Prospective Randomized Multicenter Study Research Articles

Comparison of Rigid and Soft-Brace Treatments for Acute Osteoporotic Vertebral Compression Fracture: A Prospective, Randomized, Multicenter Study.

While bracing is the standard conservative treatment for acute osteoporotic compression fracture, the efficacy of different brace treatments has not been extensively studied. We aimed to clarify and compare the preventive effect of the different brace treatments on the deformity of the vertebral body and other clinical results in this patient cohort. This multicenter nationwide prospective randomized study included female patients aged 65–85 years with acute one-level osteoporotic compression fractures. We assigned patients within four weeks of injury to either a rigid-brace treatment or a soft-brace treatment. The main outcome measure was the anterior vertebral body compression percentage at 48 weeks. Secondary outcome measures included scores on the European Quality of Life-5 Dimensions (EQ-5D), visual analog scale (VAS) for lower back pain, and the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ). A total of 141 patients were assigned to the rigid-brace group, whereas 143 patients were assigned to the soft-brace group. There were no statistically significant differences in the primary outcome and secondary outcome measures between groups. In conclusion, among patients with fresh vertebral compression fractures, the 12-week rigid-brace treatment did not result in a statistically greater prevention of spinal deformity, better quality of life, or lesser back pain than soft-brace.

Clinical Usefulness of Simulation-Guided Catheter Ablation of Atrial Fibrillation: Updated Outcome of a Multicenter Prospective Randomized Study

Background: Catheter ablation of persistent atrial fibrillation (AF) is still challenging and is characterized by a significant AF recurrence rate; however, no optimal extra-pulmonary vein lesion set is known. We previously reported the clinical feasibility of in silico simulation-guided AF catheter ablation. Methods: We randomly assigned 118 patients with persistent AF (77.8% men, age 60.8 ± 9.9 years) to the simulation-guided ablation group (53 patients) and the empirical ablation group (55 patients) based on the operators' experience. For in silico ablation, four virtual linear and one electrogram-guided lesion sets were tested on patient heart computed tomogram-based models, and the lesion set with the fastest termination time was reported to the operator in the simulation-guided ablation group. The primary outcome was freedom from atrial tachyarrhythmias lasting longer than 30 seconds after a single procedure. The duration of the follow-up was 31.5 ± 9.4 months. Findings: Virtual in silico ablation procedures were successful in 95.2% of the patients (108/118). The clinical recurrence rate was significantly lower after a simulation-guided ablation than after an empirical ablation (20.8% vs. 40.0%, log-rank p = 0.042). Simulation-guided ablation was independently associated with a better long-term rhythm outcome of persistent AF ablation (HR = 0.29 [0.12-0.69], p = 0.005). The superiority of the rhythm outcome of the simulation-guided ablation was more significant in males, non-obese patients with a less remodeled atrium (left atrial dimension <50 mm), ejection fraction ≥ 50%, and those without hypertension or diabetes (p <0.01). There were no significant differences between the groups for the total procedure time (p = 0.403), ablation time (p = 0.510), and major complication rate (p = 0.900). Interpretation: Among patients with persistent AF, the simulation-guided ablation was superior to the empirical catheter ablation regarding the rhythm outcome. Trial Registration Number: This study was registered with the ClinicalTrials.gov number NCT02171364 Funding Statement: This work was supported by a grant [HI18C0070] from the Korea Health 21 R&D Project, Ministry of Health and Welfare and a grant [NRF-2017R1A2B4003983] from the Basic Science Research Program run by the National Research Foundation of Korea (NRF), which is funded by the Ministry of Science, ICT & Future Planning (MSIP). Declaration of Interests: The authors declare that they have no conflicts of interest. Ethics Approval Statement: The study protocol adhered to the Declaration of Helsinki and was approved by the institutional review board of each participating center. Written informed consent was obtained from all patients.

