Treatment of esophageal tumors using high intensity intraluminal ultrasound: first clinical results

<p>Abstract</p> <p>Background</p> <p>Esophageal tumors generally bear a poor prognosis. Radical surgery is generally the only curative method available but is not feasible in the majority of patients; palliative therapy with stent placement is generally performed. It has been demonstrated that High Intensity Ultrasound can induce rapid, complete and well-defined coagulation necrosis. Thus, for the treatment of esophageal tumors, we have designed an ultrasound applicator that uses an intraluminal approach to fill up this therapeutic gap.</p> <p>Methods</p> <p>Thermal ablation is performed with water-cooled ultrasound transducers operating at a frequency of 10 MHz. Single lesions extend from the transducer surface up to 10 mm in depth when applying an intensity of 14 W/cm²for 10s. A lumen inside the therapy applicator provides path for an endoscopic ultrasound imaging probe operating at a frequency of 12 MHz. The mechanical rotation of the applicator around its axis enables treatment of sectorial or cylindrical volumes. This method is thus particularly suitable for esophageal tumors that may develop only on a portion of the esophageal circumference. Previous experiments were conducted from bench to <it>in vivo </it>studies on pig esophagi.</p> <p>Results</p> <p>Here we report clinical results obtained on four patients included in a pilot study. The treatment of esophageal tumors was performed under fluoroscopic guidance and ultrasound imaging. Objective tumor response was obtained in all cases and a complete necrosis of a tumor was obtained in one case. All patients recovered uneventfully and dysphagia improved significantly within 15 days, allowing for resuming a solid diet in three cases.</p> <p>Conclusion</p> <p>This clinical work demonstrated the efficacy of intraluminal high intensity ultrasound therapy for local tumor destruction in the esophagus.</p

High-intensity-focused ultrasound in the treatment of primary prostate cancer: the first UK series

BACKGROUND: The use of minimally invasive ablative therapies in localised prostate cancer offer potential for a middle ground between active surveillance and radical therapy. METHODS: An analysis of men with organ-confined prostate cancer treated with transrectal whole-gland HIFU (Sonablate 500) between 1 February 2005 and 15 May 2007 was carried out in two centres. Outcome data (side-effects using validated patient questionnaires, biochemical, histology) were evaluated. RESULTS: A total of 172 men were treated under general anaesthetic as day-case procedures with 78% discharged a mean 5 h after treatment. Mean follow-up was 346 days (range 135-759 days). Urethral stricture was significantly lower in those with suprapubic catheter compared with urethral catheters (19.4 vs 40.4%, P = 0.005). Antibiotics were given to 23.8% of patients for presumed urinary tract infection and the rate of epididymitis was 7.6%. Potency was maintained in 70% by 12 months, whereas mild stress urinary incontinence (no pads) was reported in 7.0% (12 out of 172) with a further 0.6% (1 out of 172) requiring pads. There was no rectal toxicity and no recto-urethral fistulae. In all, 78.3% achieved a PSA nadir <= 0.5 mu g ml(-1) at 12 months, with 57.8% achieving <= 0.2 mu g ml(-1). Then, 8 out of 13 were retreated with HIFU, one had salvage external beam radiotherapy and four chose active surveillance for small-volume low-risk disease. Overall, there was no evidence of disease (PSA <0.5 mu g ml(-1) or negative biopsy if nadir not achieved) after one HIFU session in 92.4% ( 159 out of 172) of patients. CONCLUSION: HIFU is a minimally invasive, day-case ablative technique that can achieve good biochemical outcomes in the short term with minimal urinary incontinence and acceptable levels of erectile dysfunction. Long-term outcome needs further evaluation and the inception of an international registry for cases treated using HIFU will significantly aid this health technology assessment. British Journal of Cancer (2009) 101, 19-26. doi: 10.1038/sj.bjc.6605116 www.bjcancer.com Published online 9 June 2009 (C) 2009 Cancer Research U

Adverse Events of Extracorporeal Ultrasound-Guided High Intensity Focused Ultrasound Therapy

High-intensity focused ultrasound (HIFU) is considered to be an alternative to surgery. Extracorporeal ultrasound-guided HIFU (USgFU) has been clinically used to treat solid tumors. Preliminary trials in a small sample of a Western population suggested that this modality was safe. Most trials are performed in China thereby providing comprehensive data for understanding the safety profile. The aim of this study was to evaluate adverse events of USgFU therapy.Clinical data were searched in 2 Chinese databases. Adverse events of USgFU were summarized and compared with those of magnetic resonance-guided HIFU (MRgFU; for uterine, bone or breast tumor) and transrectal ultrasound-guided HIFU (for prostate cancer or benign prostate hyperplasia). USgFU treatment was performed using 7 types of device. Side effects were evaluated in 13262 cases. There were fewer adverse events in benign lesions than in malignant lesions (11.81% vs. 21.65%, p<0.0001). Rates of adverse events greatly varied between the disease types (0-280%, p<0.0001) and between the applied HIFU devices in both malignant (10.58-44.38%, p<0.0001) and benign lesions (1.67-17.57%, p<0.0001). Chronological analysis did not demonstrate a decrease in the rate of adverse events. Based upon evaluable adverse events, incidences in USgFU were consistent with those in MRgFU or transrectal HIFU. Some side effects frequently occurred following transrectal HIFU were not reported in USgFU. Several events including intrahepatic metastasis, intraoperative high fever, and occlusions of the superior mesenteric artery should be of particular concern because they have not been previously noted. The types of adverse events suggested that they were ultrasonic lesions.The frequency of adverse events depended on the location of the lesion and the type of HIFU device; however, side effects of USgFU were not yet understood. USgFU did not decrease the incidence of adverse events compared with MRgFU

The incidence of chronic scrotal pain after vasectomy: a prospective audit.

