Tag: Article of the Week

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Video: MRI can assess the eligibility of patients with prostate cancer for AS

June 4, 2014/by admin Z.9

Role of multiparametric 3.0-Tesla magnetic resonance imaging in patients with prostate cancer eligible for active surveillance

Bong H. Park, Hwang G. Jeon, Seol H. Choo, Byong C. Jeong, Seong I. Seo, Seong S. Jeon, Han Y. Choi and Hyun M. Lee

Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Current address: Bong H. Park, Department of Urology, Incheon St. Mary’s Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea

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OBJECTIVE

• To evaluate predictors of more aggressive disease and the role of multiparametric 3.0-T magnetic resonance imaging (MRI) in selecting patients with prostate cancer for active surveillance (AS).

PATIENTS AND METHODS

• We retrospectively assessed 298 patients with prostate cancer who met the Prostate Cancer Research International: Active Surveillance (PRIAS) criteria, defined as T1c/T2, PSA level of ≤10 ng/mL, PSA density (PSAD) of <0.2 ng/mL², Gleason score <7, and one or two positive biopsy cores.

• All patients underwent preoperative MRI, including T2-weighted, diffusion-weighted, and dynamic contrast-enhanced imaging, as well as radical prostatectomy (RP) between June 2005 and December 2011.

• Imaging results were correlated with pathological findings to evaluate the ability of MRI to select patients for AS.

RESULTS

• In 35 (11.7%) patients, no discrete cancer was visible on MRI, while in the remaining 263 (88.3%) patients, a discrete cancer was visible.

• Pathological examination of RP specimens resulted in upstaging (>T2) in 21 (7%) patients, upgrading (Gleason score >6) in 136 (45.6%), and a diagnosis of unfavourable disease in 142 (47.7%) patients.

• The 263 patients (88.3%) with visible cancer on imaging were more likely to have their cancer status upgraded (49.8% vs 14.3%) and be diagnosed with unfavourable disease (52.1% vs 14.3%) than the 35 patients (11.7%) with no cancer visible upon imaging, and these differences were statistically significant (P < 0.001 for all).

• A visible cancer lesion on MRI, PSAD, and patient age were found to be predictors of unfavourable disease in multivariate analysis.

CONCLUSION

• MRI can predict adverse pathological features and be used to assess the eligibility of patients with prostate cancer for AS.

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Article of the week: Enhanced Recovery Programme for radical cystectomy

May 28, 2014/by admin Z.9

Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by prominent members of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one

Implementation of the Exeter Enhanced Recovery Programme for patients undergoing radical cystectomy

Thomas J. Dutton, Mark O. Daugherty, Robert G. Mason and John S. McGrath

Exeter Surgical Health Services Research Unit, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK

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OBJECTIVES

• To describe our experience with the implementation and refinement of an enhanced recovery programme (ERP) for radical cystectomy (RC) and urinary diversion.

• To assess the impact on length of stay (LOS), complication and readmission rates.

PATIENTS AND METHODS

• In all, 165 consecutive patients undergoing open RC (ORC) and urinary diversion between January 2008 and April 2013 were entered into an ERP.

• A retrospective case note review was undertaken.

• Outcomes recorded included LOS, time to mobilisation, complication rates within the first 30 days (Clavien-Dindo classification) and readmissions.

RESULTS

• All patients were successfully entered into the ERP.

• As enhanced recovery principles became embedded in the unit, LOS reduced from a mean of 14 days over the initial year of the ERP to a mean of 9.2 days.

• The complication rate was 6.6% for Clavien ≥3, and 43.5% for Clavien ≤2. The 30-day mortality rate was 1.2%.

• The 30-day readmission rate was 13.9%.

• In the most contemporary subset of 52 patients: the median time after ORC to sit out of bed, mobilise and open bowels was day 1, 2 and 6, respectively.

CONCLUSIONS

• The ERP described for patients undergoing ORC appears to be safe.

• Benefits include early feeding, mobilisation and hospital discharge.

• The ERP will continue to develop with the incorporation of advancing evidence and technology, in particular the introduction of robot-assisted RC.

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Editorial: Enhanced recovery programmes: an important step towards going lean in healthcare

May 28, 2014/by Raj Pruthi

Enhanced recovery programmes (also known as clinical care pathways) are excellent examples of ‘lean thinking’. The ‘lean’ approach is derived from the management philosophy known as the ‘Toyota Production System’ (TPS) that helped the Japanese company become the world’s largest automaker. This management approach has been widely adopted throughout the manufacturing world and has revolutionised the way many businesses operate. Indeed, the concept of clinical care pathways has its roots in the management theories of the TPS, Six Sigma, Business Process Redesign, the Theory of Constraints, and other such methodologies.