Randomized Trial of Two Dosages of Rabbit Antithymocyte Globulin in Patients with Aplastic Anemia

Randomized Trial of Two Dosages of Rabbit Antithymocyte Globulin in Patients with Aplastic Anemia

Prospective Trial of Low-Fidelity Deliberate Practice of Aortic and Coronary Anastomoses (TECoG 002)

We sought to examine the feasibility of a home practice curriculum of vascular anastomosis in cardiovascular surgery using a low-fidelity simulation platform and to examine its effectiveness in skill acquisition in senior surgical trainees. We organized a multicenter prospective randomized study of senior residents and fellows, who were oriented to a low-fidelity cardiac simulator and an 8-week curriculum of independent practice of aortic and coronary anastomosis. "Treatment" trainees received a simulator and the curriculum. Control trainees received only their usual operative experience. The groups then crossed over; all were studied for 16 weeks in total. Video skill assessments were captured at 0, 8, and 16 weeks and were scored by one blinded investigator using the Joint Council on Thoracic Surgery Education Assessment tool. A post-hoc survey was distributed to invited participants following study completion. University of Minnesota Department of Surgery, Mayo Clinic Department of Cardiovascular Surgery, and the University of Texas Health Science Center at Houston. Participants used the simulator in offices, call rooms, and their homes. Program participation in the study was solicited through the Thoracic Education Cooperative Group. Four institutions expressed interest and a total of 29 trainees were invited to the study and randomized. Of these, 12 (38%) completed the curriculum and submitted the requisite 3 sets of videos (6 treatment, 6 control). All were senior residents and fellows in general and cardiothoracic surgery. No significant differences were detected in assessment scores before and after the curriculum nor before or after the control period in the overall or postgraduate year-stratified populations. Participant case numbers during the study did not have a significant effect on assessment scores. Randomized participants reported strong interest in deliberate practice of technical skills but identified competing clinical and personal obligations and significant barriers to simulation. Considerable variability in performance existed among participants who completed the study, but overall, the curriculum alone was insufficient to improve simulator Joint Council on Thoracic Surgery Education scores compared to those not undergoing the curriculum. Among senior residents and fellows, provision of a practice curriculum and simulator for repeated practice is feasible but clinical and personal responsibilities were barriers to repetitive practice.

Carbon dioxide in office diagnostic hysteroscopy: An open question. A multicenter randomized trial on 1982 procedures

Objectiveto compare carbon dioxide and saline solution distension in diagnostic hysteroscopies with regards to patient discomfort and procedural time and in accordance with the instrument diameter (5 mm vs 3.5 mm). The secondary outcome was to evaluate the role of the patient age and the obstetrical history on perception of pain and procedural time. Study designThis is a prospective multicenter randomized study including 1982 patients that underwent office diagnostic hysteroscopy in: Policlinico Abano Terme, Università Cattolica del Sacro Cuore in Rome and Ente Ecclesiastico Ospedale Generale Regionale “F. Miulli” in Acquaviva delle Fonti. They were firstly randomized according to distension medium and secondly according to instrument diameter. Pain perception after the procedure was assessed by VAS (Visual Analogue Scale) score and procedural time was registered. Mann-Whitney U test was used to compare data. ResultsLower pain score and procedural time were recorded with the employment of Carbon Dioxide (p < 001). Patient discomfort and procedural time were significantly influenced by the instrument diameter independent of the distension medium used, though in the subgroup where gas was employed VAS score after 1 min (VAS1) resulted lower compared to saline solution in both the traditional and mini-hysteroscopy procedures (p < 001). ConclusionCarbon dioxide and saline solution are both suitable distension media for outpatient diagnostic hysteroscopy; nonetheless, carbon dioxide confers advantages in terms of pain perception and procedural time.

Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin Durable Polymer Everolimus-Eluting Stents

BackgroundCoronary drug-eluting stent development has introduced new metal alloys, changes in stent architecture, and bioresorbable polymers. Whether these advancements improve long-term clinical safety and efficacy has been inconsistent in prior studies. ObjectivesThe authors sought to compare late-term clinical outcomes among patients treated with an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP SES) and a thin strut (81 μm) durable polymer everolimus-eluting stent (DP EES) in a large randomized trial. MethodsBIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with Up to Three De Novo or Restenotic Coronary Artery Lesions V) was an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Analysis of pre-specified 2-year clinical outcomes was performed. ResultsAmong 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 2-year TLF rate was 7.5% for BP SES and 11.9% for DP EES (−4.33% treatment difference; 95% confidence interval: −8.16% to −0.91%; p = 0.015), driven by differences in target vessel myocardial infarction (MI) (5.3% vs. 9.5%; p = 0.01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%; p = 0.04). Rates of cardiac death or MI were 7.0% versus 10.4% for BP SES and DP EES, respectively (p = 0.047). Late/very late definite stent thrombosis was statistically lower for BP SES compared with DP EES (0.1% vs. 1.0%; p = 0.045). ConclusionsIn a large randomized trial, significant differences in both TLF and target vessel–related MI persisted through 2 years, favoring treatment with BP SES over DP EES. Significantly lower cumulative target lesion revascularization and late/very late stent thrombosis were also observed with BP SES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946)

Prolonging the duration of post-infusion scalp cooling in the prevention of anthracycline-induced alopecia: a randomised trial in patients with breast cancer treated with adjuvant chemotherapy.

Scalp cooling as a method to reduce the incidence of chemotherapy-induced alopecia (CIA) is increasingly used in daily practice worldwide. However, in patients treated with 5-fluorouracil, epirubicin and cyclophosphamide (FEC), scalp cooling fails in 48-67% of patients. This study investigated the efficacy of extended duration of post-infusion scalp cooling in breast cancer patients treated with this regimen. In this prospective multi-centre randomised study, 102 patients with early breast cancer treated with adjuvant FEC chemotherapy were randomly assigned in a 1:1 ratio to a post-infusion cooling time of 90 or 150min. The primary endpoint was the need to wear a wig or other head covering to mask visible hair loss. Sixteen out of 48 patients (33%) treated with 90min of post-infusion cooling did not need any head covering, compared with 21 out of 46 patients (45%) treated with 150min of post-infusion cooling (p= 0.2). WHO grades 2-3 (moderate-complete) alopecia were reported more often in patients treated with 90-min post-infusion cooling time (n= 25/51 (49%) versus n= 17/51 (33%); p= 0,02). Scalp cooling was well-tolerated (mean Visual Analogue Score 7.4) and only three patients (3%) stopped due to intolerance during treatment. Extending the duration of 90-min post-infusion scalp cooling to 150min in patients treated with adjuvant FEC chemotherapy was well-tolerated but did not significantly diminish the need for head covering. However, grades 2-3 alopecia was seen less often with prolonged post-infusion scalp cooling.

TCT-707 A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects with up to two de novo Coronary Artery Lesions – BIOFLOW IV: 3 Year Clinical Results

The aim of the BIOFLOW-IV study is to compare the safety and effectiveness of the Orsiro Sirolimus Eluting Stent (SES) with Xience Prime/Xience Xpedition Everolimus Eluting Stent (EES) in a prospective, multicenter, randomized controlled noninferiority trial in a mixed population of Caucasian and

Nasal high-frequency oscillatory ventilation and CO2 removal: A randomized controlled crossover trial.

