6 research outputs found
A nonâinferiority comparative analysis of microâultrasonography and MRIâtargeted biopsy in men at risk of prostate cancer
Objective: To compare the efficacy of multiparametric magnetic resonance imaging (mpMRI)-directed and micro-ultrasonography (micro-US)-directed biopsy for detecting clinically significant (Grade Group >1) prostate cancer (csPCa).
Materials and methods: A total of 203 patients were prospectively enrolled at three institutions across Germany and Austria in the period from January 2019 to December 2019. During each biopsy, the urologist was blinded to the mpMRI report until after the micro-US targets had been assessed. After unblinding, targets were then sampled using software-assisted fusion, followed by systematic samples. The primary outcome measure was non-inferiority of micro-US to detect csPCa, with a detection ratio of at least 80% that of mpMRI.
Results: A total of 79 csPCa cases were detected overall (39%). Micro-US-targeted biopsy detected 58/79 cases (73%), while mpMRI-targeted biopsy detected 60/79 (76%) and non-targeted (completion sampling) samples detected 45/79 cases (57%). mpMRI-targeted samples alone detected 7/79 (9%) csPCa cases which were missed by micro-US-targeted and non-targeted samples. Three of these seven were anterior lesions with 2/7 in the transition zone. Micro-US-targeted samples alone detected 5/79 (6%) and completion sampling alone detected 4/79 cases (5%). Micro-US was non-inferior to mpMRI and detected 97% of the csPCa cases detected by mpMRI-targeted biopsy (95% CI 80-116%; P = 0.023).
Conclusions: This is the first multicentre prospective study comparing micro-US-targeted biopsy with mpMRI-targeted biopsy. The study provides further evidence that micro-US can reliably detect cancer lesions and suggests that micro-US biopsy might be as effective as mpMRI for detection of csPCA. This result has significant implications for increasing accessibility, reducing costs and expediting diagnosis
Extended Criteria Donors in Living Kidney Transplantation Including Donor Age, Smoking, Hypertension and BMI
Purpose: An expansion of selection criteria for deceased organ transplantation already exists to manage the current donor shortage. Comparable evaluation of risk factors for living donors should be investigated to improve this issue.
Patients and methods: Our retrospective single-centre study analysed 158 patients with living kidney transplants performed between February 2006 and June 2012. We investigated the influence of donor risk factors (RF) including body mass index over 30 kg/m2, age >60 years, active nicotine abuse and arterial hypertension on postoperative kidney function with focus on the recipients. This was measured for long-term survival and glomerular filtration rate (GFR) in a 5-year follow-up.
Results: Overall, out of 158 living donors, 84 donors were identified to have no risk factors, whereas 74 donors had at least one risk factor. We noted a significant higher delayed graft function (p=0.042) in the first 7 days after transplantation, as well as lower GFR of recipients of allografts with risk factors in the first-year after transplantation. In our long-term results, there was no significant difference in the functional outcome (graft function, recipient and graft survival) between recipients receiving kidneys from donors with no and at least one risk factors. In the adjusted analysis of subgroups of different risk factors, recipients of donors with "age over 60 years" at time of transplantation had a decreased transplant survival (p=0.014).
Conclusion: Thus, a careful expansion for selection criteria for living donors with critical evaluation could be possible, but especially the age of the donors could be a limited risk factor
Morphological analysis of injured gluteal muscles after intraoperative transplantation of allogeneic mesenchymal stromal cells in THA patients
Einleitung: Beim transglutealen Zugang zur Implantation einer
HuÌfttotalendoprothese (HTEP) wird der Musculus gluteus medius (GM) inzidiert,
um eine optimale Darstellung fuÌr den Gelenkersatz zu erreichen. Vor allem bei
schwereren MuskelschaÌdigungen kann es zu einer unvollstaÌndigen Reparatur
kommen, die auf Basis des Verlustes kontraktiler Einheiten sowie deren Ersatz
durch Fett- und Bindegewebe zu funktionellen EinschraÌnkungen fuÌhrt. Die
MoÌglichkeit Regenerationsprozesse durch zellbasierte TherapieansaÌtze zu
unterstuÌtzen wird aktuell vielseitig untersucht. Ziel dieser Arbeit ist es,
den Einfluss von mesenchymalen Stromazellen der Plazenta (Placental expanded
stromal cell product, PLX Zellen) auf den traumatisierten GM nach einer HTEP-
Implantation anhand von morphologischen Parametern zu evaluieren. Methodik: In
einer monozentrischen, placebo-kontrollierten, doppelblinden, prospektiven
Studie wurden 20 Patienten drei Gruppen randomisiert zugeordnet und
untersucht. Nach der HTEP-Implantation wurden folgende Studieninterventionen
verglichen: intramuskulaÌre Applikation von 1) Placebo (N=7), 2) 150 x 106
(N=7) und 3) 300 x 106 (N=6) PLX Zellen. Zur Analyse der Makromorphologie
wurden Magnetresonanztomografie- (MRT) Aufnahmen praÌoperativ und 6, 12 sowie
