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Abstract Background One-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH. Methods This study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients. Discussion In this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions. Trial registration ClinicalTrials.gov NCT05686525. Registered on January 17, 2023, https://clinicaltrials.gov/study/NCT05686525 .

Abstract Background Current management of mesenteric ischemia is primarily endovascular stent treatment. Typical CMI symptoms are postprandial abdominal pain, food fear, weight loss, and diarrhea. Revascularization is often necessary, as mesenteric ischemia may progress to bowel necrosis and death if left untreated. This study aims to compare the outcome using bare metal stent (BMS) or covered stent (CS) in the endovascular treatment of chronic and acute on chronic mesenteric ischemia. Methods This is an investigator-driven, prospective, randomized, single-blinded, and single-center, national cohort study at the Copenhagen University Hospital, Denmark. A total of 98 patients with chronic mesenteric ischemia (CMI) and acute-on-chronic mesenteric ischemia (AoCMI) will be randomized to treatment with either BeSmooth BMS (Bentley Innomed GmbH) or BeGraft CS (Bentley Innomed GmbH). Randomization occurs intraoperatively after lesion crossing. Discussion There is currently no published data from prospective controlled trials regarding the preferred type of stent used for the treatment of chronic and acute-on-chronic mesenteric ischemia. This trial will evaluate the short- and long-term outcome of BMS versus CS when treating CMI and AoCMI, as well as the benefit of a more intense postoperative surveillance program. Trial registration ClinicalTrials.gov NCT05244629. Registered on February 8, 2022.

Background/Objectives: Genicular artery embolization (GAE) has demonstrated potential as a treatment for knee osteoarthritis by targeting inflammation and pain, although current evidence remains limited. This study used imaging biomarkers to objectively assess synovitis and possible ischemic complications following GAE. Methods: This was a prospective, single-center trial including participants with mild-to-moderate knee osteoarthritis. Ultrasound, contrast-enhanced (CE), and non-CE-MRI were performed two days before and one and six months after GAE. Ultrasound biomarkers included synovial hypertrophy, effusion, and Doppler activity. A combined effusion-synovitis score was assessed on non-CE-MRI, while CE-MRI allowed differentiation between synovium and effusion and was used to calculate whole-joint and local synovitis scores. The post-GAE MRIs were reviewed for ischemic complications. Results: Seventeen participants (aged 43–71) were treated. Significant reductions were observed in ultrasound-assessed synovial hypertrophy and Doppler activity, as well as in CE-MRI local and whole-joint synovitis scores. While reductions in effusion were noted in both ultrasound and MRI, these changes did not reach statistical significance. At one month, MRI revealed three cases of nonspecific osteonecrosis-like areas, which resolved completely by six months. Conclusions: This study demonstrated a reduction in synovitis and no permanent ischemic complication following GAE in knee osteoarthritis. Larger studies with longer follow-up are needed to confirm the long-term efficacy and safety of the procedure.

Knee osteoarthritis (OA) affects millions worldwide, leading to pain and reduced quality of life. Conventional treatments often fail to provide adequate relief, necessitating new therapeutic approaches. This study evaluated the efficacy and safety of genicular artery embolization (GAE) using permanent microspheres in patients with mild-to-moderate knee OA. In this prospective, single-center study, 17 participants underwent GAE. KOOS (Knee injury and Osteoarthritis Outcome Score), WOMAC (The Western Ontario and McMaster Universities Arthritis Index), and IPAQ (International Physical Activity Questionnaire) scores, along with physical performance tests, medication use, and dual-energy X-ray absorptiometry (DEXA) scans, were assessed at baseline and at multiple follow-up points over six months. The primary endpoint, VAS at six months, showed significant improvement (median reduction from 66 mm to 40 mm, p = 0.0004). All pain and function scores, as well as physical performance tests, improved significantly. No clinically relevant changes in medication use or DEXA parameters were observed after six months. Only minor, self-limiting adverse events occurred. This study indicates that GAE is a promising minimally invasive treatment for knee OA, providing significant pain relief and functional improvement. However, further long-term, randomized trials are needed to confirm these findings and establish optimal patient selection criteria.

