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INTRODUCTION: Autologous cell-based therapies (CBT) to treat chronic kidney disease (CKD) with diabetes are novel and can potentially preserve renal function and decelerate disease progression. CBT dosing schedules are in early development and may benefit from individual bilateral organ dosing and kidney-dependent function to improve efficacy and durability. The objective of this open-label, phase 2 randomized controlled trial (RCT) is to evaluate participants' responses to rilparencel (Renal Autologous Cell Therapy-REACT®) following bilateral percutaneous kidney injections into the kidney cortex with a prescribed dosing schedule versus redosing based on biomarker triggers. METHODS: Eligible participants with type 1 or 2 diabetes and CKD, eGFR 20-50 mL/min/1.73 m2, urine albumin-to-creatinine ratio (UACR) 30-5,000 mg/g, hemoglobin >10 g/dL, and glycosylated hemoglobin <10% were enrolled. After a percutaneous kidney biopsy and bioprocessing ex vivo expansion of selected renal cells, participants were randomized 1:1 into two cohorts determined by the dosing scheme. Cohort 1 receives 2 cell injections, one in each kidney 3 months apart, and cohort 2 receives one injection and the second dose only if there is a sustained eGFR decline of ≥20 mL/min/1.73 m2 and/or UACR increase of ≥30% and ≥30 mg/g, confirmed by re-testing. CONCLUSION: The trial is fully enrolled with fifty-three participants. Cell injections and follow-up clinical visits are ongoing. This multicenter phase 2 RCT is designed to investigate the efficacy and safety of rilparencel with bilateral kidney dosing and compare two injection schedules with the potential of preserving or improving kidney function and delaying kidney disease progression among patients with stages 3a-4 CKD with diabetes.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Nefropatías Diabéticas , Insuficiencia Renal Crónica , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Tratamiento Basado en Trasplante de Células y Tejidos/métodos , Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 1/terapia , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/terapia , Nefropatías Diabéticas/terapia , Tasa de Filtración Glomerular , Riñón , Insuficiencia Renal Crónica/terapia , Trasplante Autólogo/métodos , Resultado del TratamientoRESUMEN
INTRODUCTION: Cell-based therapies potentially delay the trajectory toward end-stage kidney disease (ESKD) in late stage 4 diabetic chronic kidney disease (DKD). We describe the trial design, baseline patient characteristics, and early results of an IRB-approved phase II multicenter clinical trial, utilizing Renal Autologous Cell Therapy (REACT) in adults with pre-ESKD due to type 2 DKD. The trial objectives were safety and tolerability of REACT by assessment of the procedure, product administration, and renal-specific adverse events in addition to evaluate the impact on renal function following injection. METHODS: Ten adults with an eGFR of 14-20 mL/min/1.73 m2 were enrolled in a single-arm open-label trial. Following a percutaneous kidney biopsy, an ex vivo expansion of selected renal cells that form the REACT was injected into the cortex of the biopsied kidney with CT image guidance. Each participant received two doses of the REACT product at 6-month intervals. A 6-month observation pre-trial was required to establish patients' "own" baseline and rate of DKD progression. RESULTS: Five men and 5 women underwent 19 REACT injections (1 participant received only one injection). Their baseline characteristics were as follows: 3 Hispanic/Latino, 7 non-Hispanic, 7 white; mean (SD) age: 58.9 years (5.22), BMI 35.8 (8.2), eGFR (sCR) 15.5 (2.72), eGFR (sCR + Cys-C) 17.7 (3.67) mL/min/1.73 m2, sCr 3.6 mg/mL (0.73), Cys-C 2.6 mg/mL (0.52), and log random UACR 7.9 mg/g (1.01). The pre- and post-injection eGFR slope was -6.5 mL/min/1.73 m2 and -3.9 mL/min/1.73 m2. No cell-related adverse events occurred, and two procedure-related hematomas required observation without transfusion or angiographic interventions. Dialysis was delayed a mean of 16 months (range 6-28 months). At 15 months, 2 patients (20%) have eGFR slope stability and have not commenced renal replacement therapy. CONCLUSION: Trials that include patients with an eGFR of <20 mL/min/1.73 m2 are uncommon, and none to date involve autologous homologous cell-based treatments. REACT has the potential to stabilize or delay dialysis in high-risk late stage 4 DKD.