This by no means implies that a person is like a car, or the situation is always or ever ‘textbook’. Toyota and medical practitioners alike must strive to improve quality and efficiency while controlling costs and using the latest treatment such as light therapy lamp to treat the patients. And, in the case of healthcare, all of these goals must come under the provision of optimising patient care.

Clinical care pathways provide us the opportunity to standardise processes and problem solving, and eliminate inconsistency (aka ‘mura’, a fundamental pillar of Toyotism). The result is that in every aspect of the delivery of care, there exist clear expectations and demonstrated capabilities. Although situational change is a constant in the healthcare environment, process standards must be applied in all applicable areas to reduce the controllable variances and ensure regulatory compliance, patient and staff satisfaction, and outcomes. Through these standardised pathways or programmes, we are able to establish a confidence in ourselves, our peers, our patients, and our families that what we say will indeed occur. In other words, the right process will produce the right results.

Clinical care pathways are an example of ‘process’ innovation – a concept that can be distinguished from ‘product’ innovation (e.g. drug development, diagnostic tests, robotic and other surgical tools). Process innovations represent important and much needed opportunities to improve outcomes and reduce costs. Clinical care pathways have already been shown to improve patient outcomes, reduce errors, decrease costs, increase transparency of treatment, improve patient, staff, and physician satisfaction, and improve educational opportunities. Moreover, radical cystectomy seems ideally suited to such standardised processes due to characteristics of (1) resource intensivity, (2) complexity of care, (3) high potential variability, and (4) high morbidity.

In this month’s BJU International, Dutton et al. [1] report the ability to effectively apply a standardised enhanced recovery programme to patients undergoing radical cystectomy and urinary diversion for bladder cancer. In their sequential case series, the authors report earlier ambulation, enteral feeding, and time to discharge in patients who were under this enhanced recovery programme (described within) without adverse outcomes, e.g. increased re-admission rates. Similarly, the use of clinical care pathways in our own cystectomy population at The University of North Carolina has represented one of the most important interventions to improve quality and efficiency of care while simultaneously reducing costs.

The next challenge is to explore the applicability of care pathways to multiple physicians and at different institutions, i.e. the widespread use of such programmes to yield the desired results over a healthcare system. Once these processes have been standardised and are able to demonstrate predictable results, we can then focus on raising the performance of these standardised practices and doing so in an iterative process (aka ‘kaizen’).

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Raj S. Pruthi and Mathew C. Raynor
Department of Urology and the Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

Reference

Dutton TJ, Daugherty MO, Mason RG, McGrath JS. Implementation of the Exeter Enhanced Recovery Programme for patients undergoing radical cystectomy. BJU Int 2014; 113: 719–725

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Article of the week: Moving up a GEAR: evaluating robotic dry lab exercises

May 21, 2014/by admin Z.9

If you only have time to read one article this week, it should be this one

Face, content, construct and concurrent validity of dry laboratory exercises for robotic training using a global assessment tool

Patrick Ramos, Jeremy Montez, Adrian Tripp, Casey K. Ng, Inderbir S. Gill and Andrew J. Hung

USC Institute of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

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OBJECTIVES

• To evaluate robotic dry laboratory (dry lab) exercises in terms of their face, content, construct and concurrent validities.

• To evaluate the applicability of the Global Evaluative Assessment of Robotic Skills (GEARS) tool to assess dry lab performance.

MATERIALS AND METHODS

• Participants were prospectively categorized into two groups: robotic novice (no cases as primary surgeon) and robotic expert (≥30 cases).

• Participants completed three virtual reality (VR) exercises using the da Vinci Skills Simulator (Intuitive Surgical, Sunnyvale, CA, USA), as well as corresponding dry lab versions of each exercise (Mimic Technologies, Seattle, WA, USA) on the da Vinci Surgical System.

• Simulator performance was assessed by metrics measured on the simulator. Dry lab performance was blindly video-evaluated by expert review using the six-metric GEARS tool.

• Participants completed a post-study questionnaire (to evaluate face and content validity).

• A Wilcoxon non-parametric test was used to compare performance between groups (construct validity) and Spearman’s correlation coefficient was used to assess simulation to dry lab performance (concurrent validity).