To compare short-term application of nasal high-frequency oscillatory ventilation (nHFOV) with nasal continuous positive airway pressure (nCPAP). nHFOV improves CO2 removal with respect to nCPAP in preterm infants needing noninvasive respiratory support and persistent oxygen supply after the first 72 h of life. Multicenter non-blinded prospective randomized crossover study. Thirty premature infants from eight tertiary neonatal intensive care units, of mean ± SD 26.4 ± 1.8 weeks of gestational age and 921 ± 177 g of birth weight. Infants were randomly allocated in a 1:1 ratio to receive a starting treatment mode of either nCPAP or nHFOV delivered by the ventilator CNO (Medin, Germany), using short binasal prongs of appropriate size. A crossover design with four 1-h treatment periods was used, such that each infant received both treatments twice. The primary outcome was the mean transcutaneous partial pressure of CO2 (TcCO2 ) value during the 2-h cumulative period of nHFOV compared with the 2-h cumulative period of nCPAP. Significantly lower TcCO2 values were observed during nHFOV compared with nCPAP: 47.5 ± 7.6 versus 49.9 ± 7.2 mmHg, respectively, P = 0.0007. A different TcCO2 behavior was found according to the random sequence: in patients starting on nCPAP, TcCO2 significantly decreased from 50.0 ± 8.0 to 46.6 ± 7.5 mmHg during nHFOV (P = 0.001). In patients starting on nHFOV, TcCO2 slightly increased from 48.5 ± 7.8 to 49.9 ± 6.7 mmHg during nCPAP (P = 0.13). nHFOV delivered through nasal prongs is more effective than nCPAP in improving the elimination of CO2 .

The influence of antyhypertensive therapy of valsartan and fixed combination with hydrochlorothiazide use on pulse-wave velocity and central arterial pressure in patients with arterial hypertension of 1-2 grades in international VICTORY clinical trial

Objective - to explore influence of valsartan monotherapy use and its use in combination with hydrochlorothiazide (HCTZ) on pulse-wave velocity (PWV) and central arterial pressure (CAP) in patients with arterial hypertension (AH) of 1-2 grades in international VICTORY clinical trial. Materials and methods. The international multicenter prospective randomized clinical study VICTORY that lasted for 16 weeks included patients with 1-2 grades AH. In patients who previously received antihypertensive therapy a 7 days washout period was carried out. All patients started their therapy with 80 mg valsartan (Valsacor®, KRKA, Slovenia); in Russia the starter dose of Valsacor®, KRKA was 160 mg in previously treated patients that did not influence the study results. If after 4 weeks of treatment BP was more than 140/90 mm hg (more than 130/80 mm hg in high risk patients or in diabetes mellitus patients) the dose of valsartan was increased to 160 mg (320 mg in Russia) or diuretic in fixed combination with valsartan was added (160 mg valsartan/12.5 mg HCTZ): Valsacor® H 160 (KRKA, Slovenia). If target BP after 8 weeks of treatment was not reached valsartan dose was increased to 320 mg or fixed combination of valsartan and diuretic (160 mg/12.5 mg) was used. If target BP after 12 weeks of treatment was not reached - valsartan and diuretic 320 mg/12.5 mg were used. PWV and CAP (SphygmoCor®, AtCorMedical) were assessed at baseline and after 16 weeks of treatment. The primary endpoints were assessment of the impact of studied medications on aortic stiffness, aortic augmentation index and comparison of absolute medians of reached central and peripheral BP reduction with baseline value. Results. Of 365 patients included in the study 74 were included in PWV and CAP study subgroup. Valsartan and its combination with HCTZ were effective in CBP reduction. The mean absolute reduction of central systolic and diastolic BP after 16 weeks of treatment was 19.7±12.9 mm hg and 13.9±8.5 mm hg, respectively (р

A prospective randomized multicentre study of the impact of gallium-68 prostate-specific membrane antigen (PSMA) PET/CT imaging for staging high-risk prostate cancer prior to curative-intent surgery or radiotherapy (proPSMA study): clinical trial protocol.

