine whether a sequential chemotherapy with dose-dense oxaliplatin (FOLFOX7) and irinotecan (FOLFIRI; irinotecan plus 5-fluorouracil/leucovorin) is superior to FOLFOX4. The chemotherapy timing was not imposed, and was perioperative or postoperative. PATIENTS AND METHODS: In this open-label, phase III trial, patients with resectable or resected metastases were randomly assigned either to 12 cycles of FOLFOX4 (oxaliplatin 85 mg/m(2)) or 6 cycles of FOLFOX7 (oxaliplatin 130 mg/m(2)) followed by 6 cycles of FOLFIRI (irinotecan 180 mg/m(2)). Randomization was done centrally, with stratification by chemotherapy timing, type of local treatment (surgery versus radiofrequency ablation with/without surgery), and Fong's prognostic score. The primary end point was 2-year disease-free survival (DFS). RESULTS: A total of 284 patients were randomized, 142 in each treatment group. Chemotherapy was perioperative in 168 (59.2%) patients and postoperative in 116 (40.8%) patients. Perioperative chemotherapy was preferentially proposed for synchronous metastases, whereas postoperative chemotherapy was more frequently used for metachronous metastases. Two-year DFS was 48.5% in the FOLFOX4 group and 50.0% in the FOLFOX7-FOLFIRI group. In the multivariable analysis, more than one metastasis [hazard ratio (HR) = 2.15] and synchronous metastases (HR = 1.63) were independent prognostic factors for shorter DFS. Five-year overall survival (OS) rate was 69.5% with FOLFOX4 versus 66.6% with FOLFOX7-FOLFIRI. CONCLUSIONS: FOLFOX7-FOLFIRI is not superior to FOLFOX4 in patients with resectable metastatic CRC. Five-year OS rates observed in both groups are the highest ever reported in this setting, possibly reflecting the pragmatic approach to chemotherapy timing. CLINICAL TRIALS NUMBER: NCT00268398.

Hepatic artery ligation for arterial rupture following liver transplantation: a reasonable option.

Hepatic artery (HA) rupture after liver transplantation is a rare complication with high mortality. This study aimed to review the different managements of HA rupture and their results. From 1997 to 2007, data from six transplant centers were reviewed. Of 2649 recipients, 17 (0.64%) presented with HA rupture 29 days (2-92) after transplantation. Initial management was HA ligation in 10 patients, reanastomosis in three, aorto-hepatic grafting in two and percutaneous arterial embolization in one. One patient died before any treatment could be initiated. Concomitant biliary leak was present in seven patients and could be subsequently treated by percutaneous and/or endoscopic approaches in four patients. Early mortality was not observed in patients with HA ligation and occurred in 83% of patients receiving any other treatment. After a median follow-up of 70 months, 10 patients died (4 after retransplantation), and 7 patients were alive without retransplantation (including 6 with HA ligation). HA ligation was associated with better 3-year survival (80% vs. 14%; p=0.002). Despite its potential consequences on the biliary tract, HA ligation should be considered as a reasonable option in the initial management for HA rupture after liver transplantation. Unexpectedly, retransplantation was not always necessary after HA ligation in this series.

Tumor size of hepatocellular carcinoma in noncirrhotic liver: a controversial predictive factor for outcome after resection.

BACKGROUND: Hepatocellular carcinoma in noncirrhotic liver (NC-HCC) presents usually with large size, which is seen as a contraindication to liver transplantation (LT) or even resection. The objective of our single-center study was to identify prognostic factors following resection of large NC-HCCs and to subsequently devise a treatment strategy (including LT) in selected patients. METHODS: From 2000 to 2010, 89 patients who had hepatic resection for NC-HCC (large ≥ 8 cm in 52) were analyzed with regard to pathological findings, postoperative and long-term outcome. RESULTS: Five patients died postoperatively. After a mean follow-up of 35 ± 30 months, NC-HCC recurred in 36 patients (26/47 survivors in group 8 cm+, 10/37 in group 8 cm-; p = 0.007). Five-year overall (OS) and disease-free survival (DFS) rates were significantly worse for group 8 cm+ (43.4% vs. 89.2% and 39.3% vs. 60.7% for group 8 cm-, p < 0.05). Seven patients underwent re-hepatectomy and/or LT for isolated intrahepatic recurrence, with 5-year DFS of 57.1%. In a multivariate analysis, the factors associated with poor OS and DFS were vascular invasion and tumor size ≥ 8 cm in the overall population and vascular invasion, fibrosis and satellite nodules in group 8 cm+. Adjuvant transarterial chemotherapy was a protective factor in group 8 cm+. In 22 isolated NC-HCC cases with no vascular invasion or fibrosis, tumor size had no impact on five-year DFS (85%). CONCLUSIONS: Although patients with NC-HCC ≥ 8 cm had a poorer prognosis, the absence of vascular invasion or fibrosis was associated with excellent survival, regardless of the tumor size. In recurrent patients, aggressive treatment (including LT) can be considered.