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Diabetes Mellitus Tipo 2 , Nefropatías Diabéticas , Fallo Renal Crónico , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Diabetes Mellitus Tipo 2/complicaciones , Nefropatías Diabéticas/diagnóstico , Nefropatías Diabéticas/etiología , Nefropatías Diabéticas/terapia , Tasa de Filtración Glomerular , Riñón/fisiología , Fallo Renal Crónico/diagnóstico , Fallo Renal Crónico/etiología , Fallo Renal Crónico/terapia , Diálisis Renal , Estudios Multicéntricos como Asunto , Ensayos Clínicos Fase II como Asunto , Tratamiento Basado en Trasplante de Células y TejidosRESUMEN
BACKGROUND: Cell therapies explore unmet clinical needs of patients with chronic kidney disease with the potential to alter the pathway toward end-stage kidney disease. We describe the design and baseline patient characteristics of a phase II multicenter clinical trial utilizing the novel renal autologous cell therapy (REACT), by direct kidney parenchymal injection via the percutaneous approach in adults with type 2 diabetic kidney disease (T2DKD), to delay or potentially avoid renal replacement therapy. DESIGN: The study conducted a prospective, multicenter, randomized control, open-label, phase II clinical trial between an active treatment group (ATG) receiving REACT from the beginning of the trial and a contemporaneous deferred treatment group (DTG) receiving standard of care for 12 months before crossing over to receive REACT. OBJECTIVES: The objective of this study was to establish the safety and efficacy of 2 REACT injections with computed tomography guidance, into the renal cortex of patients with T2DKD administered 6 months apart, and to compare the longitudinal change in renal function between the ATG and the DTG. SETTING: This was a multicenter study conducted in major US hospitals. PATIENTS: We enrolled eighty-three adult patients with T2DKD, who have estimated glomerular filtration rates (eGFRs) between 20 and 50 mL/min/1.73 m2. METHODS: All patients undergo an image-guided percutaneous kidney biopsy to obtain epithelial phenotype selective renal cells isolated from the kidney tissue that is then expanded ex vivo over 4-6 weeks, resulting in the REACT biologic product. Patients are randomized 1:1 into the ATG or the DTG. Primary efficacy endpoints for both study groups include eGFR measurements at baseline and at 3-month intervals, through 24 months after the last REACT injection. Safety analyses include biopsy-related complications, REACT injection, and cellular-related adverse events. The study utilizes Good Clinical and Manufacturing Practices and a Data and Safety Monitoring Board. The sample size confers a statistical power of 80% to detect an eGFR change in the ATG compared to the DTG at 24 months with an α = 0.05. LIMITATIONS: Blinding cannot occur due to the intent to treat procedure, biopsy in both groups, and open trial design. CONCLUSION: This multicenter phase II randomized clinical trial is designed to determine the efficacy and safety of REACT in improving or stabilizing renal function among patients with T2DKD stages 3a-4.
