A novel needle guide system to perform percutaneous laser ablation of liver tumors using the multifiber technique

Costanzo, Giovan Giuseppe Di; D’Adamo, Giuseppe; Tortora, Raffaella; Zanfardino, F.; Mattera, Silvana; Francica, Giampiero; Pacella, Claudio Maurizio

doi:10.1177/0284185113489825

Cited by 39 publications

(40 citation statements)

References 36 publications

(35 reference statements)

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“…EudraVigilance (EV) is the central database of reports of suspected spontaneous ADR reports and ADRs reported in clinical trials for all medicinal products authorized in the European Economic Area (EEA) [15]. In compliance with the EU pharmacovigilance legislation, ADRs are reported to EV by regulatory agencies in member states where the ADR occurred.…”

Section: Methodsmentioning

confidence: 99%

“…EV was set up in December 2001 to facilitate the electronic reporting of ADRs in the EEA. Data should be transmitted in accordance with the ICH E2B (R2) standard [15]. The minimum information required for an ADR report to enter the EV database is the following parameters: type of reporter, patient, at least one suspected active substance/medicinal product, and at least one suspected ADR (Volume 9A) [15].…”

Section: Methodsmentioning

confidence: 99%

“…Data should be transmitted in accordance with the ICH E2B (R2) standard [15]. The minimum information required for an ADR report to enter the EV database is the following parameters: type of reporter, patient, at least one suspected active substance/medicinal product, and at least one suspected ADR (Volume 9A) [15]. The EV database is not publically accessible, and authorisation for data access was given by the European Medicines Agency.…”

Section: Methodsmentioning

confidence: 99%

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Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

Aagaard

Hansen

2013

BMC Pharmacol Toxicol

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BackgroundReporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European consumer for nervous system medications.MethodsADRs reported by consumers for nervous system medications (ATC group N) from 2007 to 2011 and located in the European ADR database, EudraVigilance, were analysed. Data were categorized with respect to age and sex, category and seriousness of reported ADRs and medications. The unit of analysis was one ADR.ResultsWe located 4766 ADRs reported for nervous system medications, and one half of these were serious including 19 deaths. Less than 5% of ADRs were reported in children. Totally, 58% of ADRs were reported for women, 42% for men. The majority of reported ADRs were of the types “nervous system disorders” (18% of total ADRs) followed by “psychiatric disorders” (18% of total ADRs) and “general disorders” (15% of total ADRs) which also were the system organ classes in which the majority of serious ADRs were found. ADR reports encompassed medicines from the therapeutic groups: antiepileptics (ATC group N03) (36% of total ADRs), parasympathomimetics (ATC group N07) (22% of total ADRs) and antidepressants ATC group N06A (9% of total ADRs). Antiepileptics were the therapeutic group with the highest share of serious ADRs (60%) followed by antidepressants (15%). Many serious ADRs were reported for pregabalin and varenicline.ConclusionsThe majority of ADRs from nervous system mediations reported by consumers that were identified from the EudraVigilance database were serious. The value of consumer reports in pharmacovigilance still remains unclarified.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

Aagaard

Hansen

2013

BMC Pharmacol Toxicol

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“…Currently, its successful use for treatment of liver cancer, lung cancer, pancreatic cancer and other tumors has been reported [10–12]. Recently, reports have supported the use of LA on thyroid lesions to achieve non-surgical targeted cytoreduction of tumor cells [13–18].…”

Section: Introductionmentioning

confidence: 99%

Detection of the Single-Session Complete Ablation Rate by Contrast-Enhanced Ultrasound during Ultrasound-Guided Laser Ablation for Benign Thyroid Nodules: A Prospective Study

Zhou

et al. 2016

BioMed Research International

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This study aimed to investigate the single-session complete ablation rate of ultrasound-guided percutaneous laser ablation (LA) for benign thyroid nodules. LA was performed in 90 patients with 118 benign thyroid nodules. Contrast-enhanced ultrasound (CEUS) was used to evaluate complete nodule ablation one day after ablation. Thyroid nodule volumes, thyroid functions, clinical symptoms and complications were evaluated 1, 3, 6, 12, and 18 months after ablation. Results showed that all benign thyroid nodules successfully underwent LA. The single-session complete ablation rates for nodules with maximum diameters ≤2 cm, 2-3 cm and ≥3 cm were 93.4%, 70.3% and 61.1%, respectively. All nodule volumes significantly decreased than that one day after ablation (P < 0.05); at the final evaluation, the volume decreased from 6.16 ± 5.21 mL to 0.05 ± 0.01 mL. Thyroid functions did not show significant differences at one month after ablation compared with that before (P > 0.05). Three patients had obvious pain during ablation; one (1.1%) had recurrent laryngeal nerve injury, but the voice returned to normal within 6 months after treatment. Thus, ultrasound-guided LA can effectively inactivate benign thyroid nodules. LA is a potentially viable minimally invasive treatment that offers good cosmetic effects.

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“…As regards LTA, the technique proposed by Pacella et al[28] and improved by Di Costanzo et al[44] uses 300-μm bare optical fibers introduced into the tumor through 21-gauge needles. The diameter of the needles is considerably smaller than RFA electrodes and MWA antennas, making LTA safer and more suitable for ablating lesions in at-risk location or in locations that are difficult to reach[11,45].…”

Section: Laser Thermal Ablation - Why Cinderella?mentioning

confidence: 99%

Laser ablation of liver tumors: An ancillary technique, or an alternative to radiofrequency and microwave?

Sartori¹,

Vece²,

Ermili³

et al. 2017

WJR

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Radiofrequency ablation (RFA) is currently the most popular and used ablation modality for the treatment of non surgical patients with primary and secondary liver tumors, but in the last years microwave ablation (MWA) is being technically improved and widely rediscovered for clinical use. Laser thermal ablation (LTA) is by far less investigated and used than RFA and MWA, but the available data on its effectiveness and safety are quite good and comparable to those of RFA and MWA. All the three hyperthermia-based ablative techniques, when performed by skilled operators, can successfully treat all liver tumors eligible for thermal ablation, and to date in most centers of interventional oncology or interventional radiology the choice of the technique usually depends on the physician’s preference and experience, or technical availability. However, RFA, MWA, and LTA have peculiar advantages and limitations that can make each of them more suitable than the other ones to treat patients and tumors with different characteristics. When all the three thermal ablation techniques are available, the choice among RFA, MWA, and LTA should be guided by their advantages and disadvantages, number, size, and location of the liver nodules, and cost-saving considerations, in order to give patients the best treatment option.

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A novel needle guide system to perform percutaneous laser ablation of liver tumors using the multifiber technique

Cited by 39 publications

References 36 publications

Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

Detection of the Single-Session Complete Ablation Rate by Contrast-Enhanced Ultrasound during Ultrasound-Guided Laser Ablation for Benign Thyroid Nodules: A Prospective Study

Laser ablation of liver tumors: An ancillary technique, or an alternative to radiofrequency and microwave?

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