Exposure for hepatic surgery in the obese patient: an innovative adaptation in time of need .

Obesity has become a major public health concern. More and more patients with substantial obesity require surgery including complex hepatobiliary interventions. The morphology of these patients can make surgery difficult, especially in terms of exposure. We report the case of an obese patient who required a left hemihepatectomy for colorectal liver metastasis. It was very difficult to obtain adequate exposure; this problem was solved by transcutaneous introduction of the handle of a broad costal margin retractor. We describe this maneuver, which allowed us to carry out the intervention under excellent conditions.

Hepatic venous pressure gradient in the assessment of portal hypertension before liver resection in patients with cirrhosis.

BACKGROUND: Preoperative measurement of hepatic venous pressure gradient (HVPG) is not performed routinely before hepatectomy in patients with cirrhosis, although it has been suggested to be useful. This study investigated whether preoperative HVPG values and indirect criteria of portal hypertension (PHT) predict the postoperative course in these patients. METHODS: Between January 2007 and December 2009, consecutive patients with resectable hepatocellular carcinoma (HCC) in a cirrhotic liver were included in this prospective study. PHT was assessed by transjugular HVPG measurement and by classical indirect criteria (oesophageal varices, splenomegaly and thrombocytopenia). The main endpoints were postoperative liver dysfunction and 90-day mortality. RESULTS: Forty patients were enrolled. A raised HVPG was associated with postoperative liver dysfunction (median 11 and 7 mmHg in those with and without dysfunction respectively; P = 0·017) and 90-day mortality (12 and 8 mmHg in those who died and survivors respectively; P = 0·026). Oesophageal varices, splenomegaly and thrombocytopenia were not associated with any of the endpoints. In multivariable analysis, body mass index, remnant liver volume ratio and preoperative HVPG were the only independent predictors of postoperative liver dysfunction. CONCLUSION: An increased HVPG was associated with postoperative liver dysfunction and mortality after liver resection in patients with HCC and liver cirrhosis, whereas indirect criteria of PHT were not. This study suggests that preoperative HVPG measurement should be measured routinely in these patients.

Safety and efficacy of sorafenib in hepatocellular carcinoma: the impact of the Child-Pugh score.

BACKGROUND: Sorafenib increases median survival and time to radiological progression in patients with advanced hepatocellular carcinoma, but its benefit for Child-Pugh B patients remains uncertain. AIM: To evaluate the safety and efficacy of sorafenib in real-life clinical practice conditions and to assess the influence of Child-Pugh class B on safety and efficacy. METHODS: All patients treated with sorafenib for advanced hepatocellular carcinoma in our institution were included prospectively. Adverse events, overall survival and time to progression were recorded. A case control study was performed to compare outcome of patients with comparable stages of hepatocellular carcinoma, but a different Child-Pugh class. RESULTS: From March 2007 to May 2009, 120 patients were included. Overall survival was 11.1 months, Child-Pugh A patients (n=100) had significantly higher median survival than Child-Pugh B patients (n=20) (13 vs. 4.5 months, P=0.0008). In multivariate analysis, Child-Pugh class B, α-fetoprotein level and total size of lesions were independent predictive factors of death. Patients with radiological progression in the first 3 months had shorter median survival (5.4 vs. 17.4 months). In a case control study, time to symptomatic progression (2.5 vs. 3.6 months), frequency of adverse events and discontinuation of sorafenib were not correlated with Child-Pugh class. CONCLUSIONS: Patients with advanced hepatocellular carcinoma treated with sorafenib had a median survival of 11 months. Sorafenib therapy must be considered with caution in Child-Pugh B patients due to their poor survival. Radiological assessment of tumour progression at an early stage may be advantageous when tailoring sorafenib therapy.