RESUMEN
BACKGROUND: Despite the recent advances in cancer treatment, the therapeutic options for patients with biliary tract cancer are still very limited and the prognosis very poor. More than 50% of newly diagnosed patients with biliary tract cancer are not amenable to curative surgical treatment and thus treated with palliative systemic treatment. Malignant bile duct obstructions in patients with perihilar and/or ductal cholangiocarcinoma (CCA) represents one of the most important challenges in the management of these patients, owning to the risk represented by developing life-threatening cholangitis which, in turn, limits the use of systemic treatment. For this reason, endoscopic stenting and/or bile duct decompression is the mainstay of treatment of these patients. Data on efficacy and safety of adding radiofrequency ablation (RFA) to biliary stenting is not conclusive. The aim of this multicenter, randomized trial is to evaluate the effect of intraductal RFA prior to bile duct stenting in patients with unresectable perihilar or ductal CCA undergoing palliative systemic therapy. METHODS/DESIGN: ACTICCA-2 is a multicenter, randomized, controlled, open-label, investigator-initiated trial. 120 patients with perihilar or ductal CCA with indication for biliary stenting and systemic therapy will be randomized 1:1 to receive either RFA plus bile duct stenting (interventional arm) or bile duct stenting alone (control arm). Patients will be stratified by trial site and tumor location (perihilar vs. ductal). Both arms receive palliative systemic treatment according to the local standard of care determined by a multidisciplinary tumorboard. The primary endpoint is time to first biliary event, which is determined by an increase of bilirubin to > 5 mg/dl and/or the occurrence of cholangitis leading to premature stent replacement and/or disruption of chemotherapy. Secondary endpoints include overall survival, safety according to NCI CTCAE v5, quality of life assessed by questionnaires (EORTC QLQ-C30 and QLQ-BIL21), clinical event rate at 6 months after RFA and total days of over-night stays in hospital. Follow-up for the primary endpoint will be 6 months, while survival assessment will be continued until end of study (maximum follow-up 30 month). All patients who are randomized and who underwent endoscopic stenting will be used for the primary endpoint analysis which will be conducted using a cause-specific Cox proportional hazards model with a frailty for trial site and fixed effects for the treatment group, tumor location, and stent material. DISCUSSION: ACTICCA-2 is a multicenter, randomized, controlled trial to assess efficacy and safety of adding biliary RFA to bile duct stenting in patients with CCA receiving palliative systemic treatment. TRIAL REGISTRATION: The study is registered with ClinicalTrials.gov (NCT06175845) and approved by the local ethics committee in Hamburg, Germany (2024-101232-BO-ff). This manuscript reflects protocol version 1 as of January 9th, 2024.
Asunto(s)
Neoplasias de los Conductos Biliares , Colangiocarcinoma , Ablación por Radiofrecuencia , Stents , Humanos , Colangiocarcinoma/terapia , Colangiocarcinoma/cirugía , Neoplasias de los Conductos Biliares/cirugía , Neoplasias de los Conductos Biliares/terapia , Ablación por Radiofrecuencia/métodos , Ablación por Radiofrecuencia/efectos adversos , Cuidados Paliativos/métodos , Masculino , Femenino , Calidad de Vida , Ablación por Catéter/métodos , Resultado del Tratamiento , AncianoRESUMEN
BACKGROUND: Currently, there is no consensus on the treatment of recurrent hepatocellular carcinoma (HCC) after hepatectomy. It is necessary to assess the efficacy and safety of radiofrequency ablation (RFA) combined with iodine-125 seeds implantation (RFA-125I) in the treatment of recurrent HCC. METHODS: This study retrospectively analyzed the clinical data of patients with postoperative recurrence of HCC receiving RFA-125I or RFA treatment from January 2013 to January 2023. Both RFA and 125I seeds implantation were performed under dual guidance of ultrasound and CT. Overall survival (OS), progression-free survival (PFS), recurrence, and complications were compared between the two groups. RESULTS: A total of 210 patients with recurrent HCC were enrolled in this study, including 125 patients in the RFA-125I group and 85 patients in the RFA group. The RFA-125I group showed a significantly better survival benefit than RFA group (median OS: 37 months vs. 16 months, P < 0.001; median PFS: 15 months vs. 10 months, P = 0.001). The uni- and multivariate analysis showed that RFA-125I was a protective factor for OS and PFS. There were no procedure-related deaths and no grade 3 or higher adverse events in both groups. CONCLUSIONS: RFA combined with 125I seeds implantation under dual guidance of ultrasound and CT is effective and safe for the treatment of HCC patients with recurrence after hepatectomy.