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Diabetes Mellitus Tipo 2 , Nefropatías Diabéticas , Insuficiencia Renal Crónica , Tratamiento Basado en Trasplante de Células y Tejidos , Ensayos Clínicos como Asunto , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/terapia , Nefropatías Diabéticas/diagnóstico , Femenino , Tasa de Filtración Glomerular , Humanos , Riñón/fisiología , Masculino , Estudios Prospectivos , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/terapia , Resultado del TratamientoRESUMEN
BACKGROUND: Advanced cell therapies with autologous, homologous cells show promise to affect reparative and restorative changes in the chronic kidney disease (CKD) nephron. We present our protocol and preliminary analysis of an IRB-approved, phase I single-group, open-label trial that tests the safety and efficacy of Renal Autologous Cell Therapy (REACT; NCT04115345) in adults with congenital anomalies of the kidney and urinary tract (CAKUT). METHODS: Adults with surgically corrected CAKUT and CKD stages 3 and 4 signed an informed consent and served as their "own" baseline control. REACT is an active biological ingredient acquired from a percutaneous tissue acquisition from the patient's kidney cortex. The specimen undergoes a GMP-compliant manufacturing process that harvests the selected renal cells composed of progenitors for renal repair, followed by image-guided locoregional reinjection into the patient's renal cortex. Participants receive 2 doses at 6-month intervals. Primary outcomes are stable renal function and stable/improved quality of life. Additional exploratory endpoints include the impact of REACT on blood pressure, vitamin D levels, hemoglobin, hematocrit and kidney volume by MRI analysis. RESULTS: Four men and 1 woman were enrolled and underwent 5 cell injections. Their characteristics were as follows: mean 52.8 years (SD 17.7 years), 1 Hispanic, 4 non-Hispanic, and 5 white. There were no renal tissue acquisition, cell injection, or cell product-related complications at baseline. CONCLUSION: REACT is demonstrating feasibility and patient safety in preliminary analysis. Autologous cell therapy treatment has the potential to stabilize or improve renal function in CAKUT-associated CKD to delay or avert dialysis. Patient enrollment and follow-up are underway.
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Corteza Renal/citología , Insuficiencia Renal Crónica/terapia , Trasplante de Células Madre , Células Madre/citología , Trasplante Autólogo , Adulto , Tratamiento Basado en Trasplante de Células y Tejidos , Células Cultivadas , Femenino , Humanos , Masculino , Persona de Mediana Edad , Calidad de Vida , Insuficiencia Renal Crónica/complicaciones , Trasplante de Células Madre/métodos , Trasplante Autólogo/métodos , Sistema Urinario/anomalías , Adulto JovenRESUMEN
Patients with acute cholecystitis sometimes require placement of percutaneous cholecystostomy catheters, either as a bridge to surgery or as primary therapy. In patients who cannot undergo surgery, subsequent removal of the catheter can lead to recurrence of cholecystitis, whereas leaving the drain in place can cause adverse events. We investigated internalization of percutaneous cholecystostomy drainage catheters, using endoscopic ultrasound (EUS)-guided placement of lumen-apposing metal stents (LAMS) as an alternative treatment strategy. Seven patients (median age, 57 years; 6 men) underwent EUS-guided cholecystoenterostomy for internalization of gallbladder drainage with EUS-guided placement of a 10- or 15-mm LAMS. All had initially been treated with placement of a percutaneous cholecystostomy catheter for cholecystitis and were later deemed unfit for cholecystectomy. Technical success was achieved in all patients in 1 endoscopic session, with subsequent removal of all percutaneous drains. Two patients required placement of self-expandable metal stents within the LAMS to successfully bridge the gallbladder and gastrointestinal lumen. No adverse events occurred after a median follow-up of 2.5 months. EUS-guided cholecystoenterostomy using a LAMS is therefore a viable option for internal gallbladder drainage in patients who have a percutaneous cholecystostomy catheter and are poor candidates for cholecystectomy.
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Colecistitis/cirugía , Drenaje/métodos , Endoscopía/métodos , Enterostomía/métodos , Vesícula Biliar/cirugía , Stents , Adulto , Anciano , Anciano de 80 o más Años , Drenaje/instrumentación , Enterostomía/instrumentación , Femenino , Humanos , Masculino , Metales , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
A multiparous obese patient with prior abdominal surgeries complained of cyclic abdominal pain located near the surgical scar. A 1 cm lesion was identified on imaging. Computed tomography-guided needle localization was performed immediately before surgery. This allowed for complete excision of the abdominal wall endometrioma and resolution of the cyclic, focal abdominal pain.