Abstract Background In recent years, adipose-derived stromal cells (ASCs) have been heavily studied for soft tissue regeneration, augmentation, and dermal wound healing. Methods In this review, we investigated the trends in injectable scaffolds for ASC delivery in the dermis, and injectable or implantable scaffolds for ASC delivery in the subcutis. A total of 547 articles were screened across three databases; of these, 22 studies were found to be eligible and were included. The scaffolds were subdivided and analyzed based on their tissue placement (dermis or subcutis), delivery method (injected or implanted), and by the origin of the materials (natural, synthetic, and combinatory). Results ASCs embedded in scaffolds generally showed improved viability. Neovascularization in the transplanted tissue was greater when undifferentiated ASCs were embedded in a combinatory scaffold or if differentiated ASCs were embedded in a natural scaffold. ASCs embedded in natural materials underwent more adipogenic differentiation than ASCs embedded in synthetic scaffolds, indicating an etiologically unknown difference that has yet to be described. Increased mechanical strength of the scaffold material correlated with improved outcome measurements in the investigated studies. Wound healing studies reported reduced healing time in all except one article due to contraction of the control wounds. Conclusions In future clinical trials, we recommend embedding ASCs in injectable and implantable scaffolds for enhanced protection, retained viability, and improved therapeutic effects. Trial registration This review was registered with PROSPERO: ID=CRD42020171534 . Graphical abstract The use of scaffolds as a vehicle for ASC delivery generally improved cell viability, angiogenesis, and wound healing in vivo compared to utilizing ASCs alone. ASCs embedded in natural materials induced more adipogenesis than ASCs embedded in synthetic materials. Adipogenic-induced ASCs further increased this effect. The included studies indicate that the seeded scaffold material influences the differentiation of ASCs in vivo. All studies investigating the mechanical strength of ASC scaffolds reported improved outcome measurements with improved mechanical strength. The results suggest that scaffolds, in general, are favorable for ASC delivery. We recommend initiating clinical studies using scaffolds based on mechanical properties and tunability to improve ASC viability. For fat regeneration, natural scaffolds are recommended.

Abstract Autologous fat grafting and implant surgery are used for volume restoration in plastic surgery. With the aim of producing a treatment superior to current solutions, we report a randomized, controlled, data assessor‐blinded clinical trial comparing fat grafts enriched with ex vivo‐expanded autologous adipose‐derived stromal cells (ASCs) to nonenriched fat grafts in breast augmentation. The intervention group received ASC‐enriched fat grafts (≥20 × 106 viable ex vivo‐expanded ASCs per milliliter fat), and the control group received conventional nonenriched fat grafts. Volume retention was measured by magnetic resonance imaging, and clinical photographs were taken simultaneously for outcome evaluation. ASC‐enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%). Clinical photos showed statistically significant superior results in the intervention group, assessed by independent clinical experts. These results improve the prospects for using culture‐expanded ASCs in both reconstructive and cosmetic volume restoration and make the procedure an attractive alternative to conventional fat grafting and implants. This study is registered at www.ClinicalTrials.gov, number H‐16046960.

Introduction Postembolisation syndrome (PES) is the most common side effect of vascular embolisation of solid organs. Although prophylactic corticosteroids are known to reduce the incidence and severity of PES, no trials investigating their efficacy have been conducted in men undergoing prostatic artery embolisation (PAE). We postulate that steroids can have a similar effect in reducing PES after PAE. This paper describes the rationale and detailed protocol for a randomised controlled trial evaluating the efficacy of dexamethasone (DEXA) in reducing PES after PAE.Methods and analysis In this single-centre, randomised, double-blind, placebo-controlled trial, we will enrol 60 individuals undergoing PAE for benign prostatic hyperplasia. Participants will be randomised to receive IV DEXA (24 mg) or placebo (saline). The primary outcomes will be postprocedural fever, pain and quality of life. The secondary outcomes will include postprocedural nausea, postprocedural medicine usage, laboratory parameters (C reactive protein, prostate-specific antigen) and early PAE results.Ethics and dissemination Ethics approval was obtained from the Danish Committee on Health Research Ethics in the Capital Region (H-20025910). The results from this trial will be disseminated through publication in peer-reviewed journals and national and international presentations.Trial registration number Clinicaltrials.gov identifier: NCT04588857; EudraCT number: 2020-000915-53.

