SIRveNIB: Selective Internal Radiation Therapy Versus Sorafenib in Asia-Pacific Patients With Hepatocellular Carcinoma.

Purpose Selective internal radiation therapy or radioembolization (RE) shows efficacy in unresectable hepatocellular carcinoma (HCC) limited to the liver. This study compared the safety and efficacy of RE and sorafenib in patients with locally advanced HCC. Patients and Methods SIRveNIB (selective internal radiation therapy v sorafenib), an open-label, investigator-initiated, phase III trial, compared yttrium-90 (90Y) resin microspheres RE with sorafenib 800 mg/d in patients with locally advanced HCC in a two-tailed study designed for superiority/detriment. Patients were randomly assigned 1:1 and stratified by center and presence of portal vein thrombosis. Primary end point was overall survival (OS). Efficacy analyses were performed in the intention-to-treat population and safety analyses in the treated population. Results A total of 360 patients were randomly assigned (RE, 182; sorafenib, 178) from 11 countries in the Asia-Pacific region. In the RE and sorafenib groups, 28.6% and 9.0%, respectively, failed to receive assigned therapy without significant cross-over to either group. Median OS was 8.8 and 10.0 months with RE and sorafenib, respectively (hazard ratio, 1.1; 95% CI, 0.9 to 1.4; P = .36). A total of 1,468 treatment-emergent adverse events (AEs) were reported (RE, 437; sorafenib, 1,031). Significantly fewer patients in the RE than sorafenib group had grade ≥ 3 AEs (36 of 130 [27.7%]) v 82 of 162 [50.6%]; P < .001). The most common grade ≥ 3 AEs were ascites (five of 130 [3.8%] v four of 162 [2.5%] patients), abdominal pain (three [2.3%] v two [1.2%] patients), anemia (zero v four [2.5%] patients), and radiation hepatitis (two [1.5%] v zero [0%] patients). Fewer patients in the RE group (27 of 130 [20.8%]) than in the sorafenib group (57 of 162 [35.2%]) had serious AEs. Conclusion In patients with locally advanced HCC, OS did not differ significantly between RE and sorafenib. The improved toxicity profile of RE may inform treatment choice in selected patients.

Expanding the donor pool for liver transplantation in the setting of an "opt-out" scheme: 3 years after new legislation.

INTRODUCTION: The revised Human Organ Transplant Act (HOTA) was implemented in Singapore in July 2004. We aim to evaluate expanding the potential donor pool for liver transplant in Singapore with the inclusion of marginal donors. MATERIALS AND METHODS: All donor referrals between July 2004 and June 2007 were studied. All potential deceased liver donors were heart-beating. After being reviewed by the transplant coordinator, potential donors were assessed by a transplant hepatologist and a transplant surgeon for suitability of organ donation strictly based on the programme's donor assessment protocol. Reasons for rejection as potential donors were documented. The clinical characteristics of all donor referrals were retrospectively reviewed, and an independent decision was made as to whether liver retrieval in each rejected case might have been possible. RESULTS: Among the 128 potential donor referrals, 20 donors (15.6%) underwent liver retrieval. Of the 20 livers retrieved, 16 were implanted and 4 were not implanted (3 unfit recipients, and 1 donor liver with 40% steatosis). Another 10 donor livers were assessed intraoperatively and were rejected because of varying levels of steatosis. Of these livers assessed, 5 donor livers had steatosis <40% and 5 had steatosis >40%. Of the remaining potential donors, 45 were deemed not possible because of prolonged hypotension (9), on-going or unresolved sepsis (13), high-risk behaviour (4), non-actualisation (8), or pre-existing medical conditions (11). Another 53 donors may potentially have been suitable donors but were rejected because of possible sepsis (13), no suitable recipients (12), transient hypotension (10), transient abnormal liver function test (6), history of alcohol ingestion (5), non-actualisation because of consent (4) and other reasons (3). Overall, it was deemed that 61 donors (47.7%) might potentially have been suitable liver donors. CONCLUSIONS: Despite new legislation (HOTA) in Singapore, the utilisation of cadaveric donor livers showed no increase in the last 3 years. By expanding our donor criteria to include marginal donors, we could potentially increase the availability of deceased donor livers to meet our waiting list demands.

Laparoscopic cholecystectomy for acute cholecystitis: safe implementation of successful strategies to reduce conversion rates.

INTRODUCTION: A higher rate of conversion to open surgery is a well-known problem in patients with acute cholecystitis undergoing laparoscopic cholecystectomy. The aim of this study is to analyze factors which may impact on conversion rates, and to analyze our outcomes following implementation of a departmental strategy in reducing conversion rates. MATERIALS AND METHODS: 122 patients with acute cholecystitis were considered for laparoscopic cholecystectomy from July 2003 to July 2007. An audit of the results of laparoscopic cholecystectomy was done in July 2005 and a departmental strategy aimed at reducing the conversion rates was introduced. The strategies included early laparoscopic cholecystectomy (within 72 hours of admission), performed or supervised by specialist hepatobiliary surgeons, and modifications of operative techniques. This study compares the conversion rates before and after that audit. Forty-eight patients (group A) were from the preaudit period and the remaining 74 (group B) were from the postaudit period. A multivariate analysis was performed to identify risk factors for conversion to open surgery and whether the strategies implemented resulted in decrease in conversion rates. RESULTS: In the group A patients, there was a conversion rate of 29.2%. Gallbladder wall thickness of greater than 5 mm was found to be a statistically significant (p = 0.028) risk factor for conversion to open surgery. In group B patients, the conversion rates were significantly lower at 6.75% (p = 0.001). Analyzing both groups of patients, using multivariate analysis, gallbladder wall thickness, increasing age, and preaudit operative period were found to be independently associated with conversion to open surgery. CONCLUSIONS: This study demonstrated that, with specific strategies to decrease conversion and with technical improvements, the conversion rates can be decreased with no demonstrable difference in postoperative complications. Gallbladder wall thickness and increasing age are risk factors for conversion to open surgery.

Close temporal association of bronchial asthma and ischemic colitis--case report and review of the literature.

We report a case of ischemic colitis in an elderly male who had initially presented with acute asthma exacerbation. The clinical course of hospitalization, surgical and pathological findings were described. We review three previously reported cases of ischemic colitis and bronchial asthma and explore possible mechanisms to explain this association. The complex interaction of smooth muscle tone and autonomic nervous system in the etiopathogenesis of bronchial asthma and ischemic colitis is discussed. Further studies should be undertaken to clarify this association.

Liver transplantation for hepatocellular carcinoma: an Asian perspective.

Liver transplantation is an established treatment modality for patients with hepatocellular carcinoma (HCC), creating a potential for disease-free, long-term survival. In Asia, due to a severe shortage of donors, resection remains the treatment of choice for patients with HCC and good liver functional reserve. The use of marginal donors, split liver grafts and grafts from living donors are potential solutions that are best performed in experienced liver transplant centres to ensure an optimal outcome. Ethical issues relating to living donor liver transplantation have yet to be fully addressed. The roles of therapies to limit tumour progression during the waiting period, such as transarterial chemoembolization, need to be further investigated in the setting of a prospective trial and their benefits better defined.