26 Wochen postoperativ durchgefuÌhrt und das Muskelvolumen und die fettige
Infiltration analysiert. FuÌr die Mikrostruktur wurden intraoperativ und 12
Wochen postoperativ eine Muskelbiopsie des GM entnommen und folgende
histologische Analysen durchgefuÌhrt: Muskelfaserdurchmesser, Anzahl der
Regeneratfasern, Fasertypverteilung, GefaÌĂdichte, Infiltration mit
T-Lymphozyten und Makrophagen. Ergebnisse: 26 Wochen postoperativ zeigte die
MRT-Analyse einen signifikanten Unterschied der Muskelvolumenzunahme bei
Patienten, welche mit 150M PLX Zellen therapiert worden waren im Vergleich zur
Placebogruppe (p=0.004). Patienten der 300M Gruppe erwiesen sich als inferior
zur 150M Gruppe mit einem GM Volumen, das zwischen Placebo und 150M lag. Die
VeraÌnderung des intramuskulaÌren Fettanteils war in allen Gruppen gleich. In
der mikromorphologischen Analyse zeigte sich ein Muster, welches schneller
ablaufende RegenerationsvorgaÌnge nach Zelltherapie beschrieb. Gekennzeichnet
war dies durch noch bestehende Anzeichen fuÌr Regeneration in der
Placebogruppe, wie Myoblasten und kleinere Faserdurchmesser, 12 Wochen
postoperativ. Angiogene Effekte sowie VeraÌnderungen der Fasertypverteilung
konnten in der Biopsie nicht beobachtet werden. Ein Einfluss der Zelltherapie
auf lokale immunologische Parameter, wie Lymphozyten- und
Makrophageninfiltration, konnte ebenfalls nicht nachgewiesen werden.
Schlussfolgerung: Die mikro- und makromorphologische Untersuchung des
traumatisierten GM nach klinischer Anwendung von PLX Zellen weist auf einen
moÌglichen Wirkmechanismus uÌber die Zunahme kontraktilen Muskelgewebes hin.
Eine schnellere Regeneration koÌnnte ebenfalls eine Rolle spielen. FuÌr
definitive Aussagen sind weitere Studien mit groÌĂeren Patientenzahlen
notwendig.Introduction: During transgluteal total hip arthroplasty (THA) the gluteus
medius muscle (GM) is incised to achieve an ideal exposure for the hip
replacement. Particularly severe muscle traumas can induce an insufficient
repair which can lead to functional limitations based on a lack of contractile
units and a replacement by fatty and fibrotic tissue. Currently the potential
to support the regeneration process by cell-based therapies is investigated
widely. The aim of this thesis is to evaluate the influence of mesenchymal
stromal cells of the placenta (placental expanded stromal cell product, PLX
cells) on the traumatized GM after THA with the focus on morphological
parameters. Method: In a monocentric, placebo-controlled, double blind,
prospective study 20 patients were randomized in three groups and examined.
After the THA the following study interventions were compared: intramuscular
application of 1) placebo (N=7), 2) 150 x 106 (N=7) and 3) 300 x 106 (N=6) PLX
cells. For the macromorphological analysis magnet resonance imaging (MRI)
images were investigated for muscle volume and fatty infiltrations
preoperatively and 6, 12, as well as 26 weeks postoperatively. For the
analysis of the microstructure muscle biopsies of the GM were removed
intraoperatively and 12 weeks postoperatively for the following measurements:
muscle fibre diameter, amount of regenerated fibres, fibre type distribution,
vessel density, infiltration of t- lymphocytes and macrophages. Results: 26
weeks postoperatively the MRI analysis demonstrated a significant difference
in the increase of muscle volume in patients treated with 150M PLX cells in
comparison to the placebo group (p=0.004). Patients of the 300M group
represented inferior to the 150M group with a GM volume which was between the
placebo and 150M. The change of intramuscular fat was equal in all groups. The
micromorphological analysis presented a pattern describing faster regeneration
processes after cell therapy. This was marked by ongoing regeneration in the
placebo group 12 weeks postoperatively, as represented by myoblasts and minor
fibre size diameter. Angiogenic effects and changes in fibre type distribution
were not detected in the biopsy. An influence of the cell therapy on local
immunological parameters, like the infiltration of the lymphocytes and the
macrophages, was equally not established. Conclusion: The micro- and
macromorphological analysis of the traumatised GM after clinical application
of PLX cells indicate an increase of contractile muscle tissue as a potential
mode of action. A faster regeneration could also be relevant. For definitive
statements further studies with higher number of patients are necessary
The Ureter in the Kidney Transplant Setting: Ureteroneocystostomy Surgical Options, Double-J Stent Considerations and Management of Related Complications
Purpose of Review: In the setting of kidney transplantation, the ureter is a common source for complications. As a result, prevention of ureteral complications and their management is of crucial importance. In this context, the purpose of this review is to summarize recent literature on the ureter in the kidney transplant setting with a special focus on new findings. We conducted a PubMed and Medline search over the last 10 years to identify all new publications related to ureteroneoimplantations, stents and management of complications in the kidney transplant setting.
