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result(s) for
"Microwaves - adverse effects"
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Microwave versus radiofrequency ablation for the treatment of liver malignancies: a randomized controlled phase 2 trial
by
Radosevic, Aleksandar
,
Grande, Luís
,
Trujillo, Macarena
in
631/67/1059
,
692/308/2779/109
,
692/308/2779/777
2022
Microwave (MWA) and radiofrequency ablation (RFA) are main ablative techniques for hepatocellular carcinoma (HCC) and colorectal liver metastasis (MT). This randomized phase 2 clinical trial compares the effectiveness of MWA and RFA as well as morphology of corresponding ablation zones. HCC and MT patients with 1.5–4 cm tumors, suitable for ablation, were randomized into MWA or RFA Groups. The primary endpoint was short-to-long diameter ratio of ablation zone (SLR). Primary technical success (TS) and a cumulative local tumor progression (LTP) after a median 2-year follow-up were compared. Between June 2015 and April 2020, 82 patients were randomly assigned (41 patients per group). For the per-protocol analysis, five patients were excluded. MWA created larger ablation zones than RFA (
p
= 0.036) although without differences in SLR (0.5 for both groups,
p
= 0.229). The TS was achieved in 98% (46/47) and 90% (45/50) (
p
= 0.108), and LTP was observed in 21% (10/47) vs. 12% (6/50) (OR 1.9 [95% CI 0.66–5.3],
p
= 0.238) of tumors in MWA vs. RFA Group, respectively. Major complications were found in 5 cases (11%) vs. 2 cases (4%), without statistical significance. MWA and RFA show similar SLR, effectiveness and safety in liver tumors between 1.5 and 4 cm.
Journal Article
Microwaves Versus Combined Microwaves and Fractional Carbon Dioxide Laser in the Treatment of Postpartum Abdominal Laxity Among Filipino Patients in a Tertiary Hospital: A Randomized, Prospective, Assessor‐Blinded, Simultaneous Split‐Abdomen Trial
by
King‐Ismael, Daisy
,
Wee, Jonnie Rose Louise R.
,
Gulmatico‐Flores, Zharlah
in
Abdomen
,
Adult
,
Combined Modality Therapy - adverse effects
2025
Background Postpartum abdominal laxity is a growing concern for women. Noninvasive options like microwave technology and fractional carbon dioxide (CO2) laser show promise, but their combined efficacy and safety require further investigation. Aim To compare the efficacy and safety of microwaves versus combined microwaves and fractional CO2 laser in the treatment of postpartum abdominal laxity among Filipino patients. Patients/Methods Thirty‐two patients with Fitzpatrick skin types III–V and postpartum abdominal laxity received three microwave sessions, with one side randomly assigned an additional fractional carbon dioxide laser session (designated as Side B, while the other as Side A). Global aesthetic improvement scale (GAIS) scores and patient satisfaction (PS) scores were determined at every follow‐up. Baseline and completion anthropometric measurements were taken, and adverse effects were recorded. Results Significant improvements in GAIS and PS scores were noted for both sides across all sessions (p < 0.001), with side B showing superior scores post‐CO2 laser (p < 0.001). A moderate correlation between metabolic equivalent (METs) scores and GAIS scores (p = 0.413, p = 0.019) indicated that higher levels of physical activity were associated with higher GAIS scores. These improvements were attributed to epidermal thickening and dermal collagen and elastin remodeling, the latter seen histologically in a representative patient. Adverse effects were mild and noted only with CO2 laser. Conclusions The combined use of the microwave system and fractional CO2 laser is safe and well tolerated and is superior to microwaves alone in the treatment of postpartum abdominal laxity.