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Carcinoma Hepatocelular , Hepatectomía , Radioisótopos de Yodo , Neoplasias Hepáticas , Recurrencia Local de Neoplasia , Ablación por Radiofrecuencia , Humanos , Neoplasias Hepáticas/cirugía , Neoplasias Hepáticas/radioterapia , Neoplasias Hepáticas/mortalidad , Neoplasias Hepáticas/patología , Carcinoma Hepatocelular/cirugía , Carcinoma Hepatocelular/radioterapia , Carcinoma Hepatocelular/mortalidad , Carcinoma Hepatocelular/patología , Radioisótopos de Yodo/uso terapéutico , Radioisótopos de Yodo/administración & dosificación , Hepatectomía/métodos , Masculino , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Ablación por Radiofrecuencia/métodos , Ablación por Radiofrecuencia/efectos adversos , Anciano , Adulto , Terapia Combinada , Resultado del Tratamiento , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND: The combination of targeted therapy and immunotherapy has improved the clinical outcomes of unresectable hepatocellular Carcinoma (HCC). However, the overall prognosis remains suboptimal. This study aims to evaluate the efficacy and safety of a novel combination of radiofrequency ablation (RFA) with lenvatinib plus sintilimab in unresectable HCC. METHODS: In this retrospective study, patients diagnosed with unresectable HCC were included and divided into two cohorts: RFA combined with lenvatinib plus sintilimab (R-L-S group) and lenvatinib plus sintilimab (L-S group). The primary efficacy endpoints were objective response rate (ORR) and progression free survival (PFS). Adverse events were analyzed to assess the safety profiles. RESULTS: The median follow-up periods for the entire cohort were 14.0 months. The R-L-S group (n = 60) had a significantly higher ORR than those with L-S alone (n = 62) (40.0% vs. 20.9%; p = 0.022). Moreover, patients in the R-L-S group had improved median PFS (12 vs. 8 months; p = 0.013) and median overall survival (24 vs. 18 months; p = 0.037), as compared with lenvatinib and sintilimab alone. No significant difference in treatment related adverse event (TRAE) of any grade between the two groups. The most common TRAEs of grade ≥ 3 were fatigue 10.0% (6/60) and hand-foot skin reaction 10.0% (6/60) in the R-L-S group and hand-foot skin reaction 11.3% (7/62) in the L-S group. CONCLUSION: In unresectable HCC patients, the incorporation of RFA to lenvatinib plus sintilimab demonstrated improved efficacy without compromising safety compared with lenvatinib plus sintilimab alone.
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Anticuerpos Monoclonales Humanizados , Protocolos de Quimioterapia Combinada Antineoplásica , Carcinoma Hepatocelular , Neoplasias Hepáticas , Compuestos de Fenilurea , Quinolinas , Ablación por Radiofrecuencia , Humanos , Carcinoma Hepatocelular/tratamiento farmacológico , Carcinoma Hepatocelular/terapia , Carcinoma Hepatocelular/mortalidad , Carcinoma Hepatocelular/patología , Carcinoma Hepatocelular/cirugía , Quinolinas/uso terapéutico , Quinolinas/administración & dosificación , Quinolinas/efectos adversos , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/terapia , Neoplasias Hepáticas/patología , Neoplasias Hepáticas/cirugía , Neoplasias Hepáticas/mortalidad , Masculino , Femenino , Compuestos de Fenilurea/administración & dosificación , Compuestos de Fenilurea/uso terapéutico , Compuestos de Fenilurea/efectos adversos , Persona de Mediana Edad , Anciano , Estudios Retrospectivos , Ablación por Radiofrecuencia/métodos , Ablación por Radiofrecuencia/efectos adversos , Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/efectos adversos , Terapia Combinada , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Adulto , Resultado del Tratamiento , Anciano de 80 o más AñosRESUMEN
BACKGROUND AND AIMS: Radiofrequency ablation (RFA) is a well-established treatment for Barrett's esophagus (BE) in the United States. Similarly, endoscopic submucosal dissection (ESD) has been widely performed for early esophageal carcinoma. However, conducting ESD after RFA can be technically challenging. The aim of this study was to assess the feasibility and safety of ESD in patients with prior RFA. METHODS: This study was a single-center retrospective analysis of patients who underwent esophageal ESD after undergoing prior RFA treatment for BE. RESULTS: Of 44 esophageal ESD cases, 7 underwent prior RFA. In those 7 cases, the en bloc resection rate was 100%, and the R0 resection rate was 86%. No acute or delayed adverse events or rehospitalizations occurred in any patient. CONCLUSIONS: ESD may be a feasible and safe option for patients with a history of RFA. It could be considered for esophageal neoplasms in patients previously treated with RFA for BE.
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Esófago de Barrett , Resección Endoscópica de la Mucosa , Neoplasias Esofágicas , Estudios de Factibilidad , Ablación por Radiofrecuencia , Humanos , Esófago de Barrett/cirugía , Esófago de Barrett/patología , Resección Endoscópica de la Mucosa/métodos , Resección Endoscópica de la Mucosa/efectos adversos , Masculino , Femenino , Estudios Retrospectivos , Persona de Mediana Edad , Anciano , Ablación por Radiofrecuencia/métodos , Ablación por Radiofrecuencia/efectos adversos , Neoplasias Esofágicas/cirugía , Neoplasias Esofágicas/patología , Esofagoscopía/métodos , Anciano de 80 o más AñosRESUMEN
Thermal ablation modalities (cryoablation, radiofrequency ablation, and microwave ablation) have long been noted to occasionally induce a systemic antitumoral response. With the widespread use of checkpoint inhibitors, there is a significant interest in whether thermal ablation can promote immune system tumor recognition and increase checkpoint inhibitor response rates. In this review, we examine the current state of preclinical and clinical evidence examining the combination of checkpoint inhibitor therapies and thermal ablation modalities as well as discuss remaining the unanswered questions and directions for future research.
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Criocirugía , Neoplasias , Ablación por Radiofrecuencia , Humanos , Neoplasias/terapia , Inmunoterapia/efectos adversos , Criocirugía/efectos adversos , Ablación por Radiofrecuencia/efectos adversos , Terapia CombinadaRESUMEN
PURPOSE: To investigate the feasibility, safety, and clinical outcomes of image-guided thermal ablation in patients with hepatic epithelioid hemangioendothelioma (HEHE). MATERIALS AND METHODS: This was a multicenter retrospective investigation of 18 patients (43.9 years [SD ± 14.8]; 6 men) who underwent image-guided thermal ablation for HEHE between January 2013 and February 2023. A total of 31 ablation sessions (24 involving microwave ablation and 7 involving radiofrequency ablation) were evaluated. The rates of technical success, adverse events, and outcomes were assessed. The KaplanâMeier method was used to estimate progression-free survival (PFS) and overall survival (OS) rates. The risk factors affecting PFS were investigated using Cox proportional hazard regression analysis. RESULTS: The technical success rate was 93.5% (29/31). No major adverse events occurred. Local tumor progression occurred after 2 sessions (6.5%, 2/31), and intrahepatic distant metastasis occurred after 16 sessions (51.6%, 16/31). During the medium follow-up time of 37.2 months (range, 3-117 months), the OS and PFS rates were 87.6% and 62.2%, respectively, at 1 year; 75.5% and 37.4%, respectively, at 3 years; and 75.5% and 37.4%, respectively, at 5 years. The median OS and PFS were 90.5 months (95% CI: 68.1-112.8) and 23.8 months (95% CI: 15.4-32.2), respectively. According to the multivariate analysis, a larger tumor size (P = .026) was associated with shorter PFS. CONCLUSIONS: Image-guided thermal ablation is a feasible and safe treatment option for patients with HEHE that resulted in local tumor control and a favorable long-term prognosis.
