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In patients with unresectable liver metastases from colorectal cancer (CRCLM), systemic doublet or triplet chemotherapy and targeted therapy is considered a standard first-line treatment. Hepatic arterial infusion of oxaliplatin (HAI-ox) generates a high response rate, but this still needs to be confirmed in a randomized trial. We incorporated HAI-ox in doublet or triplet + targeted therapy to validate its efficacy.The OSCAR study is an ongoing randomized phase III trial comparing FOLFOX + targeted therapy according to RAS status, or FOLFOXIRI + bevacizumab in patients eligible for triplet therapy, with the same regimen but with HAI-ox instead of IV-ox as the first-line treatment for CRCLM.Main eligibility criteria are colorectal cancer, unresectable liver metastasis, no extra-hepatic metastases except pulmonary nodules if ≤3 and10 mm, ECOG performance status 0 or 1.The primary endpoint is progression-free survival (PFS). A difference of 4 months for the median PFS in favor of HAI-ox is expected (HR = 0.73). Secondary endpoints include overall survival, overall response rate, secondary liver resection, safety, and quality of life.This study is planned to include 348 patients to demonstrate the superiority of HAI-ox over systemic oxaliplatin in first-line CRCLM treatment (NCT02885753).

Purpose The purpose of this study was to assess the feasibility and efficacy of docetaxel-loaded bead chemoembolization in spontaneous prostate cancer in a canine model. Materials and methods Five pet dogs with histopathologically proven prostate cancer were referred for prostate artery chemoembolization (PACE). After PACE, all animals were followed, including pharmacokinetic study and clinical and biological evolution, until death. Pelvic contrast-enhanced computed tomography examination was performed at one and two months. Animals were subjected to pathological examination after death. Results Both prostate arteries were successfully chemoembolized in all dogs. A median dose of 18 mg (Q1, Q3; 11.8, 20 mg) docetaxel loaded in 3 mL of 50–100 µm super absorbent polymer beads was injected into each dog. At one month, four of the five dogs were still alive and the median prostate volume was 51% lower (prePACE median prostate volume, 18.4 mL [Q1, Q3; 12, 32.1 mL] vs. postPACE median prostate volume, 6.2 mL [Q1, Q3; 6.2, 11 mL]). At two months, three dogs died because of disease progression. The two remaining dogs showed a 70% median decrease in prostate volume. Prostate pathological examination showed 73% of necrosis. No worsening of urinary symptoms was observed. Pharmacokinetic analysis showed limited systemic passage of docetaxel. All dogs died of metastatic spread at nine months. Conclusion This study suggests that PACE is feasible and safe for the treatment of spontaneous prostate cancer in a canine model and may provide a new approach to treat selected patients with prostate cancer.

International audience; Purpose: the purpose of this multicenter study was to evaluate the clinical success at three months of prostate artery embolization (PAE), assess PAE safety in centers with various experiences and identify factors associated with PAE success.Patients and methods: this multicenter, retrospective study included patients who underwent PAE for lower urinary tract symptoms (LUTS) including those with indwelling urinary catheter. PAE clinical success was defined as either 25% improvement of the International Prostate Symptom Score (IPSS) or 1-point improvement of quality of life (QoL) score, or catheter removal at three months. Multivariable analyses were performed using a logistic regression adjusted on patient variables, technical parameters and center experience in PAE.Results: a total of 383 men (mean age, 68.4±9.7 [standard deviation] years; range: 46-94) with LUTS, including 99 (25.8%) patients with indwelling urinary catheter, were included in seven centers from January 2017 to March 2019. Five patients reported major complications (1.3%), three (0.8%) penile ulceration, three (0.8%) acute urinary retention, one (0.3%) prostatic abscess, and 56 (14.6%) minor complications. Follow up data were available for 271 patients (center 1: n= 159; other centers: n= 112). Clinical success was reported in 232 patients (85.6%). In multivariable analyses, presence of cardiovascular comorbidities (diabetes, stroke history, myocardial infarction and lower limb artery disease) was the single independent variable inversely associated with PAE clinical success (odds ratio= 0.396; 95% confidence interval: 0.17-0.91; P= 0.029). There was no center effect.Conclusion: our results show that PAE is safe and effective in centers with various PAE experiences. Cardiovascular comorbidity is the single independent variable associated with PAE failure.

Background The aim of this ancillary study of the SARAH trial is to compare health-related quality of life (HRQoL) in patients with locally advanced or inoperable hepatocellular carcinoma (HCC) treated with transarterial radioembolisation (TARE) or sorafenib. Methods This study included randomised patients who received either TARE or at least one dose of sorafenib with no major deviation in the protocol and who had at least one QoL follow-up assessment in addition to the baseline evaluation. QoL was assessed from the date of randomisation using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire, until disease progression or other reasons for stopping study participation. Data were analysed using linear mixed and time-dependent models. Results A total of 285 patients were included (122 and 163, in the TARE and sorafenib groups, respectively). Questionnaire completion rates were similar (77.5% versus 80.4%, in the TARE and sorafenib groups, respectively, p = 0.25). Longitudinal HRQoL analysis showed a significant treatment and time effects for fatigue and global health status, and significant treatment, time and treatment by time interaction effects for appetite loss, diarrhoea and social functioning. The median time to deterioration for the global health status was 3.9 months (95% confidence interval [CI] 3.7–4.3) versus 2.6 months (95% CI 2.0–3.0) in the TARE and sorafenib groups, respectively. Conclusions HRQoL was preserved longer with TARE than with sorafenib in locally advanced HCC. These data could be used to optimise management of patients with advanced or inoperable HCC.

