Efficacy of ethanol ablation for treatment of benign cystic thyroid nodules: the first hospital-based study in Vietnam

MedPharmRes ◽  
2020 ◽  
Vol 4 (1) ◽  
pp. 18-22
Author(s):  
Van Bang Nguyen ◽  
Van Vy Hau Nguyen ◽  
Binh Thang Tran ◽  
Chi Van Le
Keyword(s):  
Thyroid Nodules ◽  
Multiple Logistic Regression Analysis ◽  
Volume Reduction ◽  
Efficacy And Safety ◽  
Inclusion Criteria ◽  
Ethanol Ablation ◽  
Institutional Review ◽  
Thyroid Cyst ◽  
Secondary Endpoints ◽  
Written Informed Consent

Background: In Vietnam, surgery or aspiration is preferred to treat thyroid cysts however each of them still have limitations. Purposes of this study were to evaluate the efficacy and safety of ethanol ablation in treating thyroid cysts and determine factors that predict the outcome of treatment. Methods: This prospective study was approved by the Ethics Committee of the Institutional Review Board of Family hospital and written informed consent for procedures was obtained. From May 2018 to March 2019, 23 patients who underwent treatment for thyroid cysts by EA were enrolled in this study and were followed up for 1 month at Family hospital. The primary endpoint was efficient after one month as the volume reduction ratio was ≥ 50%. Secondary endpoints were improvements in symptoms, cosmetic scores, and safety. Multiple logistic regression analysis was used. Results: In the finding, from May 2018 to March 2019, only 17 patients who matched inclusion criteria were included in the analyst, including 7 purely thyroid cysts, and 10 predominantly cystic nodules. Mean volume decreased significantly from 5.21 ± 3.37 ml to 2.35 ± 2.52 ml in corresponding to 52.87% of volume reduction with p < 0.05. Ethanol ablation (EA) success rate was 52.90% after 1 month. Symptoms and cosmetic scores were improved significantly. The thyroid function was constant. No adverse events occurred. Purely thyroid cyst was a predictive factor contributing to the success of EA. Conclusion: EA seems likely to be a safe and an efficient therapy for patients who had purely or predominantly cystic thyroid nodules.

Impact of Protocolized Pharmacist Intervention on Critical Activated Partial Thromboplastin Time Values With Heparin Infusions

2021 ◽  
pp. 875512252110319
Author(s):  
Rachelle Barry ◽  
Craig A. Stevens ◽  
Trina Huynh ◽  
Dmitri Lerner
Keyword(s):  
Therapeutic Range ◽  
Partial Thromboplastin Time ◽  
Academic Research ◽  
Pharmacist Intervention ◽  
Activated Partial Thromboplastin Time ◽  
Efficacy And Safety ◽  
Time In Therapeutic Range ◽  
Institutional Review ◽  
Secondary Endpoints ◽  
Research Consortium

Background: Unfractionated heparin (UFH) infusions are commonly managed with nurse-driven nomograms titrated to activated partial thromboplastin time (aPTT). In some patients, anti-Xa values may be more appropriate measures of anticoagulation. At the present institution, an update to the nurse-driven aPTT nomogram requires pharmacist notification and clinical assessment for critically supratherapeutic aPTT results. Objective: The purpose of this study was to evaluate the efficacy and safety of the nomogram update. Methods: A single-center, retrospective, pre-post analysis was conducted in patients treated with UFH who experienced a critical aPTT during the 6 months preceding and following the nomogram update. Patients with erroneous critical aPTT results were excluded. The primary endpoint was the time in therapeutic range (Rosendaal method) from the first critical aPTT until UFH discontinuation. Secondary endpoints included the proportion of patients transitioned to anti-Xa monitoring and the incidence of Bleeding Academic Research Consortium (BARC) 2, 3, 5 bleeding. Data were analyzed by the χ2 test. The study was institutional review board approved. Results: Of 277 UFH infusions, 142 belonged to the pre-implementation group and 135 to the post-implementation group. Baseline aPTTs were similar between the 2 groups. Time in therapeutic range was 58.1% versus 62.4% of between groups ( P = .467). UFH was transitioned to pharmacist-driven anti-Xa monitoring in 16.2% versus 40.3% of patients ( P < .001). BARC 2, 3, 5 bleeding occurred in 23.2% versus 13.4% of patients ( P < .001). Conclusions: Application of these data suggest improved safety and efficacy outcomes with directed pharmacist management of UFH in patients with critically elevated aPTTs.