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Estudios de Factibilidad , Hemangioendotelioma Epitelioide , Neoplasias Hepáticas , Supervivencia sin Progresión , Humanos , Masculino , Neoplasias Hepáticas/cirugía , Neoplasias Hepáticas/patología , Neoplasias Hepáticas/mortalidad , Neoplasias Hepáticas/diagnóstico por imagen , Femenino , Persona de Mediana Edad , Hemangioendotelioma Epitelioide/cirugía , Hemangioendotelioma Epitelioide/patología , Hemangioendotelioma Epitelioide/mortalidad , Hemangioendotelioma Epitelioide/diagnóstico por imagen , Estudios Retrospectivos , Adulto , Factores de Riesgo , Factores de Tiempo , Ablación por Radiofrecuencia/efectos adversos , Ablación por Radiofrecuencia/mortalidad , Microondas/uso terapéutico , Microondas/efectos adversos , Progresión de la Enfermedad , Adulto Joven , Anciano , China , Resultado del TratamientoRESUMEN
OBJECTIVE: This metanalysis aims to assess the efficacy and safety of biliary stenting along with radiofrequency ablation compared with stents alone to treat malignant biliary obstruction (MBO) due to extrahepatic biliary strictures secondary to cholangiocarcinoma, pancreatic cancer, and metastatic cancer. METHODS: A systemic search of major databases through April 2022 was done. All original studies were included comparing radiofrequency ablation with stenting versus stenting alone for treating malignant biliary strictures. The primary outcomes of interest were the difference in the mean stent patency and overall survival (OS) days between the 2 groups. The secondary outcome was to compare the adverse events of the 2 groups. The mean difference in the stent patency and OS days was pooled by using a random-effect model. We calculated the odds ratio to compare the adverse events between the 2 groups. RESULTS: A total of 13 studies with 1339 patients were identified. The pooled weighted mean difference in stent patency was 43.50 days (95% CI, 25.60-61.41), favoring the RFA plus stenting. Moreover, the pooled weighted mean difference in OS was 90.53 days (95% CI, 49.00-132.07), showing improved survival in the RFA group. Our analysis showed no statistically significant difference in adverse events between the 2 groups OR 1.13 (95% CI, 0.90-1.42). CONCLUSION: Our analysis showed that RFA, along with stent, is safe and is associated with improved stent patency and overall patient survival in malignant biliary strictures. More robust prospective studies should assess this association further.
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Neoplasias de los Conductos Biliares , Sistema Biliar , Ablación por Catéter , Colestasis , Ablación por Radiofrecuencia , Humanos , Estudios Prospectivos , Constricción Patológica/etiología , Colestasis/etiología , Colestasis/cirugía , Ablación por Radiofrecuencia/efectos adversos , Drenaje/efectos adversos , Stents/efectos adversos , Resultado del Tratamiento , Ablación por Catéter/efectos adversos , Neoplasias de los Conductos Biliares/complicaciones , Neoplasias de los Conductos Biliares/cirugíaRESUMEN
OBJECTIVE: Superficial venous incompetence (SVI) is a common disease that causes significant quality of life (QoL) impairment. There is a need for more health economic evaluations of SVI treatment. The aim of this study was to perform a cost effectiveness analysis in patients with great saphenous vein (GSV) incompetence comparing radiofrequency ablation (RFA), high ligation and stripping (HL/S), and no treatment or conservative treatment with one year follow up. METHODS: Randomised controlled trial economic analysis from an ongoing trial; 143 patients (156 limbs) with GSV incompetence (CEAP clinical class 2 - 6) were included. Treatment was performed with RFA or HL/S. Follow up was performed up to one year using duplex ultrasound, revised venous clinical severity score (r-VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and EuroQol-5D-3L (EQ-5D-3L). RESULTS: Seventy-eight limbs were treated with RFA and HL/S respectively. No treatment or conservative treatment was assumed to have zero in treatment cost and no treatment benefit. In the RFA group, one limb had reflux in the GSV after one month and three limbs after one year. In HL/S, two limbs had remaining reflux in the treated area at one month and one year. Both disease severity (r-VCSS, p = .004) and QoL (AVVQ, p = .021 and EQ-5D-3L, p = .028) were significantly improved over time. The QALY gain was 0.21 for RFA and 0.17 for HL/S. The cost per patient was calculated as 1 292 for RFA and 2 303 for HL/S. The cost per QALY (compared with no treatment or conservative treatment) was 6 155 for RFA and 13 549 for HL/S. With added cost for days absent from work the cost per QALY was 7 358 for RFA and 24 197 for HL/S. The cost per QALY for both methods was well below the threshold suggested by Swedish National Board of Health. CONCLUSION: RFA is more cost effective than HL/S and no treatment or conservative treatment at one year follow up.