Purpose To evaluate the influence of intravesical prostatic protrusion (IPP) on clinical outcomes after prostatic artery embolization (PAE) in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. Materials and methods All consecutive patients who underwent PAE for lower urinary tract symptoms between January 2017 and January 2019 were retrospectively included. IPP was evaluated on pre-treatment magnetic resonance imaging examination and symptoms were assessed at follow-up consultations using the international prostate symptom score (IPSS) and quality of life (QOL) questionnaire. IPPs were classified as grade 1 ( 10 mm). Results A total of 160 consecutive men (mean age 65 ± 7.8 [SD] years; range: 45–89 years), underwent PAE. The mean IPSS was 21 ± 7.3 (SD) (range: 5–35) and prostate volume 87 ± 38 (SD) mL (range: 30–200 mL). The IPP grade was 1 for 28 (28/160; 18%), 2 for 52 (52/160; 33%), and 3 for 80 (80/160; 50%) patients. There were no significant differences in IPSS at baseline between the three IPP grades. Patients with severe (grade 3) IPP had a significantly higher reduction in IPSS than those with non-severe IPP (grade 1 or 2), with estimated mean reductions of 12 ± 2.5 (SD) (range: −4–28) and 8.3 ± 1.9 (SD) (range: −8–21) (P = 0.02), respectively. The mean reduction in the QOL score was 3.0 for grade 3 and 2.0 for grade 1 or 2 IPP (P = 0.02). Conclusions The degree of IPP does not limit the efficacy of PAE in patients with lower urinary tract symptoms due to benign prostatic hyperplasia.

The effect of prostate artery embolization (PAE) on male sexual function is currently the subject of debate in the literature. The main purpose of this study was to define changes in all domains of sexual activity after PAE, using the international index of erectile function score (IIEF-15). A single-center retrospective study was conducted on 129 patients (mean age of 65.5 ± 7 years), who underwent PAE from February 2014 to January 2017 for symptomatic benign prostatic hyperplasia (BPH). Fifty consecutive patients fulfilling the inclusion criteria were evaluated before and after PAE follow-up using the IIEF-15, IPSS, prostate volume (PV) and cardiovascular risk factor and BPH drugs. The IIEF-15 domains analyzed were: erectile function (EF) ejaculation and orgasm (Ej/O), sexual desire (SD), intercourse satisfaction (IS) and overall satisfaction (OS). A paired sample t test or Wilcoxon signed-rank test was used to compare IIEF-15 between baseline and follow-up. The study showed nonsignificant change in IIEF-15 total score (58.0 ± 13.8 SD; p = 0.71) and the five domains (EF 24.5 ± 7.0 SD, p = 0.82; EJ/O 8.2 ± 2.3 SD, p = 0.50; SD 7.2 ± 2.7 SD, p = 0.57; IS 10.3 ± 3.0 SD, p = 0.77; OS 8.2 ± 2.7 SD; p = 0.11) after PAE. We also found a significant improvement in IPSS score after PAE. Based on the IIEF-15 questionnaire, PAE was showed to allow good urinary symptoms results and no deterioration in sexual function.

We investigated the clinical effects of bead size in irinotecan-loaded beads chemoembolization (DEBIRI) used for treating liver-dominant colorectal cancer. Between March 2009 and January 2018, all consecutive patients with colorectal cancer liver metastases referred for DEBIRI at our tertiary center were included in an observational study. Patients were treated exclusively with either 100-mg irinotecan-loaded DC beads of 70–150 μm (small bead group or SB) or 100–300 μm (large bead group or LB) in diameter, in addition to systemic therapy. Liver tumor response rate at 3 months, liver and overall progression-free survival (PFS) and overall survival were estimated. In total, 84 patients with liver-dominant progressive disease underwent 232 DEBIRI sessions. Fifty-four patients were treated in the SB group and 30 patients in the LB group. Liver progression-free rates at 3 months were 86.7% for the LB group and 79.6% for the SB group (NS). Median liver-PFS and overall PFS were, respectively, 7.15 months and 7.15 months for the LB group and 7.65 and 7.55 months for the SB group (NS). Median overall survival was 13.04 months for the LB group and 15.59 months for the SB group (p = 0.04). Specific treatment grade 3 + 4 toxicity occurrence was 5 (17%) in the LB group and 20 (37%) in the SB group. No significant difference in patient outcome was observed between DEBIRI bead sizes of 70–150 μm and 100–300 μm. A trend toward higher treatment-specific toxicity was observed with the smaller beads.

International audience; Purpose: The SARAH (Sorafenib Versus Radioembolization in Advanced Hepatocellular Carcinoma) trial (ClinicalTrials.gov Identifier NCT01482442) did not show a significant survival benefit for patients treated with transarterial radioembolization (TARE) compared with continuous oral sorafenib. The improved toxicity profile of patients treated with TARE in the trial, however, could result in a quality of life benefit in economic evaluations. Our objective was to perform a cost-utility analysis of TARE versus sorafenib for locally advanced and inoperable hepatocellular carcinoma.Methods: This study used patient-level data of the SARAH trial regarding resource use, progression-free and overall survival, and quality of life for the within-trial period for the patients who received at least 1 dose of sorafenib or 1 treatment with TARE according to their randomization arm. Data were extrapolated by using a partitioned survival model that incorporated costs and health outcomes, measured in life-years and quality-adjusted life-years (QALYs).Findings: The use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib. The aerage cost for the TARE arm was €17,179 (95% CI, 9,926-24,280) higher than the sorafenib arm, for an incremental cost-effectiveness ratio of €3,153,086/QALY. The probabilistic sensitivity analysis revealed a 50% risk that the TARE strategy was dominated. TARE was consistently dominated by sorafenib or had an incremental cost-effectiveness ratio more than €450,000/QALY in all sensitivity analyses.Implications: This economic evaluation of SARAH found that using radioembolization with yttrium-90 microspheres for the treatment of hepatocellular carcinoma was not a cost-effective option at the usually accepted willingness-to-pay thresholds.

Purpose The purpose of this study was to report the clinical evaluation of a 3D-printed protective face shield designed to protect interventional radiologists from droplet transmission of the SARS-Cov-2. Materials and methods A protective face shield consisting in a standard transparent polymerizing vinyl chloride (PVC) sheet was built using commercially available 3D printers. The 3D-printed face shield was evaluated in 31 interventional procedures in terms of ability to perform the assigned intervention as usual, quality of visual comfort and tolerance using a Likert scale (from 1, as very good to 5, as extremely poor). Results The mean rating for ability to perform the assigned intervention as usual was 1.7 ± 0.8 (SD) (range: 1–4). The mean visual tolerance rating was 1.6 ± 0.7 (SD) (range: 1–4). The mean tolerability rating was 1.4 ± 0.7 (SD) (range: 1–3). Conclusion The 3D-printed protective face shield is well accepted in various interventions. It may become an additional option for protection of interventional radiologists.