Accurate staging of patients with prostate cancer (PCa) is important for therapeutic decision-making. Relapse after surgery or radiotherapy of curative intent is not uncommon and, in part, represents a failure of staging with current diagnostic imaging techniques to detect disease spread. Prostate-specific membrane antigen (PSMA) positron-emission tomography (PET)/computed tomography (CT) is a new whole-body scanning technique that enables visualization of PCa with high contrast. The hypotheses of this study are that: (i) PSMA-PET/CT has improved diagnostic performance compared with conventional imaging; (ii) PSMA-PET/CT should be used as a first-line diagnostic test for staging; (iii) the improved diagnostic performance of PSMA-PET/CT will result in significant management impact; and (iv) there are economic benefits if PSMA-PET/CT is incorporated into the management algorithm. The proPSMA trial is a prospective, multicentre study in which patients with untreated high-risk PCa will be randomized to gallium-68-PSMA-11 PET/CT or conventional imaging, consisting of CT of the abdomen/pelvis and bone scintigraphy with single-photon emission CT/CT. Patients eligible for inclusion are those with newly diagnosed PCa with select high-risk features, defined as International Society of Urological Pathology grade group ≥3 (primary Gleason grade 4, or any Gleason grade 5), prostate-specific antigen level ≥20ng/mL or clinical stage ≥T3. Patients with negative, equivocal or oligometastatic disease on first line-imaging will cross over to receive the other imaging arm. The primary objective is to compare the accuracy of PSMA-PET/CT with that of conventional imaging for detecting nodal or distant metastatic disease. Histopathological, imaging and clinical follow-up at 6months will define the primary endpoint according to a predefined scoring system. Secondary objectives include comparing management impact, the number of equivocal studies, the incremental value of second-line imaging in patients who cross over, the cost of each imaging strategy, radiation exposure, inter-observer agreement and safety of PSMA-PET/CT. Longer-term follow-up will also assess the prognostic value of a negative PSMA-PET/CT. This trial will provide data to establish whether PSMA-PET/CT should replace conventional imaging in the primary staging of select high-risk localized PCa, or whether it should be used to provide incremental diagnostic information in selected cases.

Sa1732 - The Effects and Adherence of Asacol® Comparing 2.4G Once Daily with 800Mg Three Times or 1200Mg Twice Daily for Maintain Therapy in the Ulcerative Colitis: Prospective Multicenter Randomized Study

Sa1732 - The Effects and Adherence of Asacol® Comparing 2.4G Once Daily with 800Mg Three Times or 1200Mg Twice Daily for Maintain Therapy in the Ulcerative Colitis: Prospective Multicenter Randomized Study

Re: Value of an Immediate Intravesical Instillation of Mitomycin C in Patients with Non-muscle-invasive Bladder Cancer: A Prospective Multicentre Randomised Study in 2243 patients

Abstract Background The efficacy of an immediate single chemotherapy instillation after transurethral resection of a bladder tumour (TURBT) in patients with non–muscle-invasive bladder cancer (NMIBC) remains a topic of debate. Evidence is even more scarce when an immediate instillation is followed by adjuvant instillations. Objective To compare the effect of a mitomycin C (MMC) instillation within 24h to an instillation 2 wk after TURBT in patients with NMIBC with or without adjuvant instillations. Design, Setting, and participants Between 1998 and 2003, 2844 NMIBC patients were randomised for immediate versus delayed MMC instillation after TURBT. Patients were categorised in low-risk (LOR), intermediate-risk (IMR), and high-risk (HIR) groups. Total numbers of instillations in these groups were 1, 9, and 15, respectively. Outcome measurements and statistical analysis Primary end point was 3-yr recurrence risk for the IMR and HIR groups and 5-yr risk for the LOR group. Secondary outcomes were time to recurrence and incidence of adverse events. Analyses were performed with the log-rank test, Cox-regression, and χ 2 test in SPSS. Results and limitations A total of 2243 patients were eligible on an intention-to-treat basis. Recurrence risks were 43% and 46% in the LOR group (5-yr follow-up, p =0.11), 20% and 32% in the IMR group (3-yr follow-up, p =0.037), and 28% and 35% in the HIR group (3-yr follow-up, p =0.007), for an immediate and a delayed instillation, respectively. For all patients, the recurrence risk was 27% (95% confidence interval [CI], 24–30) in the immediate and 36% (95% CI, 33–39) in the delayed instillation group ( p p p =0.08). The risk groups in our study differ slightly from the current guidelines, which is a limitation of our study. Conclusions An immediate, single instillation after TURBT reduces the recurrence risk in NMIBC patients, independent of the number of adjuvant installations. Patient summary A single instillation of chemotherapy after the resection of non–muscle-invasive bladder cancer reduces the recurrence risk, even if patients are treated with an adjuvant schedule of instillations.