scholarly journals Efficacy and safety of ultrasound (US)-guided radiofrequency ablation of benign thyroid nodules

2021 ◽  
Vol 52 (1) ◽  
Author(s):  
Mai S. Abd El-Galil ◽  
Ali H. Ali ◽  
Raef M. Botros ◽  
Yasser I. Abd El-Khaleq ◽  
Osama M. A. Hetta
Keyword(s):  
Radiofrequency Ablation ◽  
Thyroid Function ◽  
Thyroid Nodules ◽  
Volume Reduction ◽  
Rf Ablation ◽  
Efficacy And Safety ◽  
Invasive Treatment ◽  
Life Threatening ◽  
Benign Thyroid Nodules ◽  
Benign Thyroid

Abstract Background We evaluated 45 benign thyroid nodules of 40 patients treated with radiofrequency (RF) ablation and followed up for 6 months. The inclusion criteria included unilateral or bilateral thyroid nodules with compression symptoms or cosmetic problems, cytological confirmation of benignity without atypical cells, and patient refusal or unfit for surgery. There was no predilection for the size, number, ultrasound nature of the nodules, (solid, cystic, or complex). RF ablation was performed using Mygen (M-3004) RF generator from RF Medical Co., Ltd, South Korea. The volume of the nodules and clinical problems were evaluated before and after the procedure. Complications and factors related to volume reduction were evaluated. The purpose of the study is to evaluate the efficacy and safety of US-guided radiofrequency (RF) ablation in the treatment of benign thyroid nodules. Results The volume reduction ratio (%) of the thyroid nodules was statistically significant. The mean VRR was 58.41 ± 15.27SD at 1 month, 73.26 ± 11.22SD at 3 months, and 82.54 ± 12.49SD at 6 months. P value was < 0.001. The radiofrequency ablation did not affect the normal thyroid function of the 38 patients who were euthyroid at the start of the study. Thyroid function normalized 1 month after ablation of the two autonomously functioning thyroid nodules. The compressive symptoms resolved in 22 patients (55%) and improved in the rest of the 18 patients (45%) with the median decreased from 8 (IQR 6–9), range 4–10 before treatment to 0 (IQR 0–1), range 0–3 after 6 months. Cosmetic problems improved in all 40 patients by P value < 0.001. The procedure had no sustained or life-threatening complications. Conclusions RF ablation was effective in reducing the size of the benign thyroid nodules and in controlling nodule-related compressive symptoms as well as cosmetic problems. There were no major complications sustained and no life-threatening complications or sequelae happened. RF ablation can be used as an alternative non-surgical minimally invasive treatment for patients with benign thyroid nodules.

Ultrasound Elastography Predicts Thyroid Nodule Volume Reduction Rate After Percutaneous Ethanol Ablation

2020 ◽  
pp. 000313482095149
Author(s):  
Mohamed Abdelgawad ◽  
Hosam Shalaby ◽  
Mounika Akkera ◽  
Yasmine Rashad ◽  
Lee Grace ◽  
...  
Keyword(s):  
Thyroid Nodules ◽  
Reduction Rate ◽  
Thyroid Stimulating Hormone ◽  
Relative Volume ◽  
Volume Reduction ◽  
Ultrasound Elastography ◽  
Relative Reduction ◽  
Ethanol Ablation ◽  
Procedural Complications ◽  
Us Elastography

Objectives To evaluate the safety and efficacy of percutaneous ethanol ablation (PEA) on indeterminate thyroid nodules (Bethesda III and IV) based on ultrasound (US) elastography by assessing the volume reduction rate (VRR), relative reduction in size, resolution of compressive symptoms, and post-procedural complications. Materials and Methods This is a retrospective cohort study of all thyroid nodules treated with PEA by a single surgeon at a North American tertiary referral center. Study variables included demographics, nodule characteristics, Bethesda classification, US elastography, presence of compressive symptoms, thyroid function, and post-procedural complications. Relative volume reductions and VRR were calculated at 3- and 6-month follow-ups. Results Thirty-four thyroid nodules were evaluated in 22 patients. All thyroid nodules underwent a fine needle aspiration prior to PEA. After 6 months, 45% of all thyroid nodules exhibited a VRR of ≥50%. A significant VRR was achieved in the soft thyroid nodules at 6 months (42.15% ± 31), compared to the stiff nodules with 30.92% ± 91.53, P < .05. Post-PEA thyroid stimulating hormone levels did not significantly change after the procedure. Compressive symptoms resolved in all 5 patients who reported it. One patient developed transient vocal cord paresis that resolved in 3 months. Discussion To the best of our knowledge, this is the largest series of PEA for thyroid nodules in North America. Ultrasound elastography is a useful adjunct in predicting the success of PEA for nonmalignant thyroid nodules. Percutaneous ethanol ablation is both a safe and effective alternative to surgery for relief of compressive symptoms in select patients.