RESULTS

• The mean number of robotic cases experienced for novices was 0 and for experts the mean (range) was 200 (30–2000) cases.

• Expert surgeons found the dry lab exercises both ‘realistic’ (median [range] score 8 [4–10] out of 10) and ‘very useful’ for training of residents (median [range] score 9 [5–10] out of 10).

• Overall, expert surgeons completed all dry lab tasks more efficiently (P < 0.001) and effectively (GEARS total score P < 0.001) than novices. In addition, experts outperformed novices in each individual GEARS metric (P < 0.001).

• Finally, in comparing dry lab with simulator performance, there was a moderate correlation overall (r = 0.54, P < 0.001). Most simulator metrics correlated moderately to strongly with corresponding GEARS metrics (r = 0.54, P < 0.001).

CONCLUSIONS

• The robotic dry lab exercises in the present study have face, content, construct and concurrent validity with the corresponding VR tasks.

• Until now, the assessment of dry lab exercises has been limited to basic metrics (i.e. time to completion and error avoidance). For the first time, we have shown it is feasibile to apply a global assessment tool (GEARS) to dry lab training.

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Editorial: Validating dry lab exercises for robotic surgical skills training

May 21, 2014/by Kamran Ahmed

Standardising and structuring of robotic surgery curricula: validation and integration of non-technical skills is required

Kamran Ahmed and Oliver Brunckhorst

Surgical simulation has advanced tremendously over the last two decades with the development of laparoscopic and robotic surgery. Because these procedures have a steep learning curve and because of the reduced training times experienced by trainees, safe adjuncts to operating room training are required [1]. Simulation training is a novel approach to surgical training and has been validated as a training and assessment tool and has been shown to improve a surgeon’s performance in the operating room.

In the present paper, Ramos et al. [2] evaluate the face, content, construct and concurrent validity of robotic dry laboratory (dry lab) exercises. They developed similar tasks to those included in the validated virtual reality da Vinci Skills Simulator using the da Vinci Surgical System in a dry lab environment. They also explored the applicability of Global Evaluative Assessment of Robotic Skills (GEARS) to assess dry lab performance. Good responses from the expert cohort with regard to realism and usefulness as a training tool confirmed the face and content validity of the dry lab exercises, whilst concurrent validity was also established, with experts outperforming novices in all but one of the individual metrics. Finally the simulator composite score achieved from the virtual reality simulator and GEARS scores from the dry lab exercises moderately correlated, thereby also establishing concurrent validity.

The present study raises an interesting question about the definitions of what constitutes an expert in robotic surgery. There are no consistent definitions of a ‘novice’ or an ‘expert’. A recent review has shown that the learning curve in the literature varies from 80 to 250 cases in robot-assisted laparoscopic prostatectomies, depending on previous open or laparoscopic experience and the outcome measures used [1]. With this in mind, Ramos et al. classified ‘experts’ as those performing >30 cases as the primary surgeon. This should be taken into consideration as the experts were so vital in establishing the face, content and construct validity of the dry lab curriculum. Additionally, although it has been shown that simulation models are valid and reliable for the initial phase of training and assessment in urological procedures, this is not the case for advanced and specialist level skill learning.

The present study provides validated dry lab exercises which could be incorporated into a robotic surgery training curriculum. With several simulators now having been validated for robotic surgery, integration of these within a structured robotic surgery curriculum is required. Steps have been taken to set out an effective curriculum similar to that which exists for laparoscopic surgery. The Fundamental Skills of Robotic Surgery is a simulation-based curriculum which has been validated and has a proven educational impact [3]. The Fundamentals of Robotic Surgery curriculum has also recently been laid out, but this is still in the process of validation [4]. One of the biggest initiatives in urology, however, was recently announced by the European Association of Robotic Urology Section Congress 2013 [5]. A multinational push to implement a standardized curriculum set out a multi-step curriculum which uses various techniques, including online theoretical training, simulation and observation and finally fellowship prior to certification, then allowing the surgeon to perform independent surgery. The next step for these curricula is for them to be fully validated and implemented, with the patient outcomes then being analysed.

