SS 209 - Oncological embolisation
Purpose: To present a modified technique of TAE for HCC, using both microspheres and cyano-acrylate glue. To report on its feasibility and effects on disease progression and tumour devascularisation.
Methods and Materials: Inclusion criteria were: a)HCC according to the AASLD criteria, b) unsuitable for surgery and c) multidisciplinary consensus on performing TAE. Exclusion criteria were: 1) Child-Pugh C, 2) GI bleeding, 3) encephalopathy and 4) portal thrombosis. All patient underwent preoperative MDCT or CE-MRI. TAE was performed entering the artery feeding the tumour, sparing the most healthy liver. Cone-beam CT was used for confirmation. After full embolisation with 40 or 100µm microspheres, a mixture of averagely 0.3mL cyano-acrylate/Lipiodol in a 1:10 ratio was injected. Follow-up was at 30days, 3months and every 6months. Response rates were assessed with mRECIST criteria.
Results: Between 2013 and 2016, 64 patients and 78 HCCs were treated. Overall survival was 93%; 54 patients at one year follow-up resulted in 24 complete responses (44%), 20 partial responses (37%), 4 stable disease (7%) and 16 progressive disease (30%). Forty-six tumours were completely devascularised at 1 year control (71%), 17 had a residual supply (26%), two did not show any devascularisation (3%). One case was complicated by a late-onset abscess of the treated lesion; another patient had postoperative pancreatitis. Both complications were treated conservatively.
Conclusion: TAE with microspheres and cyano-acrylate glue for HCC is safe and feasible, offering desirable rates of one-year disease control and tumour devascularisation. These appear in line and in some cases better to those reported in the current literature for standard TAE.
Tumour response and survival outcomes of very small drug eluting beads used in trans-arterial chemoembolisation for unresectable hepatocellular carcinoma
Purpose: The purpose of the study is to evaluate the tumour response rate and survival outcomes of a transarterial chemoembolisation (TACE) of unresectable hepatocellular carcinoma (HCC) using 75 microns Oncozene (Boston Scientific, MA, USA) drug-eluting beads (DEB).
Methods and Materials: We retrospectively reviewed the medical records and radiologic studies of 109 patients who had their first TACE for HCC between November 2013 and August 2016 using 75 microns Oncozene DEB. The primary endpoint of the study was tumour response rate which was categorised according to mRECIST and the toxicity profile using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The secondary endpoint was patient survival.
Results: The study included 89 (81.7%) males with a mean age of 64.1 years. Overall tumour response was 23% complete response (CR), 66% objective response (OR) and 90% disease control (DC). CR, OR and DC were 27%, 64%, and 89% respectively in Child-Pugh A patients, and 27%, 72% and 92% respectively in BCLC stages A and B patients. CR, OR and DC were 15%, 71% and 91% respectively in Child-Pugh B and C patients, and 16%, 55% and 87% respectively in BCLC stages C and D patients. Grades 3 toxicity was seen in 10% of the patients and only 1 with grade 4. The 6, 12 and 18-month survival were 97%, 84%, and 72% respectively.
Conclusion: The present study shows very good tumour response rate and survival outcomes for TACE using 75 microns Oncozene DEB, with very low toxicity profile.
Evaluation of a newly developed biodegradable embolic agent for transcatheter arterial embolisation in a rabbit renal model
Purpose: Evaluation of embolic effect, biocompatibility and biodegradability of a novel temporary embolic agent
Methods and Materials: Superselective embolization of the lower kidney pole was performed with bland (n=15) and SPIO-loaded (n=9) polydioxanone microspheres (90-500 µm) in 24 New Zealand White rabbits (female; 2,5-3,5 kg; 12-16 weeks) under fluoroscopy. Embolization effect was evaluated on DSA and MRI (T1-TSE pre/post-contrast, T2-TSE, T2*-GRE). 4 animals were sacrificed immediately after embolization. 20 animals underwent control angiograms and MRI 1 (n=3), 4 (n=3), 8 (n=3), 12 (n=8) and 16 weeks (n=3) post embolization. Final angiograms were compared with post-embolization angiograms for evaluation of embolization success and arterial reperfusion. Kidneys were harvested for histopathological analysis of embolic effect, biocompatibility and biodegradability.