Asunto(s)
Análisis Costo-Beneficio , Calidad de Vida , Ablación por Radiofrecuencia , Vena Safena , Insuficiencia Venosa , Humanos , Ligadura/economía , Vena Safena/cirugía , Vena Safena/diagnóstico por imagen , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/economía , Insuficiencia Venosa/diagnóstico por imagen , Femenino , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Ablación por Radiofrecuencia/economía , Ablación por Radiofrecuencia/efectos adversos , Años de Vida Ajustados por Calidad de Vida , Factores de Tiempo , Procedimientos Quirúrgicos Vasculares/economía , Procedimientos Quirúrgicos Vasculares/efectos adversos , Procedimientos Quirúrgicos Vasculares/métodos , Anciano , Ablación por Catéter/economía , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Adulto , Costos de la Atención en Salud , Várices/cirugía , Várices/economía , Várices/diagnóstico por imagen , Análisis de Costo-EfectividadRESUMEN
BACKGROUND AND AIM: Esophageal squamous cell neoplasia (ESCN) is predominant in Asia. Endoscopic mucosal resection and endoscopic submucosal dissection (ESD) have both been recommended worldwide, however the application of endoscopic radiofrequency ablation (RFA) for treatment of early superficial ESCN remains inconclusive. We conducted a meta-analysis to study the effectiveness of RFA for early superficial ESCN. METHODS: Three major bibliographic databases were reviewed for the enrollment of case series and cohort trials prior to August 23, 2023. We included adults diagnosed with early superficial ESCN who had been receiving endoscopic RFA or ESD if the treatments were available. Our focus was on the 12-month histological complete response rate (CR) and 3-month histological CR, as well as the acute and late postoperative adverse events (AEs) rate during the at follow-up periods. RESULTS: Nine studies were enrolled for qualitative synthesis of narrative review, with eight trials involving a total of 447 participants for analysis. The pooled 12-month and 3-month histological CR were 0.83 (95% CI, 0.59-0.94, I2 = 80%) and 0.74 (95% CI, 0.67-0.80, I2 = 0%), respectively. As for safety, the acute and late postoperative AEs were 0.11 (95% CI, 0.05-0.26, I2 = 68%) and 0.19 (95% CI, 0.14-0.26, I2 = 0%), respectively. In subgroup analysis, the incidence of bleeding, laceration and perforation after endoscopic RFA showed 0.06, 0.06 and 0.02, respectively. When compared with ESD, RFA showed lower acute AEs and late AEs without any obvious significance. CONCLUSIONS: For early superficial ESCN, endoscopic RFA achieved both higher 12-month complete remission and late complication postoperatively when compared to 3-month histological CR and acute AEs separately, while the stricture was encountered most commonly. The choice between endoscopic RFA and ESD remains inconclusive.
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Resección Endoscópica de la Mucosa , Neoplasias Esofágicas , Carcinoma de Células Escamosas de Esófago , Ablación por Radiofrecuencia , Humanos , Neoplasias Esofágicas/cirugía , Neoplasias Esofágicas/patología , Ablación por Radiofrecuencia/efectos adversos , Ablación por Radiofrecuencia/métodos , Resección Endoscópica de la Mucosa/efectos adversos , Resección Endoscópica de la Mucosa/métodos , Carcinoma de Células Escamosas de Esófago/cirugía , Carcinoma de Células Escamosas de Esófago/patología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Resultado del TratamientoRESUMEN
PURPOSE: The subtrigonal perivesical nerve plexus contains a large proportion of the bladder's innervation. A transurethral radiofrequency ablation approach has successfully denervated this region to alleviate overactive bladder symptoms, with some urothelial heat injury. We report a novel transvaginal RFA device (DENERA) and assess its feasibility and efficacy in denervating the perivesical nerve plexus of in vivo sheep. METHODS: In 14 adult female in vivo sheep, pulsed radiofrequency energy was applied transvaginally for three cycles of 4 min, maintaining the tissue temperature at 45°C, with 30 s of rest between each cycle. The control group (n = 4) was sacrificed without ablation, and various groups were sacrificed 1 week (n = 3), 4 weeks (n = 4), and 12 weeks (n = 3) after ablation. The bladder subtrigones were harvested then analyzed with H&E, S100, and TH immunostaining to quantify their neural density and neural vacuolization. RESULTS: The ablation procedure increased the neural vacuolization the most at 1 week and decreased the neural density the most at 4 weeks, with both variables displaying a significant change followed by a slight rebound towards baseline at 12 weeks. The H&E analysis showed that the needles penetrated deep into the subtrigonal detrusor muscle. The sheep recovered from the procedure with no complications or damage in the bladder wall or urothelium. CONCLUSIONS: This study shows that one DENERA treatment can cause subtrigonal denervation with some rebound afterwards and no complications. DENERA may become a promising OAB treatment option that can ablate the perivesical plexus without harming the urothelium.
Asunto(s)
Ablación por Radiofrecuencia , Vejiga Urinaria Hiperactiva , Animales , Ovinos , Femenino , Vejiga Urinaria/cirugía , Vejiga Urinaria/inervación , Vejiga Urinaria Hiperactiva/cirugía , Ablación por Radiofrecuencia/efectos adversos , Ablación por Radiofrecuencia/métodosRESUMEN
OBJECTIVE: To evaluate the complications associated with microwave ablation (MWA) in treating persistent/recurrent hyperparathyroidism (HPT) post-surgical or ablative treatments. MATERIALS AND METHODS: From January 2015 to December 2022, 87 persistent/recurrent HPT patients (primary HPT [PHPT]: secondary HPT [SHPT] = 13:74) who underwent MWA after surgical or ablative treatment were studied. Grouping was based on ablation order (initial vs. re-MWA), prior treatment (parathyroidectomy [PTX] vs. MWA), and etiology (PHPT vs. SHPT). The study focused on documenting and comparing treatment complications and analyzing major complication risk factors. RESULT: Among the 87 patients, the overall complication rate was 17.6% (15/87), with major complications at 13.8% (12/87) and minor complications at 3.4% (3/87). Major complications included recurrent laryngeal nerve (RLN) palsy (12.6%) and Horner syndrome (1.1%), while minor complications were limited to hematoma (3.4%). Severe hypocalcemia noted in 21.6% of SHPT patients. No significant differences in major complication rates were observed between initial and re-MWA groups (10.7% vs. 13.8%, p = 0.455), PTX and MWA groups (12.5% vs. 15.4%, p = 0.770), or PHPT and SHPT groups (15.4% vs. 13.5%, p > 0.999). Risk factors for RLN palsy included ablation of superior and large parathyroid glands (>1.7 cm). All patients recovered spontaneously except for one with permanent RLN palsy in the PTX group (2.1%). CONCLUSION: Complication rates for MWA post-surgical or ablative treatments were comparable to initial MWA rates. Most complications were transient, indicating MWA as a viable and safe treatment option for persistent/recurrent HPT patients.