Benign Prostatic Hyperplasia (BPH) concerns 50% of men older that 60 Years old and can induce symptoms also earlier. Medical treatment are mostly alpha blockers (AB), 5-alpha reductase inhibitors (5ARI) and phospho-diesterase inhibitors. In case of failure or poor tolerance of drug treatment, surgery can be indicated, after evaluation of the Bladder Outlet Obstruction (BOO), based on urodynamic studies. Endoscopic or open surgery is selected according to the size of the prostate, the expertise of the urologist and patient preference. Surgical treatment is very efficient but carries frequent complications, especially retrograde ejaculation which is very frequent and can compromise fertility and sexual pleasure. Prostatic Artery Embolisation, an outpatient intervention performed by Interventional Radiologists and available in France since 2012 is a new alternative to surgery in case of failure or poor tolerance of medical treatment. It consists in super-selective injection of calibrated micro-particles into both prostatic arteries after femoral artery puncture at the groin. It is safe and efficient and provides appropriate symptomatic improvement BOO related to BPH.

Purpose To evaluate the safety and efficacy of percutaneous transarterial embolization (PTAE) for the treatment of spontaneous soft-tissue hematomas (SSTHs) and identify variables predictive of short-term outcome. Materials and Methods Between 2011 and 2017, the outcome was retrospectively analyzed for 112 patients (mean age ± standard deviation, 72 years ± 14; range, 28-92 years), including 65 women (mean age, 73 years ± 12.7; range, 39-92 years) and 47 men (mean age, 70 years ± 14.9; range, 28-91 years), with SSTH treated with PTAE. Thirty-day mortality, technical and clinical success, simplified acute physiology score (SAPS) II, anticoagulation, embolic agent, hematoma volume and location, serum hemoglobin level, hemodynamic instability, and presence of active bleeding at CT and/or angiography were recorded. Clinical success was defined as cessation of bleeding as determined by hemodynamic stability and/or serum hemoglobin level stabilization after PTAE. Univariable and multivariable analyses were performed by using a Cox model to identify variables associated with time to death. Results Mortality rate was 26.8% (30 of 112 patients), angiographic success rate was 95.5% (107 of 112 patients), and clinical success rate was 83% (93 of 112 patients). For surviving patients, mean SAPS II was 19.6 ± 7.1 (range, 13-31) and mean hematoma volume was 862 cm3 ± 618 (range, 238-1887 cm3). For deceased patients, mean SAPS II was 42 ± 13.2 (range, 18-63) and mean hematoma volume was 1419 cm3 ± 788 (range, 251-3492 cm3). SAPS II (P < .001), hematoma volume (P = .01), and retroperitoneal location (P = .01) were independently associated with fatal outcome. Conclusion Percutaneous transarterial embolization is effective for the emergency treatment of spontaneous soft-tissue hematomas. Simplified acute physiology score II, hematoma volume, and retroperitoneal location are predictors of short-term outcome. © RSNA, 2019 Online supplemental material is available for this article.

To determine whether intraprocedural C-arm cone-beam CT (CBCT) parenchymal blood volume (PBV) can predict the response of colorectal cancer liver metastases (CRCLM) 2 months after irinotecan drug–eluting bead (DEBIRI) chemoembolization. This single-center observational study was compliant with the Helsinki Declaration and approved by our institutional review board. Thirty-four consecutive CRCLM patients referred for DEBIRI chemoembolization were enrolled between March 2015 and December 2016. Tumor size was assessed at baseline and 2 months after DEBIRI chemoembolization by multidetector CT (Response Evaluation Criteria in Solid Tumors RECIST 1.0), and PBV was measured before and after DEBIRI chemoembolization. Two independent readers reviewed all data. We determined the potential correlation (Spearman’s rank correlation) between intraprocedural PBV values and tumor response at 2 months. The relationship between tumor response and PBV was studied using a mixed model. A logistic regression model was applied to study the relationship between patient “Responder/Non-responder” and PBV. There was a strong correlation between baseline PBV or the percent change of PBV and the 2-month tumor response (rho = − 0.8587 (p = 0.00001) and rho = 0.8027 (p = 0.00001), respectively). The mixed model showed that an increase of 1 ml/1000 ml in PBV of a tumor before DEBIRI chemoembolization led to a 0.54 mm decrease in diameter (p

BackgroundWhereas first-line bronchial artery embolisation (BAE) is considered standard of care for the management of severe haemoptysis, it is unknown whether this approach is warranted for non-severe haemoptysis.Research questionTo assess the efficacy on bleeding control and the safety of first-line BAE in non-severe haemoptysis of mild abundance.Study design and methodsThis multicentre, randomised controlled open-label trial enrolled adult patients without major comorbid condition and having mild haemoptysis (onset ResultsBleeding recurrence at day 30 after randomisation (primary outcome) occurred in 4 (11.8%) of 34 patients in the BAE strategy and 17 (44.7%) of 38 patients in the medical strategy (difference −33%; 95% CI −13.8% to −52.1%, p=0.002). The 90-day bleeding recurrence-free survival rates were 91.2% (95% CI 75.1% to 97.1%) and 60.2% (95% CI 42.9% to 73.8%), respectively (HR=0.19, 95% CI 0.05 to 0.67, p=0.01). No death occurred during follow-up and no bleeding recurrence needed surgery.Four adverse events (one major with systemic emboli) occurred during hospitalisation, all in the BAE strategy (11.8% vs 0%; difference 11.8%, 95% CI 0.9 to 22.6, p=0.045); all eventually resolved.ConclusionIn non-severe haemoptysis of mild abundance, BAE associated with medical therapy had a superior efficacy for preventing bleeding recurrences at 30 and 90 days, as compared with medical therapy alone. However, it was associated with a higher rate of adverse events.Trial registration numberNCT01278199