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Pared Abdominal , Endometriosis/diagnóstico por imagen , Pared Abdominal/cirugía , Adulto , Endometriosis/cirugía , Femenino , Humanos , Cirugía Asistida por Computador , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND: Optimal administration of transarterial chemoembolization (TACE), the standard approach for intermediate-stage hepatocellular carcinoma (HCC), requires clinical and technical expertise. We sought to evaluate whether TACE retains its effectiveness when administered across a broad range of health care settings. Furthermore, as the use of yttrium(90) (Y(90)) radioembolization has been increasing, we explored the comparative effectiveness of Y(90) as an alternative to TACE. METHODS: Patients with HCC diagnosed from 2004 through 2009 treated initially with TACE or Y(90) were identified from the SEER-Medicare linkage. Key covariates included prediagnosis α-fetoprotein (AFP) screening, complications of cirrhosis, and tumor extent. Effect of treatment, patient, and health care system factors on overall survival (OS) was evaluated using multivariable Cox proportional hazards. Stratified OS estimates are provided. Propensity score (PS) weighting was used to compare effectiveness of Y(90) with TACE. RESULTS: Of 1528 patients who underwent intra-arterial embolization, 577 received concurrent chemotherapy (eg, TACE). Median OS was 21 months (95% CI, 18-23) following TACE and 9 months (95% CI, 1-41) following Y(90). Refined survival estimates stratified by stage, AFP screening, and liver comorbidity are presented. The 90-day mortality rate after TACE was 21% to 25% in patients with extrahepatic spread or vascular invasion. In the PS-weighted analysis, Y(90) was associated with inferior survival, with an adjusted hazard ratio of 1.39 (95% CI, 1.02-1.90). CONCLUSIONS: The effectiveness of TACE is generalizable to Medicare patients receiving care in a variety of treatment settings. However, early posttreatment mortality is high in patients with advanced disease. We found no evidence of improved outcomes with Y(90) compared with TACE. Survival estimates from this large cohort can be used to provide prognostic information to patients considering palliative TACE.
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Antineoplásicos/administración & dosificación , Carcinoma Hepatocelular/terapia , Quimioembolización Terapéutica/métodos , Neoplasias Hepáticas/terapia , Radioisótopos de Itrio/administración & dosificación , Anciano , Carcinoma Hepatocelular/mortalidad , Carcinoma Hepatocelular/patología , Femenino , Humanos , Cirrosis Hepática/complicaciones , Neoplasias Hepáticas/mortalidad , Neoplasias Hepáticas/patología , Masculino , Medicare , Persona de Mediana Edad , Invasividad Neoplásica , Estadificación de Neoplasias , Puntaje de Propensión , Programa de VERF , Tasa de Supervivencia , Carga Tumoral , Estados Unidos , alfa-Fetoproteínas/metabolismoRESUMEN
Enterocutaneous fistulae (ECFs) are abnormal sinus tract communications between the alimentary system and skin surface that can cause significant management problems and cost to the health care system. Interventional radiology can play an important role in diagnosis and treatment when conventional measures fail and additional surgery is difficult or poses a high risk. The management of patients with fistulae requires operator ingenuity and dedication, a multidisciplinary team approach, and an understanding of the pathophysiology. This article reviews the major issues in ECF management and the role of interventional radiology.
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Fístula Intestinal/diagnóstico , Fístula Intestinal/terapia , Radiología Intervencionista , HumanosRESUMEN
With improved genetic testing and genomic sequencing, abnormalities are increasingly being identified in affected or germline tissues in DNA of patients with vascular tumors, vascular malformations, and lymphedema. Recognition of the genetics of vascular anomalies should help clinicians make more specific diagnoses, anticipate diagnosis-specific morbidities, provide better genetic counseling, and have a better understanding of the pathogenesis of these anomalies. Growing pharmacologic options, including therapies targeted to specific mutations, with obvious parallels to cancer treatment now allow the pediatric hematologist-oncologist to assume a more prominent role in clinical care and research for patients with these diagnoses. We summarize genes and genetic loci that have been associated with vascular anomalies and offer guidelines for patient evaluations.
