Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360).

Background: Hepatocellular carcinoma (HCC) is the most frequent liver malignancy and a leading cause of cancer death in the world. In unresectable HCC patients, transcatheter arterial (chemo-) embolization (TAE/TACE) has shown a disease response in 15-55% of cases. Though multiple TAE/TACE courses can be administered in principle, Stereotactic Body Radiotherapy (SBRT) has emerged as an alternative option in the case of local relapse following multiple TAE/TACE courses. Methods: This is a single-center, prospective, randomized, controlled, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of the intermediate stage of HCC after an incomplete response following TAE/TACE (NCT02323360). The primary endpoint is 1-year local control (LC): 18 events were needed to assess a 45% difference (HR: 0.18) in favor of SBRT. The secondary endpoints are 1-year Progression-Free Survival (PFS), Distant Recurrence-Free Survival (DRFS), Overall Survival (OS) and the incidence of acute and late complications. Results: At the time of the final analysis, 40 patients were enrolled, 19 (49%) in the TAE/TACE arm and 21 (51%) in the SBRT arm. The trial was prematurely closed due to slow accrual. The 1- and 2-year LC rates were 57% and 36%. The use of SBRT resulted in superior LC as compared to TAE/TACE rechallenge (median not reached versus 8 months, p = 0.0002). PFS was 29% and 16% at 1 and 2 years, respectively. OS was 86% and 62% at 1 year and 2 years, respectively. In the TAE arm, PFS was 13% and 6% at 1 and 2 years, respectively. In the SBRT arm, at 1 and 2 years, PFS was 37% and 21%, respectively. OS at 1 and 2 years was 75% and 64% in the SBRT arm and 95% and 57% in the TACE arm, respectively. No grade >3 toxicity was recorded. Conclusions: SBRT is an effective treatment option in patients affected by inoperable HCC experiencing an incomplete response following ≥1 cycle of TAE/TAC.

Image-guided thermal ablation in autonomously functioning thyroid nodules. A retrospective multicenter three-year follow-up study from the Italian Minimally Invasive Treatment of the Thyroid (MITT) Group.

OBJECTIVES: To report the results of a multicenter retrospective evaluation of the clinical outcomes of thermal ablation (TA) in a large series of autonomously functioning thyroid nodules (AFTN) with a follow-up protracted up to 3 years. METHODS: Patients treated with single TA for an AFTN in Italy were included. Changes in nodule volume, TSH values, and ongoing anti-thyroid therapy were assessed at the 2-, 6-, 12-, 24-, and 36-month follow-up controls. Complications and need of any additional therapy after TA were also registered. RESULTS: A total of 361 patients (244 females, 117 males, median age 58 years, IQR 46-70 years) were included. Nodule volume was significantly reduced at all time points (p < 0.001) (median volume reduction 58% at 6-month and 60% at 12-month). Serum TSH values increased significantly at all time points. After TA, anti-thyroid therapy was withdrawn in 32.5% of patients at 2 months, in 38.9% at 6 months, and in 41.3% at 12 months. A significant difference in the rate of patients who withdrawn medical therapy at 12 months was registered between small (< 10 mL) (74%), medium (49%), or large (> 30 mL) nodules (19%). A single major complication occurred (0.25%). Additional treatments were needed in 34/361 (9.4%) of cases including 4 (1.1%) surgical treatment. CONCLUSIONS: Image-guided thermal ablation offers a further safe and effective therapeutic option in patients with AFTN. Clinical outcomes are significantly more favorable in small than in large size AFTN. KEY POINTS: • Thermal ablations (TA) can be safely and effectively used in patients with autonomously functioning thyroid nodules (AFTN). • TA results in a clinically significant nodule volume reduction that is paralleled by TSH level normalization and anti-thyroid drug therapy discontinuation (after TA anti-thyroid therapy was withdrawn in 41.3% at 12 months). • Clinical outcomes after TA are more favorable in small nodules, and when a large amount of thyroid nodule tissue is ablated.

Minimally-invasive treatments for benign thyroid nodules: a Delphi-based consensus statement from the Italian minimally-invasive treatments of the thyroid (MITT) group.