Purpose Radioembolization has emerged as a treatment modality for patients with primary and secondary liver tumours. This observational study CIRT-FR (CIRSE Registry for SIR-Spheres Therapy in France) aims to evaluate real-life clinical practice on all patients treated with transarterial radioembolization (TARE) using SIR-Spheres yttrium-90 resin microspheres in France. In this interim analysis, safety and quality of life data are presented. Final results of the study, including secondary effectiveness outcomes, will be published later. Overall, CIRT-FR is aiming to support French authorities in the decision making on reimbursement considerations for this treatment. Methods Data on patients enrolled in CIRT-FR from August 2017 to October 2019 were analysed. The interim analysis describes clinical practice, baseline characteristics, safety (adverse events according to CTCTAE 4.03) and quality of life (according to EORTC QLQ C30 and HCC module) aspects after TARE. Results This cohort included 200 patients with hepatocellular carcinoma (114), metastatic colorectal cancer (mCRC; 38) and intrahepatic cholangiocarcinoma (33) amongst others (15). TARE was predominantly assigned as a palliative treatment (79%). 12% of patients experienced at least one adverse event in the 30 days following treatment; 30-day mortality was 1%. Overall, global health score remained stable between baseline (66.7%), treatment (62.5%) and the first follow-up (66.7%). Conclusion This interim analysis demonstrates that data regarding safety and quality of life generated by randomised-controlled trials is reflected when assessing the real-world application of TARE. Trial Registration Clinical Trials.gov NCT03256994.

BACKGROUND: About 70-80% of patients with colorectal liver metastases appear as ineligible for a curative treatment approach. Transarterial chemoembolisation (TACE) using irinotecan-eluting beads has emerged as a promising treatment option in cases with irresectable liver metastases. Despite being in clinical practice for years, little is known about the treatment characteristics and outcomes when used as per routine hospital practice. METHODS: Patients with hepatic metastases from colorectal cancer origin, admitted to contributing centres to receive TACE with drug-eluting LifePearl® Microspheres loaded with irinotecan, as part of their standard care, will be consecutively added to the registry. Data will be collected until the end of study, loss to follow-up or death. Primary endpoint is the characterisation of the treatment usage at the selected sites in Europe. Secondary endpoints include outcome parameters, safety and toxicity, as well as quality of life. CONCLUSION AND AIMS: This multicentre, international, prospective observational study conducted in European centres plans to collect real-life data. This data will form an evidence-base from which conclusions can be drawn on how to improve patient selection and optimise treatment protocols when treating with TACE using irinotecan-eluting microspheres. Trial registration NCT03086096. ispartof: DIGESTIVE AND LIVER DISEASE vol:52 issue:8 pages:857-861 ispartof: location:Netherlands status: published

To prospectively evaluate the feasibility and reproducibility of the semiquantitative measurement of the unenhanced area of the prostate by trans-abdominal contrast-enhanced ultrasound (CEUS) performed immediately after prostate artery embolization (PAE) as a prognostic factor of success.Thirty-nine patients with PAE were prospectively included. They all underwent pre- and post-PAE trans-abdominal prostate CEUS. Two readers independently evaluated the pre- and post-PAE unenhanced area using a semiquantitative method: unenhanced areas were measured on 3 different slices (basis, middle, and apex) and reported to the whole prostate area. The mean of the three measures was reported semiquantitatively in classes of ten percent and quartiles. We evaluated correlation with clinical success, at 3 months after PAE, defined as a 25% reduction in the International Prostatic Symptoms Score and a Quality of life 3.Twenty-three patients who had bilateral PAE were analyzed. Pre-PAE trans-abdominal prostate CEUS showed visible early and marked enhancement of the entire prostate in all patients. After PAE, all patients had a semiquantitatively measured unenhanced area 25%. The semiquantitative measurement was found to be highly reproducible, with an interclass correlation 0.8. No correlation was found between the area of unenhanced tissue and clinical success evaluated at 3 months.Trans-abdominal prostate CEUS performed early after PAE provides reproducible results and is a valuable tool to evaluate unenhanced areas of the prostate.3, local non random sample.

Background Chemo-embolisation with drug-eluting beads loaded with irinotecan (DEBIRI) increased survival as compared with intravenous irinotecan in chemorefractory patients with liver-dominant metastases from colorectal cancer (LMCRC). First-line DEBIRI with systemic chemotherapy may increase survival and secondary resection. Methods In the FFCD-1201 single-arm Phase 2 study, patients with untreated, non-resectable LMCRC received DEBIRI plus mFOLFOX6. Four courses of DEBIRI were performed alternating right and left lobe or two sessions with both lobes treated during the same session. Results Fifty-seven patients were enrolled. Grade 3–5 toxicities were more frequent when both lobes were treated during the same session (90.5% versus 52.8%). Nine-month PFS rate was 53.6% (95% CI, 41.8–65.1%). The objective response rate (RECIST 1.1) was 73.2%, and the secondary R0 surgery was 33%. With a median follow-up of 38.3 months, median OS was 37.4 months (95% CI, 25.7–45.8), and median PFS 10.8 months (95% CI, 8.2–12.3). Conclusions Front-line DEBIRI + mFOLFOX6 should not be recommended as the hypothesised 9-month PFS was not met. However, high response rate, deep responses, and prolonged OS encourage further evaluation in strategies integrating biologic agent, in particular in patients with secondary surgery as the main goal. Clinical trial registration NCT01839877.

