Prospective double-blinded randomized controlled trial of Microwave versus RadioFrequency Ablation for hepatocellular carcinoma (McRFA trial).

BACKGROUND: Microwave (MWA) and radiofrequency ablation are the commonly used local ablation for hepatocellular carcinoma (HCC). Studies comparing both techniques are scarce. The aim of this study was to compare the efficacy of MWA versus RFA as a treatment for HCC. METHODS: Patients with HCC who were suitable for local ablation were randomized into MWA or RFA. All patients were followed up regularly with contrast-enhanced computed tomography (CT) performed at 1, 3, 6 and 12 months after ablation. Both patients and the radiologists who interpreted the post-procedure CT scans were blinded to the treatment allocation. Treatment-related morbidity, overall and disease-free survivals were analyzed. RESULTS: A total of 93 patients were recruited. Among them, 47 and 46 patients were randomized to MWA and RFA respectively. Patients in two groups were comparable in baseline demographics and tumor characteristics. With a median follow-up of around 30 months, there were no significant difference in the treatment-related morbidity, overall and disease-free survivals. MWA had a significantly shorter overall ablation time when compared with RFA (12 min vs 24 min, p < 0.001). CONCLUSIONS: MWA is no different to RFA with respect to completeness of ablation and survivals. It is, however, as safe and effective as RFA in treating small HCC.

Does Intermittent Pringle Maneuver Increase Postoperative Complications After Hepatectomy for Hepatocellular Carcinoma? A Randomized Controlled Trial.

BACKGROUND: In a previous study, we have shown that intermittent Pringle maneuver (IPM) might increase postoperative complications after hepatectomy for various indications. Complications which thought to be related to IPM were ascites, pleural effusion, wound infection and intra-abdominal collection. The aim of this study was to test the hypothesis that applying IPM during hepatectomy for hepatocellular carcinoma (HCC) could increase postoperative complications. METHODS: Between January 2013 and October 2016, eligible patients who received elective open hepatectomy for HCC were randomized to have IPM or no Pringle maneuver (NPM). Occurrence of various types of postoperative complications was specifically looked for. A routine postoperative day 5 abdominal ultrasound examination and chest X-ray were done to detect and grade any radiological ascites, pleural effusion and intra-abdominal collection. RESULTS: Fifty IPM and 50 NPM patients with histological proven HCC were recruited for final analysis. Demographics and operative parameters were comparable between the two groups. The postoperative complication rates were similar (IPM 36.0 vs. NPM 28.0%, P = 0.391). However, in the IPM group, more patients developed radiological posthepatectomy ascites (42.0 vs. 22.0%, P = 0.032) and pleural effusion (66.0 vs. 38.0%, P = 0.005). In patients with histologically proven cirrhosis, there were 28 IPM and 25 NPM patients. Again, there was no difference in postoperative complication rate but more radiological posthepatectomy ascites and pleural effusion in the IPM group. CONCLUSION: This trial was not able to detect a difference in postoperative complications whether IPM was applied or not, but use of IPM was associated with more subclinical ascites and pleural effusion. (ClinicalTrials.gov NCT01759901). TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01759901.

Phase I/II study of temsirolimus for patients with unresectable Hepatocellular Carcinoma (HCC)- a correlative study to explore potential biomarkers for response.

BACKGROUND: The oncogenic PI3K/Akt/mTOR pathway is frequently activated in HCC. Data on the mTOR inhibitor, temsirolimus, is limited in HCC patients with concomitant chronic liver disease. The objectives of this study were: (1) In phase I, to determine DLTs and MTD of temsirolimus in HCC patients with chronic liver disease; (2) In phase II, to assess activity of temsirolimus in HCC, and (3) to explore potential biomarkers for response. METHODS: Major eligibility criteria included histologically confirmed advanced HCC and adequate organ function. In Phase I part of the study, temsirolimus was given weekly in 3-weekly cycle; dose levels were 20 mg (level 1), 25 mg (level 2) and 30 mg (level 3). The MTD was used in the subsequent phase II part; the primary endpoint was PFS and secondary endpoints were response and OS. In addition, exploratory analysis was conducted on pre-treatment tumour tissues to determine stathmin, pS6, pMTOR or p-AKT expressions as potential biomarkers for response. Overall survival and PFS were calculated using the Kaplan-Meier method. Reassessment CT scans were done every 6 weeks. All adverse events were reported using CTCAE v3. RESULTS: The Phase I part consisted of 19 patients, 2 of 6 patients at level 3 experienced DLT; dose level 2 was determined to be the MTD. The phase II part consisted of 36 patients. Amongst 35 assessable patients, there were 1 PR, 20 SD and 14 PD. Overall, the median PFS was 2.83 months (95% C.I. 1.63-5.24). The median OS was 8.89 months (95% C.I. 5.89-13.30). Grade ≥ 3 that occurred in > 10% of patients included thrombocytopenia (4) and hyponatraemia (4). Exploratory analysis revealed that disease stabilization (defined as CR + PR + SD > 12 weeks) in tumours having high and low pMTOR H-scores to be 70% and 29% respectively (OR 5.667, 95% CI 1.129-28.454, p = 0.035). CONCLUSIONS: In HCC patients with chronic liver disease, the MTD of temsirolimus was 25 mg weekly in a 3-week cycle. The targeted PFS endpoint was not reached. However, further studies to identify appropriate patient subgroup are warranted. TRIAL REGISTRATION: This study has been registered in ClinicalTrials.gov (Id: NCT00321594) on 1 December 2010.

Delayed stent deformity and fracture of Djumbodis dissection system.

In recent years, a novel approach using the Djumbodis dissection system aortic stent has been introduced as an alternative to aortic arch replacement in acute type A aortic dissection involving the arch. From 2010 to 2013, we treated 7 patients with acute type A aortic dissection using the technique of replacing the ascending aorta with interposition graft and stenting of the aortic arch with the Djumbodis dissection system. We followed up the patients with serial imaging and in 3 consecutive patients who had been followed up for more than 10 months, we noted significant deformity and fracture of the Djumbodis stent.

Intra-arterial revascularisation therapy for acute ischaemic stroke: initial experience in a Hong Kong hospital.

OBJECTIVES: To assess the outcome of acute ischaemic stroke patients who received intra-arterial therapy in our unit. DESIGN: Case series. SETTING: A tertiary hospital in Hong Kong. PATIENTS: Patients with ischaemic stroke due to large artery occlusion treated within 6 hours from symptom onset between January 2007 and May 2011. INTERVENTION: Acute intra-arterial revascularisation therapy. MAIN OUTCOME MEASURES: Primary outcome was functional independence (modified Rankin Scale score of ≤ 2) at 3 months. Secondary outcome was rate of recanalisation. Safety outcomes were symptomatic intracranial haemorrhage and 3-month mortality. RESULTS: Twenty-one patients with a mean age of 67 years fulfilled the inclusion criteria. Their mean National Institutes of Health Stroke Scale score was 18. The mean onset-to-puncture time was 212 minutes. Nine received intra-arterial tissue plasminogen activator alone, 11 had an adjunctive mechanical thrombectomy, and one received balloon angioplasty without tissue plasminogen activator. At the end of the procedure, thrombolysis grade 2a or better was attained in 18 (86%) of the patients, and 8 (38%) achieved functional independence at 3 months. Rates of symptomatic intracranial haemorrhage and 3-month mortality were 10% and 24%, respectively. CONCLUSION: In this setting, intra-arterial revascularisation therapy appeared safe and efficacious for this selected group of ischaemic stroke patients with large artery occlusions. Experience gained from this pilot study may help improve clinical outcomes of such patients.

Minimizing single-port access in video-assisted wedge resection, with a hookwire.

Single-port video-assisted thoracic surgery lung resection is increasing in popularity. In selected cases, the incision length of single-port video-assisted thoracic lung wedge resection can be minimized by preoperative strategic positioning of a percutaneous hookwire to allow intraoperative traction of the lung nodule to facilitate endostapler wedge resection, thereby substituting the sponge-holding forceps for lung retraction during the procedure.

Surgical ablation of hepatocellular carcinoma with 2.45-GHz microwave: a critical appraisal of treatment outcomes.

OBJECTIVE: To evaluate the efficacy and safety of a new generation of 2.45-GHz microwave to ablate hepatocellular carcinoma by surgical approach. DESIGN; Case series with prospective follow-up. SETTING: A university teaching hospital in Hong Kong. PATIENTS: From March 2009 to January 2011, 26 consecutive patients (19 men and 7 women) with a median age of 63 (range, 49-79) years with hepatocellular carcinoma were recruited. Five (19%) of the patients had recurrent hepatocellular carcinoma after previous treatment. INTERVENTION: Microwave ablation for hepatocellular carcinomas (one tumour, n=24; two tumours, n=2) using a laparoscopic (n=16) or open approach (n=10). MAIN OUTCOME MEASURES: Operative mortality and morbidity, rate of incomplete ablation, recurrence rate, and survival rate. RESULTS: The median tumour diameter was 3.8 cm (range, 2.0-6.0 cm). Complications occurred in five (19%) of the patients; only one was ablation-related, and there was no operative mortality. One (4%) of the patients experienced incomplete ablation. Recurrent tumours were noted in 11 (42%) of the patients (5 were local, 2 were remote, and 4 were multifocal) after a median follow-up of 14 (range, 4-26) months. The failure rate for local disease control was 23%, and was 14% if patients with recurrent hepatocellular carcinoma were excluded. All but one patient survived until the time of censorship. The mean survival was 25 (standard deviation, 1) months. CONCLUSION: This new-generation microwave technique is safe and effective for local ablation of hepatocellular carcinoma. It is a valuable treatment option for patients who are not candidates for hepatectomy.

Comparison of clinical outcomes of tris-acryl microspheres versus polyvinyl alcohol microspheres for uterine artery embolization for leiomyomas: results of a randomized trial.

PURPOSE: To compare tris-acryl microspheres and polyvinyl alcohol (PVA) microspheres as embolic agents in uterine artery embolization (UAE) for uterine leiomyomas in terms of clinical outcome, inflammatory response, and adverse reactions. MATERIALS AND METHODS: A double-blinded randomized controlled trial was performed, with 27 patients in the tris-acryl microsphere group and 29 in the PVA microsphere group. The primary endpoint was clinical success, defined as a 2-year freedom from subsequent surgery as a result of persistent or deteriorated symptoms. Secondary endpoints included (i) posttreatment leiomyoma enlargement, (ii) leiomyoma volume reduction at 3 and 9 months, (iii) significant residual intratumoral perfusion, (iv) increase in inflammatory and stress markers, (v) incidence of complications, and (vi) duration of hospital stay. RESULTS: There was no statistically significant difference between the two groups in patient demographics, clinical presentation, initial tumor findings, change in inflammatory and stress markers after treatment, incidence of complications, and duration of hospital stay. Tris-acryl microspheres were associated with a higher rate of clinical success than PVA microspheres (96.3% [26 of 27] vs 69% [20 of 29]; P = .012), a lower incidence of posttreatment leiomyoma enlargement (P = .030), and a lower incidence of significant residual intratumoral perfusion (P = .030). CONCLUSIONS: In the treatment of uterine leiomyomas, UAE with tris-acryl microspheres was associated with a higher clinical success rate, a lower incidence of tumor enlargement, and no significant differences in adverse reactions and inflammatory response compared with the use of PVA microspheres. Tris-acryl microspheres therefore represent the preferred agent for UAE of uterine leiomyomas.

Embolization efficacy and treatment effectiveness of transarterial therapy for unresectable hepatocellular carcinoma: a case-controlled comparison of transarterial ethanol ablation with lipiodol-ethanol mixture versus transcatheter arterial chemoembolization.

PURPOSE: To compare the embolization efficacy and treatment effectiveness of transarterial ethanol ablation (TEA) versus those of chemoembolization and evaluate the correlation between embolization efficacy and treatment effectiveness of these treatments for hepatocellular carcinoma (HCC). MATERIALS AND METHODS: A case-controlled study was undertaken with 30 patients in each group matched based on Child-Pugh grade, tumor characteristics, and performance status. Primary endpoints were embolization efficacy (ie, Lipiodol retention within tumor at 2 months) and treatment effectiveness as evaluated by tumor response, disease progression, progression-free survival, and overall survival. The secondary endpoint was correlation between embolization efficacy and treatment effectiveness. RESULTS: Lipiodol retention was greater in the TEA group (89.5% +/- 10.7% vs 47.5% +/- 21.2%; P < .0001). The tumor progression rate at 1 year was higher in the chemoembolization group (five of 30 vs zero of 30; P = .0261). One- and 2-year overall survival rates were higher in the TEA group (93.3% and 80.0%, respectively, vs 73.3% and 43.3%, respectively; P = .0053). One- and 2-year extrahepatic disease progression rates were lower in the TEA group (P = .0002). There were no differences in progression-free survival and intrahepatic disease progression rates at 1 and 2 years. Patients with greater Lipiodol retention (ie, >60%) had better treatment outcomes at 1 year than those with lesser retention, with higher overall survival rates (88.9% vs 66.7%; P = .0192), lower intrahepatic disease progression rates (25.6% vs 59.4%; P = .0169), lower extrahepatic disease progression rates (0.31% vs 35.5%; P = .0047), and higher progression-free survival rates (72.1% vs 36.3%; P = .005). CONCLUSIONS: The embolization efficacy and treatment effectiveness of TEA are probably superior to those of chemoembolization for HCC.