scholarly journals Treatment rationale and design of a phase I single-arm open trial of a modified vaginal pipe for use in total laparoscopic hysterectomies

2019 ◽  
Author(s):  
Fumitake Ito ◽  
Tetsuya Kokabu ◽  
Hiroshi Matsushima ◽  
Akemi Koshiba ◽  
Taisuke Mori ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Uterine Fibroids ◽  
Operation Time ◽  
Laparoscopic Hysterectomy ◽  
Total Laparoscopic Hysterectomy ◽  
Conventional Model ◽  
Institutional Review ◽  
Medical Facilities ◽  
Secondary Endpoints ◽  
Written Informed Consent

Abstract Background: The Vagi-Pipe® is a useful device for performing total laparoscopic hysterectomy. The conventional model of the Vagi-Pipe® is unable to grasp the uterus during colpotomy for recovery of the resected uterus. However, the modified C-Type Vagi-Pipe® model has a shape that allows insertion into the vagina without removing the uterus manipulator. This study aimed to prospectively investigate the safety and efficacy of the C-Type Vagi-Pipe® in total laparoscopic hysterectomies. Methods: A total of 25 female subjects between 20 and 60 years old with uterine fibroids or adenomyosis will be included in this study. Patients with complications considered unsuitable for this study by the investigators will be excluded. The C-Type Vagi-Pipe® will be used rather than the conventional Vagi-Pipe® when performing total laparoscopic hysterectomy. The primary outcome will be safety, and the secondary endpoints will be operation time, bleeding volume, and presence of complications. The protocol was approved by the institutional review board of Kyoto Prefectural University of Medicine. In accordance with the Declaration of Helsinki, written informed consent will be obtained from all patients before registration. Discussion: This study seeks to confirm the safety and effectiveness of the C-Type Vagi-Pipe® for total laparoscopic hysterectomy. Once confirmed, the introduction of the C-Type Vagi-Pipe® is expected to make the total laparoscopic hysterectomy procedure easier to perform and thereby allow it to be performed in many more medical facilities. Results of the study will be disseminated via publications in peer-reviewed journals. Trial registration: Japan Registry of Clinical Trials (jRCT), jRCTs052180221. Registered 18 March 2019 - Retrospectively registered, https://jrct.niph.go.jp/search

Ethanol ablation of cystic thyroid nodules: an effective and not aggressive treatment

2019 ◽  
Author(s):  
Inigo Hernando ◽  
Julian Cuesta ◽  
Alberto Mingo ◽  
Sara Jimenez ◽  
Monica Marazuela ◽  
...  
Keyword(s):  
Thyroid Nodules ◽  
Aggressive Treatment ◽  
Ethanol Ablation

scholarly journals Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study

Cephalalgia ◽  
2021 ◽  
pp. 033310242110241
Author(s):  
Shuu-Jiun Wang ◽  
Artemio A Roxas ◽  
Bibiana Saravia ◽  
Byung-Kun Kim ◽  
Debashish Chowdhury ◽  
...  
Keyword(s):  
Latin America ◽  
Middle East ◽  
Primary Endpoint ◽  
Episodic Migraine ◽  
Acute Migraine ◽  
Efficacy And Safety ◽  
Medication Treatment ◽  
Significant Difference ◽  
Specific Medication ◽  
Secondary Endpoints