Benign thyroid nodules are a common clinical occurrence and usually do not require treatment unless symptomatic. During the last years, ultrasound-guided minimally invasive treatments (MIT) gained an increasing role in the management of nodules causing local symptoms. In February 2018, the Italian MIT Thyroid Group was founded to create a permanent cooperation between Italian and international physicians dedicated to clinical research and assistance on MIT for thyroid nodules. The group drafted this list of statements based on literature review and consensus opinion of interdisciplinary experts to facilitate the diffusion and the appropriate use of MIT of thyroid nodules in clinical practice. (#1) Predominantly cystic/cystic symptomatic nodules should first undergo US-guided aspiration; ethanol injection should be performed if relapsing (level of evidence [LoE]: ethanol is superior to simple aspiration = 2); (#2) In symptomatic cystic nodules, thermal ablation is an option when symptoms persist after ethanol ablation (LoE = 4); (#3) Double cytological benignity confirmation is needed before thermal ablation (LoE = 2); (#4) Single cytological sample is adequate in ultrasound low risk (EU-TIRADS ≤3) and in autonomously functioning nodules (LoE = 2); (#5) Thermal ablation may be proposed as first-line treatment for solid, symptomatic, nonfunctioning, benign nodules (LoE = 2); (#6) Thermal ablation may be used for dominant lesions in nonfunctioning multinodular goiter in patients refusing/not eligible for surgery (LoE = 5); (#7) Clinical and ultrasound follow-up is appropriate after thermal ablation (LoE = 2); (#8) Nodule re-treatment can be considered when symptoms relapse or partially resolve (LoE = 2); (#9) In case of nodule regrowth, a new cytological assessment is suggested before second ablation (LoE = 5); (#10) Thermal ablation is an option for autonomously functioning nodules in patients refusing/not eligible for radioiodine or surgery (LoE = 2); (#11) Small autonomously functioning nodules can be treated with thermal ablation when thyroid tissue sparing is a priority and ≥80% nodule volume ablation is expected (LoE = 3).

Real-Time US-18FDG-PET/CT Image Fusion for Guidance of Thermal Ablation of 18FDG-PET-Positive Liver Metastases: The Added Value of Contrast Enhancement.

PURPOSE: To assess the feasibility of US-18FDG-PET/CT fusion-guided microwave ablation of liver metastases either poorly visible or totally undetectable with US, CEUS and CT, but visualized by PET imaging. MATERIALS AND METHODS: Twenty-three patients with 58 liver metastases underwent microwave ablation guided by image fusion system that combines US with 18FDG-PET/CT images. In 28/58 tumors, 18FDG-PET/CT with contrast medium (PET/CECT) was used. The registration technical feasibility, registration time, rates of correct targeting, technical success at 24 h, final result at 1 year and complications were analyzed and compared between the PET/CT and PET/CECT groups. RESULTS: Registration was successfully performed in all cases with a mean time of 7.8 + 1.7 min (mean + standard deviation), (4.6 + 1.5 min for PET/CECT group versus 10.9 + 1.8 min for PET/CT group, P < 0.01). In total, 46/58 (79.3%) tumors were correctly targeted, while 3/28 (10.7%) and 9/30 (30%) were incorrectly targeted in PET/CT and PET/CECT group, respectively (P < 0.05). Complete ablation was obtained at 24 h in 70.0% of cases (n = 40 tumors), 23/28 (82.1%) in the PET/CECT group and 17/30 (56.7%) in the PET/CT group (P < 0.037). Fourteen tumors underwent local retreatment (11 ablations, 2 with resection and 1 with stereotactic body radiation therapy), while 4 tumors could not be retreated because of distant disease progression and underwent systemic therapy. Finally, 54/58 (93.1%) tumors were completely treated at 1 year. One major complication occurred, a gastrointestinal hemorrhage which required surgical repair. CONCLUSIONS: Percutaneous ablation of 18FDG-PET-positive liver metastases using fusion imaging of real-time US and pre-acquired 18FDG-PET/CT images is feasible, safe and effective. Contrast-enhanced PET/CT improves overall ablation accuracy and shortens procedural duration time.

Emergency Transarterial Embolization in Postoperative Hip Bleeding: Indications, Techniques, and Results in a Retrospective Cohort.

BACKGROUND: The aim of this study is to report the results of transarterial embolization (TAE) in the setting of postoperative bleeding after hip surgery. METHODS: We retrospectively evaluated 40 patients (male:female = 15:25, median age = 68 years) who underwent TAE from 2006 to 2016: 77.5% underwent total hip arthroplasty, 20% open reduction internal fixation, and 2.5% external fixation. Preangiographic multidetector computed tomography angiography was performed in 20 (49%) cases, and 9 of them showed arterial extravasation. Twenty-seven TAEs were performed within a week from surgery; active bleeding was seen in 33 (80.5%) angiograms. Gelatin sponge, microparticles, coils, n-butyl cyanoacrylate, and combinations of them were used as embolic materials. RESULTS: Bleeding was controlled in all cases. The most frequently embolized arteries were branches of the deep femoral artery (n = 17). Permanent embolization agents (microparticles, coils, n-2-butyl-cyanoacrylate) were used in 88% of cases; temporary agents (gelfoam) in 12%. One procedure was complicated by arterial dissection. Hospital discharge averaged 20 days post-TAE (median = 17, range = 3-104). One-month survival rate was 97.5%. One patient died of ischemic bowel perforation. CONCLUSION: TAE is safe and effective in stopping the bleeding of the hip region and should be performed early, to avoid irreversible ischemic damage. Multidetector computed tomography angiography can be used to confirm doubtful evidence of ongoing bleeding. Several embolic materials can be used, each one offering different advantages. Low complication and mortality rates were observed. TAE seems to be the ideal first-line intervention when postoperative bleeding of the operated hip is detected.