Erratum: Outcomes of the Multimodal Treatment of Malignant Pleural Mesiothelioma: The Role of Surgery

[This corrects the article on p. 35 in vol. 51, PMID: 29430427.].

Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial

ObjectiveTo determine whether a 2-week methotrexate (MTX) discontinuation after vaccination improves the efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis (RA).MethodsIn this prospective randomised parallel-group multicentre study, patients...

MynxGrip® vascular closure device versus manual compression for hemostasis of percutaneous transfemoral venous access closure: Results from a prospective multicenter randomized study.

Evaluate the safety of MynxGrip® for common femoral vein closure. This is a multicenter, randomized, prospective study of 208 patients who were slated to undergo diagnostic/interventional procedures via femoral venous access. Patients were randomized 1:1 to receive venous hemostasis via MynxGrip® (n = 104) or manual compression (n = 104) utilizing 5, 6, and 7 Fr sheaths. Bilateral calf and thigh circumferences were measured serially. Patients were followed up through hospital discharge. There were no differences in the baseline characteristics between the two groups. There was no difference between the groups for venous thrombosis, (0%, p = 1). Overall, there was no significant change in access site calf (-0.18 ± 1.38 cm, p = 0.18) or thigh diameter (0.33 ± 2.86, p = 0.81). In both groups, none of the patients had major or minor vascular complications, access site infection, nerve injury, or access site bleeding requiring transfusion. The pre- to post-procedure hemoglobin drop was -0.51 ± 1.1 vs. -0.64 ± 1.3 g/dL, p = 0.59 in the manual compression group and MynxGrip® group, respectively. Time to hemostasis, was significantly lower in the MynxGrip® group compared to the manual compression group with 0.12 ± 0.89 vs. 7.6 ± 5.7 min, respectively (p < 0.001). The MynxGrip® extravascular sealant is safe and effective for femoral venous access site closure.

P358Efficacy and safety of unilateral groin puncture with single trans-septal catheter ablation for paroxysmal atrial fibrillation: A multi-center prospective randomized study

P358Efficacy and safety of unilateral groin puncture with single trans-septal catheter ablation for paroxysmal atrial fibrillation: A multi-center prospective randomized study

Impact of 3-week citrulline supplementation on postprandial protein metabolism in malnourished older patients: The Ciproage randomized controlled trial

