Endovascular revascularization of acute arterial mesenteric ischemia: report of a 3-year experience from an intestinal stroke center unit.

OBJECTIVE: To report the 3-year experience of endovascular revascularization of acute arterial mesenteric ischemia (AMI) from an intestinal stroke center unit (ISCU). METHOD: All data from patients admitted to the ISCU between January 2016 and January 2019 for arterial AMI who underwent endovascular recanalization were prospectively acquired and retrospectively analyzed. Patient demographics, clinical and laboratory characteristics at presentation, and CT scans were reviewed. The type (thrombolysis, thrombectomy, stenting) and the outcome of endovascular procedures (technical success or failure, complications) were noted. Care pathways were described focusing on post-procedural treatments (surgical revascularization, bowel resection) and the mortality rate was evaluated in subgroups. RESULTS: Fifty-eight patients (34 men [59%], mean 69 ± 29 years) were included. Endovascular revascularization was technically successful in 51/58 (88%) patients, and 10 (17%) patients had post-procedural complications. Stenting and in situ thrombolysis were performed in most patients (n = 33 and n = 19, respectively). Thirty-two patients (55%) were recurrence-free and required no further treatment after the procedure, while 9 (16%), 5 (9%), and 5 (9%) patients underwent 2nd-line bowel resection, surgical revascularization, or both. Overall, 46 (79%), 45 (78%), and 34 patients (63%) were alive at 3 months, 1 year, and 3 years. No significant difference in survival was found in care pathways or baseline characteristics. CONCLUSION: Endovascular revascularization is highly feasible for the treatment of arterial AMI, and is associated with an acceptable rate of complications. Results of endovascular revascularization shall only be interpreted as part of a multidisciplinary patient management strategy. KEY POINTS: • Endovascular revascularization is highly feasible for the treatment of arterial AMI, and is associated with an acceptable rate of complications. • Several techniques are available to perform endovascular revascularization, and their use depends on the cause, the location, and the quality of underlying arteries of patients. • Results of endovascular revascularization shall only be interpreted in relation to its role in an integrated multidisciplinary and patient management strategy.

Predictive factors of severe abdominal pain during and after transarterial chemoembolization for hepatocellular carcinoma.

OBJECTIVES: To prospectively assess the frequency of severe abdominal pain during and after transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) using the visual analog scale (VAS), and to identify predictive factors. METHODS: Ninety-eight TACE performed in 80 patients (mean 65 ± 12 years old, 60 men) were consecutively and prospectively included. Abdominal pain was considered severe if the VAS ≥ 30/100 after treatment administration, or if opioid analgesic (grades 2-3) intake was required during hospitalization. Patient and tumor characteristics as well as technical factors associated with severe pain were identified by binary logistic regression. RESULTS: The criterion for severe pain was met in 41/98 (42%) of procedures (peri-procedural pain 30/98 [31%] and opioid consumption during hospitalization 24/98 [25%]). Multivariate analysis identified age (odds ratio [OR] = 0.943 (95% confidence interval 0.895-0.994), p = 0.029), cirrhosis (OR = 0.284 (0.083-0.971), p = 0.045), and alcoholic liver disease (OR = 0.081 (0.010-0.659), p = 0.019) as negative predictive factors of severe abdominal pain. Severe abdominal pain occurred in or after 1/13 (8%), 8/34 (24%), 22/41 (54%), and 10/10 (100%) TACE sessions when none, one, two, and three of the protective factors were absent, respectively (p < 0.001). The area under the ROC curve of the combination of factors for the prediction of severe abdominal pain was 0.779 (CI 0.687-0.871). CONCLUSION: Severe abdominal pain was frequent during and after TACE revealing a clinically relevant and underestimated problem. A predictive model based on three readily available clinical variables suggests that young patients without alcoholic liver disease or cirrhosis could benefit from reinforced analgesia. KEY POINTS: • Severe abdominal pain occurs in 43% of TACE for HCC. • Younger age, absence of cirrhosis, and absence of alcoholic liver disease were identified as independent predictive factors of severe abdominal pain. • A simple combination of the three abovementioned features helped predict the occurrence of severe abdominal pain.