Journal Article
Effectiveness of Butorphanol in alleviating intra- and post-operative visceral pain following microwave ablation for hepatic tumor: a dual-central, randomized, controlled trial
2024
Many patients who underwent hepatic percutaneous microwave ablation (MWA) reported experiencing pain during the procedure. This study utilized a well-designed multicentral, randomized, and placebo-controlled format to investigate the effects of Butorphanol. Patients who underwent MWA were randomly assigned to either Butorphanol or normal saline group. The primary outcomes of the study were assessed by measuring the patients' intraoperative pain levels using a 10-point visual analog scale (VAS). Secondary outcomes included measuring postoperative pain levels at the 6-h mark (VAS) and evaluating comprehensive pain assessment outcomes. A total of 300 patients were divided between the control group (n = 100) and the experimental group (n = 200). Butorphanol showed statistically significant reductions in intraoperative pain levels compared to the placebo during surgery (5.00 ± 1.46 vs. 3.54 ± 1.67, P < 0.001). Significant differences were observed in postoperative pain levels at the 6-h mark and in the overall assessment of pain (1.39 + 1.21 vs. 0.65 + 0.81, P < 0.001). Butorphanol had a significant impact on reducing the heart rate of patients. The empirical evidence supports the effectiveness of Butorphanol in reducing the occurrence of visceral postoperative pain in patients undergoing microwave ablation for hepatic tumor. Furthermore, the study found no noticeable impact on circulatory and respiratory dynamics.
Journal Article
Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for the TUMT-PAE-1 trial
by
Lönn, Lars Birger
,
Kristensen-Alvarez, Anna
,
Widecrantz, Steven John
in
Aged
,
Benign prostatic hyperplasia
,
Biomedicine
2024
Background
One-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH.
Methods
This study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients.
Discussion
In this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions.
Trial registration
ClinicalTrials.gov NCT05686525. Registered on January 17, 2023,
https://clinicaltrials.gov/study/NCT05686525
.
Journal Article
Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial
by
van Laarhoven, C. J. H. M.
,
Napp, Vicky
,
Morris, Stephen
in
Ablation
,
Ablation (Surgery)
,
Analysis
2018
Background
Although surgical resection has been considered the only curative option for colorectal liver metastases (CLM), thermal ablation has recently been suggested as an alternative curative treatment. A prospective randomised trial is required to define the efficacy of resection vs ablation for the treatment of colorectal liver metastases.
Methods
Design and setting:
This is a multicentre, open, randomised controlled non-inferiority trial design with internal pilot and will be performed in tertiary liver centres in UK and The Netherlands.
Participants:
Eligible patients will be those with colorectal liver metastases at high surgical risk because of their age, co-morbidities or tumour burden and who would be suitable for liver resection or thermal ablation.
Intervention:
Thermal ablation as per local policy.
Control:
Surgical liver resection performed as per centre protocol.
Co-interventions:
Further chemotherapy will be offered to patients as per current practice.
Outcomes
Pilot study: Same as main study and in addition patients and clinicians’ acceptability of the trial to assist in optimisation of recruitment.
Primary outcome: Disease-free survival (DFS) at two years post randomisation.
Secondary outcomes: Overall survival, timing and site of recurrence, additional therapy after treatment failure, quality of life, complications, length of hospital stay, costs, trial acceptability, DFS measured from end of intervention.
Follow-up:
24 months from randomisation; five-year follow-up for overall survival.
Sample size:
330 patients to demonstrate non-inferiority of thermal ablation.
Discussion
This trial will determine the effectiveness and cost-effectiveness of thermal ablation vs surgical resection for high-risk people with colorectal liver metastases, and guide the optimal treatment for these patients.
Trial registration
ISRCTN Registry,
ISRCTN52040363
. Registered on 9 March 2016.
