Study protocol: the TRAnsplant BIOpsies (TRABIO) study - a prospective, observational, multicentre cohort study to assess the treatment of kidney graft rejections.

INTRODUCTION: Despite continued efforts, long-term outcomes of kidney transplantation remain unsatisfactory. Kidney graft rejections are independent risk factors for graft failure. At the participating centres of the TRAnsplant BIOpsies study group, a common therapeutic standard has previously been defined for the treatment of graft rejections. The outcomes of this strategy will be assessed in a prospective, observational cohort study. METHODS AND ANALYSIS: A total of 800 kidney transplantation patients will be enrolled who undergo a graft biopsy because of deteriorating kidney function. Patients will be stratified according to the Banff classification, and the influence of the treatment strategy on end points will be assessed using regression analysis. Primary end points will be all-cause mortality and graft survival. Secondary end points will be worsening of kidney function (≥30% decline of estimated Glomerular Filtration Rate [eGFR] or new-onset large proteinuria), recurrence of graft rejection and treatment response. Baseline data and detailed histopathology data will be entered into an electronic database on enrolment. During a first follow-up period (within 14 days) and subsequent yearly follow-ups (for 5 years), treatment strategies and clinical course will be recorded. Recruitment at the four participating centres started in September 2016. As of August 2020, 495 patients have been included. ETHICS AND DISSEMINATION: Ethical approval for the study has been obtained from the ethics committee of Kiel (AZ B 278/16) and was confirmed by the committees of Munich, Mainz and Stuttgart. The results will be reported in a peer-reviewed journal, according to the Strengthening the Reporting of Observational Studies in Epidemiology criteria. TRIAL REGISTRATION NUMBER: ISRCTN78772632; Pre-results.

CT fluoroscopy-guided percutaneous vertebroplasty in spinal malignancy: technical results, PMMA leakages, and complications in 202 patients.

OBJECTIVE: To retrospectively evaluate the incidence and clinical impact of local polymethylmethacrylate (PMMA) leaks and pulmonary cement embolisms occurring under CT fluoroscopy-guided vertebroplasty of symptomatic malignant vertebral osteolyses. MATERIALS AND METHODS: From December 2001 to June 2009, 202 cancer patients (116 women, 86 men; age 63.2±8.6 years) with painful malignant vertebral osteolyses underwent vertebroplasty, with or without vertebral compression fracture. A total of 331 vertebrae were treated in 231 sessions under CT fluoroscopy guidance (120 kV; 10­25 mA; single slice, 4-, 16-, and 128-row CT). In the pre-vertebroplasty CT, the following items were assessed: osteolytic destruction (0, ≤25, ≤50, ≤75, or ≤100%) of vertebral cross-sectional area, posterior wall, and circumference; presence of perivertebral and degree of epidural (no, mild, moderate) soft tissue involvement. Local PMMA leaks were analyzed using the post-vertebroplasty CT. Pulmonary cement embolisms were evaluated in all patients having undergone radiography (CR; n053) or CT (n088) of the chest after vertebroplasty due to their underlying disease. Patient charts were reviewed regarding adverse events. RESULTS: Of 331 treated vertebrae, 32, 20.2, and 15.7% showed more than 50% osteolytic involvement of the vertebral cross-sectional area, posterior wall, and circumference, respectively. Mild or moderate epidural involvement was seen in 13.0 and 8.4%. Local PMMA leakage rate was 58.6% (194 of 331 vertebrae). Pulmonary cement embolisms (segmental, n010; central, n01) were seen after 7.8% of the procedures with follow-up imaging of the chest. No major complications occurred within a 30-day period after vertebroplasty. CONCLUSION: Vertebroplasty of spinal malignancy can be safely performed under CT fluoroscopy guidance even in patients with substantial osteolytic involvement. In our patient collective, PMMA leaks and pulmonary cement embolisms visualized in post-procedural radiography and CT images had no clinical impact.

CT fluoroscopy-guided percutaneous vertebroplasty in patients with multiple myeloma: analysis of technical results from 44 sessions with 67 vertebrae treated.

PURPOSE: This study aimed to assess the results of computed tomography (CT) fluoroscopy-guided vertebroplasty in patients with multiple myeloma, focusing on the frequency and clinical impact of polymethylmethacrylate (PMMA) leaks. MATERIALS AND METHODS: From December 2001 to August 2008, 39 patients (17 females, 22 males; mean age, 65±7 years) with multiple myeloma suffering from painful spinal osteolyses underwent vertebroplasty. A total of 67 vertebrae were treated in 44 sessions under CT fluoroscopy (single-slice, 4-row CT, and 16-row CT). In the planning CT scan, osteolytic destruction (i.e., none, ≤25%, ≤50%, ≤75%, or ≤100%) was assessed regarding the vertebral cross-sectional area, the cortical border of the spinal canal, and the outer circumference. CT performed after vertebroplasty was used to detect local PMMA leaks. Patient charts were retrospectively reviewed with special respect to peri and postinterventional adverse events. Clinical outcomes were assessed on a visual analog scale (VAS) 24 hours before, 24 hours after, and 6 months after vertebroplasty. RESULTS: Overall, 37.3%, 12.0%, and 6.0% of vertebrae showed at least 50% osteolytic involvement of the cross-sectional area, spinal canal, and outer vertebral cortex, respectively. Intradiscal, intraspinal, paravertebral, and intercostovertebral/posterolateral leaks were seen in 21.6%, 35.1%, 43.3%, and 0% of vertebrae, respectively. The ratio of basivertebral to segmental venous leaks was 16.2%/40.5%. No major complications occurred. The mean VAS score decreased significantly (P < 0.05) from 6.4 at 24 hours before vertebroplasty to 3.2 at a mean follow-up of 9.0 months. CONCLUSION: Vertebroplasty in multiple myeloma can be performed safely under CT fluoroscopy, even with substantial destruction of the vertebral cross-sectional area or cortical bone. A high clinical success rate was achieved, regardless of whether PMMA leaks were present.