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Técnicas de Ablación , Hiperparatiroidismo Secundario , Ablación por Radiofrecuencia , Humanos , Microondas/efectos adversos , Técnicas de Ablación/efectos adversos , Ablación por Radiofrecuencia/efectos adversos , Hiperparatiroidismo Secundario/cirugía , Parálisis/etiología , Estudios RetrospectivosRESUMEN
BACKGROUND: To compare radiofrequency ablation (RFA) and cyanoacrylate closure (CAC) for large-diameter great saphenous vein (GSV) insufficiency between diameters of 12 and 16 mm. METHODS: This study is a single-center retrospective study. Subjects who underwent endovenous treatment with RFA (Group A) or CAC (Group B) for GSV insufficiency between June 2015 and June 2021 who were followed up for at least 2 years were included in the study. Subjects who had a 12-mm to 16-mm target vessel diameter and subjects with grade 3 and grade 4 reflux were included. Subjects' demographic data (age, sex), body mass indices, clinical, etiological, anatomic, pathophysiologic classification, GSV diameter, reflux grade, target vessel length, preoperative venous clinical severity score (VCSS), procedural time, postoperative first-day pain scores, postoperative 14th-day patient satisfaction scale, and postoperative complications were noted. In follow-up, subjects were evaluated with duplex ultrasonography and VCSS at 1, 6, 12, and 24 months. RESULTS: In total, 142 subjects were included (n = 71 for both groups). The mean GSV diameter was 13.21 ± 1.00 for Group A and 13.51 ± 0.97 for Group B. The groups did not differ in terms of age, sex, body mass index, clinical, etiological, anatomic, pathophysiologic classification, GSV diameter, reflux grade, target GSV length, preoperative VCSS, complications, postoperative 24-hr pain status or postoperative 14-day patient satisfaction scale (P > 0.05 for all comparisons). The procedure time was significantly shorter in Group B (34.68 ± 4.22 min for Group A vs. 22.59 ± 4.5 min for Group B, P = 0.001). In the 1-month and 6-month Duplex ultrasonography of the subjects, partial closure and patency rates in Group B were significantly higher than those in Group A (P = 0.003 and P = 0.025, respectively). At the 12-month and 24-month evaluation, closure rates did not show a statistically significant difference between the groups (P = 0.056 and P = 0.090, respectively). Preoperative and 1-month VCSS measurements did not show a statistically significant difference between groups (P > 0.05 for all comparisons). The 6-month, 12-month, and 24-month VCSS measurements of Group A were significantly higher than those in Group B. (P = 0.043, P = 0.009 and P = 0.002, respectively). CONCLUSIONS: Both RFA and CAC were found to be effective in the treatment of large-diameter GSV incompetency. The complication rates were similar between the 2 techniques. CAC had a shorter procedure time. Although the closure rates in the early postoperative period were better in the RFA group, long-term follow-up demonstrated similar patency rates. The functional results in the long-term follow-up were better in the RFA group.
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Cianoacrilatos , Vena Safena , Insuficiencia Venosa , Humanos , Vena Safena/diagnóstico por imagen , Vena Safena/fisiopatología , Vena Safena/cirugía , Estudios Retrospectivos , Femenino , Masculino , Insuficiencia Venosa/diagnóstico por imagen , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/fisiopatología , Insuficiencia Venosa/terapia , Persona de Mediana Edad , Resultado del Tratamiento , Cianoacrilatos/efectos adversos , Cianoacrilatos/administración & dosificación , Factores de Tiempo , Adulto , Anciano , Ablación por Radiofrecuencia/efectos adversos , Procedimientos Endovasculares/efectos adversos , Adhesivos Tisulares/uso terapéutico , Adhesivos Tisulares/efectos adversosRESUMEN
BACKGROUND: Evaluation of the efficacy and safety of cyanoacrylate closure (CAC) for treating incompetent great saphenous veins (GSVs) compared to radiofrequency ablation (RFA). METHODS: In this prospective, randomized controlled study, 248 symptomatic subjects with incompetent GSVs were assigned to either CAC or RFA. The primary end point, complete closure of the target GSV, was determined using a duplex ultrasound examination. RESULTS: In this study, 248 patients (mean age 33.64 ± 8.06 years including 71% women) were treated with either CAC (n = 128) or RFA (n = 120) between August 2018 to May 2022. As a follow-up, after a 1-month duration, the closure rates were 128/128 at the CAC and 154/158 at the RFA. At month 24, closure rates were 122/128 at CAC and 146/158 at RFA. Apart from phlebitis and pigmentation, the incidences of bruising, skin burn, and paresthesia were lower in the CAC group compared to the RFA group. The mean procedural times were shorter for CAC. The satisfaction level with the treatment was moderately higher among CAC patients than RAF patients. CONCLUSIONS: This study suggests that Cyanoacrylate glue closure of the GSV and RFA are effective techniques for managing primary varicose veins. Cyanoacrylate glue closure of the GSV appears to have a lower rate of complications and higher satisfaction levels, rapid return to normal activities, and improved procedure time without the need for perivenous tumescent anesthesia and postprocedure compression stockings when compared to RFA.