Recent Findings: Performance of the âLich-Gregoirâ technique for ureteroneocystostomy seems to be favourable in regard to postoperative complications when compared with other methods described in the literature. Moreover, major urologic complications can be further reduced by ureteral stenting.
Summary: A new approach for management of ureteral strictures in renal transplants is presented. We discussed the usage of a ureteral stent covered with a biostable polymer aiming to prevent tissue ingrowth into the lumen as a new option for management of ureteral stricture in the kidney transplant setting
Follow-Up of Men Who Have Undergone Focal Therapy for Prostate Cancer with HIFUâA Real-World Experience
Purpose: To determine oncological and functional outcomes and side effects after focal therapy of prostate cancer (PCa) with high-intensity focused ultrasound (HIFU). Methods: This retrospective single-center study included 57 consecutive patients with localised PCa. Aged 18â80 with â€2 suspicious lesions on mpMRI (PIRADS â„ 3), PSA of â€15 ng/mL, and an ISUP GG of â€2. HIFU was performed between November 2014 and September 2018. All men had an MRI/US fusion-guided targeted biopsy (TB) combined with a TRUS-guided 10-core systematic biopsy (SB) prior to focal therapy. HIFU treatment was performed as focal, partial, or hemiablative, depending on the prior histopathology. Follow-up included Questionnaires (IIEF-5, ICIQ, and IPSS), prostate-specific antigen (PSA) measurement, follow-up mpMRI, and follow-up biopsies. Results: The median age of the cohort was 72 years (IQR 64â76), and the median PSA value before HIFU was 7.3 ng/mL (IQR 5.75â10.39 ng/mL). The median follow-up was 27.5 (IQR 23â41) months. At the time of the follow-up, the median PSA value was 2.5 ng/mL (IQR 0.94â4.96 ng/mL), which shows a significant decrease (p p < 0.001). The rate of post-HIFU complications was low, at 19.3% (11 patients). The limitation of this study is the lack of long-term follow-up. Conclusions: HIFU as a therapy option for nonmetastatic, significant prostate cancer is effective in the short term for carefully selected patients and shows a low risk of adverse events and side effects
Immunomodulatory placentalâexpanded, mesenchymal stromal cells improve muscle function following hip arthroplasty
Abstract Background No regenerative approach has thus far been shown to be effective in skeletal muscle injuries, despite their high frequency and associated functional deficits. We sought to address surgical traumaârelated muscle injuries using local intraoperative application of allogeneic placentaâderived, mesenchymalâlike adherent cells (PLXâPAD), using hip arthroplasty as a standardized injury model, because of the high regenerative and immunomodulatory potency of this cell type. Methods Our pilot phase I/IIa study was prospective, randomized, double blind, and placeboâcontrolled. Twenty patients undergoing hip arthroplasty via a direct lateral approach received an injection of 3.0 Ă 108 (300 M, n = 6) or 1.5 Ă 108 (150 M, n = 7) PLXâPAD or a placebo (n = 7) into the injured gluteus medius muscles. Results We did not observe any relevant PLXâPADârelated adverse events at the 2âyear followâup. Improved gluteus medius strength was noted as early as Week 6 in the treatmentâgroups. Surprisingly, until Week 26, the lowâdose group outperformed the highâdose group and reached significantly improved strength compared with placebo [150 M vs. placebo: P = 0.007 (baseline adjusted; 95% confidence interval 7.6, 43.9); preoperative baseline values mean ± SE: placebo: 24.4 ± 6.7 Nm, 150 M: 27.3 ± 5.6 Nm], mirrored by an increase in muscle volume [150 M vs. placebo: P = 0.004 (baseline adjusted; 95% confidence interval 6.0, 30.0); preoperative baseline values GM volume: placebo: 211.9 ± 15.3 cm3, 150 M: 237.4 ± 27.2 cm3]. Histology indicated accelerated healing after cell therapy. Biomarker studies revealed that lowâdose treatment reduced the surgeryârelated immunological stress reaction more than highâdose treatment (exemplarily: CD16+ NK cells: Day 1 P = 0.06 vs. placebo, P = 0.07 vs. 150 M; CD4+ Tâcells: Day 1 P = 0.04 vs. placebo, P = 0.08 vs. 150 M). Signs of lateâonset immune reactivity after highâdose treatment corresponded to reduced functional improvement. Conclusions Allogeneic PLXâPAD therapy improved strength and volume of injured skeletal muscle with a reasonable safety profile. Outcomes could be positively correlated with the modulation of early postoperative stressârelated immunological reactions