Factors Associated with Tumor Progression After Percutaneous Ablation of Hepatocellular Carcinoma: Comparison Between Monopolar Radiofrequency and Microwaves. Results of a Propensity Score Matching Analysis.

PURPOSE: To identify risk factors for local and distant intrahepatic tumor progression after percutaneous ablation of HCC and to compare MWA with monopolar RFA. MATERIALS AND METHODS: Consecutive patients with early or very early HCC who underwent percutaneous monopolar RFA or MWA were included. Factors associated with local and distant tumor progression were identified. Propensity score matching (PSM) was used to limit bias. Statistical analyses were performed with the Kaplan-Meier method using the log-rank test and Cox regression models. RESULTS: One hundred ninety HCC (mean diameter 23 ± 8.6 mm) were treated by RFA (n = 90, 47%) or MWA (n = 100, 53%) in 152 patients (mean age 63 ± 11, 79% men) between 2009 and 2016. The technical success rate was 97.4% (n = 185 HCC). After a median follow-up of 24.6 months (IQR: 9.7-37.2), 43 (23%), HCC showed local tumor progression [after a median of 13.4 months (IQR: 5.8-24.3)] and 91 (63%) patients had distant intrahepatic tumor progression (after a median of 10.4 months (IQR: 5.7-22). The cox model after PSM identified treatment by RFA (HR, 2.89; P = 0.005), HCC size ≥ 30 mm (HR, 3.12; P = 0.007) and vascular contact (HR, 3.43; P = 0.005) as risk factors for local progression. Factors associated with distant intrahepatic progression were HCC ≥ 30 mm (HR, 1.94; P = 0.013), serum AFP > 100 ng/mL (HR, 2.56; p = 0.002), and hepatitis B carrier (HR, 0.51; p = 0.047). CONCLUSION: The rate of local HCC progression was lower after MWA than monopolar RFA, regardless of tumor size and vascular contact. The ablation technique did not influence the risk of distant intrahepatic tumor progression.

Clinical impact of a new cone beam CT angiography respiratory motion artifact reduction algorithm during hepatic intra-arterial interventions.

OBJECTIVES: To assess the impact of recently developed respiratory motion correction software on contrast-enhanced cone beam CT angiography (CBCT-a) for intraprocedural image guidance during intra-arterial liver-directed therapy. METHODS: From 2015 to 2017, two groups of patients who underwent intra-arterial liver-directed therapy with (breathing, n = 30) or without (still, n = 30) significant respiratory motion artifacts were retrospectively included. All CBCT-a were processed with and without dedicated respiratory motion correction software. Four readers independently assessed the following in both reconstructions (motion correction ON and OFF): (1) overall image quality on a 0-to-5 point scale, and (2) presence of relevant peri-procedural information on tumor and vasculature (overall vessel geometry, visibility of extrahepatic vessels, target tumor conspicuity, visibility of tumor feeders). RESULTS: Motion correction increased the average image quality in the breathing group from 2.0 ± 0.9 to 2.9 ± 1.0 (p < 0.01). The visibility of vessel geometry, extrahepatic vessels, and tumor feeders was significantly improved for all readers, and tumor conspicuity was improved for three readers. The average image quality was not significantly different between reconstructions in the still group (motion correction ON and OFF), for any of the readers (4.0 ± 0.6 vs 4.2 ± 0.6; p = 0.12). There was no change in the visibility of vessel geometry, extrahepatic vessels, tumor feeders, or tumor conspicuity for the four readers using the respiratory motion correction software in this group. CONCLUSIONS: Using the dedicated respiratory motion correction software during intra-arterial liver-directed procedures increases the visualization of relevant peri-procedural information and image quality in CBCT-a corrupted by respiratory motion artifacts without affecting these elements in still CBCT-a. KEY POINTS: • The use of respiratory motion correction software could reduce the need for cone beam CT angiography acquisition retake. • Motion correction software significantly increases the visibility of vessel geometry, extrahepatic vessels, and tumor feeders, as well as tumor conspicuity in cone beam CT angiography corrupted by respiratory motion artifacts. • The use of respiratory motion correction software on cone beam CT angiography uncorrupted by respiratory motion artifact does not result in decreased image quality.