Asunto(s)
Ablación por Radiofrecuencia , Várices , Insuficiencia Venosa , Adulto , Femenino , Humanos , Masculino , Cianoacrilatos/efectos adversos , Estudios Prospectivos , Ablación por Radiofrecuencia/efectos adversos , Vena Safena/diagnóstico por imagen , Vena Safena/cirugía , Factores de Tiempo , Resultado del Tratamiento , Várices/diagnóstico por imagen , Várices/cirugía , Insuficiencia Venosa/diagnóstico por imagen , Insuficiencia Venosa/terapia , Insuficiencia Venosa/etiologíaRESUMEN
BACKGROUND: Chronic venous insufficiency is a common medical condition that afflicts over 30 million adults in the United States. Treatment and management have changed dramatically over the past 20 years with the introduction of various endovenous therapies, including radiofrequency ablation (RFA) and cyanoacrylate closure using the Venaseal system. In this study, we explore a direct comparison of outcomes between RFA and VenaSeal conducted by a single surgeon within a managed care organization. METHODS: Between May 2020 and December 2021, there were 87 patients undergoing 97 total procedures who were treated with either VenaSeal (n = 55) or RFA (n = 42), conducted by a single surgeon within a managed care organization. Primary outcomes included successful greater saphenous vein (GSV) closure, postoperative deep vein thrombosis (DVT), embolization, saphenofemoral junction (SFJ) thrombosis, skin reaction (allergic or thrombophlebitis), or procedure-related emergency room (ER) and urgent care (UC) visits. Retrospective chart review was conducted to describe patient demographics, indications for treatment, treatment details (number of access sites and indication for treatment), as well as follow-up adjunctive vein procedures (sclerotherapy and stab phlebectomy). RESULTS: All patients had postprocedural ultrasound (US) performed within 7 days by the operating surgeon and mean overall patient follow-up from index procedure was 12 months; 2 patients were lost to follow-up due to death. All operations utilized intraoperative US, and SFJ thrombosis was not observed in any patient postprocedure. The average age of VenaSeal and RFA groups was 59.05 and 59.51 years, respectively. The average number of access sites during the procedure for VenaSeal and RFA was 1.56 and 1.20, respectively. Of the 55 VenaSeal treatments, 9.1% of patients reported postoperative skin reactions, and 9.1% of patients underwent subsequent stab phlebectomy (22 stabs on average). Of the 42 RFA treatments, 7.1% of RFA patients reported postoperative skin reactions, and 9.5% underwent subsequent stab phlebectomy (36 stabs on average). The percentage of patients who had postoperative UC or emergency department visits related to the procedure in the VenaSeal and RFA groups was 3.6% and 0%, respectively. CONCLUSIONS: Both VenaSeal and RFA demonstrated effective vein closure of the GSV at 12-month follow-up, with VenaSeal demonstrating continued noninferiority to RFA. Based on our data, postoperative skin reactions do not appear to be significantly higher with VenaSeal treatment, as previously reported.
Asunto(s)
Ablación por Catéter , Ablación por Radiofrecuencia , Várices , Insuficiencia Venosa , Adulto , Humanos , Persona de Mediana Edad , Ablación por Catéter/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento , Ablación por Radiofrecuencia/efectos adversos , Insuficiencia Venosa/diagnóstico por imagen , Insuficiencia Venosa/cirugía , Vena Safena/diagnóstico por imagen , Vena Safena/cirugía , Programas Controlados de Atención en Salud , Várices/diagnóstico por imagen , Várices/cirugía , Várices/etiologíaRESUMEN
BACKGROUND: This study aimed to retrospectively compare the clinical outcomes of endovenous microwave versus radiofrequency ablation combined with foam sclerotherapy in patients with lower limb varicose veins. METHODS: We identified patients with lower limb varicose veins treated with endovenous microwave ablation or radiofrequency ablation with foam sclerotherapy between January 2018 and June 2021 at our institution. Patients were followed-up for 12 months. Clinical results, including the pre-post-Aberdeen Varicose Vein Questionnaire and post-Aberdeen Varicose Vein Questionnaire and Venous Clinical Severity Score, were compared. Complications were documented and treated accordingly. RESULTS: We included 287 cases (295 limbs total; endovenous microwave ablation + foam sclerosing agent: n = 142, 146 limbs; radiofrequency ablation + foam sclerosing agent: n = 145, 149 limbs). The operative time was shorter for endovenous microwave ablation than radiofrequency ablation (42.58 ± 15.62 min vs. 65.46 ± 24.38 min, P < 0.05); however, other procedural parameters did not differ. Furthermore, hospitalization costs for endovenous microwave ablation were lower than those for radiofrequency ablation (21,063.74 ± 850.47 yuan vs. 23,312.40 ± 1,035.86 yuan, P < 0.05). At the 12-month follow-up, the great saphenous vein closure rate was similar in both groups (endovenous microwave ablation, 97% [142/146] vs. radiofrequency ablation, 98% [146/149]; P > 0.05). Additionally, the satisfaction or incidence rates of complications were not different among the groups. In both groups, the Aberdeen Varicose Vein Questionnaire and Venous Clinical Severity Score values were significantly lower 12 months postsurgery than before surgery; however, the postoperative values did not differ. CONCLUSIONS: Endovenous microwave ablation effectively treated lower limb varicose veins, with similar short-term effects as radiofrequency ablation. Moreover, it had a shorter operative time and was less expensive than endovenous radiofrequency ablation.