Purpose Transarterial chemoembolisation (TACE) using irinotecan-eluting beads is an additional treatment option for colorectal cancer liver metastases (CRLM) patients that are not eligible for curative treatment approaches. This interim analysis focuses on feasibility of the planned statistical analysis regarding data distribution and completeness, treatment intention, safety and health-related quality of life (HRQOL) of the first 50 patients prospectively enrolled in the CIrse REgistry for LifePearl™ microspheres (CIREL), an observational multicentre study conducted across Europe. Methods In total, 50 patients ≥ 18 years diagnosed with CRLM and decided to be treated with irinotecan-eluting LifePearl™ microspheres TACE (LP-irinotecan TACE) by a multidisciplinary tumour board. There were no further inclusion or exclusion criteria. The primary endpoint is the categorisation of treatment intention, and secondary endpoints presented in this interim analysis are safety, treatment considerations and HRQOL. Results LP-irinotecan TACE was conducted in 42% of patients as salvage therapy, 20% as an intensification treatment, 16% as a first-line treatment, 14% a consolidation treatment and 8% combination treatment with ablation with curative intent. Grade 3 and 4 adverse events were reported by 4% of patients during procedure and by 10% within 30 days. While 38% reported a worse, 62% reported a stable or better global health score, and 54% of patients with worse global health score were treated as salvage therapy patients. Conclusion This interim analysis confirms in a prospective analysis the feasibility of the study, with an acceptable toxicity profile. More patients reported a stable or improved HRQOL than deterioration. Deterioration of HRQOL was seen especially in salvage therapy patients. Trial Registration NCT03086096.

Resume Le terme « recherche clinique » designe toute recherche menee sur l’homme en vue du developpement des connaissances biologiques ou medicales. Applicable depuis novembre 2016, la loi Jarde a redefini les contours de la recherche clinique en France. Le changement le plus notable est qu’on ne parle plus de recherche biomedicale mais de « recherche impliquant la personne humaine ». Ainsi, toutes les recherches doivent etre autorisees par un comite de protection des personnes (CPP) avant de pouvoir debuter ; cela inclut aussi les recherches observationnelles telles que les cohortes retrospectives. Autre nouveaute, le CPP est attribue de maniere aleatoire, sur un site internet dedie. Seules les recherches sur donnees (obtenues dans le cadre strict du soin) font exception parce qu’elles n’impliquent pas la personne humaine ; il s’agit en general des donnees extraites de l’entrepot de donnees ou du dossier patient informatise. L’objectif de cet article est d’aider les radiologues interventionnels a comprendre et a optimiser leurs activites de recherche clinique dans le respect du cadre legal nouvellement defini.

The development of prostatic artery embolization has led to better understand the complex male pelvic arterial anatomy. To the best of our knowledge, there is still no precise description of the distribution of the branches of the prostatic artery (PA) after its origin. In this study, the patterns of prostatic feeders near to and into the prostate were analyzed, and a classification was proposed. This study is based on angiograms of 101 consecutive male patients, mean age 70, who underwent PAE between December 2013 and June 2016, to treat symptomatic benign prostatic hyperplasia. The proposed classification is derived from the analysis of 143 solitary PAs from 199 hemipelves (72%). Pattern A was defined as an artery feeding only the prostate, patterns B and C as a PA with a concomitant large supply to the penis (pattern B) or to the rectum (pattern C). A pattern A was found in 89/143 (62%), a pattern B in 16/143 (12%) and pattern C in 38/143 (26%). Protection of a penile/rectal supply was never required in pattern A, while it was performed in 14/16 (87%) of pattern B, and in 7/38 (18%) of pattern C PAs. The PErFecTED technique could be performed in 51%, 50 and 55% of cases in pattern A to C. This study proposes a new classification of intra-/extra-prostatic arterial distribution of the PA that could be helpful to prevent complications of PAE. Further prospective angiographic investigations are necessary to confirm its clinical value.

The effect of prostate artery embolization (PAE) on male sexual function is currently the subject of debate in the literature. The main purpose of this study was to define changes in all domains of sexual activity after PAE, using the international index of erectile function score (IIEF-15).A single-center retrospective study was conducted on 129 patients (mean age of 65.5 ± 7 years), who underwent PAE from February 2014 to January 2017 for symptomatic benign prostatic hyperplasia (BPH). Fifty consecutive patients fulfilling the inclusion criteria were evaluated before and after PAE follow-up using the IIEF-15, IPSS, prostate volume (PV) and cardiovascular risk factor and BPH drugs. The IIEF-15 domains analyzed were: erectile function (EF) ejaculation and orgasm (Ej/O), sexual desire (SD), intercourse satisfaction (IS) and overall satisfaction (OS). A paired sample t test or Wilcoxon signed-rank test was used to compare IIEF-15 between baseline and follow-up.The study showed nonsignificant change in IIEF-15 total score (58.0 ± 13.8 SD; p = 0.71) and the five domains (EF 24.5 ± 7.0 SD, p = 0.82; EJ/O 8.2 ± 2.3 SD, p = 0.50; SD 7.2 ± 2.7 SD, p = 0.57; IS 10.3 ± 3.0 SD, p = 0.77; OS 8.2 ± 2.7 SD; p = 0.11) after PAE. We also found a significant improvement in IPSS score after PAE.Based on the IIEF-15 questionnaire, PAE was showed to allow good urinary symptoms results and no deterioration in sexual function.

La embolizacion arterial de la prostata es una nueva modalidad terapeutica minimamente invasiva propuesta en el marco de ensayos, que esta en fase de validacion en el tratamiento de la hiperplasia benigna de prostata desde 2010. La hiperplasia benigna de prostata (HBP) es una patologia muy frecuente en los varones mayores de 50 anos. Esta entidad se define por una serie de argumentos que engloban la asociacion de signos funcionales urinarios con un aumento del volumen prostatico. Afecta al 50% de los varones de forma muy variable y puede tener una gran repercusion sobre la calidad de vida. La HBP puede tener una repercusion negativa sobre el reservorio vesical y, excepcionalmente, sobre el aparato urinario superior. El papel del urologo en el tratamiento de la HBP es acompanar a su paciente durante la evolucion de esta patologia tratando los sintomas molestos a la vez que se conserva el aparato urinario, pero tambien la funcion sexual. Ante un fracaso, la mala tolerabilidad de los tratamientos farmacologicos o una HBP complicada (retencion de orina, calculos vesicales, insuficiencia renal obstructiva, infecciones repetidas, etc.), la cirugia es la opcion clasica, pero puede presentar un riesgo elevado de morbilidad segun el contexto o alterar la funcion sexual. La embolizacion arterial de la prostata es una nueva alternativa a la cirugia, que aun no forma parte de los tratamientos de referencia. Este nuevo tratamiento minimamente invasivo, con escasa morbilidad pero muy tecnico, podria permitir, en indicaciones bien seleccionadas, evitar o retrasar la cirugia cuando se establezca la indicacion en el marco de un equipo multidisciplinario urologico y radiologico.