Journal Article
The application of microwaves in axillary hyperhidrosis: Curative effect observation of a pathological examination over 1 year
by
He, Xiaolin
,
Huang, Wanxiao
,
Duan, Zhiyi
in
Axilla - pathology
,
axillary hyperhidrosis
,
efficacy
2024
Background In Asia, axillary hyperhidrosis is a frequent problem for many people, and the consequent excessive sweating can seriously affect many aspects of daily life and even lead to mental disorders. Microwave therapy is a new, non‐invasive treatment method for axillary hyperhidrosis, whose energy and long‐term effectiveness still needs to be clinically validated. Objective The aim of this study was to evaluate the clinical efficacy, safety, histological changes, and psychological status of microwave devices in the treatment of axillary hyperhidrosis and osmidrosis. Method We conducted a prospective self‐controlled study in a top‐tier Chinese hospital. After a 5/5 energy treatment session, a skin biopsy was taken to observe histological changes both before and after treatment. An iodine starch test was used to determine the sweating range. We evaluated symptoms of improved efficacy using the Hyperhidrosis Disease Severity Scale (HDSS) and assessed changes in life status with the DLQI. In the case of concurrent underarm odor, odor‐5, VAS, and Young‐Jin Park grading were used to assess odor relief. The effect of odor on psychology was assessed by using a psychological status symptom checklist (scl‐90). The study period was 1 year. Results We observed 20 patients in this study. Of those, 90% met the primary treatment endpoint of a decrease in axillary hyperhidrosis symptomatology to below grade 2 on the HDSS score (p < 0.001). Furthermore, 75% of patients achieved a treatment endpoint of at least 50% reduction in VAS (p < 0.001). 70% of patients achieved a treatment endpoint of at least 50% reduction in odor‐5 (p < 0.001). The iodine starch test showed that the region decreased 99% from the baseline to 12 months after follow‐up had ended (p < 0.001). Eight patients volunteered to undergo histological examination; their average light density of immunohistochemistry decreased from 1.04 (0.4–2.11) to 0.07 (0.04–0.46; p < 0.05). The immunohistochemical positive number for sweat glands was initially 104 (59.75–132.5) but was 41.5 (29.75–62) after the procedure. None of the patients experienced any serious adverse reactions. Conclusion The treatment demonstrated high effectiveness, safety, and short‐lived adverse reactions.
Journal Article
Cellular Phone Irradiation of the Head Affects Heart Rate Variability Depending on Inspiration/Expiration Ratio
2018
Mobile phones may have harmful health effects and clinical examinations report ambiguous results of exposure concerning neurophysiological and cardiovascular actions.
This study investigated heart rate asymmetry (HRA) and heart rate variability (HRV) parameters with 1:2 and 1:1 metronome-paced inspiration/expiration ratios during short-term 1,800MHz GSM cellular phone exposure in 20 healthy volunteers.
Significant HRA changes by Porta and Guzik indices were not found on exposure compared to sham exposure. Time-domain HRV parameters on exposure showed significant differences at 1:1 paced, but not at 1:2 paced breathing compared to sham exposure. A mild post-exposure effect was observed regarding root mean square of successive RR-differences.
The findings reflect persisting acute effects of GSM handset emission on the autonomic nervous system. Exploring its influences on health status and survival needs further studies. Symmetrical breathing can be used as a sensitizing factor in other HRV/HRA analysis studies.
Journal Article
Pain control for patients with hepatocellular carcinoma undergoing CT-guided percutaneous microwave ablation
2018
Background
Hepatic percutaneous microwave ablation (MWA) is usually performed in patients under conscious sedation. Nonetheless, many patients reported pain during the procedure. The current study investigated the safety and effectiveness of analgesia given at personalized dosage during the MWA procedure.
Methods
A total of 100 patients with hepatocellular carcinomas (HCCs) were included in this study. These patients underwent CT-guided percutaneous MWA between February and October 2017. Patients were randomized into two groups: Experimental group (
n
= 50) and Control group (n = 50). Patients in the Control group were given 5 mg of morphine intravenously, followed by 10 mg of morphine injected subcutaneously 30 min before surgery. Patients in the Experimental group were given a personalized dosage of morphine during the procedure when the Visual Analogue Scale (VAS) was ≥4. Other clinical and treatment parameters were also analysed.
