Llaser ablation vs radiofrequency ablation for benign non-functioning thyroid nodules: six-month results of a randomised, parallel, open-label, trial (LARA trial)

2020 ◽  
Author(s):  
Roberto Cesareo ◽  
Pacella Claudio Maurizio ◽  
Valerio Pasqualini ◽  
Giuseppe Campagna ◽  
Pantano Angelo Lauria ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Thyroid Nodules ◽  
Open Label ◽  
Open Label Trial

scholarly journals Laser Ablation Versus Radiofrequency Ablation for Benign Non-Functioning Thyroid Nodules: Six-Month Results of a Randomized, Parallel, Open-Label, Trial (LARA Trial)

Thyroid ◽  
2020 ◽  
Vol 30 (6) ◽  
pp. 847-856 ◽  
Author(s):  
Roberto Cesareo ◽  
Claudio Maurizio Pacella ◽  
Valerio Pasqualini ◽  
Giuseppe Campagna ◽  
Mario Iozzino ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Laser Ablation ◽  
Thyroid Nodules ◽  
Open Label ◽  
Open Label Trial

Laser ablation versus radiofrequency ablation for benign non-functioning thyroid nodules: twelve-month results of a randomized, parallel-arm, open-label trial

2021 ◽  
Author(s):  
Roberto Cesareo ◽  
Silvia Manfrini ◽  
Valerio Pasqualini ◽  
Cesare Ambrogi ◽  
Gianfranco Sanson ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Laser Ablation ◽  
Thyroid Nodules ◽  
Open Label ◽  
Open Label Trial

scholarly journals OR18-07 Laser Ablation Versus Radiofrequency Ablation for Benign Non-Functioning Thyroid Nodules: Six-Month Results of a Randomised, Parallel, Open-Label, Trial (Lara Trial)

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Roberto Cesareo ◽  
Claudio Maurizio Pacella ◽  
Valerio Pasqualini ◽  
Giuseppe Campagna ◽  
Mario Iozzino ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Thyroid Nodules ◽  
Volume Reduction ◽  
High Rate ◽  
Open Label ◽  
Significant Difference ◽  
Nodule Volume ◽  
The Difference ◽  
Receive Treatment ◽  
One Year

Abstract ABSTRACT Background: Up to now, there are no direct prospective studies comparing Laser (LA) and radiofrequency ablation (RFA). We aimed to compare, in a head- to-head clinical trial, the efficacy and safety of both techniques in a population affected by solid or predominantly solid benign non-functioning thyroid nodules (BNTN). Methods. LARA is a six-month, single-use, randomized, superiority, open-label, parallel trial. We enrolled subjects with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems or patients without symptoms who experienced a volume increase >20% in one year. Nodules underwent core needle biopsy (CNB) to evaluate the histological architecture. Patients were randomly assigned (1:1) to receive treatment with either LA or RFA. The primary endpoint was to evaluate the difference in nodule volume reduction between the RF and the LA group at six months. Moreover, we aimed to assess the differences between groups in the rate of nodules with greater than 50% base volume reduction (successful rate) at six months after treatment. ClinicalTrials.gov: number NCT02714946. Findings: From January 2016 to November 2018, 60 patients were randomly assigned (30 participants per group). In the whole study population, the average volume of nodules was 25 ml. The two groups were similar in terms of basal nodule volume, thyroid function, histology, symptoms/cosmetic score and procedure time. At six months, participants in the RFA group showed a reduction volume of 64·3% (95% CI: 57·5% - 71·2%) compared to 53·2% (95% CI: 47·2% - 59·2%) in the LA group (p= 0·015) and this difference was also confirmed in a linear regression model adjusted for age, baseline volume and proportion of cellular component (Laser vs. RFA percent change Delta= -12·8, P=0·018).We have not recorded any significant difference in terms of successful rate at six months after treatment between the two groups (86·7% in the RFA vs 66·7% in the LA, p=0·127). At six months, both symptoms and cosmetic scores improved (compressive symptom score: 2·13 vs 3·9 for RFA, p < 0·001; 2·4 vs. 3·87 for LA, p < 0·001; cosmetic score: 1·65 vs 2·2 for RFA p <0·001, 1·85 vs 2·2 for LA p <0·001) without any statistically significant difference between the two groups. No statistical difference between the two groups was detected at six months as regards the TSH level. High rate of cellularity negatively affects the volume reduction in RFA group (r coefficient -0·41, p=0·034) while histological features did not affect the efficacy of the LA. The adverse event rates were 37% and 43% for RFA and LA, respectively, with no requirement for hospitalization. Interpretation: Both techniques are very effective in reducing the volume of thyroid nodules. RFA appears to be more effective than LA, but both techniques showed no difference in terms of success rate six months after treatment. The safety of the two techniques is very satisfactory.

