Effect of urea cream on sorafenib-associated hand-foot skin reaction in patients with hepatocellular carcinoma: A multicenter, randomised, double-blind controlled study.

BACKGROUND: Hand-foot skin reaction (HFSR) is the most common adverse event during sorafenib treatment in patients with hepatocellular carcinoma (HCC). In the present study, we aimed to investigate the role of urea cream in the prevention of HFSR or amelioration of HFSR severity. PATIENTS AND METHODS: Patients with HCC were treated with either placebo cream or urea cream for 12 weeks concomitantly with sorafenib treatment. HFSR development, the Hand-Foot Skin Reaction and Quality of Life (HF-QoL) questionnaire score, and adverse events were assessed at 2, 4, 8 and 12 weeks. RESULTS: Of the 288 patients, 247 patients, with 117 patients in the placebo control group and 130 patients in the urea cream group, were analysed. The urea cream group showed a trend towards a lower cumulative incidence of any-grade HFSR (log-rank, P = 0.247) and severe HFSR of grade II or higher (log-rank, P = 0.394) without statistical significance. In the incidence by time point, the incidence of severe HFSR of grade II or higher was significantly lower in the urea cream group than in the placebo control group at 2 weeks (13.8% versus 23.9%, P = 0.042). The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks. CONCLUSIONS: Treatment with urea cream showed a lower incidence of severe sorafenib-induced HFSR at 2 weeks and reduced the tendency of HFSR development in HCC patients. Therefore, treatment with urea cream may be considered for prophylaxis or improvement of HFSR grade in HCC patients treated with sorafenib. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03212625).

Features of extrahepatic metastasis after radiofrequency ablation for hepatocellular carcinoma.

BACKGROUND: Extrahepatic metastasis (EHM) of hepatocellular carcinoma (HCC) is associated with poor outcomes. However, the clinical features and risk factors of EHM of HCC after radiofrequency ablation (RFA) remain unclear. AIM: To elucidate the characteristics and risk factors of EHM after RFA for HCC. METHODS: From January 2008 to December 2017, we retrospectively enrolled 661 patients who underwent RFA as first-line treatment for HCC at 2 tertiary hospitals. The inclusion criteria were age ≥ 18 years, a diagnosis of HCC, and treatment-naivety. Abdominal computed tomography (CT) or magnetic resonance imaging (MRI) and alpha-fetoprotein measurements were routinely performed at 1 mo after RFA and followed-up at intervals of 3-6 mo. Univariate analyses were performed using the chi-squared test or Student's t-test, and univariate and multivariate analyses were performed via logistic regression, as appropriate. RESULTS: EHM was diagnosed in 44 patients (6.7%) during a median follow-up period of 1204 days. The 10-year cumulative rate of HCC recurrence and EHM was 92.7% and 33.7%, respectively. Initial recurrence was most often intrahepatic, and the rate of extrahepatic recurrence at initial recurrence was only 1.2%. The median time to the diagnosis of EHM was 2.68 years, and 68.2% of patients developed EHM within 2 years of the first recurrence, regardless of recurrence-free survival and 75.0% of patients developed EHM within 5 years after first recurrence. EHM was mostly diagnosed via abdominal CT/MRI in 33 (75.0%) and 38 of 44 patients (86.4%) with EHM had either positive abdominal CT scan results or serum AFP level elevation. In multivariate analysis, recurrence-free survival < 2 years, ablation zone/tumor size < 2, and alpha-fetoprotein level > 400 IU/mL were associated with a high EHM risk. CONCLUSION: EHM occurs following multiple intrahepatic recurrences after RFA and combined contrast-enhanced abdominal CT and serum AFP were useful for surveillance. Patients especially with high-risk factors require close follow-up for EHM.

Perirenal fat stranding on CT: is there an association with bladder outlet obstruction?

OBJECTIVE: To determine the association between perirenal fat stranding (PFS) on CT and bladder outlet obstruction (BOO). METHODS: CT scans from 122 patients who had undergone urodynamic study for lower urinary tract symptoms (LUTS) were registered after exclusion of patients with renal or retroperitoneal disease. Images were independently reviewed by two radiologists and compared with those of 244 age- and sex-matched control patients without LUTS. The PFS severity was scored on a four-point scale, and the interobserver agreement was assessed with kappa statistics. The severity score and incidence was compared between the groups, and the association with baseline characteristics was analyzed. For the LUTS group, an association between PFS severity and urodynamic and laboratory data was evaluated. RESULTS: PFS was more frequent and more severe in the LUTS group than in the control group (p-value < 0.001); its presence was significantly associated with male gender and older age (p-value < 0.001). PFS was predominantly bilateral in both groups (80.1-93.2%). In the LUTS group, PFS severity scores were significantly correlated with the maximum flow rate, maximum detrusor pressure and estimated glomerular filtration rate (p-value < 0.001). Interobserver agreements were excellent for PFS presence (κ = 0.883) and severity (κ = 0.816). CONCLUSION: Severe PFS was observed in older, male patients with LUTS. PFS severity was associated with the degree of BOO and impaired renal function. ADVANCES IN KNOWLEDGE: Recognition of PFS on the CT scan may warrant further evaluation of BOO and appropriate management to prevent renal impairment.

Guidewire cannulation increases the success rate of needle-knife fistulotomy for difficult bile duct access.

BACKGROUND AND AIM: Selective bile duct cannulation is a prerequisite for performing therapeutic endoscopic biliary intervention. This study aimed to evaluate if using a soft-tipped guidewire to cannulate the bile duct would increase the success rate of needle-knife fistulotomy for difficult bile duct access. METHODS: We reviewed sixty 60 patients with difficult bile duct access who underwent conventional cannulation with radiocontrast dye (29) or guidewire cannulation (31) after needle-knife fistulotomy. RESULTS: There were no significant differences in the demographic data between the two groups. The initial success rate of selective bile duct cannulation was significantly higher in the guidewire cannulation group compared with the conventional cannulation group: 100% versus 79.3%, P = 0.009. The success rate of selective biliary cannulation in the patients with non-dilated common bile duct (< 8 mm) was significantly higher in the guidewire cannulation group compared with the conventional cannulation group: 100% versus 68.4%, P = 0.003. The incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis was not significantly different between the two groups. No serious complications occurred in either group. CONCLUSIONS: In this retrospective and small case series, guidewire cannulation after needle-knife fistulotomy increased the success rate of selective bile duct cannulation in patients with difficult bile duct access.