Citrulline (CIT), is not extracted by the splanchnic area, can stimulate muscle protein synthesis and could potentially find clinical applications in conditions involving low amino acid (AA) intake, such as in malnourished older subjects. Our purpose was to research the effects of CIT supplementation on protein metabolism in particular on non-oxidative leucine disposal (NOLD, primary endpoint), and splanchnic extraction of amino acids in malnourished older patients. This prospective randomized multicenter study determined whole-body and liver protein synthesis, splanchnic protein metabolism and appendicular skeletal muscle mass (ASMM) in 24 malnourished older patients [80-92 years; 18 women and 6 men] in inpatient rehabilitation units. All received an oral dose of 10g of CIT or an equimolar mixture of six non-essential amino acids (NEAAs), as isonitrogenous placebo, for 3 weeks. NOLD and albumin fractional synthesis rates were not different between the NEAA and CIT groups. Splanchnic extraction of dietary amino acid tended to decrease (p=0.09) in the CIT group (45.2%) compared with the NEAA group (60.3%). Total differences in AA and NEAA area under the curves between fed-state and postabsorptive-state were significantly higher in the CIT than in the NEAA group. There were no significant differences for body mass index, fat mass (FM), lean mass (LM) or ASMM in the whole population except for a tendential decrease in FM for the citrulline group (p=0.089). Compared with Day 1, lean mass and ASMM significantly increased (respectively p=0.016 and p=0.018) at Day 20 in CIT-treated women (mean respective increase of 1.7kg and 1.1kg), and fat mass significantly decreased (p=0.001) at Day 20 in CIT-group women (mean decrease of 1.3kg). Our results demonstrate that CIT supplementation has no effect on whole-body protein synthesis or liver protein synthesis in malnourished older subjects. However, CIT supplementation was associated with a higher systemic AA availability. In the subgroup of women, CIT supplementation increased LM and ASMM, and decreased FM.

Outcomes of the Multimodal Treatment of Malignant Pleural Mesiothelioma: The Role of Surgery

BackgroundThe treatment of malignant pleural mesothelioma (MPM) is challenging, and multimodal treatment including surgery is recommended; however, the role of surgery is debated. The treatment outcomes of MPM in Korea have not been reported. We analyzed the outcomes of MPM in the context of multimodal treatment, including surgery.MethodsThe records of 29 patients with pathologically proven MPM from April 1998 to July 2015 were retrospectively reviewed. The treatment outcomes of the surgery and non-surgery groups were compared.ResultsThe overall median survival time was 10.6 months, and the overall 3-year survival rate was 25%. No postoperative 30-day or in-hospital mortality occurred in the surgery group. Postoperative complications included tachyarrhythmia (n=4), pulmonary thromboembolism (n=1), pneumonia (n=1), chylothorax (n=1), and wound complications (n=3). The treatment outcomes between the surgery and non-surgery groups were not significantly different (3-year survival rate: 31.3% vs. 16.7%, respectively; p=0.47). In a subgroup analysis, there was no significant difference in the treatment outcomes between the extrapleural pneumonectomy group and the non-surgery group (3-year survival rate: 45.5% vs. 16.7%, respectively; p=0.23).ConclusionMultimodal treatment incorporating surgery did not show better outcomes than non-surgical treatment. A nationwide multicenter data registry and prospective randomized controlled studies are necessary to optimize the treatment of MPM.

Endplate changes after lumbar discectomy with and without implantation of an annular closure device.

The implantation of a bone-anchored annular closure device (ACD) might be associated with the developed new endplate changes (EPC) after surgery. A post hoc analysis has been done in patients from a prospective randomized multicenter study. All patients underwent limited lumbar discectomy with intraoperative randomization into the groups limited lumbar discectomy alone or additional ACD implantation. Low-dose lumbar computed tomography (CT) and clinical investigations were performed preoperatively and 12months after the operation. A total of 554 patients were randomized. After exclusion of dropouts, the per-protocol population included 493 patients (251 in the control group and 242 in the ACD group); the follow-up rate was ≥ 90%. The number of patients showing EPC at baseline was similar in both groups. The number of patients showing EPC and the total EPC lesion area significantly increased in both groups over time, but significantly increased more in the EPC group for the superior and inferior endplate (all P < 0.0001). There was no association of pre-existing number and size of EPC with sex, age, or smoking habits. Correlation of clinical variables showed no relation with number, size, and increase of EPC area after surgery. Patients with primary lumbar disc herniation show EPC in the corresponding segments. There is a significant increase of lesion number and size within 12months after discectomy. This increase is significantly more pronounced in the ACD group. Presence and growth of EPC is not correlated with low-back pain or ODI.