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Predisposición Genética a la Enfermedad/genética , Hemangioma/genética , Linfedema/genética , Malformaciones Vasculares/genética , Neoplasias Vasculares/genética , Niño , HumanosRESUMEN
Introduction: Chronic kidney disease (CKD) is a worldwide disease without cure. Selected renal cells (SRCs) can augment kidney function in animal models. This study correlates the phenotypical characteristics of autologous homologous SRCs (formulated product called Renal Autologous Cell Therapy [REACT]) injected into patients' kidneys with advanced type 2 diabetes-related CKD (D-CKD) to clinical and laboratory findings. Methods: A total of 22 adults with type 2 D-CKD underwent a kidney biopsy followed by 2 subcortical injections of SRCs, 7 ± 3 months apart. There were 2 patients who had only 1 injection. We compared annualized estimated glomerular filtration rate (eGFR) slopes pre- and post-REACT injection using the 2009 CKD-EPI formula for serum creatinine (sCr) and the 2012 CKD-EPI Creatinine-Cystatin C equation and report clinical/laboratory changes. Fluorescent Activated Cell Sorting (FACS) Analysis for renal progenitor lineages in REACT and donor vascular endothelial growth factor A (VEGF-A) analysis were performed. Longitudinal parameter changes were analyzed with longitudinal linear mixed effects model. Results: At baseline, the mean diabetes duration was 18.4 ± 8.80 years, glycated hemoglobin (Hgb) was 7.0 ± 1.05, and eGFR was 40.3 ± 9.35 ml/min per 1.73 m2 using the 2012 CKD-EPI cystatin C and sCr formulas. The annualized eGFR slope (2012 CKD-EPI) was -4.63 ml/min per 1.73 m2 per year pre-injection and improved to -1.69 ml/min per 1.73 m2 per year post-injection (P = 0.015). There were 7 patients who had an eGFR slope of >0 ml/min per 1.73 m2 postinjection. SRCs were found to have cell markers of ureteric bud, mesenchyme cap, and podocyte sources and positive VEGF. There were 2 patients who had remote fatal adverse events determined as unrelated with the biopsies/injections or the REACT product. Conclusion: Our cell marker analysis suggests that SRCs may enable REACT to stabilize and improve kidney function, possibly halting type 2 D-CKD progression.
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PURPOSE: To evaluate the feasibility, efficacy, and safety of a temporary balloon tamponade technique for managing subclavian arterial injury secondary to inadvertent central venous catheter placement. MATERIALS AND METHODS: Patients with subclavian arterial injury caused by inadvertent placement of a central venous catheter (size range 7-F to 7.5-F) who were treated only with temporary balloon tamponade between February 2002 and October 2009 were included. A temporary balloon tamponade technique was used to treat 13 patients (6 men and 7 women; mean age 56.7 years; age range 28-80 years). Technical success, total balloon inflation time, and complications were evaluated. RESULTS: Technical success was achieved with the temporary balloon tamponade technique in 13 cases (100%). Eight patients were treated with one balloon inflation, and five patients with two inflations (mean inflations 1.4). The mean total balloon inflation time was 14 minutes ± 13. There was no recurrent bleeding, hematoma, or pseudoaneurysm that required additional interventional procedures or surgical repair. A thrombus was identified in the subclavian arterial lumen after removal of the balloon catheter in one case; however, the thrombus was nonocclusive and asymptomatic. CONCLUSIONS: Temporary balloon tamponade seems to be technically feasible and effective with a good safety profile in the management of subclavian arterial injury caused by inadvertent central venous catheter placement. Intraluminal thrombus can be an associated complication of the procedure.
