Transurethral High Power (80W) Potassium-Titanyl-Phosphase (KTP) Laser Vapourisation of the Prostate Compared with Holmium Laser Ablation of the Prostate: A Single Centre Randomised Controlled Trial in Patients with Obst. Benign Prostatic Hyperplasia

2013 ◽  
Author(s):  
Ranjan Thilagarajah
Keyword(s):  
Benign Prostatic Hyperplasia ◽  
Laser Ablation ◽  
Randomised Controlled Trial ◽  
High Power ◽  
Controlled Trial ◽  
Prostatic Hyperplasia ◽  
Holmium Laser ◽  
Ktp Laser ◽  
Single Centre ◽  
Randomised Controlled

scholarly journals The Design and Rationale of a Multicentre Randomised Controlled Trial Comparing Transperineal Percutaneous Laser Ablation With Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia

2021 ◽  
Vol 8 ◽  
Author(s):  
Wei Zhang ◽  
Weituo Zhang ◽  
Qian Guo ◽  
Lei Chen ◽  
Zheying Meng ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Benign Prostatic Hyperplasia ◽  
Laser Ablation ◽  
Randomised Controlled Trial ◽  
Transurethral Resection ◽  
Controlled Trial ◽  
Prostatic Hyperplasia ◽  
Post Surgery ◽  
Randomised Controlled ◽  
Percutaneous Laser Ablation

Background: Transurethral resection of the prostate (TURP) is regarded as the “gold standard” for the treatment of benign prostatic hyperplasia (BPH) in elderly men. However, ~15% of patients who had undergone TURP had intraoperative and postoperative complications, such as bleeding, urinary incontinence and urethral stricture. Transperineal percutaneous laser ablation (TPLA) is a method that places the optical fibre directly into the prostate with the guidance of ultrasound imaging, and the percutaneous transperineal approach is performed distal to the urethra and rectum to protect these structures and reduce urethral or postoperative infection. Several studies on TPLA for BPH treatment have been reported recently; however, high-quality randomised controlled trial (RCT) to evaluate its efficacy, safety, and long-term follow up remain absent.Methods: This study is a multicentre, open-label RCT to assess the efficacy and safety of TPLA vs. TURP to treat BPH. We hypothesise that the TPLA has non-inferior efficacy to TURP in the International Prostate Symptom Score (IPSS) at 3 months changing from the baseline and lower incidence of post-surgery complications. One hundred and fourteen patients with BPH will be recruited at 19 sites and randomly assigned at 1:1 to TPLA or TURP groups. The patients will be followed up at 1, 3, 6, 12, and 24 months after the procedure.Discussion: The study will be the first multicentre clinical trial including 16 participating centres in China, Italy, Switzerland, and Poland with relatively large sample size 114. By comprehensively compare the safety and efficacy of TPLA with TURP in patients with BPH, especially concerning the improvement of lower urinary tract symptoms (LUTS) and complication incidence, the study will help to illustrate the clinical value of TPLA and provide a beneficial alternative treatment for BPH patients.Clinical Trial Registration: The study has been registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn), identifier [ChiCTR1900022739].

scholarly journals Efficacy of dexamethasone in reducing the postembolisation syndrome in men undergoing prostatic artery embolisation for benign prostatic hyperplasia: protocol for a single-centre, randomised, double-blind, placebo-controlled trial—the ‘DEXAPAE’ study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e047878
Author(s):  
Petra Svarc ◽  
Hein Vincent Stroomberg ◽  
Ruben Juhl Jensen ◽  
Susanne Frevert ◽  
Mats Håkan Lindh ◽  
...  
Keyword(s):  
Benign Prostatic Hyperplasia ◽  
Controlled Trial ◽  
Specific Antigen ◽  
Prostatic Hyperplasia ◽  
Common Side Effect ◽  
Single Centre ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomised Controlled ◽  
Prostatic Artery

IntroductionPostembolisation 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 analysisIn 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 disseminationEthics 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 numberClinicaltrials.gov identifier: NCT04588857; EudraCT number: 2020-000915-53.

Ex-vivo gene therapy of human vascular bypass grafts with E2F decoy: the PREVENT single-centre, randomised, controlled trial

The Lancet ◽  
1999 ◽  
Vol 354 (9189) ◽  
pp. 1493-1498 ◽  
Author(s):  
Michael J Mann ◽  
Anthony D Whittemore ◽  
Magruder C Donaldson ◽  
Michael Belkin ◽  
Michael S Conte ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Randomised Controlled Trial ◽  
Ex Vivo ◽  
Controlled Trial ◽  
Bypass Grafts ◽  
Single Centre ◽  
Vascular Bypass ◽  
Ex Vivo Gene Therapy ◽  
Vascular Bypass Grafts ◽  
Randomised Controlled

scholarly journals Prospective, single-centre, randomised controlled trial to evaluate the efficacy and safety of ischaemia-free liver transplantation (IFLT) in the treatment of end-stage liver disease

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e035374
Author(s):  
Changjun Huang ◽  
Shanzhou Huang ◽  
Yunhua Tang ◽  
Qiang Zhao ◽  
Dongping Wang ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Liver Disease ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Single Centre ◽  
Donor Liver ◽  
End Stage Liver Disease ◽  
Randomised Controlled ◽  
End Stage

IntroductionDuring conventional liver transplantation (CLT), ischaemia-reperfusion injury (IRI) is inevitable and is associated with complications such as early allograft dysfunction (EAD), primary non-function and ischaemic-type biliary lesions. We have established a novel procedure called ischaemia-free liver transplantation (IFLT). The results from a pilot study suggest that IFLT might prevent IRI and yield better transplant outcomes than CLT. The purpose of this study was to further assess the efficacy and safety of IFLT versus CLT in patients with end-stage liver disease.Methods and analysisThis is an investigator-initiated, open-label, phase III, prospective, single-centre randomised controlled trial on the effects of IFLT in patients with end-stage liver disease. Adult patients (aged 18–75 years) eligible for liver transplantation will be screened for participation in this trial and will be randomised between the IFLT group (n=34) and the CLT group (n=34). In the IFLT group, the donor liver will be procured, preserved and implanted with continuous normothermic machine perfusion (NMP). In the CLT group, the donor liver will be procured after a fast cold flush, preserved in 0°C–4°C solution and implanted under hypothermic and hypoxic conditions. Patients in both groups will be managed according to the standard protocol of our centre. The primary end point is the incidence of EAD after liver transplantation. Intraoperative and postoperative parameters of donor livers and recipients will be observed and recorded, and postoperative liver graft function, complications and recipient and graft survival will be evaluated. After a 12-month follow-up of the last enrolled recipient, the outcomes will be analysed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.Ethics and disseminationThe protocol was reviewed and approved by the Ethics Committee of The First Affiliated Hospital of Sun Yat-sen University. The findings will be disseminated to the public through conference presentations and peer-reviewed scientific journals.Trial registration numberChiCTR1900021158.

Sign in / Sign up

Export Citation Format

Share Document