Nodule size as predictive factor of efficacy of radiofrequency ablation in treating autonomously functioning thyroid nodules

2018 ◽  
Author(s):  
Andrea Palermo ◽  
Anda Mihaela Naciu ◽  
Mario Iozzino ◽  
Valerio Pasqualini ◽  
Carla Simeoni ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Predictive Factor ◽  
Thyroid Nodules ◽  
Nodule Size ◽  
Autonomously Functioning Thyroid Nodules

Our experience in the first year of radiofrequency ablation of benign thyroid nodules

2018 ◽  
Author(s):  
Raul Rodriguez Escobedo ◽  
Silvia Gonzalez Martinez ◽  
Fernando Garcia Urruzola ◽  
Soraya Lanes Iglesias ◽  
Alicia Martin Nieto ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Thyroid Nodules ◽  
First Year ◽  
Benign Thyroid Nodules ◽  
Benign Thyroid

Daily consumption of fermented soymilk helps to improve facial wrinkles in healthy postmenopausal women in a randomized, parallel-group, open-label trial

2018 ◽  
Vol 8 (2) ◽  
pp. 107 ◽  
Author(s):  
Mitsuyoshi Kano ◽  
Kazuyoshi Haga ◽  
Kouji Miyazaki ◽  
Fumiyasu Ishikawa
Keyword(s):  
Postmenopausal Women ◽  
Maximum Depth ◽  
Liquid Chromatography Mass Spectrometry ◽  
Daily Consumption ◽  
Open Label ◽  
Facial Wrinkle ◽  
Crow’S Feet ◽  
Parallel Group ◽  
Secondary Endpoints ◽  
Open Label Trial

Background: Soymilk fermented by lactobacilli and/or bifidobacteria is attracting attention due to the excellent bioavailability of its isoflavones. We investigated the effects of fermented soymilk containing high amounts of isoflavone aglycones on facial wrinkles and urinary isoflavones in postmenopausal women in a randomized, parallel-group, open-label trial. Healthy Japanese women were randomly divided into active (n = 44, mean age 56.3 ± 0.5) or control (n = 44, mean age 56.1 ± 0.5) groups, who consumed or did not consume a bottle of soymilk fermented by Bifidobacterium breve strain Yakult and Lactobacillus mali for 8 weeks. Maximum depth of wrinkles around the crow’s feet area and other wrinkle parameters were evaluated as primary and secondary endpoints respectively at weeks 0, 4, and 8 during the consumption period. Urinary isoflavone levels were determined by liquid chromatography-mass spectrometry. Results: The active group demonstrated significant improvements in the maximum depth (p=0.015) and average depth (p=0.04) of wrinkles, and significantly elevated urinary isoflavones (daidzein, genistein, and glycitein; each p < 0.001) compared with the control during the consumption period. No serious adverse effects were recorded.Conclusion: These findings suggest that fermented soymilk taken daily may improve facial wrinkles and elevate urinary isoflavones in healthy postmenopausal women.Key words: postmenopausal women; isoflavone; fermented soymilk; phytoestrogen; facial wrinkle 

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