OBJECTIVE: To assess the extent of scrotal pain in men before and after vasectomy, to produce accurate data for the benefit of men considering this procedure, and hence improved informed consent about the outcomes, as chronic scrotal pain after vasectomy is a poorly quantified clinical problem. PATIENTS AND METHODS: Between November 2004 and January 2006 nine surgeons carried out vasectomies in 625 men (mean age 39.9 years, sd 5.6) under local anaesthesia. A questionnaire was devised to establish the presence of any scrotal or testicular pain, and to characterize this discomfort; 6 months after the procedure a modified version of the same questionnaire was administered. RESULTS: In all, 593 (94.7%) men returned the preoperative questionnaires and were entered into the study; 488 (82.2%) of these completed the follow-up questionnaire, giving a mean (sd) follow-up of 6.8 (1.6) months. In all, 65 men reported new-onset scrotal pain at 7 months (14.7%). The mean visual analogue score for this pain was 3.4/10. Four men (0.9%) in the responding group described pain after vasectomy as 'quite severe and noticeably affecting their quality of life'. CONCLUSION: At 7 months after vasectomy about 15% of previously asymptomatic men have some degree of scrotal discomfort. These early data indicate that chronic scrotal pain after vasectomy is a genuine entity, but a longer-term follow-up in this group will be important to allow further evaluation of how this pain develops with time

Visually directed high-intensity focused ultrasound for organ-confined prostate cancer: A proposed standard for the conduct of therapy.

OBJECTIVE: To propose a standard for the conduct of visually directed transrectal high-intensity focused ultrasound (HIFU) and to offer a formal description of the changes observed on B-mode ultrasonography (US) during this procedure. We describe our early experience of using two different treatment methods; algorithm-based HIFU and visually directed HIFU for the treatment of organ-confined prostate cancer. PATIENTS AND METHODS: Between November 2004 and October 2005, 34 men were treated using the Sonablate-500 (Focus Surgery, Indianapolis, IN, USA) as primary therapy for T1 or T2 prostate cancer. None had had previous hormone therapy and all had &gt; or = 3-month PSA nadirs recorded at the follow-up. Nine men were treated using an algorithm-based protocol (group 1) and 25 using visually directed therapy (group 2). The conduct of visually directed treatment was described and changes seen using B-mode US were categorized using three 'Uchida' grades. RESULTS The mean PSA nadir achieved in group 2 was 0.15 ng/mL, vs 1.51 ng/mL in group 1 (P &lt; 0.005). In group 2, 21 of 25 men achieved PSA nadirs of &lt; or = 0.2 ng/mL 3 months after treatment. Seven men achieved undetectable PSA values. The occurrence rate of treatment-related toxicity was similar in both groups. CONCLUSION: Visually directed, transrectal HIFU enables clinically important and statistically significantly lower PSA nadirs to be achieved than algorithm-based HIFU. This is the first reported experience of visually directed HIFU for the treatment of organ-confined prostate cancer. We think that this is the first attempt to standardize the conduct of therapy; such standardization facilitates teaching it, and makes it possible to derive quality standards. The standardization of the conduct of therapy is a key step in the process of health technology assessment

Preliminary experience using high-intensity focused ultrasound for the treatment of kidney and liver tumours

High-intensity focused ultrasound (HIFU) provides a potentially non-invasive alternative to conventional therapies. We have been using the extracorporeal ultrasound-guided Model-JC Tumor Therapy System (HAIFU™ Technology Co, China) in clinical trials to evaluate the safety and feasibility of treating renal and liver tumours. 30 patients have been treated (22 liver and 8 kidney tumours), all of whom were available for adverse event reporting. Of the 22 liver tumours, 20 are evaluable for response to treatment; 14 were followed up with magnetic resonance imaging (MRI) alone, and 6 with both MRI and histological resection. Evidence of ablation was seen in 20/20 (100%) cases radiologically, and 6/6 (100%) cases histologically. Of the 8 kidney tumours treated, 7 are evaluable; 2 were followed up with MRI alone, and 5 with both MRI and histological resection. Evidence of ablation was seen in 4/7 (57%) radiologically and 1/5 (20%) histologically. Mild, moderate or severe transient pain was reported by 16 (53%), 7 (23%) and 1 (3%) patients, respectively. Superficial skin toxicity was seen in 7 patients (23%). Renal function was unaffected, and all patients were fit for discharge from hospital the day after treatment. Early results show that this technique is feasible, and carries a low morbidity. © 2005 American Institute of Physics