Efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for hepatitis C in Korea: a Phase 3b study

Despite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for 12 weeks in HCV-infected Korean adults. Methods: This Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir–velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen ≥ 4 weeks received sofosbuvir–velpatasvir–voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment. Results: Of 53 participants receiving sofosbuvir–velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir–velpatasvir–voxilaprevir achieved SVR 12. Overall, sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported. Conclusions: Treatment with sofosbuvir–velpatasvir or sofosbuvir–velpatasvir–voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.

Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study

Background@#The advancement of treatment with direct-acting antiviral (DAA) agents has improved the cure rate of hepatitis C virus (HCV) infection close to 100%. The aim of our study was to assess the real-world effectiveness and safety of DAA regimens for the treatment of patients with chronic HCV genotype 2. @*Methods@#We retrospectively analyzed the clinical data of patients treated with sofosbuvir plus ribavirin (SOF + RBV) or glecaprevir/pibrentasvir (G/P) for chronic HCV genotype 2 infection at seven university hospitals in the Korean southeast region. @*Results@#SOF + RBV therapy produced an 89% and 98.3% sustained virologic response 12 week (SVR12) after treatment completion in the full analysis set and per-protocol set, respectively, and the corresponding values for G/P therapy were 89.5% and 99.2%, respectively. The difference between the treatments was probably because 6.2% (59/953) of patients in the SOF + RBV group did not complete the treatment and 9.8% (14/143) in the G/P group did not test HCV RNA after treatment completion. Adverse events (A/Es) were reported in 59.7% (569/953) and 25.9% (37/143) of the SOF + RBV and G/P groups, respectively. In the SOF + RBV group, 12 (1.26%) patients discontinued treatment owing to A/Es, whereas no patients discontinued treatment because of A/Es in the G/P group. @*Conclusion@#In both treatment groups, SVR was high when treatment was completed.However, there was a high dropout rate in the SOF + RBV group, and the dropout analysis showed that these were patients with liver cirrhosis (LC; 43/285, 15.1%), especially those with decompensated LC (12/32, 37.5%). Therefore, an early initiation of antiviral therapy is recommended for a successful outcome before liver function declines. Furthermore, patients with decompensated LC who are considered candidates for SOF + RBV treatment should be carefully monitored to ensure that their treatment is completed, especially those with low hemoglobin and high alanine transaminase.

Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study

Background@#The advancement of treatment with direct-acting antiviral (DAA) agents has improved the cure rate of hepatitis C virus (HCV) infection close to 100%. The aim of our study was to assess the real-world effectiveness and safety of DAA regimens for the treatment of patients with chronic HCV genotype 2. @*Methods@#We retrospectively analyzed the clinical data of patients treated with sofosbuvir plus ribavirin (SOF + RBV) or glecaprevir/pibrentasvir (G/P) for chronic HCV genotype 2 infection at seven university hospitals in the Korean southeast region. @*Results@#SOF + RBV therapy produced an 89% and 98.3% sustained virologic response 12 week (SVR12) after treatment completion in the full analysis set and per-protocol set, respectively, and the corresponding values for G/P therapy were 89.5% and 99.2%, respectively. The difference between the treatments was probably because 6.2% (59/953) of patients in the SOF + RBV group did not complete the treatment and 9.8% (14/143) in the G/P group did not test HCV RNA after treatment completion. Adverse events (A/Es) were reported in 59.7% (569/953) and 25.9% (37/143) of the SOF + RBV and G/P groups, respectively. In the SOF + RBV group, 12 (1.26%) patients discontinued treatment owing to A/Es, whereas no patients discontinued treatment because of A/Es in the G/P group. @*Conclusion@#In both treatment groups, SVR was high when treatment was completed.However, there was a high dropout rate in the SOF + RBV group, and the dropout analysis showed that these were patients with liver cirrhosis (LC; 43/285, 15.1%), especially those with decompensated LC (12/32, 37.5%). Therefore, an early initiation of antiviral therapy is recommended for a successful outcome before liver function declines. Furthermore, patients with decompensated LC who are considered candidates for SOF + RBV treatment should be carefully monitored to ensure that their treatment is completed, especially those with low hemoglobin and high alanine transaminase.