Dual-energy computed tomography (DECT) can estimate tissue vascularity and perfusion via iodine quantification. The aim of this systematic review was to outline current and emerging clinical applications of iodine quantification within the gastrointestinal tract using DECT. The search was conducted with three databases: EMBASE, Pubmed and The Cochrane Library. This identified 449 studies after duplicate removal. From a total of 570 selected studies, 30 studies were enrolled for the systematic review. The studies were categorized into four main topics: gastric tumors (12 studies), colorectal tumors (8 studies), Crohn’s disease (4 studies) and miscellaneous applications (6 studies). Findings included a significant difference in iodine concentration (IC) measurements in perigastric fat between T1–3 vs. T4 stage gastric cancer, poorly and well differentiated gastric and colorectal cancer, responders vs. non-responders following chemo- or chemoradiotherapy treatment among cancer patients, and a positive correlation between IC and Crohn’s disease activity. In conclusion, iodine quantification with DECT may be used preoperatively in cancer imaging as well as for monitoring treatment response. Future studies are warranted to evaluate the capabilities and limitations of DECT in splanchnic flow.

Postembolization syndrome (PES) is the most common side effect of vascular embolization of solid organs. The aim of this review was to determine the incidence of PES and its individual components after prostatic artery embolization (PAE). A systematic review with a pre-specified search strategy for PubMed, Embase, Web of Science and Cochrane Library was performed according to PRISMA guidelines. Studies in English regarding PAE in humans with 10 or more participants were eligible for inclusion. No restrictions on participant demographics or PAE technique were imposed. The search returned 378 references, of which 32 studies with a total of 2116 patients met the inclusion criteria. The results for overall PES frequency and individual PES components were presented as median (interquartile range, (IQR)). Overall median PES frequency was 25.5% (12.5–45.8). The two most frequent individual PES components were dysuria/urethral burning and local pain, with a median frequency of 21.7% (13.8–33.3) and 20% (5.4–29.4), respectively. Most outcome measures were characterized by a marked lack of uniformity and inconsistency in reporting across studies. Development of a uniform reporting system would help the clinicians recognize and treat PES accordingly.

Patient-specific rehearsal (PsR) is a new concept whereby a procedure can be rehearsed virtually using the exact patient’s anatomical data prior to performing the real procedure. The aim of this study was to ascertain if endovascular virtual-reality PsR simulation enhanced performance in real life. This was done by performing a systematic review following the preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines. A literature search was conducted in PubMed, Embase, The Cochrane Library and Web of Science concerning PsR in endovascular procedures. All publications were handled using Covidence. Reference lists were also screened. Data extracted from the studies were realism rating, procedure time, fluoroscopy time, contrast volume, number of angiograms and reduction of errors. Kirkpatrick’s four-level model for measuring the efficiency of training was used for guidance of the relevance of studies. The search yielded 1155 results after the exclusion of duplicates, and 11 studies were included. Four studies had a control group, including one randomized trial; the remaining seven were feasibility studies. The realism was rated high, and overall, the studies showed improvements in procedure time, fluoroscopy time and contrast volume after PsR. One study assessed and confirmed the reduction in errors after PsR. Only two studies included more than 15 patients in their cohort. Kirkpatrick’s model was applied to all studies, with one study reaching level 4. All studies found the concept of PsR to be feasible and realistic. The studies with a control group showed a reduction of overall procedure time, radiation exposure and potential errors in endovascular procedures following PsR.