Summary Introduction Hepatic arterial infusion (HAI) chemotherapy with oxaliplatin is an accepted option in the management of colorectal cancer (CRC) with dominant liver metastases (LM). However, despite prolonged control, some patients experience disease progression. On the other hand, oxaliplatin leads to dose-limiting toxicity. In these cases, the use of a second-line HAI with an alternative drug has never been reported to date. We evaluated treatment outcomes in patients receiving second-line HAI with 5-FU or mitomycin C, after first-line HAI of oxaliplatin in heavily pretreated patients. Material and methods Between March 2010 and June 2016, this observational study included 24 patients with unresectable CRC LM and treated with HAI of 5-FU (17 patients) or mitomycin C (7 patients), after HAI of oxaliplatin. Results Mean age was 61.7 years. Forty-two percent of patients (10/24) had extra-hepatic metastases and 75% (18/24) at least 8 liver metastases. Including HAI of oxaliplatin, all patients had previously received at least 2 lines of chemotherapy ± targeted agents (100%) and 96% (23/24) received concomitant systemic therapies together with HAI of 5-FU or mitomycin C. The overall objective response rate and disease control rate were, respectively, 42% (10/24) and 71% (17/24). Median progression-free survival and overall survival (OS) were, respectively, 5.6 and 25.8 months; hepatic progression-free survival was 8.5 months. Thirteen percent (3/24) of the patients received further curative intent treatment after HAI 5-FU and mitomycin C. No toxic death occurred and the toxicity profile was acceptable. Conclusions HAI of 5-FU or mitomycin C is an alternative option in patients with predominant CRC LM, when they experience disease progression or do not tolerate HAI of oxaliplatin.

Purpose The aim of this study was to assess the feasibility, safety and efficacy of percutaneous radiofrequency ablation of lung metastases from colorectal carcinoma using C-arm cone beam computed tomography (CBCT) guidance. Material and methods This single-center prospective observational study was performed from August 2013 to August 2016, and included consecutive patients referred for radiofrequency ablation of lung metastases from colorectal cancer. Radiofrequency ablation procedures were performed under C-arm CBCT guidance. Feasibility was assessed by probe accuracy placement, time to accurate placement and number of C-arm CBCT acquisitions to reach the target lesion. Safety was assessed by the report of adverse event graded using the common terminology criteria for adverse events (CTCAE-V4.0). Efficacy was assessed by metastases response rate using RECIST 1.1 and 18FDG-PET-CT tumor uptake at 6 months. Results Fifty-four consecutive patients (32 men, 22 women) with a mean age of 63 ± 8 (SD) years (range: 51–81 years) with a total of 56 lung metastasis from colorectal metastases were treated in a single session. The mean tumor diameter was 25.6 ± 4.5 (SD) mm (range: 17–31 mm). Median time to insert the needle into the target lesion was 10 min (range: 5–25 min). Median number of needles repositioning and C-arm CBCT acquisition per patient was 1 (range: 0–3) and 4 (range: 3–6) respectively. The accuracy for radiofrequency ablation probe placement was 2 ± 0.2 (SD) mm (range: 0–9 mm). Pneumothorax requiring chest tube placement occurred in one patient (CTCAE-V4.0 grade 3). At 6 months, all patients were alive with tumor response rate of −27% and had no significant activity on the 18FDG-PET CT follow-up. Conclusion Percutaneous radiofrequency ablation of lung metastases from colorectal cancer under C-arm CBCT guidance is feasible and safe, with immediate and short-term results similar to those obtained using conventional CT guidance.

Gene-directed enzyme prodrug therapy (GDEPT) is a “Trojan-horses” suicide gene therapy that consists of tumor-targeted gene delivery (vectorized by mesenchymal stem cells MSCs) encoding an enzyme that converts a harmless prodrug into cytotoxic metabolites in situ. Then, cytotoxic metabolites passively diffuse in the neighboring tumor cells and kill them (bystander effect). The goal of our study was to assess the feasibility and efficacy of intra-arterial administration of MSCs transduced with an optimized gene (MSC-CYP2B6TM-RED) followed by intravenous administration of cyclophosphamide (CPA) into the VX2 rabbit liver tumor. Nine rabbits with a VX2 liver tumor were randomly assigned into three groups: Control group A (one rabbit) free of any treatment; Control group B (two rabbits) receiving intravenous injection of cyclophosphamide at day 3 and CPA at day 14; and Group C (six rabbits) receiving the GDEPT treatment, consisting of successive intra-arterial injection of transduced-MSCs at days 0 (n = 6) and 11 (n = 3), followed by injection of CPA at days 3 (n = 6) and 14 (n = 3). The tumor response was assessed by ultrasound scan every 7 days and histopathological analysis at sacrifice (D25). There was a significant difference in the tumor volume between control groups (A + B) and group C at D7: 38/19 cm3 (p = 0.024); D11: 51/20 cm3 (p = 0.024), and D25: 121/37 cm3 (p = 0.048). Tumor necrosis was significantly greater and metastatic spread was lower for rabbits who received GDEPT (78% of total tumor surface) than for control animals (A + B) (22% of total tumor surface (p = 0.006). Intra-arterial delivery of transduced-MSCs is feasible and, after CPA injection, resulted in 78% tumor necrosis (p = 0.006) and less metastasis in a VX2 liver tumor model.

Interventional radiology provides a wide variety of vascular, nonvascular, musculoskeletal, and oncologic minimally invasive techniques aimed at therapy or palliation of a broad spectrum of pathologic conditions. Outcome data for these techniques are globally evaluated by hospitals, insurance companies, and government agencies targeting in a high-quality health care policy, including reimbursement strategies. To analyze effectively the outcome of a technique, accurate reporting of complications is necessary. Throughout the literature, numerous classification systems for complications grading and classification have been reported. Until now, there has been no method for uniform reporting of complications both in terms of definition and grading. The purpose of this CIRSE guideline is to provide a classification system of complications based on combining outcome and severity of sequelae. The ultimate challenge will be the adoption of this system by practitioners in different countries and health economies within the European Union and beyond.