Lipiodol retention pattern after TACE for HCC is a predictor for local progression in lesions with complete response.

BACKGROUND: To evaluate the predictive value of the lipiodol retention pattern for local progression of HCC with a complete response (CR) on CT according to mRECIST criteria after a first session of conventional chemoembolization (cTACE). METHODS: From January 2014 to May 2016 all consecutive patients undergoing a first cTACE session for HCC were identified. Inclusion criteria were the presence of ≤3 HCCs and available pre- and post-cTACE CT. Tumor response was classified according to mRECIST criteria. The analysis focused on tumors with a CR. The lipiodol retention pattern in these tumors was classified as complete (C-Lip, covering the entire tumor volume), or incomplete (I-Lip). Local progression was defined as the reappearance of areas of enhancement on arterial-phase images with washout on portal/delayed phase images within 2 cm from treated tumors on follow-up CT. RESULTS: The final population included 50 patients with 82 HCCs. A total of 46 (56%) HCCs were classified with a CR, including 16 (35%) with I-Lip, and 30 (65%) with C-Lip. After a median follow-up of 14 months (3.2-35.9 months), 15/16 (94%) and 10/30 (30%) of I-Lip and C-Lip HCCs showed local progression on CT, respectively (p < 0.001), with no significant difference in the time to progression (mean 11.1 ± 2 vs. 13.4 ± 3 months for I-Lip and C-Lip, respectively p = 0.51). CONCLUSIONS: HCCs with incomplete lipiodol retention after a first cTACE session have a high risk of local progression even when there is a CR according to mRECIST, and should be considered to be incompletely treated.

Splenic Artery Aneurysms, A Rare Complication of Type 1 Gaucher Disease: Report of Five Cases.

Type 1 Gaucher disease is a rare genetic lysosomal disorder due to acid betaglucosidase deficiency. The main features are thrombocytopenia, anemia, hepatosplenomegaly and complex skeletal disease. Complications include pulmonary hypertension, cirrhosis and splenic infarction; comorbidities, such as autoimmune phenomena, B-cell malignancies and Parkinson disease also occur. Visceral aneurysms have been only rarely noted in Gaucher disease. We report the retrospective data from patients with Gaucher disease type 1 and splenic arterial aneurysm. We describe the different outcomes of a giant splenic arterial aneurysm in five patients with type 1 Gaucher disease and discuss the main possible pathophysiological explanations. Aneurysms of the splenic artery are rare in Gaucher disease but are probably greatly under-reported.

Surgical revascularization of the celiac artery for persistent intestinal ischemia in short bowel syndrome.

BACKGROUND AND OBJECTIVES: Without prompt superior mesenteric artery (SMA) revascularization, acute mesenteric ischemia (AMI) frequently leads to death or short bowel syndrome (SBS). In SBS patients, persistent or chronic intestinal ischemia (PII) of the remnant bowel can lead to recurrences of AMI. Since SMA revascularization is sometimes unfeasible, celiac artery (CA) revascularization may improve blood supply to the remnant bowel. The aim of this study was to describe and to assess our experience of the CA revascularization in case of SMA occlusion unsuitable for revascularization in the setting of PII in SBS patients. METHODS: All consecutive patients with i) SBS consecutive to AMI, ii) persistent intestinal ischemia (PII), iii) irreversible SMA occlusion, i.e unsuitable for radiological or surgical revascularization and iv) occlusion or severe stenosis of the CA were included. RESULTS: Thirteen patients (7 males/6 females, mean age = 47.2 ±â€¯12.1 years) were included. The mean length of remnant small bowel was 47 ±â€¯39 cm and 77% of patients had a stoma. The types of revascularization included anterograde aorto-hepatic bypass n = 11 (84%), ilio-hepatic bypass n = 1 (8%) and endarterectomy n = 1 (8%). Major adverse events were observed in 5 cases: bypass graft infection (n = 2), hemorrhagic pericarditis (n = 2), hemorrhagic shock (n = 2) and aortic false aneurysm (n = 1). After a mean follow-up of 27.0 ±â€¯25.2 months, symptoms of PII relieved in 12 cases (92%) allowing for digestive surgical rehabilitation with continuity restoration in 7 patients (54%). PN was weaned for 2 patients. One-year and 3-year survival rates were 73.8% and 73.8% respectively. No recurrence of AMI or further need for bowel resection was noticed. CONCLUSION: For patients with SBS suffering from PII with CA occlusion or stenosis without possibility of SMA revascularization, the surgical revascularization of the CA allowed digestive rehabilitation with acceptable morbidity and mortality rates.

Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial.

BACKGROUND: Sorafenib is the recommended treatment for patients with advanced hepatocellular carcinoma. We aimed to compare the efficacy and safety of sorafenib to that of selective internal radiotherapy (SIRT) with yttrium-90 (90Y) resin microspheres in patients with hepatocellular carcinoma. METHODS: SARAH was a multicentre, open-label, randomised, controlled, investigator-initiated, phase 3 trial done at 25 centres specialising in liver diseases in France. Patients were eligible if they were aged at least 18 years with a life expectancy greater than 3 months, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, Child-Pugh liver function class A or B score of 7 or lower, and locally advanced hepatocellular carcinoma (Barcelona Clinic Liver Cancer [BCLC] stage C), or new hepatocellular carcinoma not eligible for surgical resection, liver transplantation, or thermal ablation after a previously cured hepatocellular carcinoma (cured by surgery or thermoablative therapy), or hepatocellular carcinoma with two unsuccessful rounds of transarterial chemoembolisation. Patients were randomly assigned (1:1) by a permutated block method with block sizes two and four to receive continuous oral sorafenib (400 mg twice daily) or SIRT with 90Y-loaded resin microspheres 2-5 weeks after randomisation. Patients were stratified according to randomising centre, ECOG performance status, previous transarterial chemoembolisation, and presence of macroscopic vascular invasion. The primary endpoint was overall survival. Analyses were done on the intention-to-treat population; safety was assessed in all patients who received at least one dose of sorafenib or underwent at least one of the SIRT work-up exams. This study has been completed and the final results are reported here. The trial is registered with ClinicalTrials.gov, number NCT01482442. FINDINGS: Between Dec 5, 2011, and March 12, 2015, 467 patients were randomly assigned; after eight patients withdrew consent, 237 were assigned to SIRT and 222 to sorafenib. In the SIRT group, 53 (22%) of 237 patients did not receive SIRT; 26 (49%) of these 53 patients were treated with sorafenib. Median follow-up was 27·9 months (IQR 21·9-33·6) in the SIRT group and 28·1 months (20·0-35·3) in the sorafenib group. Median overall survival was 8·0 months (95% CI 6·7-9·9) in the SIRT group versus 9·9 months (8·7-11·4) in the sorafenib group (hazard ratio 1·15 [95% CI 0·94-1·41] for SIRT vs sorafenib; p=0·18). In the safety population, at least one serious adverse event was reported in 174 (77%) of 226 patients in the SIRT group and in 176 (82%) of 216 in the sorafenib group. The most frequent grade 3 or worse treatment-related adverse events were fatigue (20 [9%] vs 41 [19%]), liver dysfunction (25 [11%] vs 27 [13%]), increased laboratory liver values (20 [9%] vs 16 [7%]), haematological abnormalities (23 [10%] vs 30 [14%]), diarrhoea (three [1%] vs 30 [14%]), abdominal pain (six [3%] vs 14 [6%]), increased creatinine (four [2%] vs 12 [6%]), and hand-foot skin reaction (one [<1%] vs 12 [6%]). 19 deaths in the SIRT group and 12 in the sorafenib group were deemed to be treatment related. INTERPRETATION: In patients with locally advanced or intermediate-stage hepatocellular carcinoma after unsuccessful transarterial chemoembolisation, overall survival did not significantly differ between the two groups. Quality of life and tolerance might help when choosing between the two treatments. FUNDING: Sirtex Medical Inc.

Risks factors for severe pain after selective liver transarterial chemoembolization.

BACKGROUND & AIMS: Post-procedural pain is frequent after transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC), and is only partially prevented by treatment selectivity. Our aim was to determine the risk factors of severe pain after selective TACE for HCC. METHODS: From January 2012 to June 2014, all treatment-naïve patients undergoing a first selective TACE were included. Risk factors for severe pain, that is, the need for opioid analgesics (grade II-III), were identified by uni- and multivariate analysis. Internal validation of a logistic regression model for prediction of opioid intake was done with bootstrapping. RESULTS: We analysed 335 tumours (mean 47 ± 37 mm) in 159 patients (131 men), mean 63.4 years old (20-92). Twenty-seven patients (17%) requested opioids. In univariate analysis, opioid intake was associated with young age (P=.021), doxorubicin dose received (P=.031), large HCC (P=.038), absence of chronic liver disease (P<.001) and alpha-foetoprotein levels (P=.03). In multivariate analysis, opioid intake was associated with young age (OR=0.65 per 10 years increment, P=.048), absence of chronic liver disease (OR=31.7, P<.001) and a higher fraction of the doxorubicin dose (OR=1.32 per 10% increment, P=.009). The optimism-corrected area under the curve of the prediction model for opioid intake using these three factors was 0.751. CONCLUSION: In patients with HCC treated with TACE, selective procedure does not always prevent from severe pain. Young patients without chronic liver disease may be more susceptible to severe pain.

Long-term Outcome and Analysis of Dysfunction of Transjugular Intrahepatic Portosystemic Shunt Placement in Chronic Primary Budd-Chiari Syndrome.

Purpose To evaluate the long-term safety, technical success, and efficacy of transjugular intrahepatic portosystemic shunt (TIPS) in a series of patients with Budd-Chiari syndrome (BCS), and to determine the predictors of shunt dysfunction. Materials and Methods From 2004 to 2013, all patients with primary BCS referred for TIPS placement were included in the study. The primary and secondary technical success rates and the number and types of early (ie, before day 7) complications were noted. Factors associated with dysfunction were analyzed with uni- and multivariate analyses. Survival was analyzed with Kaplan-Meier curves. Results Fifty-four patients (34 women [63%]; mean age, 36 years ± 12 [standard deviation]) were included. Twenty-eight patients (52%) had myeloproliferative neoplasms. The mean Model for End-Stage Liver Disease score was 14.5 ± 4. The most frequent indication for TIPS was refractory ascites (50 of 54; 93%). Primary and secondary technical success rates were 93% and 98%, respectively. Early complications occurred in 17 patients (32%). After a mean follow-up of 56 months ± 41 (interquartile range, 22-92), 22 patients (42%) experienced at least one episode of TIPS dysfunction (median delay between administration of TIPS and first episode of dysfunction, 10.8 months). Cumulative 1-, 2-, 3-, 5-, and 10-year primary patency rates were 64%, 59%, 54%, 45%, and 45%, respectively. Dysfunction was associated with a myeloproliferative neoplasm (hazard ratio, 8.18; 95% confidence interval: 1.45, 46.18; P = .017), more than two initial stents (hazard ratio, 3.90; 95% confidence interval:1.16, 13.10; P = .027), and the occurrence of early complications (hazard ratio, 11.34; 95% confidence interval: 1.82, 70.69; P = .009). The 10-year survival rate was 76%. Conclusion TIPS placement in patients with chronic primary BCS was associated with a nonnegligible rate of early complications and required endovascular revision or revisions in 42% of patients. Nevertheless, secondary patency was close to 100%, and long-term survival was good. © RSNA, 2016 Online supplemental material is available for this article.

Role of the transjugular intrahepatic portosystemic shunt in the management of severe complications of portal hypertension in idiopathic noncirrhotic portal hypertension.