Objective EMPOwER, a double-blind, randomised, phase 3 study, evaluated the efficacy and safety of erenumab in adults with episodic migraine from Asia, the Middle East, and Latin America. Methods Randomised patients (N = 900) received monthly subcutaneous injections of placebo, erenumab 70 mg, or 140 mg (3:3:2) for 3 months. Primary endpoint was change from baseline in monthly migraine days at Month 3. Other endpoints included achievement of ≥50%, ≥75%, and 100% reduction in monthly migraine days, change in monthly acute migraine-specific medication treatment days, patient-reported outcomes, and safety assessment. Results At baseline, mean (standard deviation) age was 37.5 (9.9) years, 81.9% were women, and monthly migraine days was 8.2 (2.8). At Month 3, change from baseline in monthly migraine days (primary endpoint) was −3.1, −4.2, and −4.8 days for placebo, erenumab 70 mg, and erenumab 140 mg, respectively, with a statistically significant difference for erenumab versus placebo (P = 0.002 [70 mg], P < 0.001 [140 mg]). Both erenumab doses were also significantly superior to placebo on all secondary endpoints, including the proportion of patients achieving ≥50% reduction from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication treatment days and change from baseline in the Headache Impact Test-6™ scores. The safety profile of erenumab was comparable with placebo; no new safety signals were observed. Conclusions This study of erenumab in patients with episodic migraine from Asia, the Middle East, and Latin America met all primary and secondary endpoints. A consistent numerical benefit was observed with erenumab 140 mg versus erenumab 70 mg across all efficacy endpoints. These findings extend evidence of erenumab’s efficacy and safety to patients under-represented in previous trials. ClinicalTrials.gov identifier: NCT03333109

scholarly journals Comparison of clinical efficacy and safety between dexmedetomidine and propofol among patients undergoing gastrointestinal endoscopy: a meta-analysis

2021 ◽  
Vol 49 (7) ◽  
pp. 030006052110327
Author(s):  
Weihua Liu ◽  
Wenli Yu ◽  
Hongli Yu ◽  
Mingwei Sheng
Keyword(s):  
Clinical Efficacy ◽  
Lower Risk ◽  
Gastrointestinal Endoscopy ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Similar Efficacy ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Inclusion Criteria ◽  
Weighted Mean

Objective To compare the clinical efficacy and safety of dexmedetomidine and propofol in patients who underwent gastrointestinal endoscopy. Methods Relevant studies comparing dexmedetomidine and propofol among patients who underwent gastrointestinal endoscopy were retrieved from databases such as PubMed, Embase, and Cochrane Library. Results Seven relevant studies (dexmedetomidine group, n = 238; propofol group, n = 239) met the inclusion criteria. There were no significant differences in the induction time (weighted mean difference [WMD] = 3.46, 95% confidence interval [CI] = −0.95–7.88, I2 = 99%) and recovery time (WMD = 2.74, 95% CI = −2.72–8.19, I2 = 98%). Subgroup analysis revealed no significant differences in the risks of hypotension (risk ratio [RR] = 0.56, 95% CI = 0.25–1.22) and nausea and vomiting (RR = 1.00, 95% CI = 0.46–2.22) between the drugs, whereas dexmedetomidine carried a lower risk of hypoxia (RR = 0.26, 95% CI = 0.11–0.63) and higher risk of bradycardia (RR = 3.01, 95% CI = 1.38–6.54). Conclusions Dexmedetomidine had similar efficacy and safety profiles as propofol in patients undergoing gastrointestinal endoscopy.

485 Efficacy and Safety of Once- and Twice-Nightly Dosing of Lower-Sodium Oxybate in Adults With Idiopathic Hypersomnia

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A191-A192
Author(s):  
Isabelle Arnulf ◽  
Anne Marie Morse ◽  
Patricia Chandler ◽  
Rupa Parvataneni ◽  
Dan Chen ◽  
...  
Keyword(s):  
Sodium Oxybate ◽  
Mean Difference ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Patient Global Impression ◽  
Idiopathic Hypersomnia ◽  
Secondary Endpoints ◽  
Global Impression Of Change