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Oclusión con Balón , Cateterismo Venoso Central/efectos adversos , Catéteres de Permanencia/efectos adversos , Hemorragia/terapia , Arteria Subclavia/lesiones , Lesiones del Sistema Vascular/terapia , Adulto , Anciano , Anciano de 80 o más Años , Oclusión con Balón/efectos adversos , Cateterismo Venoso Central/instrumentación , Diseño de Equipo , Estudios de Factibilidad , Femenino , Hemorragia/diagnóstico por imagen , Hemorragia/etiología , Humanos , Enfermedad Iatrogénica , Masculino , Persona de Mediana Edad , North Carolina , Radiografía Intervencional , Estudios Retrospectivos , Arteria Subclavia/diagnóstico por imagen , Trombosis/etiología , Factores de Tiempo , Resultado del Tratamiento , Lesiones del Sistema Vascular/diagnóstico por imagen , Lesiones del Sistema Vascular/etiologíaRESUMEN
As the basic units of biological organization, stem cells and their progenitors are essential for developing and regenerating organs and tissue systems using their unique self-renewal capability and differentiation potential into multiple cell lineages. Stem cells are consistently present throughout the entire human development, from the zygote to adulthood. Over the past decades, significant efforts have been made in biology, genetics, and biotechnology to develop stem cell-based therapies using embryonic and adult autologous or allogeneic stem cells for diseases without therapies or difficult to treat. Stem cell-based therapies require optimum administration of stem cells into damaged organs to promote structural regeneration and improve function. Maximum clinical efficacy is highly dependent on the successful delivery of stem cells to the target tissue. Direct image-guided locoregional injections into target tissues offer an option to increase therapeutic outcomes. Interventional radiologists have the opportunity to perform a key role in delivering stem cells more efficiently using minimally invasive techniques. This review discusses the types and sources of stem cells and the current clinical applications of stem cell-based therapies. In addition, the regulatory considerations, logistics, and potential roles of interventional Radiology are also discussed with the review of the literature.
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PURPOSE: To assess the success of direct percutaneous puncture of the recanalized paraumbilical vein (RPUV) for access and visualization of the portal vein (PV) to guide transhepatic puncture during transjugular intrahepatic portosystemic shunt (TIPS) creation. The predictive value of successful catheterization based on preprocedural vein diameter was analyzed. MATERIALS AND METHODS: A retrospective review of all TIPS procedures from 2002 to 2008 performed at a single institution was conducted, and a subset of procedures in which portal venography was attempted via the paraumbilical vein were identified. In this subset, TIPS outcomes and diameters of the RPUV near the skin puncture site and left PV junction were measured and analyzed with a two-tailed Student t test. RESULTS: During the study period, 114 TIPSs were created. RPUV punctures were found in 22 patients (19.3%) and portal venography was successful in 14 of the 22 patients (64%), all without complications. In the remainder (n = 8), access via the RPUV failed secondary to a small vein diameter (< 0.3 cm; n = 3), moderate to severe vessel tortuosity (n = 4), and distal thrombosis (n = 1). Puncture, catheterization, and portal venography was successful when the paraumbilical vein measured a mean of 0.75 cm at the skin and a mean of 0.84 cm at the junction with the left PV when analyzed against the failed attempts. CONCLUSIONS: Portal venography via the RPUV is a feasible and probably safe alternative to other methods of PV opacification during TIPS procedures.