Prognostic factors in hepatocellular carcinoma patients with bone metastases

PURPOSE: To identify the prognostic factors that could influence survival and to compare prognoses of the patients with the number of the risk factors that might assist in the adequate management of hepatocellular carcinoma (HCC) patients with bone metastases that showed a heterogeneous range of survival. MATERIALS AND METHODS: A total of 41 patients, treated with radiotherapy (RT) for bone metastases from HCC from 2014 to 2017, were enrolled retrospectively. Survival was determined by the Kaplan–Meier method from the start of the RT for metastatic bone lesions. Pre-RT clinical features were evaluated and their influences on survival were analyzed. The significant factors were considered to compare survivals according to the number of prognostic factors. RESULTS: Median follow-up was 6.0 months (range, 0.5 to 47.0 months). The median overall survival was 6.5 months, and the 1-year and 2-year survival rates were 35.5% and 13.5%, respectively. Multivariate analysis revealed that the Child-Pugh class A group, alpha-fetoprotein increased more than 30 ng/mL, and HCC size of more than 5 cm were associated with worse overall survival. The median survivals in HCC with none, 1, 2, and 3 of the aforementioned risk factors were 19.5, 9.0, 2.5, and 1.0 months, respectively (p < 0.05). CONCLUSION: Our results show that the overall survivals were significantly different according to the number of the risk factors among HCC patients with bone metastases who showed various lengths of survival.

Drug Induced Liver Injury by Prophylactic Administration of Albendazole / 대한소화기학회지

Albendazole is used as a typical antiparasitic agent worldwide. The side effects of albendazole may include nausea, vomiting, abdominal pain, dizziness, headache, alopecia, and increased liver enzymes. Mild elevation of the liver enzyme has been reported in more than 10% of cases, but drug induced liver injury was reported to be very rare. A 30-year-old woman visited the Dong-A University Hospital with anorexia, nausea, jaundice, and elevated liver enzyme. For diagnosis, other acute hepatitis etiologies were excluded, but the prophylactic administration of albendazole was verified. This paper introduces a case of drug-induced liver injury through the prophylactic administration of albendazole. Physicians should be aware of severe liver injury as one of the side effects of albendazole.

Drug Induced Liver Injury by Prophylactic Administration of Albendazole / 대한소화기병학회잡지

Albendazole is used as a typical antiparasitic agent worldwide. The side effects of albendazole may include nausea, vomiting, abdominal pain, dizziness, headache, alopecia, and increased liver enzymes. Mild elevation of the liver enzyme has been reported in more than 10% of cases, but drug induced liver injury was reported to be very rare. A 30-year-old woman visited the Dong-A University Hospital with anorexia, nausea, jaundice, and elevated liver enzyme. For diagnosis, other acute hepatitis etiologies were excluded, but the prophylactic administration of albendazole was verified. This paper introduces a case of drug-induced liver injury through the prophylactic administration of albendazole. Physicians should be aware of severe liver injury as one of the side effects of albendazole.

Scoring System for Factors Affecting Aggravation of Lumbar Disc Herniation

PURPOSE: To investigate the various imaging factors associated with aggravation of lumbar disc herniation (LDH) and develop a scoring system for prediction of LDH aggravation. MATERIALS AND METHODS: From 2015 to 2017, we retrospectively reviewed the magnetic resonance imaging (MRI) findings of 60 patients (30 patients with aggravated LDH and 30 patients without any altered LDH). Imaging factors for MRI evaluation included the level of LDH, disc degeneration, back muscle atrophy, facet joint degeneration, ligamentum flavum thickness and interspinous ligament degeneration. Flexion-extension difference was measured with simple radiography. The scoring system was analyzed using receiver operating characteristic (ROC) analysis. RESULTS: The aggravated group manifested a higher grade of disc degeneration, back muscle atrophy and facet degeneration than the control group. The ligamentum flavum thickness in the aggravated group was thicker than in the group with unaltered LDH. The summation score was defined as the sum of the grade of disc degeneration, back muscle atrophy and facet joint degeneration. The area under the ROC curve showing the threshold value of the summation score for prediction of aggravation of LDH was 0.832 and the threshold value corresponded to 6.5. CONCLUSION: Disc degeneration, facet degeneration, back muscle atrophy and ligamentum flavum thickness are important factors in predicting aggravation of LDH and may facilitate the determination of treatment strategy in patients with LDH. The summation score is available as supplemental data.