Abstract Introduction Idiopathic hypersomnia (IH) is a rare central hypersomnolence disorder. In a randomized, controlled study of lower-sodium oxybate (LXB; Xywav™) in adults with IH (NCT03533114), significant differences for LXB compared with placebo were observed in Epworth Sleepiness Scale (ESS; primary efficacy endpoint), self-reported Patient Global Impression of Change (PGIc), and IH Severity Scale (IHSS; key secondary endpoints). In this clinical study, investigators were permitted to initiate LXB dosing on a once-nightly or twice-nightly regimen. Methods Eligible participants aged 18–75 years began LXB treatment, administered once or twice nightly during an open-label treatment/titration and optimization period (OLTTOP; 10–14 weeks); dose amount/regimen could be adjusted during this period. Participants next entered a 2-week, open-label, stable-dose period (SDP), then were randomized to placebo or to continue LXB treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP). P values are nominal for this exploratory analysis. Results Of 154 enrolled participants, 40 (26%) initiated LXB treatment on a once-nightly regimen. In the efficacy population (n=115), 27 participants were on a once-nightly regimen during SDP (48.1% of whom initiated treatment once nightly during OLTTOP) and 88 participants were on a twice-nightly regimen during SDP (86.4% of whom initiated treatment twice nightly during OLTTOP). During SDP, median (min, max) LXB total dose was 4.5 (2.5, 6) g/night (once-nightly group) and 7.5 (4.5, 9) g/night (twice-nightly group). ESS scores worsened in participants randomized to placebo vs those continuing LXB in the once-nightly group (n=11 and n=15, respectively; LS mean difference [95% CI]: −4.93 [−7.41, −2.46]; P=0.0004) and twice-nightly group (n=47 and n=41, respectively; LS mean difference [95% CI]: −7.44 [−9.15, −5.72]; P&lt;0.0001). Worsening was also observed in PGIc (once-nightly: 81.8% [placebo] vs 26.7% [LXB]; P=0.0077; twice-nightly: 89.4% [placebo] vs 19.5% [LXB]; P&lt;0.0001) and IHSS score (estimated median difference [95% CI], once-nightly: −9.00 [−16.0, −3.0]; P=0.0028; twice-nightly: −12.00 [−15.0, −8.0]; P&lt;0.0001). Common adverse events included nausea (21.4%), headache (16.2%), anxiety (14.9%), dizziness (11.7%), insomnia (11.7%), and vomiting (10.4%). Conclusion The efficacy and safety of LXB in IH were demonstrated for both once-nightly and twice-nightly regimens. The majority of participants initiated and remained on a twice-nightly regimen. Support (if any) Jazz Pharmaceuticals

scholarly journals Efficacy and safety of radiofrequency ablation for benign thyroid nodules in patients with previous thyroid lobectomy

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lin Yan ◽  
Mingbo Zhang ◽  
Fang Xie ◽  
Jun Ma ◽  
Jing Xiao ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Symptom Score ◽  
Thyroid Function ◽  
Thyroid Nodules ◽  
Efficacy And Safety ◽  
Thyroid Lobectomy ◽  
The Mean ◽  
Benign Thyroid Nodules ◽  
Benign Thyroid

Abstract Background Radiofrequency ablation (RFA) is recommended for the treatment of benign thyroid nodules. However, data on the clinical role of RFA for benign thyroid nodules in patients with history of thyroid lobectomy are insufficient. The purpose of this study was to evaluate the efficacy and safety of radiofrequency ablation (RFA) for benign thyroid nodules in patients who had previously undergoing thyroid lobectomy. Methods From May 2015 to October 2018, a total of 20 patients (19 females, 1 male, mean age 49.50 ± 14.26 years, range 22–74 years) with 20 benign thyroid nodules (mean volume 15.04 ± 21.17 ml, range 0.40–69.67 ml) who had undergone previous thyroid lobectomy were included in this retrospective study. Patients were followed up at 3, 6, 12 months after RFA and every 12 months thereafter by ultrasound, clinical evaluation and thyroid function. Volume, volume reduction rate (VRR), symptom score and cosmetic score were evaluated. Results During the mean follow-up time of 21.24 ± 16.41 months, the mean nodule volume decreased significantly from 15.04 ± 21.17 ml to 1.29 ± 1.17 ml (P = 0.018) with a mean VRR of 85.41 ± 12.17%. Therapeutic success was achieved in a single session for all thyroid nodules. The symptom score (P = 0.001) and cosmetic score (P = 0.001) were both significantly reduced at the last follow-up. The levels of free triiodothyronine (fT3), free thyroxine (fT4) and thyroid stimulating hormone were not significantly different at the last follow-up from those prior to treatment (all P > 0.05). No life-threatening complications or sequelae occurred after RFA. Conclusions As a minimally invasive modality, RFA was a safe, effective, and thyroid function-preserving option for patients with symptomatic benign thyroid nodules after a previous lobectomy.

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