Another aspect worth considering is the integration of non-technical skills within these curricula which has occurred in few of them. Full-immersion simulation (Fig. 1) offers the opportunity for training surgeons to develop critical skills such as communication, coordination and leadership. For the more experienced surgeon, at the later stages of a curriculum, full crisis simulation can help develop decision-making and team-working skills in difficult situations. It has been shown that integration of full-immersion simulation in simulation training is feasible and effective [6]. Surgeons performing robotic surgery need to develop the non-technical aspects alongside their technical skills, and full-immersion simulation certainly has a role to play in this and needs to be integrated within the curricula. The development of the Distributed Simulator offers a validated and low-cost method [7] of introducing full-immersion simulation into robotic surgery curricula and is an option that requires further investigation for its effectiveness in urology.

Figure 1. Aspects of non-technical skills developed through full-immersion simulation [8, 9].

In conclusion, the present study offers further examples of tasks that could be incorporated into robotic surgery training curricula. Whilst curricula exist, implementation and analysis of their effect on patient outcomes are the next steps. The integration of non-technical skills within these is important, and full-immersion simulation has an important role to play within robotic training curricula.

Kamran Ahmed*^† and Oliver Brunckhorst*^†

*MRC Centre for Transplantation, King’s College London, King’s Health Partners, and ^†Department of Urology, Guy’s Hospital, London, UK

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References

Abboudi H, Khan MS, Guru KA et al. Learning curves for urological procedures: a systematic review. BJU Int 2013; doi: 10.1111/bju.12315. [Epub ahead of print]
Ramos P, Montez J, Tripp A, Ng CK, Gill IS, Hung AJ. Face, content, construct and concurrent validity of dry laboratory exercises for robotic training using a global assessment tool. BJU Int 2014; 113: 836–842
Stegemann AP, Ahmed K, Syed JR et al. Fundamental skills of robotic surgery: a multi-institutional randomized controlled trial for validation of a simulation-based curriculum. Urology 2013; 81: 767–774
Smith R, Patel V, Satava R. Fundamentals of robotic surgery: a course of basic robotic surgery skills based upon a 14-society consensus template of outcomes measures and curriculum development. Int J Med Robot 2013; doi: 10.1002/rcs.1559 [Epub ahead of print]
Khan R, Ahmed K, Mottrie A et al. Towards a standardised training curriculum for robotic surgery: a consensus of an international multidisciplinary group of experts. Poster presented at the EAU Robotic Urology Section Congress Stockholm, Sep 3–5 2013
Shamim Khan M, Ahmed K, Gavazzi A et al. Development and implementation of centralized simulation training: evaluation of feasibility, acceptability and construct validity. BJU Int 2013; 111: 518–523
Kassab E, Tun JK, Arora S et al. ‘Blowing up the barriers’ in surgical training: exploring and validating the concept of distributed simulation. Ann Surg 2011; 254: 1059–1065
Flin R, Yule S, Paterson-Brown S, Maran N, Rowley D, Youngson G. Teaching surgeons about non-technical skills. Surgeon 2007; 5: 86–89
Undre S, Sevdalis N, Healey AN, Darzi A, Vincent CA. Observational teamwork assessment for surgery (OTAS): refinement and application in urological surgery. World J Surg 2007; 31: 1373–1381

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Article of the week: Outcomes of PCNL in England

May 14, 2014/1 Comment/by admin Z.9

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Mr. Armitage and Mr. Withington discussing their article.

If you only have time to read one article this week, it should be this one

Percutaneous nephrolithotomy in England: practice and outcomes described in the Hospital Episode Statistics database

James N. Armitage, John Withington*^†, Jan van der Meulen*^‡, David A. Cromwell*, Jonathan Glass^†, William G. Finch^§, Stuart O. Irving^§ and Neil A. Burgess^§

Department of Urology, Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, *Clinical Effectiveness Unit, The Royal College of Surgeons of England, ^†Department of Urology, Guy’s & St Thomas’ NHS Foundation Trust, ^‡London School of Hygiene and Tropical Medicine, London, and ^§Department of Urology, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK

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OBJECTIVE

• To investigate the postoperative outcomes of percutaneous nephrolithotomy (PCNL) in English National Health Service (NHS) hospitals.

PATIENTS AND METHODS

• We extracted records from the Hospital Episode Statistics (HES) database for all patients undergoing PCNL between March 2006 and January 2011 in English NHS hospitals.

• Outcome measures were haemorrhage, infection within the index admission, and rates of emergency readmission and in-hospital mortality within 30 days of surgery.

RESULTS

• A total of 5750 index PCNL procedures were performed in 165 hospitals.