Efficacy of Pegylated Interferon Monotherapy versus Sequential Therapy of Entecavir and Pegylated Interferon in Hepatitis B e Antigen-Positive Hepatitis B Patients: A Randomized, Multicenter, Phase IIIb Open-Label Study (POTENT Study) / 中华医学杂志(英文版)

<p><b>Background</b>Until now, various types of combined therapy with nucleotide analogs and pegylated interferon (Peg-INF) in patients with hepatitis B patients have been tried. However, studies regarding the benefits of de novo combination, late-add on, and sequential treatment are very limited. The objective of the current study was to identify the efficacy of sequential treatment of Peg-INF after short-term antiviral treatment.</p><p><b>Methods</b>Between June 2010 and June 2015, hepatitis B e antigen (HBeAg)-positive patients (n = 162) received Peg-IFN for 48 weeks (mono-treatment group, n = 81) and entecavir (ETV) for 12 weeks with a 48-week course of Peg-IFN starting at week 5 of ETV therapy (sequential treatment group, n = 81). The primary endpoint was HBeAg seroconversion at the end of follow-up period after the 24-week treatment. The primary endpoint was analyzed using Chi-square test, Fisher's exact test, and regression analysis.</p><p><b>Results</b>HBeAg seroconversion rate (18.2% vs. 18.2%, t = 0.03, P = 1.000) and seroclearance rate (19.7% vs. 19.7%, t = 0.03, P = 1.000) were same in both mono-treatment and sequential treatment groups. The rate of alanine aminotransferase (ALT) normalization (45.5% vs. 54.5%, t = 1.12, P = 0.296) and serum hepatitis B virus (HBV)-DNA <2000 U/L (28.8% vs. 28.8%, t = 0.10, P = 1.000) was not different in sequential and mono-treatment groups at 24 weeks of Peg-INF. Viral response rate (HBeAg seroconversion and serum HBV-DNA <2000 U/L) was not different in the two groups (12.1% vs. 16.7%, t = 1.83, P = 0.457). Baseline HBV-DNA level (7 logU/ml vs. 7.5 logU/ml, t = 1.70, P = 0.019) and hepatitis B surface antigen titer (3.6 logU/ml vs. 4.0 logU/ml, t = 2.19, P = 0.020) were lower and predictors of responder in mono-treatment and sequential treatment groups, respectively.</p><p><b>Conclusions</b>The current study shows no differences in HBeAg seroconversion rate, ALT normalization, and HBV-DNA levels between mono-therapy and sequential therapy regimens.</p><p><b>Trial Registration</b>ClinicalTrials.gov, NCT01220596; https://clinicaltrials.gov/ct2/show/NCT01220596?term=NCT01220596&rank=1.</p>

Mushroom Poisoning by Macrolepiota neomastoidea / 대한소화기학회지

There are currently over 5,000-known species of mushrooms worldwide. Only 20–25% of mushrooms have been named, and 3% of these are poisonous. More than 95% of mushroom poisoning cases occur due to difficulties associated with the identification of mushroom species. Most of the fatal mushroom poisoning cases recorded to date have been related to the Amanita species. Until now, a case of fatal poisoning caused by Macrolepiota neomastoidea (M. neomastoidea) has not been reported in Asia. A 57-year-old male patient was admitted to the emergency room with nausea, vomiting, diarrhea, and abdominal pain. He reported ingesting wild mushrooms with his mother and sister about 2 days ago. His mother and sister were treated with only supportive care, but he was admitted to the intensive care unit and underwent liver transplantation due to acute liver failure. We are reporting a case of fatal M. neomastoidea intoxication from wild mushrooms, a rare case of mushroom poisoning.