Results
A significantly less amount of morphine (
p
< 0.001) was used in the experimental group (7.18 ± 1.65 mg) than in the control group (17.40 ± 2.52 mg). No significant differences were found in the number of patients who needed to discontinue the surgery (
p
= 0.242). Other clinical parameters including heart rate, systolic and diastolic blood pressures at various time points were comparable. Importantly, a lower VAS was reported in the experimental group, indicating a lower pain intensity experienced by patients during the procedure.
Conclusion
The administration of personalized dosage of morphine to HCC patients undergoing percutaneous MWA is an effective and safe procedure for pain control.
Journal Article
Are some people sensitive to mobile phone signals? Within participants double blind randomised provocation study
by
Rubin, G James
,
Cleare, Anthony J
,
Everitt, Brian S
in
Adult
,
Cell Phone - statistics & numerical data
,
Cell phones
2006
Abstract Objective To test whether people who report being sensitive to mobile phone signals have more symptoms when exposed to a pulsing mobile signal than when exposed to a sham signal or a non-pulsing signal. Design Double blind, randomised, within participants provocation study. Setting Dedicated suite of offices at King's College London, between September 2003 and June 2005. Participants 60 “sensitive” people who reported often getting headache-like symptoms within 20 minutes of using a global system for mobile communication (GSM) mobile phone and 60 “control” participants who did not report any such symptoms. Intervention Participants were exposed to three conditions: a 900 MHz GSM mobile phone signal, a non-pulsing carrier wave signal, and a sham condition with no signal present. Each exposure lasted for 50 minutes. Main outcome measures The principal outcome measure was headache severity assessed with a 0-100 visual analogue scale. Other outcomes included six other subjective symptoms and participants' ability to judge whether a signal was present. Results Headache severity increased during exposure and decreased immediately afterwards. However, no strong evidence was found of any difference between the conditions in terms of symptom severity. Nor did evidence of any differential effect of condition between the two groups exist. The proportion of sensitive participants who believed a signal was present during GSM exposure (60%) was similar to the proportion who believed one was present during sham exposure (63%). Conclusions No evidence was found to indicate that people with self reported sensitivity to mobile phone signals are able to detect such signals or that they react to them with increased symptom severity. As sham exposure was sufficient to trigger severe symptoms in some participants, psychological factors may have an important role in causing this condition. Trial registration ISRCTN81432775 [controlled-trials.com].
Journal Article
Efficacy and Safety of Thermal Ablation for Solitary T1bN0M0 Papillary Thyroid Carcinoma: A Multicenter Study
2021
Abstract
Background
Ultrasound-guided thermal ablation plays an important role in the management of thyroid disease. The objective of this study was to evaluate the feasibility, efficacy, and safety of thermal ablation for patients with solitary T1bN0M0 papillary thyroid carcinoma (PTC) who are ineligible for or unwilling to undergo surgery.
Materials and Methods
Data pertaining to 172 patients (38 males and 134 females) who received thermal ablation therapy at 12 hospitals between April 2015 and March 2020 were retrospectively analyzed. The mean duration of follow-up was 24.9 ± 14.1 months (range, 12–60). The technical feasibility, technical success, efficacy, and safety of treatment were analyzed. Postablation tumor size at various time points was compared with preablation measurement.
Results
All patients selected for thermal ablation received enlarged ablation, according to contrast-enhanced ultrasound postablation. The maximum diameter and volume of ablation zone at 6, 12, 18, 24, 36, and 48 months postablation were significantly smaller than those recorded preablation (P < 0.05 for all). At the most recent follow-up, 106 (61.6%) tumors had completely disappeared. The rate of lymph node metastasis was 0.6% (1/172) and the incidence of new tumors was 1.2% (2/172). The overall complication rate was 5.2% (9/172) (major complications: 4.6% [8/172]; minor complications: 0.6% [1/172]). All major complications were relieved within 4 months postablation.
Conclusion
Thermal ablation may be a feasible, effective, and safe treatment option for patients with solitary T1bN0M0 PTC who are ineligible for or unwilling to undergo surgery. It may provide a novel treatment option for selected patients.
Journal Article