• During the index admission, haemorrhage was recorded in 81 patients (1.4%), 192 patients (3.8%) had a urinary tract infection (UTI), 95 patients (1.7%) had fever, and 41 patients (0.7%) had sepsis.

• There were 595 emergency readmissions in 518 patients (9.0%). Reasons for readmission were varied: 70 (1.2%) with UTI, 15 (0.3%) sepsis, 73 (1.3%) haematuria, 25 (0.4%) haemorrhage, and 25 (0.4%) acute urinary retention.

• There were 13 (0.2%) in-hospital deaths within 30 days of surgery.

CONCLUSIONS

• Haemorrhage and infection represent relatively common and potentially severe complications of PCNL.

• Mortality is extremely rare after PCNL (about one in 400 procedures overall) but almost one in 10 patients have an unplanned hospital readmission within 30 days of surgery.

• Complications of PCNL may be under-reported in the HES database and need to be corroborated using other data sources.

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Editorial: How are we doing with percutaneous nephrolithotomy in England?

May 14, 2014/by Roger Sur

Over the past several years, with publications of studies evaluating multiple aspects of nephrolithiasis using large databases, our overview of kidney stone disease has vastly expanded. The most recent addition by Armitage et al. [1], published in this issue of BJUI, gives us a view of percutaneous nephrolithotomy (PCNL) outcomes in England that we otherwise would have difficulty seeing without tapping into a database study. Several salient features of this investigation are worth pointing out.

With any study comes the uncertainty of its validity. Evidence-based medicine (EBM) theory dictates we first ask ‘Are the results valid?’ rather than ‘What are the results?’. This study reports similar outcomes to a prior database study of the BAUS, giving us confidence that data from different sources still produce somewhat similar outcomes, hence adding validity to both studies [2]. Moreover, it is further reassuring that the type of epidemiological source of the information was derived from completely different origins, i.e. Armitage et al. [1] used an administrative database from Hospital Episode Statistics (HES) to create their outcomes while the BAUS used a voluntary online prospective database for British surgeons.

The second question that forms the basis of EBM is ‘What are the results?’. The HES data confirmed several findings of PCNL seen in other studies, including in both international series from the Clinical Research Office of the Endourological Society (CROES) as well as American administrative database studies using the Nationwide Inpatient Sample (NIS) [3-5]. Overall complications occur anywhere from 6% to 15% of the time, with the most common complications including infection and bleeding. Compared with these recent studies, the HES study reports lower bleeding, UTI and sepsis rates, which the authors admit could represents an under-reporting phenomenon. Mortality is an exceedingly rare event in all these studies. Overall, complication rates are comparable and give us assurance that they align approximately with other worldwide data. Another important finding with the HES database is the decreased length of stay for patients over time. Lastly, from a physician credentialing standpoint this study has relevant findings. It suggests that the HES administrative database may be a viable source of information to assist in the surgeon validating process.

Weaknesses of administrative database studies include the lack of detail that prospective clinical databases provide. Clinically pertinent PCNL endpoints are inherently absent for both patient and surgical domains. Missing patient information includes stone size, stone-free rates, and patient obesity, which are all reflections of clinical case difficulty. Missing critical surgical information includes where (upper, mid or lower calyx), who (urologist or radiologist) and how (balloon, serial dilators) access is obtained. As mentioned above, the uncertainty of under-coding clinical information always exists.

Why are large database studies, including this article, important? These studies are timely given the recent advocating of retrograde ureteroscopic treatment of large renal calculi [6]. Publication of low complication rates with equal efficacy in an outpatient setting has made ureteroscopic treatment of partial and staghorn renal calculi attractive. Even laparoscopic anatrophic nephrolithotomy has been advocated to further challenge the ‘gold standard’ treatment of PCNL [7]. It is therefore clinically important that British PCNL complication rates are low and that length of stay is decreasing to affirm the role that PCNL has with large renal calculi.

The role of PCNL surgery for renal calculi continues to develop but, more importantly, the value of these large epidemiological studies also continues to grow. They help us to look not only from the ground level but also give us perspective from a different, if not ‘higher’ level, which taken together helps shapes our interpretation of PCNL.