Results: Evaluation of imaging modalities showed successful target embolization in 18/20 animals. In 2/20 animals the whole kidney was affected due to reflux. T2*-GRE images demonstrated the distributon of SPIO-loaded microspheres. Comparison of angiograms showed evidence of partial and complete reperfusion in 93 %. Macro- and microscopic pathological analysis revealed cell necrosis/infarct in the embolized areas. A mild acute inflammatory reaction was detected throughout and a foreign body reaction at advanced time intervals. The microspheres were increasingly degraded at sixteen weeks (Ø degradation score: 2,92/3).
Conclusion: Novel bioresorbable microspheres led to an effective occlusion of target vessels while simultaneously demonstrating good biocompatibility. The agent appeared extensively reabsorbed at sixteen weeks, thus offering advantages as a temporary embolic agent. SPIO-loaded microspheres allowed a non-invasive visualization of the microsphere distribution in MRI.
Evaluation of the effectiveness of transpulmonary chemoembolisation (TPCE) and intraarterial chemoperfusion (TACP) in treatment of colorectal lung metastases
Purpose: To assess the response, mean time to progression and mean survival time for patients with colorectal lung metastasis after palliative TPCE and TACP.
Methods and Materials: This study included 45 patients (mean age 57.3 ±13 years; 21 females, 24 males) with unresectable colorectal lung metastases, who failed or refused systemic chemotherapy, and underwent either repetitive TPCE (Group1; n= 16), TACP (Group2; n= 9) or both techniques (Group3; n= 20), between 2006 and 2015. Bilateral lung involvement was seen in 95.6% of patients and the median number of lung nodules was 14. Patients who underwent subsequent ablation were excluded. Chemotherapeutic agents were applied either through the pulmonary artery followed by embolisation (TPCE) or by means of intra-aortic chemoperfusion (TACP). The response according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1) was evaluated and survival parameters were statistically analysed.
Results: After evaluation of the tumour response; partial response (PR) was 4.5% (n=2), stable disease (SD) 62.2% (n=28) and progressive disease (PD) 33.3% (n=15). The estimated mean survival time and mean time to progression were 21 months (±2.7 SE) and 5.5 ± 0.5 months, respectively. The mean survival time was significantly (P < 0.05) higher in Group3 with mixed treatment (27.8 ± 7 months) than the other two groups; Group1 and Group2 (18.9 ± 4.2 months and 14.2 ± 4.7 months, respectively).
Conclusion: TPCE and TACP could be a promising palliative treatment with acceptable survival for patients with colorectal lung metastases who failed or are not eligible for other treatment options.
Effectiveness of intra-arterial steroid administration (IASA) for the treatment of steroid-refractory acute gastrointestinal GvHD
Purpose: The aim of this study was to retrospectively assess clinical effectiveness of intra-arterial steroid-administration (IASA) treatment in adult patients, non-responsive to systemic corticosteroids, with grade III or IV GI-aGvHD.
Methods and Materials: Clinical data of 10 adult patients (age range, 19-61 years; mean age, 42 years) with GI-aGvHD (≥grade III) non-responsive to intravenous methylprednisolone (at least 2 mg/kg/day) and received IASA into the superior and/or inferior mesenteric artery between March 2015 and January 2016 were collected. The severity of acute GvHD was determined according to the Glucksberg grading system before, 12±3 [SD], 27±4 and 54±6 days after IASA. Long-term outcomes were also recorded in 4 cases (range, 87-370 days; median, 246 days).
Results: Seven patients had grade IV and 3 patients had grade III aGvHD prior to IASA treatment, with 4 patients having stage II, 2 patients having stage III, and 4 patients having stage IV gastrointestinal involvement. After IASA treatment 6 patients at 12 days, 7 patients at 27 days, 5 patients at 54 days had gastrointestinal response. Among them, 1 patient at 12 days, 4 patients at 27 days and the same 4 patients at 54 days showed complete remission of GI-aGVHD. Seven patients were alive 54 days after treatment. At follow-up evaluation time, 5 patients were alive. Among the 4 patients who were discharged from the hospital, 3 had no gastrointestinal symptoms, 1 patient had complains about occasional symptoms.
Conclusion: IASA treatment seems to be an effective second-line treatment in adult patients suffering from steroid-refractory GI-aGvHD.