Asunto(s)
Ablación por Catéter , Terapia por Láser , Ablación por Radiofrecuencia , Várices , Insuficiencia Venosa , Humanos , Soluciones Esclerosantes , Microondas/efectos adversos , Terapia por Láser/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento , Várices/diagnóstico por imagen , Várices/cirugía , Escleroterapia/efectos adversos , Escleroterapia/métodos , Ablación por Radiofrecuencia/efectos adversos , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Vena Safena/diagnóstico por imagen , Vena Safena/cirugía , Extremidad Inferior/cirugía , Insuficiencia Venosa/cirugíaRESUMEN
BACKGROUND: Hepatocellular carcinoma (HCC) is the most common type of liver cancer, accounting for 90% of cases worldwide and a significant contributor to cancer-related deaths. This study comprehensively compares the safety and efficacy of laparoscopic liver resection (LLR) versus laparoscopic or percutaneous radiofrequency ablation (LRFA or PRFA) in patients with early and small HCC. METHODS: We systematically searched Cochrane Library, PubMed, Scopus, and Web of Science databases to include studies comparing LLR versus LRFA or PRFA in patients with early HCC meets the Milan criteria (defined as solitary nodule < 5 cm or three nodules ≤ 3 cm with no extrahepatic spread or vascular invasion). Pooled results were examined for overall survival, disease-free survival, recurrence-free survival, local, intrahepatic and extrahepatic recurrence rates, and complications. We conducted subgroup analyses based on the type of RFA. Meta-regression analyzed the association between overall survival, local recurrence, and various factors. The quality of the included studies was assessed using the Newcastle-Ottawa Scale. We analyzed the data using the R (v.4.3.0) programming language and the "meta" package of RStudio software. RESULTS: We included 19 observational studies, compromising 3756 patients. LLR showed higher 5-year overall survival compared to RFA (RR = 1.17, 95% CI [1.06, 1.3], P > 0.01). Our subgroup analysis showed that LLR had higher 5-year survival than PRFA (RR = 1.15, 95% CI [1.02, 1.31], P = 0.03); however, there was no significant difference between LLR and LRFA (RR = 1.26, 95% CI [0.98, 1.63], P = 0.07). LLR was associated with higher disease-free survival) RR = 1.19, 95% CI [1.05, 1.35], P < 0.01; RR = 1.61, 95% CI [1.31, 1.98], P < 0.01(and recurrence-free survival) RR = 1.21, 95% CI [1.09, 1.35], P < 0.01; RR = 1.45, 95% CI [1.15, 1.84], P < 0.01(at 1 and 3 years. LLR was associated with lower local (RR = 0.28, 95% CI [0.16, 0.47], P < 0.01) and intrahepatic recurrence (RR = 0.7, 95% CI [0.5, 0.97], P = 0.03) than RFA. However, complications were significantly higher with LLR (RR = 2.01, 95% CI [1.51, 2.68], P < 0.01). Our meta-regression analysis showed that younger patients had higher risk for local recurrence (P = 0.008), while age wasn't significantly linked to overall survival (P = 0.25). Other covariates like total bilirubin, alpha-fetoprotein levels, and tumor size also showed no significant associations with either overall survival or local recurrence. CONCLUSION: LLR offers improved long-term outcomes and lower recurrence rates than PRFA. However, no significant distinctions were observed between LRFA and LLR in overall survival, recurrence-free survival, and local recurrence. More robust well-designed RCTs are essential to validate our findings.
Asunto(s)
Carcinoma Hepatocelular , Laparoscopía , Neoplasias Hepáticas , Ablación por Radiofrecuencia , Humanos , Carcinoma Hepatocelular/cirugía , Hepatectomía/efectos adversos , Hepatectomía/métodos , Laparoscopía/efectos adversos , Laparoscopía/métodos , Neoplasias Hepáticas/cirugía , Recurrencia Local de Neoplasia/epidemiología , Recurrencia Local de Neoplasia/cirugía , Ablación por Radiofrecuencia/efectos adversos , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Non-small cell lung cancer (NSCLC) is a prevalent malignant tumor, and the commonly treatment modalities include surgery, radiotherapy, chemotherapy, etc. Currently, CT-guided percutaneous radiofrequency ablation (RFA) for the treatment of cancers has been widely performed. This study aimed to evaluate the safety and efficacy of this therapy in NSCLC patients. Thirty-five NSCLC patients were enrolled in this study and all received CT-guided percutaneous RFA therapy. The outcome measures included the changes in forced respiratory volume in the first second (FEV1), total lung volume (TLC), lesion size and computed tomography (CT) values of the region of interest (ROI) before and after treatment. The main efficacy measures comprised complete tumor ablation and local recurrence after initial treatment, as well as the objective response rate (ORR) and disease control rate (DCR) after 6 months of treatment. After receiving CT-guided percutaneous RFA therapy, the target lesion was effectively controlled and CT values gradually decreased. Besides, no significant changes were observed in the patient's lung function, postoperative complications were experienced by a total of 10 patients, primarily including pneumothorax, infection, lung hollowing. Fortunately, all these complications were successfully managed with appropriate treatment. Following the initial RFA treatment, 31 patients (88.57%) achieved complete ablation, while 6 patients experienced local recurrence. After 6 months of treatment, the ORR and DCR were found to be 68.57% and 82.86% respectively. CT-guided percutaneous RFA has demonstrated favorable safety and efficacy in the treatment of patients with NSCLC at different stages, which represented a promising therapeutic modality.
Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Ablación por Radiofrecuencia , Tomografía Computarizada por Rayos X , Humanos , Carcinoma de Pulmón de Células no Pequeñas/cirugía , Carcinoma de Pulmón de Células no Pequeñas/radioterapia , Neoplasias Pulmonares/cirugía , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/radioterapia , Masculino , Femenino , Persona de Mediana Edad , Ablación por Radiofrecuencia/métodos , Ablación por Radiofrecuencia/efectos adversos , Anciano , Resultado del Tratamiento , Adulto , Recurrencia Local de Neoplasia , Ablación por Catéter/métodos , Ablación por Catéter/efectos adversosRESUMEN
OBJECTIVE: Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has been constantly increasing, particularly in the treatment of pancreatic neuroendocrine neoplasms (pNENs). While emerging data in this field are accumulating, we aimed to assess the pooled efficacy and safety of EUS-RFA for pNENs. METHODS: The PubMed/Medline, Embase, and Cochrane Library databases search was conducted to identify studies reporting EUS-RFA of pNENs with outcomes of interest (efficacy and safety). The primary outcome was radiological response. Efficacy was assessed by the pooled clinical response rate, whereas safety was assessed by the pooled adverse events (AEs) rate. Heterogeneity was assessed using I2. Pooled estimates and the 95% confidence interval (CI) were calculated using a random-effect model. RESULTS: Eleven studies involving 292 patients were included. The pooled technical success rate was 99.2% (95% CI 97.9-99.9%), with no heterogeneity. The pooled complete radiological response was 87.1% (95% CI 80.1-92.8%). The pooled partial response was 11.4% (95% CI 6.2-18.1%). The pooled clinical response rate for functional pNENs was 94.9% (95% CI 90.7-97.9%), with no heterogeneity. The pooled incidence of AEs was 20.0% (95% CI 14.0-26.7%); most AEs were mild to moderate in grade, while the pooled incidence of severe AEs was 0.9% (95% CI 0.2-2.3%). The most common AEs were transient mild abdominal pain in 19 patients (6.5%), and mild to moderate pancreatitis in 23 patients (7.9%). No cases of mortality were reported. CONCLUSION: Endoscopic ultrasound-guided radiofrequency ablation resulted on a feasible approach for pNENs treatment, with excellent technical success, high radiological and clinical response, and acceptable AE rate.
Asunto(s)
Neoplasias Pancreáticas , Pancreatitis , Ablación por Radiofrecuencia , Humanos , Neoplasias Pancreáticas/cirugía , Neoplasias Pancreáticas/complicaciones , Endosonografía/métodos , Ablación por Radiofrecuencia/efectos adversos , Pancreatitis/etiología , Ultrasonografía IntervencionalRESUMEN
PURPOSE: The purpose of this study was to evaluate and compare the clinical efficacy of patients with cervical disc herniation (CDH) treated by low-temperature plasma radiofrequency ablation (LTP-RFA) as day surgery with traditional inpatients. METHODS: According to the selection criteria, single-segment mild to moderate CDH patients who received LTP-RFA from January 2020 to December 2021 were divided into day surgery procedure (DSP) group and a traditional inpatient procedure (TIP) group. The visual analogue score (VAS) and modified Japanese Orthopedic Association score (mJOA) of neurological function of patients in the two groups were recorded at the time of preoperative, and one day, three months, six months after surgery and the last follow-up respectively. The gender, age, responsible segment, surgical complications, hospitalization time, hospitalization expenses, and patient satisfaction were recorded and analyzed for both groups. The modified Macnab standard was used to evaluate the postoperative efficacy at one month and six months after operation. RESULTS: A total of 127 patients (75 in DSP;52 in TIP) with complete data were enrolled and completed six month follow-up. There were no statistically significant pre-treatment VAS scores and mJOA scores in the two groups (P>0.05). The postoperative VAS and mJOA scores in both groups were improved after surgery (P<0.05). However, there was no significant difference in VAS scores and mJOA scores between the two groups in the same postoperative period (all P > 0.05). The efficacy of MacNab was similar one month and six months after operation (P > 0.05). The hospitalization time and hospitalization cost were significantly lower in DSP group (all P<0.05). As the treatment effects were comparable, patients in both groups were similarly satisfied at discharge. CONCLUSION: LTP-RFA is an effective method for the treatment of mild to moderate CDH. We suggest that the application of LTP-RFA in DSP for mild to moderate CDH is worthy of wide application.
Asunto(s)
Desplazamiento del Disco Intervertebral , Ablación por Radiofrecuencia , Humanos , Desplazamiento del Disco Intervertebral/cirugía , Desplazamiento del Disco Intervertebral/complicaciones , Procedimientos Quirúrgicos Ambulatorios/efectos adversos , Temperatura , Resultado del Tratamiento , Ablación por Radiofrecuencia/efectos adversos , Vértebras Lumbares/cirugía , Estudios RetrospectivosRESUMEN
PURPOSE: Prior studies have described complications of radiofrequency ablation (RFA) of liver tumours. The aim of this study was to identify risk factors for hospitalization duration longer than 24 hours following RFA of liver tumours. METHODS: This retrospective, single-centre study included patients with liver tumours undergoing RFA between October 2017 and July 2020. Medical records were reviewed to collect patient, tumours, and procedure characteristics for each RFA session. The association between potential risk factors and duration of hospitalization (less than or more than 24 hours) was analyzed using univariate and multivariate logistic regressions. RESULTS: Our study included 291 patients (mean age: 65.2 ± 11.2 [standard deviation]; 201 men) undergoing 324 RFA sessions. Sixty-eight sessions (21.0%) resulted in hospitalization of more than 24 hours. Multivariate analysis identified each additional needle insertion per session (OR 1.4; 95% CI [1.1-1.9]; P = .02), RFA performed in segment V (OR 2.8; 95% CI [1.4-5.7]; P = .004), and use of artificial pneumothorax (OR 14.5; 95% CI [1.4-146.0]; P = .02) as potential risk factors. A history of hepatic encephalopathy (OR 2.6; 95% CI [1.1-6.0]; P = .03) was only significant in univariate analysis. Post-hoc, subgroup analysis of patients with hepatocellular carcinoma (69.8%) did not identify other risk factors. CONCLUSION: Risk factors for a hospitalization duration longer than 24 hours include a higher number of needle insertions per session, radiofrequency ablation in segment V, and use of an artificial pneumothorax.