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Vena Porta/cirugía , Derivación Portosistémica Quirúrgica/métodos , Punciones/métodos , Venas Umbilicales/cirugía , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Derivación Portosistémica Quirúrgica/efectos adversos , Punciones/efectos adversos , Resultado del TratamientoRESUMEN
PURPOSE: Patients with portal vein thrombosis (PVT) and hepatocellular carcinoma (HCC) have limited treatment options because of increased disease burden and diminished hepatic perfusion. Yttrium-90 ((90)Y) microspheres may be better tolerated than chemoembolization in these patients. The present study reviews the safety and efficacy of (90)Y microspheres in HCC with major PVT. MATERIALS AND METHODS: A retrospective review of HCC with main (n = 10) or first-branch (n = 12) PVT treated with (90)Y microspheres (N = 22) was conducted. Cancer of the Liver Italian Program (CLIP) scores ranged from 2 to 5, with 18% of patients having a score of 4 or greater. Imaging response at 8-12 was based on Response Evaluation Criteria In Solid Tumors. Overall survival (OS) was estimated by the Kaplan-Meier method. RESULTS: A total of 32 microsphere treatments (26 glass, six resin) were administered to 22 patients. Common grade 1/2 toxicities included abdominal pain (38%), nausea (28%), and fatigue (22%). Four posttreatment hospitalizations occurred, all less than 48 hours in duration. One death occurred 10 days after therapy. The partial response rate was 8% and progressive disease was seen in 42% of patients. Stable disease was achieved in 50% of treatments. Median OS was 7 months from initial treatment. Patients with Child-Pugh class A disease had a median OS of 7.7 months; those with class B/C disease had an OS of 2.7 months (P = .01). Median OS for patients with CLIP scores of 2/3 was 7 months, versus 1.3 months for those with scores of 4/5 (P = .04). CONCLUSIONS: Yttrium-90 microspheres are tolerated in patients with HCC and major PVT. Compared with chemoembolization, rates of severe adverse events appear low. Radiographic response rates are low. The median OS of 7 months is promising and warrants further study versus systemic therapy.
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Braquiterapia , Carcinoma Hepatocelular/radioterapia , Neoplasias Hepáticas/radioterapia , Vena Porta , Radiofármacos/administración & dosificación , Trombosis de la Vena/complicaciones , Radioisótopos de Itrio/administración & dosificación , Adolescente , Adulto , Anciano , Braquiterapia/efectos adversos , Carcinoma Hepatocelular/complicaciones , Carcinoma Hepatocelular/mortalidad , Carcinoma Hepatocelular/patología , Quimioembolización Terapéutica/efectos adversos , Supervivencia sin Enfermedad , Femenino , Humanos , Estimación de Kaplan-Meier , Neoplasias Hepáticas/complicaciones , Neoplasias Hepáticas/mortalidad , Neoplasias Hepáticas/patología , Masculino , Microesferas , Persona de Mediana Edad , North Carolina , Radiofármacos/efectos adversos , Estudios Retrospectivos , Tasa de Supervivencia , Factores de Tiempo , Resultado del Tratamiento , Trombosis de la Vena/mortalidad , Adulto Joven , Radioisótopos de Itrio/efectos adversosRESUMEN
Sirolimus (Rapamune), a mammalian target of Rapamycin (mTOR) inhibitor, which has been used extensively in children following solid organ transplantation, has been demonstrated to have anti-angiogenic activity in pre-clinical models. Limited experience suggests that it may have application to the treatment of vascular lesions. We describe our experience with a 1-year-old female with a kaposiform hemangioendothelioma and Kasabach-Merritt phenomenon who had rapid and dramatic response to sirolimus (0.1 mg/kg/day). This case provides further rationale for clinical trials of sirolimus in the treatment of vascular lesions.
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Inhibidores de la Angiogénesis/uso terapéutico , Antibióticos Antineoplásicos/uso terapéutico , Hemangioendotelioma/tratamiento farmacológico , Sirolimus/uso terapéutico , Neoplasias Cutáneas/tratamiento farmacológico , Femenino , Hemangioendotelioma/sangre , Hemangioendotelioma/patología , Humanos , Lactante , Recuento de Plaquetas , Neoplasias Cutáneas/sangre , Neoplasias Cutáneas/patologíaRESUMEN
Females with symptomatic leiomyomas (fibroids) wishing to maintain fertility are faced with difficult treatment choices. These include uterine fibroid embolization (UFE), myomectomy, hormonal therapy, MRI high intensity focused ultrasound, and myolysis. This review focuses on UFE, one of the most commonly accepted minimally invasive procedural choices among patients with symptomatic fibroids wishing to retain the option of becoming pregnant in the future, and makes comparisons to myomectomy which has historically been the surgical choice for fertility-preserving fibroid treatment. Pubmed and Google Scholar searches using keywords such as: uterine artery embolization, uterine fibroid embolization, pregnancy, complications, infertility were performed between Jan 1, 2019 and May 10, 2019. Publications were chosen based on their inclusion of information pertaining to fertility or pregnancy after UFE without being limited to single case reports.Randomized controlled trials comparing myomectomy and UFE are limited due to study size and confounding variables, but through registry data and familiarity with referring clinicians, UFE has gained wide acceptance. Healthy pregnancies following UFE have been sporadically reported but the actual fertility rate after UFE remains uncertain. Conversely, low birth weight, miscarriage and prematurity have been associated with UFE. Despite inherent risks of possible fertility issues after UFE, the procedure remains an option for females with clinically symptomatic fibroids who desire pregnancy. However, additional research regarding rates of conception and obstetrical risks of infertility following UFE is necessary.