To compare safety and clinical outcomes of embolization of the superior rectal arteries in patients with hemorrhoidal bleeding using particles and coils versus coils only. We retrospectively reviewed data for patients undergoing embolization for chronic hemorrhoidal bleeding from January 2014 to April 2017. Embolization was performed with coils alone or with particles and coils. Clinical scores (Paris bleeding severity score, Goligher classification and quality of life score) were obtained, and embolization was performed with microparticles (300–500 μm) followed by fibered pushable coils. Clinical success was defined as an improvement of > 2 points in the Paris bleeding severity score, without complications. Outcomes were compared between the two groups in a matched-pairs analysis (1:1 scenario), with patients embolized with particles and coils as the study group and patients embolized with coils alone as the control. We treated 45 consecutive patients. After matched-pairs analysis, the final study population was 38 patients (19 study group and 19 controls). Clinical success did not differ significantly between the two populations: 63% for control group and 68% for the study group (p = 0.790). The median change in clinical score was − 3 [− 6; − 1] for the control group and − 3 [− 4; − 1] for the study group (p = 0.187). Grade 1 complications were reported in 15% of patients, with no major complications. Embolization was feasible, with a technical success of 100% and no major complications. Clinical success was obtained in 66% in patients with no difference when using combined embolization with particles and coils versus coils only.

The Medical Devices Regulation (MDR) 2017/745/EU will fully apply from May 2020. Interventional radiologists use medical devices on a daily basis and so must be aware of the impact that this new regulation will have on their daily practice. In this paper, we describe the major transformation that the MDR brings to the medical devices sector, with a focus on clinical evaluations and clinical investigations. This regulation significantly tightens controls to ensure that devices are safe and effective. In addition, equivalence to already existing devices, which allowed an accelerated access to the market, will now be possible only in some cases. Furthermore, post-marketing clinical follow-up is extended under the MDR and is required for all devices. These new requirements will probably lead to a dramatic increase in the number of clinical investigations and also to a delay in the availability of certain devices on the market. In the coming years, interventional radiologists are likely to be affected by these changes in their daily practice, in terms of medical device availability and/or in terms of increased involvement in clinical investigations.

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PURPOSE To study the subscore improvement in International Prostate Symptom Scores (IPSS) after prostatic artery embolization (PAE). MATERIALS AND METHODS A single-center retrospective study was carried out with follow-up from December 2013 to July 2019 in 37 consecutive patients (66.0 ± 8.8 years old) who underwent PAE, comparing resultant scores before and after PAE. IPSS were divided into storage (IPSS-s) subscores and voiding (IPSS-v) subscores. The changes between IPSS-s and IPSS-v at 1, 3, 6, and 12 months' follow-up as well as the last follow-up were compared with baseline scores. The changes in percentages of IPSS-s and IPSS-v and the changes in average IPSS-s-to-total IPSS ratios (IPSS-s/IPSS-t) and IPSS-v-to-IPSS-t ratios (IPSS-v/IPSS-t) were also analyzed. RESULTS In the study population, consisting of 37 patients, IPSS-t significantly decreased from 16.5 ± 7.2 at baseline to 8.3 ± 5.7 at the last follow-up (4 years later) (P < .0001). Additionally, the changes in IPSS-v symptoms were greater than the changes in IPSS-s symptoms at 1, 3, 6, and 12 months' follow-up, reaching a statistical significance at 6 months with a decrease of 72.9% ± 42.4% for IPSS-v and a decrease of 50.1% ± 52.2% for IPSS-s (P = .009). CONCLUSIONS PAE can successfully reduce both IPSS-s and IPSS-v with predominant IPSS-v reduction. The improvements in both subscores were sustained for up to 4 years of follow-up.

Background This prospective study assessed the efficacy of prostate artery embolization after failure of a trial without catheter in patients suffering a first episode of acute urinary retention as a result of benign prostatic hyperplasia (BPH). Methods Patients with failure of a trial without catheter despite alpha-blocker therapy were invited to participate in this protocol. Twenty patients were included in the study, and all underwent prostate artery embolization with calibrated polyvinyl alcohol (PVA) microspheres (Bead Block, BTG Ltd., Farnham, UK). Results Successful removal of the indwelling bladder catheter and spontaneous voiding was achieved in 15 of 20 (75%) patients, and the overall clinical success at 6 months after prostate embolization was 14 of 20 (70%). No patient experienced severe adverse events. Conclusions Prostate artery embolization might be a valuable treatment after a failure of a trial without catheter. Further studies are needed to better define its place in this setting.

During PAE, preembolization angiography of the prostatic artery can show large extra-prostatic shunts, at high risk, if embolized, of rectal or penile necrosis. We report our experience with 11 consecutive patients who underwent protective embolization of large extra-prostatic shunts before successful PAE.We treated 11 consecutive male patients (mean age 67 years), part of a series of 55 consecutive male patients referred for PAE to treat LUTS due to BPH, between December 2013 and January 2015. The procedure involved the exclusion of an extra-prostatic shunt originating from the PA, prior to complete bilateral PAE. We compared the safety and efficacy of the 11 shunt exclusions followed by embolization of the PA to the other 44 basic PAE. Clinical success was defined as a decrease of 25 % or eight points of IPSS, QoL 3 or a one-point decrease, and a Qmax improvement of 25 % or 2.5 mL/s.We had a 100 % rate of occlusion of the anastomosis. Bilateral embolization of the PA was performed in all patients with no additional time of procedure (p = 0.18), but a significant increase of dose area product (p = 0.03). Distal (PErFecTED) embolization was possible in 64 %. There was no worsening of erectile dysfunction, no rectal or penile necrosis, no immediate or late other clinical complications. Clinical success was 91 % (mean follow-up: 3.5 months), compared to 78 % for the entire PAE group.PAE using the protection technique in case of large extra-prostatic shunts is as safe and effective as basic procedures and does not induce any additional time of procedure.