Pulmonic stenosis with atrial septal defect in a Siamese cat

A 6-month-old mature intact female Siamese cat presented with exertional dyspnea. Diagnostic studies revealed pleural effusion, grade 4/6 left basal systolic murmur, deep S-wave in electrocardiograph leads I, II, and III, cardiomegaly with pleural effusion on radiography, pulmonic systolic (~5.8 m/sec) and tricuspid (3.6 m/sec) regurgitant jets, atrial septal defect, and a hypoplastic right outflow tract. Based on these results, the case was diagnosed as pulmonic stenosis with atrial septal defect. To the best of our knowledge, this is the first case report describing pulmonic stenosis with atrial septal defect in a cat in Korea.

A Case of needle-tract implantation of hepatocellular carcinoma in the ovary after radiofrequency ablation / 고신대학교의과대학학술지

Radiofrequency ablation (RFA), a local ablative modality, is gaining acceptance for the treatment of liver malignancies. Despite a relatively low complication rate, tumor seeding resulting from RFA in hepatocellular carcinoma (HCC) treatment can occur. A 44-year-old woman was diagnosed with HCC. Spiral computed tomography (CT) revealed a 2.3 × 2.0-cm mass in the S5 segment, which was treated with RFA on May, 2005. Follow-up imaging, performed at 6-month intervals after RFA, showed complete tumor necrosis. In October 2009, CT revealed a heterogeneous mass, 5.7 cm in diameter, in the right ovary. Since the lesion was limited to the right ovary without evidence of spread, bilateral salpingo-oophorectomy was performed. Histopathology indicated that the metastatic spread from the HCC to the ovary was positive for hepatocyte-specific antigen on immunohistochemistry. The ovary is a rare site for HCC metastasis. Moreover, needle tract implantation of HCC in the ovary is very rare.

Intraoperative radiofrequency ablation for hepatocellular carcinoma in 112 patients with cirrhosis: a surgeon's view

PURPOSE: This retrospective study was an investigation of overall survival (OS), disease-free survival (DFS) and prognostic factors affecting OS and DFS in cirrhotic patients who received intraoperative radiofrequency ablation (IORFA). METHODS: Between April 2009 and November 2013, 112 patients (94 men, 84%; 18 women, 16%) underwent IORFA for 185 cases of hepatocellular carcinomas (HCC). Repeat IORFA was done in 9 patients during the same period (total of 121 treatments). RESULTS: All patients were followed-up for at least 12 months (mean follow-up, 32 months). Surgical resection combined with IORFA was performed in 20 patients. The technical effectiveness at 1 week was 91.78% (111 of 121). Readmission was 9.1% (11 of 121) and the most common cause was ventral hernia. Procedure-related mortality was 2.7% (3 of 112) and continued fatal biliary leakage was 1.8% (2 of 112). Local recurrence developed in 10 patients (8.9%). Most recurrence was intrahepatic. Cumulative survival was assessed in 33 patients who received IORFA as primary treatment (naive patients) and 79 non-naive patients. The cumulative DFS and OS rate at l and 3 years was 54% and 24%, and 87% and 66%, respectively. Moderate ascites (P = 0.001), tumor located segment I (P = 0.001), portal vein thrombosis (P = 0.001) had poor survival were significant factors by multivariate analysis. CONCLUSION: IORFA alone or in combination with surgical resection extends the spectrum of liver surgery. A fundamental understanding of RFA, additional comorbidities, and postablation complication are necessary to maximize the safety and efficacy of IORFA for treating HCC with cirrhosis.

A Case of Sorafenib-induced DRESS Syndrome in Hepatocelluar Carcinoma / 대한소화기학회지

Sorafenib is currently the only targeted therapy available for advanced stage hepatocellular carcinoma (HCC). Cutaneous adverse events associated with sorafenib treatment include hand-foot skin reaction, but there has been no report of drug reaction (or rash) with eosinophilia and systemic symptoms (DRESS) syndrome. Here, we report a case of 72-year-old man with HCC and alcoholic liver cirrhosis who developed skin eruptions, fever, eosinophilia, and deteriorated hepatic and renal function under sorafenib treatment. He has since successfully recovered with conservative care.

Solitary Fibrous Tumor of the Pancreas: A Case Report and Review of the Literature / 대한내과학회지

Solitary fibrous tumors (SFTs) are histologically characterized as mesenchymal tumors of probable fibroblastic origin that can arise at pleural and extrapleural sites. SFTs originating in the pancreas are extremely rare. Here, we report a case of pancreatic SFT in a 77-year-old female who presented with jaundice. A malignant neuroendocrine tumor (NET) was suspected based on radiologic findings. However, it is difficult to differentiate SFTs from a NET from radiographs and in this report, we summarize magnetic resonance imaging findings and discuss how to distinguish between SFT and NET using immunohistochemistry. Radical excision is the treatment of choice for SFT; however, in the present case, excision was not possible and close observation showed no changes 10 months after the diagnosis.

A Case of Refractory Headache with Antiphospholipid Antibody Syndrome Improved by High-Intensity Warfarin Medication

Antiphospholipid antibody syndrome (APS) is a coagulation disorder associated with antiphospholipid antibodies. Headache is common in APS patients and often unresponsive to analgesics. We report a case of refractory headache in a patient with APS, who was improved by high-intensity warfarin treatment. The mechanisms of the headache in patients with APS were presumed to be hypercoagulability of microcirculation and thrombotic occlusion of the capillaries, which were associated with antiphospholipid antibodies. Therefore, high-intensity warfarin could be considered as one of the treatments for refractory headache in patients with APS.

A case of focal nodular hyperplasia with growth progression during pregnancy

Focal nodular hyperplasia (FNH) is the second most common benign solid tumor of the liver and is usually found in young females. In FNH, spontaneous bleeding or rupture rarely occurs and malignant transformation is unlikely. The etiology of FNH is unclear, but because of female predominance and young age at onset, it seems that female hormone has an important role for the development of FNH. Although the development and the complications of hepatocellular adenomas have been related to the use of oral contraceptives and pregnancy, the influence of oral contraceptives and pregnancy on the growth and complications of FNH is controversial. Most FNH are stable in size and rarely complicated during pregnancy. We describe here a case of FNH with growth progression during pregnancy in a 27-year-old female. Her course of pregnancy and delivery was uneventful. Two months after delivery, the size of FNH was decreased.

Management of giant hepatic cysts in the laparoscopic era / 대한외과학회지

PURPOSE: We sought to evaluate the feasibility and outcomes of laparoscopic resection of giant hepatic cysts and surgical success, focusing on cyst recurrence. METHODS: From February 2004 to August 2011, 37 consecutive patients with symptomatic hepatic cysts were evaluated and treated at Dong-A University Hospital. Indications were simple cysts (n = 20), multiple cysts (n = 6), polycystic disease (n = 2), and cystadenoma (n = 9). RESULTS: The median patient age was 64 years, with a mean lesion diameter of 11.4 cm. The coincidence between preoperative imaging and final pathologic diagnosis was 54% and half (n = 19) of the cysts were located in segments VII and VIII. Twenty-two patients had American Society of Anesthesiologists (ASA) classification I and II, and nine had ASA classification III. Surgical treatment of hepatic cysts were open liver resection (n = 3), laparoscopic deroofing (n = 24), laparoscopic cyst excision (n = 4), laparoscopic left lateral sectionectomy (n = 2), hand assisted laparoscopic procedure (n = 2), and single port laparoscopic deroofing (n = 2). The mean fellow-up was 21 months, and six patients (16%) experienced radiographic-apparent recurrence. Reoperation due to recurrence was performed in two patients. Among the factors predicting recurrence, multivariate analysis revealed that interventional radiological procedures and pathologic diagnosis were statistically significant. CONCLUSION: Laparoscopic resection of giant hepatic cysts is a simple and effective method to relieve symptoms with minimal surgical trauma. Moreover, the recurrence is dependent on the type of pathology involved, and the sclerotherapy undertaken.