Roger L. Sur

Department of Urology, UC San Diego Health System, San Diego, CA, USA

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References

Armitage JN, Withington J, Van der Meulen J et al. Percutaneous nephrolithotomy in England: practice and outcomes described in the hospital episode statistics database. BJU Int 2014; 113: 777–782
Armitage JN, Irving SO, Burgess NA, British Association of Urological Surgeons Section of Endourology. Percutaneous nephrolithotomy in the United Kingdom: results of a prospective data registry. Eur Urol 2012; 61: 1188–1193
de la Rosette J, Assimos D, Desai M et al. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: indications, complications, and outcomes in 5803 patients. J Endourol 2011; 25: 11–17
Mirheydar HS, Palazzi KL, Derweesh IH, Chang DC, Sur RL. Percutaneous nephrolithotomy use is increasing in the United States: an analysis of trends and complications. J Endourol 2013; 27: 979–983
Ghani KR, Sammon JD, Bhojani N et al. Trends in percutaneous nephrolithotomy use and outcomes in the United States. J Urol 2013; 190: 558–564
Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK. Flexible ureteroscopy and laser lithotripsy for stones >2 cm: a systematic review and meta-analysis. J Endourol 2012; 26: 1257–1263
Aminsharifi A, Hadian P, Boveiri K. Laparoscopic anatrophic nephrolithotomy for management of complete staghorn renal stone: clinical efficacy and intermediate-term functional outcome. J Endourol 2013; 27: 573–578

Video: PCNL practice and outcomes in England

May 14, 2014/1 Comment/by admin Z.9

Percutaneous nephrolithotomy in England: practice and outcomes described in the Hospital Episode Statistics database

James N. Armitage, John Withington*^†, Jan van der Meulen*^‡, David A. Cromwell*, Jonathan Glass^†, William G. Finch^§, Stuart O. Irving^§ and Neil A. Burgess^§

Read the full article

OBJECTIVE

• To investigate the postoperative outcomes of percutaneous nephrolithotomy (PCNL) in English National Health Service (NHS) hospitals.

PATIENTS AND METHODS

• We extracted records from the Hospital Episode Statistics (HES) database for all patients undergoing PCNL between March 2006 and January 2011 in English NHS hospitals.

• Outcome measures were haemorrhage, infection within the index admission, and rates of emergency readmission and in-hospital mortality within 30 days of surgery.

RESULTS

• A total of 5750 index PCNL procedures were performed in 165 hospitals.

• There were 13 (0.2%) in-hospital deaths within 30 days of surgery.

CONCLUSIONS

• Haemorrhage and infection represent relatively common and potentially severe complications of PCNL.

• Mortality is extremely rare after PCNL (about one in 400 procedures overall) but almost one in 10 patients have an unplanned hospital readmission within 30 days of surgery.

• Complications of PCNL may be under-reported in the HES database and need to be corroborated using other data sources.

Read more articles of the week

Article of the week: Out of the COLD: cryoablation for locally advanced PCa

May 7, 2014/by admin Z.9

If you only have time to read one article this week, it should be this one

Cryoablation for locally advanced clinical stage T3 prostate cancer: a report from the Cryo-On-Line Database (COLD) Registry

John F. Ward, Christopher J. DiBlasio*, Christopher Williams^†, Robert Given^‡ and J. Stephen Jones

^§The University of Texas MD Anderson Cancer Center, Houston, TX, *Urology, Mount Sinai School of Medicine, Huntington, NY, ^†Urology, University of Florida and Shands Medical Center, Jacksonville, FL, ^‡Urology, Eastern Virginia Medical School, Norfolk, VA, and ^§Urology, Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA

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OBJECTIVE

• To assess the oncological and functional outcomes of primary prostate cryoablation for men with clinical stage T3 (cT3) prostate cancer, as although radical prostatectomy (RP) or external beam radiotherapy (EBRT) are the standard treatments for locally advanced cT3 prostate cancer some patients opt for nonextirpative prostate cryoablation instead.

PATIENTS AND METHODS

• The Cryo-On-Line Database (COLD) Registry was queried to identify patients with cT3 prostate cancer treated with whole-gland cryoablation (366 patients).

• We assessed biochemical disease-free survival (bDFS) using the Phoenix definition and determined reported rates of urinary incontinence and retention, sexual activity, and rectourethral fistulisation after treatment.

• Patients were subsequently assessed according to whether they were administered neoadjuvant androgen-deprivation therapy or not (ADT; 115 patients, 31.4%).

RESULTS

• For the entire cohort, the 36- and 60-month bDFS rates were 65.3% and 51.9%, respectively.