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Leiomioma/terapia , Complicaciones Neoplásicas del Embarazo/terapia , Embolización de la Arteria Uterina , Neoplasias Uterinas/terapia , Femenino , Humanos , Infertilidad Femenina/etiología , Selección de Paciente , Embarazo , Resultado del Embarazo , Embolización de la Arteria Uterina/efectos adversosRESUMEN
BACKGROUND: Despite a growing body of evidence guiding appropriate perioperative thromboprophylaxis in the general population, few data direct strategies to reduce deep venous thrombosis (DVT) and pulmonary embolism (PE) in the morbidly obese. We have implemented a novel protocol for venous thromboembolism (VTE) risk stratification in Roux-en-Y gastric bypass (RYGB) candidates at our institution, which augments clinical assessment with screening for thrombophilias, to guide retrievable inferior vena cava (IVC) filter utilization. METHODS: A retrospective review of prospectively collected data from patients who underwent primary RYGB between 2001 and 2008 at the University of North Carolina at Chapel Hill was completed. During that time, clinical assessment of VTE risk was amplified by focused plasma screening for common thrombophilias (factors VIII, IX, and XI, d-dimer, fibrinogen). Preoperative prophylactic IVC filters were offered to high-risk patients. The database was reviewed for perioperative DVTs, PEs, and filter-related complications. RESULTS: Of 330 patients, in 162 attempts, 160 had prophylactic IVC filters placed with four complications overall (2.47%). No patient had symptoms of PE during the planned 6-week filter period, though one had a PE occur immediately after filter removal (0.63%); in contrast, five of 170 patients (2.94%) without prophylactic IVC filters presented with symptomatic PE (p = 0.216). In total, 147 (91.88%) prophylactic filters were removed. CONCLUSIONS: Risk-group targeted prophylactic inferior vena cava filter placement prior to RYGB is safe with a trend towards reduced occurrence of PE.
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Derivación Gástrica , Complicaciones Posoperatorias/prevención & control , Filtros de Vena Cava , Tromboembolia Venosa/prevención & control , Femenino , Humanos , Masculino , Cuidados Preoperatorios , Embolia Pulmonar/prevención & control , Estudios Retrospectivos , Medición de RiesgoRESUMEN
Esophageal perforation with subsequent development of a mediastinal abscess is a well-known clinical entity. Etiologies including idiopathic and iatrogenic with invasive procedures have been reported in medical literatures. This condition is seriously associated with high co-morbidity and in some cases especially if intervention has not been applied associated with high mortality. For long time, open surgical intervention was the only available treatment modality for esophageal perforation with subsequent development of a mediastinal abscess. However, recently there are some other less invasive modalities that have been used with comparable if not preferable success including; self-expandable metallic or plastic stents and imaging guided percutaneous drainage of the mediastinal abscess combined with stenting. We report a patient who presented with esophageal perforation complicated with a mediastinal abscess that was treated successfully with an imaging guided percutaneous drainage of the mediastinal abscess. This case is to emphasize on the fact that endoscopic stent placement is safe and effective for esophageal perforations. Percutaneous CT-guided drainage of associated mediastinal abscesses is an uncommon procedure, but the results suggest that it is associated with high technical and clinical success rates. There should be increased involvement of interventional radiology in the management of those cases.