Four Unrecorded Wood Decay Fungi from Seoul in Korea

During the investigation of Korean indigenous fungi from Seoul, three genera-Fuscoporia, Porostereum, and Trametopsis, and four species-Fuscoporia senex, Phlebia acerina, Porostereum spadiceum, and Trametopsis cervina were found. Their morphological characteristics were examined and their identification was confirmed by molecular analysis based on internal transcribed spacer (ITS) and nuclear large subunit ribosomal DNA region sequences. These fungi are new to Korea and registered here with descriptions.

Sodium Iodide Symporter and Phosphatase and Tensin Homolog Deleted on Chromosome Ten Expression in Cholangiocarcinoma Analysis with Clinicopathological Parameters

BACKGROUND/AIMS: This study was performed to investigate the correlation of sodium iodide symporter (NIS) expression with the functionality and loss of phosphatase and tensin homolog deleted on chromosome ten (PTEN) expression in human cholangiocarcinoma (CCA). METHODS: Immunohistochemistry for the expression of NIS and PTEN was performed in 60 biopsy specimens of CCA. The clinicopathological parameters were retrospectively identified from medical records. The expression pattern of NIS and loss of PTEN expression were analyzed in association with the clinicopathological characteristics, including survival. RESULTS: Normal biliary trees displayed NIS expression, but hepatocytes did not. NIS expression was divided into two patterns: cytoplasmic and membranous. Fifty-nine cases, all except for one case, displayed NIS expression in tumor cells. Twenty-two cases (33.3%) were mixed pattern, and 39 cases (65.05%) were cytoplasmic pattern; the pure membranous pattern was not noted. There was no association between the NIS expression pattern and clinicopathological parameters, including age, sex, differentiation grade, T stage and tumor, node, metastasis stage (p>0.05). The survival rates were similar among various NIS expression patterns. Normal hepatocytes and biliary trees exhibited PTEN expression in the nucleus and cytoplasm. CCA cells displayed nuclear staining. Thirty-six (60.0%) of 60 cases displayed a loss of PTEN expression. The loss of PTEN expression was observed in the advanced T-stage group (p=0.0036), but there was no association between the loss of PTEN expression and other clinicopathological parameters (p>0.05). No association between the loss of PTEN expression and survival was noted. CONCLUSIONS: NIS is expressed in most types of human CCA. The expression pattern suggests a role in cancer development. PTEN loss expression is common in the context of human CCA, especially in the advanced T stage.

Prognostic factors for gallbladder cancer in the laparoscopy era / 대한외과학회지

PURPOSE: Hepatobiliary surgery has changed dramatically in recent decades with the advent of laparoscopic techniques. The aim of this retrospective study was to compare survival rates according to stages, adjusting for important prognostic factors. METHODS: A retrospective study of a 17-year period from January 1994 to April 2011 was carried out. The cases studied were divided into two time period cohorts, those treated in the first 9-years (n = 109) and those treated in the last 7-years (n = 109). RESULTS: An operation with curative intent was performed on 218 patients. The 5-year survival rates according to the depth of invasion were 86% (T1), 56% (T2), 45% (T3), and 5% (T4). The number of cases of incidental gallbladder cancer found during 3,919 laparoscopic cholecystectomies was 96 (2.4%). Incidental gallbladder cancer revealed a better survival rate (P = 0.003). Iatrogenic bile spillage was found in 20 perforations of the gallbladder during laparoscopic cholecystectomies, 16 preoperative percutaneous transhepatic gallbladder drainages and 16 percutaneous transhepatic biliary drainages; only percutaneous transhepatic biliary drainage patients showed a significantly lower survival rate than patients without iatrogenic bile spillage (P < 0.034). Chemoradiation appeared to improve overall survival (P < 0.001). Multivariate analysis also revealed that time period, type of surgery, surgical margin, lymphovascular invasion, lymph node involvement, and chemoradiation therapy had significant effects. CONCLUSION: This study found that the prognosis of gallbladder cancer is still determined by the stage at presentation due to the aggressive biology of this tumor. Early diagnosis, radical resection and appropriate adjuvant therapy can increase overall survival.