• Patients who received neoadjuvant ADT had statistically nonsignificantly higher 36- and 60-month bDFS rates (68.0% and 55.4%, respectively) than patients who did not receive neoadjuvant ADT (55.3% and 36.9%, respectively).

• The after treatment urinary incontinence rate was 2.6%; urinary retention rate, 6.0%; sexual activity rate, 30.4%; and rectourethral fistulisation rate, 1.1%.

CONCLUSIONS

• Cryoablation for patients with cT3 prostate cancer leads to less favourable bDFS than that after RP or RT for the same group of men.

• The after treatment rectourethral fistulisation rates for patients with cT3 disease are higher than in those with organ-confined prostate cancer treated with cryoablation; however, urinary dysfunction and sexual activity rates are similar for men with cT3 to those reported from this same registry in men with cT2 disease.

• The addition of neoadjuvant ADT (though not studied prospectively here) should be strongly considered if a patient with cT3 prostate cancer is to be treated with cryoablation.

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Editorial: Cryosurgery for clinical T3 prostate cancer

May 7, 2014/by Osamu Ukimura

There are limited data available on the outcomes of cryosurgery for clinical T3 prostate cancer, and as such, the role of cryosurgery for clinical T3 disease is currently undetermined [1]. Modern cryosurgery of the prostate, utilizing gas-based third-generation technology, a real-time monitoring system with ultrasonography and thermocouples, is associated with a low complication rate [7], although comparative outcomes of the different treatment modalities and long-term follow-up data remain to be seen.

Several aspects of cryosurgery can make it difficult to adequately control locally advanced prostate cancer. First, cryosurgery for clinical T3 cancer requires unique surgical expertise to control local disease while minimizing side-effects. Secondly, staging of locally advanced prostate cancer is challenging – it is difficult to accurately identify the extent of extracapsular extension, seminal vesicle involvement and/or lymph node metastasis. Thirdly, challenges in managing clinical T3 disease include the requirement of a more extensive ablation technique to appropriately target the extraprostatic disease and seminal vesicle involvement as well as treatment for possible microscopic metastasis, which might not be clinically detectable.

Two recent randomized trials compared outcomes of external beam radiation therapy with those of cryosurgery (including cT3 diseases with use of neo-adjuvant androgen deprivation therapy [ADT]), with contrasting results [2, 3]. Chin et al. [2] reported superiority of biochemical disease-free survival favouring external beam radiation therapy in relatively more advanced (bulky) disease, while Donnelly et al. [3] reported significantly fewer positive biopsy rates favouring cryosurgery in the relatively less advanced disease. These findings could suggest that more advanced bulky cases that require wider local control of bulky extraprostatic diseases are not suitable for cryosurgery, while in appropriately selected cases with fewer extraprostatic diseases, cryosurgery is an acceptable option (when combined with neo-adjuvant ADT). Although appropriately extended cryo-lesions that achieve lethal temperatures can control extraprostatic disease, there is a certain limitation in the extension of cryo-lesions without injury to vital peri-prostate organs, such as the urinary sphincter, rectal wall, bladder wall and ureters.

Evolving accuracy of preoperative diagnostic imaging to assess extraprostatic disease can enhance outcomes, and staging tissue sampling from suspected extraprostatic disease could also identify actual microscopic extension of the extraprostatic disease [4]. A recently updated nomogram predicting lymph node invasion [5] suggests that the probability of lymph node invasion in patients with cT3, PSA level >10 ng/mL, and biopsy primary Gleason grade 4 is 20% or greater. Clearly, the preoperative risk assessment of lymph node involvement using such a modern calculator is pertinent for appropriate patient selection. Finally, management decision should be made by a multidisciplinary team.

When combined with radiotherapy, neo-adjuvant ADT for high-risk and locally advanced prostate cancer has been associated with clinical benefit; however, when combining neo-adjuvant ADT with prostatectomy, there is pathological down-staging and reduction in the surgical positive margin but minimal improvement in overall or disease-free survival [6]. The role of neo-adjuvant and adjuvant ADT when combined with cryosurgery is still unknown. Clearly, a prospective study is needed to determine the optimal duration and method of ADT (whether to use LHRH analogue or combined blockade) and to analyse the side-effects, the quality of life and the cost-effectiveness of a combination of cryosurgery with ADT for cT3a and cT3b prostate cancer.

Osamu Ukimura, Andre Luis de Castro Abreu, Andrew J. Hung and Inderbir S. Gill
USC Institute of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

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References

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