Adjuvant stereotactic body radiotherapy following transarterial chemoembolisation using small diameter drug eluting beads in patients with unresectable hepatocellular carcinoma
Purpose: The purpose of this study is to assess tumour response and locoregional control in patients with unresectable intermediate-stage hepatocellular carcinoma (HCC) treated with transarterial chemoembolisation using small diameter drug-eluting beads (DEB-TACE) compared to DEB-TACE followed by adjuvant stereotactic body radiotherapy (DEB-TACE-SBRT).
Methods and Materials: We retrospectively reviewed the medical records of patients with HCC and tumor size ≥3cm between November 2013 and June 2016 who underwent DEB-TACE using 75µm Oncozene beads (Boston Scientific) (n=56) or DEB-TACE-SBRT using 45Gy over 3 fractions (n=12). Tumours response was assessed using m-RECIST criteria.
Results: There were no significant baseline differences between the two groups. The number of lesions was not statistically significant between the 2 group (p=0.771). However, the diameter of the largest lesion as well as the total tumour diameter was larger in the DEB-TACE group (p=0.025 and 0.006 respectively). The tumour response according to mRECIST criteria did not show any significant difference between the 2 groups (p=0.251). After censoring for liver transplantation, the DEB-TACE-SBRT group showed better progression free survival (PFS) of 18 months compared to 9 months in the DEB-TACE group (p=0.006).
Conclusion: The study suggests that in patients with HCC of ≥3cm, treatment with DEB-TACE-SBRT provides better locoregional control with longer PFS, compared to DEB-TACE. Further prospective randomised controlled trial with larger number of patients is required to validate these results and to determine if there is an overall survival advantage.
Extended liver venous deprivation: the most powerful interventional radiology technique for liver preparation before major hepatectomy?
Purpose: Relatively high rates of post-hepatectomy liver failure (PHLF) have been reported after portal vein embolization (PVE) or ALPPS despite adequate future remnant liver (FRL) volume. FRL function is probably a better endpoint than FRL volume to decide for resection and can be calculated by 99mTc-mebrofenin hepatobiliary scintigraphy (HBS). The aim of this study was to assess safety and efficacy of extended liver venous deprivation (eLVD), i.e. combination of right PVE and right and middle hepatic vein embolization before major hepatectomy for FRL functional increase.
Methods and Materials: eLVD was performed in non-cirrhotic patients referred for major hepatectomy in a context of small FRL (baseline FRL<25% of the total liver volume or FRL function <2.69%/min/m2). All patients underwent 99mTc-mebrofenin HBS and computed tomographic evaluations.
Results: Ten consecutive patients underwent eLVD before surgery for liver metastases (n=8), Klatskin tumour (n=1) and gallbladder carcinoma (n=1). FRL function increased by 64.3% (range=28.1-107.5%) at day 21. In patients with serial measurements, FRL function was maximum at day 7 (+65.7±16%). The FRL volume increased by +53.4% at 7 days (+25±8 cc/day). Thirty-one days (range=22-45 days) after eLVD, 9/10 patients were resected. No PHLF (“50-50” criteria or peak bilirubin >7 mg/dL) was reported. Two grade II and one grade III complications (Dindo-Clavien classification) occurred. No patient died within 90 days following surgery.
Conclusion: eLVD is safe and provides marked and very rapid increase in liver function, unprecedented for an interventional radiology procedure. If these results are confirmed prospectively, this technique could replace PVE and challenge ALPPS.
Prototype metal artifact reduction algorithm in flat panel CT: performance in patients with intraarterial angiography during hepatic selective internal radiotherapy
Purpose: To retrospectively compare the effect of a prototype metal artifact reduction (MAR) algorithm in flat panel (FP)-CT on quantitative and qualitative image parameters in patients undergoing intraarterial (ia)-angiography during selective internal radiotherapy (SIRT) of hepatic masses.
Methods and Materials: After ia-catheter placement in celiac trunk application of 36ml contrast-agent (Ultravist®300 18ml + 18ml NaCl 0.9%) a FP-CT was acquired (Artis zeego, Siemens Healthineers) using a 8s rotation protocol (200 degrees rotation, 397 projections) in 29 patients (11 female), including 16 patients with arterial metallic coils. Image reconstructions with and without MAR were evaluated quantitatively by region-of-interest (ROI) measurements of attenuation in most pronounced streak-artifacts and qualitatively assessing visibility of hepatic parenchyma and vessels in near (2cm) and far field (5cm) of artifact sources (catheter curvature and coils). Paired Wilcoxon sign rank and Student t-test were used to compare quantitative measurements and qualitative scores of corrected and uncorrected images.