To evaluate the pharmacokinetic profile (PK) and embolization effect of 70-150-μm doxorubicin eluting beads (DEBs) following intra-arterial injection (i.a.) in the rabbit liver VX2 tumour model.In this ACUC-approved study, 25 white New Zealand rabbits were randomly assigned into a small DEB group (SDB, n = 7, 70-150-μm DEBs), large DEB group (LDB, n = 7, 100-300-μm DEBs), untreated controls (n = 7), and doxorubicin controls (n = 4, without tumour, received i.a. 12.5 mg doxorubicin). Plasma PK was assessed up to 180 min post-injection. Drug tissue and liver enzyme levels, radiologic tumor response and histopathologic tumour necrosis were assessed at 7 days.Mean tumour doxorubicin concentrations were 922.83 nM (SD = 722.05) and 361.48 nM (SD = 473.23) for the SDB and LDB, respectively (p = 0.005). There was no statistically significant difference in tumour doxorubicinol, plasma doxorubicin and doxorubicinol PK values. More beads were observed in the SDB tumours (p = 0.01). Liver enzymes increased and gradually declined over the observation period, with significantly higher values in the SDB.In this preclinical study, plasma PK of i.a.-injected 70-150-μm DEBs was not different than that of 100-300-μm DEBs. More beads and higher tissue doxorubicin levels were observed in the SDB tumours.• Small and large doxorubicin-eluting beads show similar plasma pharmacokinetic profiles. • Higher tissue doxorubicin levels were observed in the small bead group. • Liver enzymes were overall significantly higher in the small bead group.

To assess the impact of prostatic arterial embolisation (PAE) on various prostate gland anatomical zones. We retrospectively reviewed paired MRI scans obtained before and after PAE for 25 patients and evaluated changes in volumes of the median lobe (ML), central gland (CG), peripheral zone (PZ) and whole prostate gland (WPV) following PAE. We used manual segmentation to calculate volume on axial view T2-weighted images for ML, CG and WPV. We calculated PZ volume by subtracting CG volume from WPV. Enhanced phase on dynamic contrasted-enhanced MRI was used to evaluate the infarction areas after PAE. Clinical results of International Prostate Symptom Score and International Index of Erectile Function questionnaires and the urodynamic study were evaluated before and after PAE. Significant reductions in volume were observed after PAE for ML (26.2 % decrease), CG (18.8 %), PZ (16.4 %) and WPV (19.1 %; p

Summary Introduction Most liver metastases from colorectal cancer (CRC) are unresectable at diagnosis. Systemic chemotherapy allows secondary surgical resection in 10 to 20% of patients. Hepatic intra-arterial treatments could enhance response and resection rate. We therefore designed a prospective phase II trial testing the transarterial chemoembolization (TACE) using drug-eluting beads loaded with irinotecan (DEBIRI) with concomitant systemic FOLFOX regimen, the FFCD 1201 trial, in patients with liver limited metastatic CRC. Case report A 48-year old patient was operated from an occlusive sigmoid adenocarcinoma. Magnetic resonance imaging showed 6 bilobar liver metastasis. The patient was considered as non-eligible for surgery initially. Patient was included in the FFCD 1201 trial and received 5 cycles of FOLFOX and 2 sessions of DEBIRI, with a quite good tolerability. Post-treatment evaluation showed a partial response and sufficient tumor shrinkage to make liver metastasis resectable. Right hepatectomy associated with wedge resection in the left liver was performed and pathological findings showed a complete pathological response (CPR). Conclusion Combination of DEBIRI with FOLFOX could increase tumor shrinkage leading to secondary resection of liver metastases from CRC. This combination may also, as shown here for the first time in a patient with unresectable LM, induce CPR of all LM, known to be associated with better outcome. Our case also emphasizes the difficulty to morphologically assess pathological response and the need for new tool to better select patients who should be resected. Further results of the FFCD 1201 trial will bring more information on this new combination therapy.

This is a single-center retrospective analysis of 3 patients (mean age, 61 y ± 8.6) who underwent repeat prostatic artery (PA) embolization (PAE; rPAE) because of clinical failure after PAE. Revascularization of the central gland through a recanalized PA was the most frequent pattern observed (5 of 7; 71.4%), followed by revascularization through penile collateral vessels (2 of 7; 28.6%). Technical success during rPAE was achieved in 5 hemiprostates (83.3%). Clinical success at 6 months after rPAE was achieved in 2 of 3 patients (66.6%). Implications of these findings could be valuable to those performing PAE.

This study aimed to estimate the accuracy of dual-phase C-arm cone beam computed tomography (CBCT) for the detection of colorectal cancer liver metastases, as compared with multidetector computed tomography (MDCT). Between March 2014 and December 2016, 49 consecutive patients referred for intra-arterial treatment for colorectal cancer liver metastases were enrolled in a single-center observational study. All patients were examined with MDCT and with dual-phase C-arm cone beam computed tomography performed after iodine injection in the proper hepatic artery before intra-arterial treatment. Two blinded observers independently reviewed all examinations. Diagnostic accuracy was determined using both a six-cell matrix method and a “worst-case scenario.” Readers identified at MDCT 264 colorectal liver metastases and 43 other liver lesions. The early and late arterial phase showed 240 and 277 liver lesions respectively. A certainty of the diagnosis was obtained in 63% and 85% at the early (EAP) and late arterial phase (LAP), respectively. Streak artifacts or liver segment truncation, or inadequate enhancement was responsible for the inability to see or to correctly adjudicate a lesion to a diagnosis in 27% and 15% of the cases at the EAP and LAP. The “worst-case scenario” yielded a Se and Sp of 58% and 51%, respectively, at EAP and 84% and 70%, respectively, at LAP. On CBCT, EAP showed limited accuracy. LAP provided the best tumor detectability. • The early arterial phase (EAP) yielded poor accuracy: Se = 58% and Sp = 51% (p

Summary 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 ( 90 Y) 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 90 Y-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 [ 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.

Objectives The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items. Study Design and Setting A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. Results Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. Conclusion To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices.