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

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].

Long-Term Efficacy of Ultrasound-Guided Percutaneous Laser Ablation for Low-Risk Papillary Thyroid Microcarcinoma: A 5-Year Follow-Up Study

Objective. To evaluate the long-term efficacy and safety of ultrasound-guided percutaneous laser ablation (PLA) for the treatment of low-risk papillary thyroid microcarcinoma (PTMC). Methods. From June 2012 to May 2015, 105 patients with solitary, pathologically confirmed PTMC lesions were treated with ultrasound-guided PLA. Nodule location, nodule volume, thyroid function, and clinical symptoms were evaluated before ablation. Contrast-enhanced ultrasound (CEUS) was performed 1 h after treatment to evaluate whether the ablation was complete. Ultrasound examination was performed at 1, 3, 6, and 12 months after ablation and every 6 months thereafter to determine the size of the ablation area and search for recurrence in the thyroid parenchyma and lymph node metastasis. Thyroid function was examined before and 1 month after ablation. Fine needle aspiration biopsy was performed for any suspicious metastatic lymph nodes and recurrent lesions in the thyroid. Results. All 105 lesions were completely inactivated after one ablation, making the success rate for single ablation 100%. The average ablation time was 2.78 ± 1.05 min, and the average ablation energy was 505 ± 185 J. All patients could tolerate and complete the ablation. No serious complications occurred during the treatment; only minor side effects such as pain and local discomfort were reported. The volume reduction rates were − 781.14 ± 653.29 % at 1 h posttreatment and − 268.65 ± 179.57 % , − 98.39 ± 76.58 % , 36.78 ± 30.32 % , 75.55 ± 21.81 % , 96.79 ± 10.57 % , and 100% at 1, 3, 6, 12, 18, and 24 months after ablation, respectively. This rate remained 100% at the later follow-up times. Overall, 28 (26.67%), 74 (70.48%), 96 (91.43%), and 103 (100%) were completely absorbed by 6, 12, 18, and 24 months after PLA. One patient developed another lesion 12 months after ablation, and two patients had central cervical lymph node metastasis 24 months after ablation. Conclusion. PLA is a safe and effective alternative clinical treatment for low-risk PTMC.

Therapeutic Effects of Ultrasound-Guided Percutaneous Laser Ablation for Primary Thyroid Microcarcinoma

Background: Ultrasound-guided percutaneous laser ablation, as a minimally invasive ablation method, has been widely used in the treatment of benign and malignant tumors. The objective of the current study is to determine the efficacy and safety of ultrasound-guided percutaneous laser ablation (PLA) for unifocal papillary thyroid micro carcinomas (PTMC).Methods: A total of 18 patients were included in this study. Patients with a single PTMC were treated via the PLA method, and postoperative complications, tumor size and recurrence rate were followed up and recorded.Results: Data suggested that three patients underwent a secondary ablation, and the remaining 15 patients underwent a single ablation without serious complications. No recurrence or metastasis was found among the follow-up patients, and the tumor sizes decreased significantly from 12 months following PLA treatment.Conclusions: Ultrasound-guided PLA is a new therapeutic means that can be used as an alternative to PTMC treatment.

Ultrasound–guided percutaneous laser ablation for pancreatic cancer: a new treatment option

Background & purpose‎: Most patients with pancreatic cancer (PC) suffer from an unresectable tumor at the time of diagnosis with limited treatment effectiveness. The purpose of this study is to investigate the feasibility and safety of percutaneous laser ablation (LA) for locally advanced and metastatic PC.Methods: Between September 2016 and April 2018, nine patients (mean age, 65.2 ± 5.4 years; age range, 62–68 years) with histologically proved PC were prospectively included to undergo ultrasound-guided LA. Effect including safety, pain perception and survival were evaluated. Results: Three patients were with locally advanced PC (stage III) and six with metastases (stage IV). All patients underwent LA in one session. The mean largest tumor diameter was ‎5.2±0.8 ‎cm (range, 4.2-6.9cm). Ablation power of all patients was 5 W and the mean ablation energy was 8.3±2.4 KJ (range 4.4-12KJ). Mean ablation volume was 17.1±3.2ml (range 13.0-22.1ml), which reached 89.1±7.4% (range 80.2-98.0%) of tumor volume. After a median follow-up period of 9.7 months (range, 6-15 months), the median survival from diagnosis was 11.2 months. Four stage IV patients died during 6.5-12.5 months after LA because of one hepatic encephalopathy and three tumor progression. No major complications occurred. Pain symptom achieved significant remission (P < 0.001) and patients experienced ameliorative physical function after LA. Percutaneous LA for unresectable PC is generally well tolerated. Conclusions: Preliminary results are encouraging with tumor size reducing and physical function significant improvement. US-guided percutaneous LA provides a new minimally invasive therapy modality for PC.