Results: Quantitative evaluation showed significant reduction of near field streak-artifacts with MAR (p<0.001), while remaining stable in far field and unaffected organs (all p>0.05). Qualitative image scores in near field were significantly improved after MAR (all p<0.005). Standard deviation of attenuation values in the near field decreased significantly after MAR (p<0.05). There was no significant difference in the amount of artifact reduction between catheter curvature and metallic coils (p<0.01).
Conclusion: MAR quantitatively and qualitatively improves image quality for visibility of hepatic parenchyma and vessels in near field of artifact sources in patients undergoing FP-CT ia-angiography for SIRT.
Locoregional treatments for HCC in patients with high risk for intraprocedural bleeding: is single-step combined therapy safe and feasible?
Purpose: To assess feasibility, safety, and efficacy of single-step combined therapy with radiofrequency ablation and drug-eluting beads transarterial chemoembolisation (RFA+TACE) in patients with HCC and low platelet count. Primary endpoints were major and minor complications, and death rates during and after the procedure.
Methods and Materials: Our single-centre retrospective study involved 115 cirrhotic patients (Child-Pugh A5-B7) with HCC, who underwent combined treatment between 2010 and 2015. Patients were divided into 3 groups by platelet count (>150.000/mm3, low risk; >50.000/mm3-<150.000/mm3, average risk; <50.000/mm3, high risk). Single-step combined treatment was performed with RFA during balloon occlusion of the tumour-feeding artery followed by selective TACE. Feasibility, safety, and efficacy were evaluated in terms of technical success, peri-procedural mortality and morbidity rates, laboratory values variations, blood transfusion needing, and 1-month TC follow-up.
Results: Technical success was obtained in all patients. There were no major complications. There was a significant increase of minor complications rate in group C after RFA only, all successfully treated with the subsequent TACE. No patient required blood transfusion, nor post-procedural surgical treatment. The 3 groups did not significantly differ in terms of platelet count, INR and haemoglobin before and after the procedure, nor in terms of complete response rates at 1-month CT-follow-up.
Conclusion: Single-step combined treatment with RFA+TACE seems to be a safe, feasible, and effective treatment in patients with HCC at high risk for intraprocedural bleeding due to low platelet count, broadening the range of curative treatment. Chemoembolisation after radiofrequency ablation helps preventing iatrogenic hepatic bleeding.
Prospective randomised FAST II trial: evaluation of the response after regional chemoembolisation (TACE) of hepatocellular carcinoma (HCC) with two different protocols
Purpose: To compare two different embolisation protocols for transarterial chemoembolisation (TACE) regarding tumour volume, RECIST/mRECIST criteria and apparent diffusion coefficient (ADC) in a double-blinded randomised study.
Methods and Materials: In total 49 patients (32 men; 17 women; mean 70 years; range 43-84) with hepatocellular carcinoma (HCC) were included. The treatment protocol included three TACE sessions in 4-week intervals with MRI prior to TACE and four weeks after the last TACE. Two treatment groups were determined using a randomisation sheet: in group 1 TACE was performed using Lipiodol only, in group 2 using Lipiodol combined with EmboCept®S. Tumour volume, RECIST and mRECIST were evaluated for every scan, ADC only for first and last MRI.
Results: An average tumour volume reduction of 2.15% was documented in group 1 vs 1.39% in group 2 (p=0.3849), diameter reduction was 11.8% (group 1) vs 18.32% (group 2; p=0.72). Regarding the RECIST/mRECIST criteria group 1 showed stable disease (SD) in 18 cases, progressive disease (PD) in 4 cases and partial response (PR) in 1 case. Group 2 showed PR in 4 cases, SD in 20 cases and PD in 2 cases. During treatment the ADC coefficient raised on average 878.46mm2/s in group 1 vs 578.91mm2/s in group 2 (p=0.4336).
Conclusion: No significant benefit in local tumour-control was documented in group 1 vs group 2. A correlation of the decrease of tumour volume after TACE and an increase in the ADC was observed. This indicates that the ADC might be an individual predictor for success of TACE.