UNLABELLED: Idiopathic noncirrhotic portal hypertension is a heterogeneous group of diseases characterized by portal hypertension in the absence of cirrhosis. The efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) in this population are unknown. The charts of patients with idiopathic noncirrhotic portal hypertension undergoing TIPS in seven centers between 2000 and 2014 were retrospectively reviewed. Forty-one patients were included. Indications for TIPS were recurrent variceal bleeding (n = 25) and refractory ascites (n = 16). Patients were categorized according to the presence (n = 27) or absence (n = 14) of significant extrahepatic comorbidities. Associated conditions were hematologic, prothrombotic, neoplastic, immune, and exposure to toxins. During follow-up (mean 27 ± 29 months), variceal rebleeding occurred in 7/25 (28%), including three with early thrombosis of the stent. Post-TIPS overt hepatic encephalopathy was present in 14 patients (34%). Eleven patients died, five due the liver disease or complications of the procedure and six because of the associated comorbidities. The procedure was complicated by hemoperitoneum in four patients (10%), which was fatal in one case. Serum creatinine (P = 0.005), ascites as indication for TIPS (P = 0.04), and the presence of significant comorbidities (P = 0.01) at the time of the procedure were associated with death. Mortality was higher in patients with significant comorbidities and creatinine ≥100 µmol/L (P < 0.001). CONCLUSION: In patients with idiopathic noncirrhotic portal hypertension who have normal kidney function or do not have severe extrahepatic conditions, TIPS is an excellent option to treat severe complications of portal hypertension. (Hepatology 2016;64:224-231).

Post-hepatectomy liver failure: Should we consider venous outflow?

INTRODUCTION: Post-hepatectomy liver failure (PHLF) is one of the most serious complications of liver resection and is associated with high morbidity and mortality rates. PRESENTATION OF CASE: We report a case of PHLF involving clinical presentation of posthepatectomy-related 'small-for-size' syndrome (SFSS) secondary to obstructed venous outflow in the liver remnant, following extended right hepatectomy. DISCUSSION: PHLF is similar to SFSS in liver transplantation (LT) in terms of pathogenesis, clinical presentation and outcomes. Although inflow hypertension is clearly implicated in the pathogenesis of SFSS some authors have suggested that outflow obstruction is a potential pathogenic factor. CONCLUSION: The present case support the hypothesis that outflow obstruction could lead symptoms similar to SFSS.

Revascularization of acute mesenteric ischemia after creation of a dedicated multidisciplinary center.

OBJECTIVE: Arterial acute mesenteric ischemia (AAMI) is a vascular and gastroenterologic emergency, most often surgical, still associated with a poor prognosis and frequent short bowel syndrome in survivors. We report the results of revascularization in AAMI patients after the creation of an intestinal stroke center. METHODS: Since July 2009, we developed a multimodal and multidisciplinary management for AMI, focusing on intestinal viability and involving gastroenterologists, vascular and abdominal surgeons, radiologists, and intensive care specialists. This management was the first step to the creation of an intestinal stroke center, based on the stroke unit model. All patients received: (1) a specific medical protocol; (2) endovascular and/or open surgical revascularization whenever possible; and/or (3) resection of non-viable small bowel. We aimed to study survival, morbidity, type of revascularization, and bowel resection in patients who benefited from arterial revascularization in our intestinal stroke center. RESULTS: Eighty-three patients with AMI were prospectively enrolled in the intestinal stroke center. Among them, 29 patients with AAMI underwent revascularization. The mean age was 50.2 ± 12 years, with 41% of male gender. The mean follow-up was 22.7 ± 19 months. Overall 2-year survival was 89.2%, and 30-day operative mortality was 6.9%. Surgical revascularization included bypass grafting (65%), endarterectomy with patch angioplasty (21%) ± retrograde open mesenteric stenting of the superior mesenteric artery (7%), and endovascular revascularization as first stage procedure (38%). The 2-year primary patency rate of open revascularization was 88%. The rate and the median length of bowel resected were 24% and 43 cm (range, 36-49 cm), respectively. CONCLUSIONS: In our experience, revascularization of AAMI patients as part of a multidisciplinary and multimodal management leads to encouraging results. Vascular surgeons have a central role in a dedicated intestinal stroke center.

Assessment of liver ablation using cone beam computed tomography.

AIM: To investigate the feasibility and accuracy of cone beam computed tomography (CBCT) in assessing the ablation zone after liver tumor ablation. METHODS: Twenty-three patients (17 men and 6 women, range: 45-85 years old, mean age 65 years) with malignant liver tumors underwent ultrasound-guided percutaneous tumor ablation [radiofrequency (n = 14), microwave (n = 9)] followed by intravenous contrast-enhanced CBCT. Baseline multidetector computed tomography (MDCT) and peri-procedural CBCT images were compared. CBCT image quality was assessed as poor, good, or excellent. Image fusion was performed to assess tumor coverage, and quality of fusion was rated as bad, good, or excellent. Ablation zone volumes on peri-procedural CBCT and post-procedural MDCT were compared using the non-parametric paired Wilcoxon t-test. RESULTS: Rate of primary ablation effectiveness was 100%. There were no complications related to ablation. Local tumor recurrence and new liver tumors were found 3 mo after initial treatment in one patient (4%). The ablation zone was identified in 21/23 (91.3%) patients on CBCT. The fusion of baseline MDCT and peri-procedural CBCT images was feasible in all patients and showed satisfactory tumor coverage (at least 5-mm margin). CBCT image quality was poor, good, and excellent in 2 (9%), 8 (35%), and 13 (56%), patients respectively. Registration quality between peri-procedural CBCT and post-procedural MDCT images was good to excellent in 17/23 (74%) patients. The median ablation volume on peri-procedural CBCT and post-procedural MDCT was 30 cm(3) (range: 4-95 cm(3)) and 30 cm(3) (range: 4-124 cm(3)), respectively (P-value > 0.2). There was a good correlation (r = 0.79) between the volumes of the two techniques. CONCLUSION: Contrast-enhanced CBCT after tumor ablation of the liver allows early assessment of the ablation zone.

Radioembolisation with yttrium‒90 microspheres versus sorafenib for treatment of advanced hepatocellular carcinoma (SARAH): study protocol for a randomised controlled trial.

BACKGROUND: Untreated advanced hepatocellular carcinoma (HCC) is linked to poor prognosis. While sorafenib is the current recommended treatment for advanced HCC, radioembolisation (RE; also called selective internal radiation therapy or SIRT) with yttrium-90 microspheres has shown efficacy in cohort studies. However, there are no head-to-head trials comparing radiation therapy with yttrium-90 microspheres and sorafenib in advanced HCC. The SARAH trial has been designed to compare the efficacy and safety of sorafenib therapy and RE using yttrium-90 resin microspheres (SIR-Spheres™; Sirtex Medical Limited, North Sydney, Australia) in patients with advanced HCC. Quality of life (QoL) and cost-effectiveness will also be compared between therapies. METHODS/DESIGN: SARAH is a prospective, randomised, controlled, open-label, multicentre trial comparing the efficacy of RE with sorafenib in the treatment of patients with advanced HCC. The trial aims to recruit adults with a life expectancy of >3 months, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1, and: advanced HCC according to the Barcelona criteria (stage C) or recurrent HCC after surgical or thermoablative treatment who are not eligible for surgical resection, liver transplantation or thermal ablation; or two rounds of failed chemoembolisation. Patients will be randomised 1:1 to receive either RE or sorafenib 400 mg twice daily. All patients will be monitored for between 12 and 48 months following start of treatment. The primary endpoint of the SARAH trial is overall survival (OS). Secondary endpoints include: adverse events, progression-free survival at 6 months; tumour response rate; general or liver disease-specific QoL scores; and cost of each treatment strategy. Assuming an increase in median OS of 4 months with RE versus sorafenib therapy, randomising at least 400 patients (200 in each treatment arm) will be sufficient for 80% power and a bilateral alpha risk of 5%; therefore, 440 patients will be enrolled to allow for 10% loss of patients due to ineligibility. DISCUSSION: The SARAH trial is the first randomised head-to-head study to compare RE with sorafenib in advanced HCC, and will establish the potential role of RE in HCC treatment guidelines. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01482442, first received 28 November 2011.

Preservation of the arterial vascularisation after hepatic artery pseudoaneurysm following orthotopic liver transplantation: long-term results.

BACKGROUND: Hepatic artery pseudoaneurysm (HAP) is a serious complication of orthotopic liver transplantation (OLT). The aim of this study was to determine risk factors for HAP and the best management of this complication. MATERIAL AND METHODS: Between 1990 and 2005, 787 OLT were performed at our center. Patients who developed HAP were identified from our prospective database and risk factors of HAP were identified. Management of HAP was analyzed retrospectively. RESULTS: There were 16 OLT (2.5%) complicated by HAP [median delay =13 days; range: 4-100 days]. Presentation was massive bleeding with shock (n=13), pain (n=2), or transient gastrointestinal bleeding (n=1). Bacteriological culture of HAP wall or ascites fluid was positive in 13 (81%) patients. Bilio-enteric anastomosis and biliary leak were identified as risk factors for HAP (p=0.011 and 0.002, respectively), whereas indication for OLT, surgical technique (full-graft OLT versus other techniques), and re-LT were not. Mortality rate after HAP rupture was 53% (7/13), but no deaths occurred in the 3 patients treated before rupture. Treatment included: excision and immediate revascularization [n=7; early mortality =2 (28%), long-term graft survival =4 (57%)], hepatic artery ligation [n=5; early mortality =3 (80%);, long-term graft survival with good liver function =0], and endovascular treatment [n=2; early mortality =0, long-term survival with good liver function =2]. CONCLUSIONS: HAP post-OLT carries a high mortality rate when detected after rupture, but recognition before rupture usually allows a successful outcome. Reconstruction with bilio-enteric anastomosis and postoperative biliary leak increase the risk for HAP. In these settings, CT with contrast injection should be performed to screen for HAP when there is any suspicion. Graft revascularization should be attempted whenever possible.

Hepatic cysts treated with percutaneous ethanol sclerotherapy: time to extend the indications to haemorrhagic cysts and polycystic liver disease.

OBJECTIVES: To describe the long-term clinical and morphological outcome of symptomatic hepatic cysts treated with percutaneous ethanol sclerotherapy (PES). METHODS: From December 2003 to September 2011, all patients with hepatic cysts undergoing PES with a follow-up after 12 months were included. Evolution of the volume of the cysts and clinical and biological data were recorded. Features of the cyst were evaluated in each patient: simple, haemorrhagic or developed on underlying polycystic liver disease (PCLD). RESULTS: Fifty-eight cysts (median volume 666 mL) were treated in 57 patients (52 women, mean age 58 years (18-80)). Twenty-two patients (39 %) had simple hepatic cysts, 19 (33 %) had dominant cysts on PCLD and 20 had haemorrhagic cysts (34.5 %), including 4 with PCLD. After a mean 27.3 months of follow-up, the final median cystic volume was 13.5 mL (p < 0.0001), and the median reduction in cyst volume was 94 % (58-100 %). Treatment was satisfactory in 95 % of the patients (54/57) (symptoms disappeared in 45/57 (79 %), decreased in 9/57 (16 %)). There was no clinical or morphological difference between patients with PCLD, haemorrhagic cysts or simple cysts. CONCLUSION: The clinical and morphological efficacy of a single session of PES is very high, regardless of the presence of intracystic haemorrhage or underlying PCLD. KEY POINTS: • The clinical efficacy of percutaneous ethanol sclerotherapy is very high. • Haemorrhagic content should not be a contraindication for percutaneous sclerotherapy. • Dominant cysts on polycystic liver disease should be treated with PES. • Imaging follow-up should not be performed shortly after the procedure.