DOI: 10.1089/end.2015.1511 CROES COUNCIL Chairman Jean de la Rosette, M.D. Amsterdam (The Netherlands) Adrian Joyce, M.S. Leeds (UK)
JOIN THE PREMIER RESEARCH OFFICE IN THE FIELD OF ENDOUROLOGY
Stavros Gravas, M.D. Larissa (Greece) Jorge Gutierrez-Aceves, M.D. Winston Salem (USA) Dean Assimos, M.D. Birmingham (USA) Ying-Hao Sun, M.D. Shanghai (China) Tadashi Matsuda, M.D. Osaka ( Japan)
Take part in publications and presentations that offer exposure to your institution Become a member of the global research network of Endourologists Be recognized as a centre of excellence in the field of Endourology
TREASURER John Denstedt, M.D. London (Canada)
EXECUTIVE DIRECTOR Sonja van Rees Vellinga Amsterdam (The Netherlands) [email protected]
383
THE CROES GLOBAL PERCUTANEOUS NEPHROLITHOTOMY STUDY REVISITED Janak Desai, Alleemudder Adam, and Sam Dutta
Percutaneous nephrolithotomy (PCNL), shockwave lithotripsy (SWL) and retrograde intrarenal surgery (RIRS) are currently the three main interventions available for stone disease, which accounts for a third of the workload in a typical urology department, that has virtually eliminated the need for open surgery.1 Since first described, PCNL has become the standard of care for stones greater than 2 cm and has the highest stone-free rate (SFR).2,3 It is also associated with the highest morbidity, which led initially to a fall in its use because of the emergence of SWL and then a subsequent rise as the technique became refined and the equipment was improved and miniaturized.4 The global Clinical Research Office of the Endourological Society (CROES) study, published by de la Rosette and associates5 in 2011, described the current indications, perioperative morbidity, and SFR of standard PCNL in 5803 patients from 96 centers in 26 countries. In the majority of procedures, the stones were in the lower pole (44.8%), access was achieved by the urologist (90.1%), the patient was in the prone position (80.3%), and the subcostal route was preferred (83.3%). The procedure was uneventful in most cases (85.5%) but was associated with a risk of bleeding (7.8%) and necessitating transfusion (5.7%), fever (10.5%), renal pelvis perforation (3.4%), hydrothorax (1.8%), and failure to complete the procedure (1.7%). The SFR was 75.7% and a large proportion needed no further treatment (84.5%). A similar study from the United Kingdom with 987 patients, with a slightly higher proportion of staghorn stones (30%), also found the complication rate was low but with a SFR of 68% that was still more than with RIRS and SWL.6 Although generally regarded as a safe and effective procedure, PCNL is increasingly being challenged by RIRS and minimally invasive PCNL using miniaturized instruments. The use of RIRS has traditionally been reserved for lower pole stones when SWL has failed but is now being attempted with increased confidence for larger stones as technology moves on through the use of flexible, digital, and smaller caliber scopes. The downside to this technique includes the size of fragments that can be removed and the higher cost associated with disposable materials such as access sheaths, guidewires, laser fibers, and baskets.7 For example, the cost is almost double compared with ultra-mini PCNL (UMP), which has implications in financial-conscious developing countries.8 A recent meta-analysis comparing standard PCNL with RIRS found the operative times were similar, but PCNL was associated with a significantly higher SFR at the expense of more blood loss, complications, and admission stay.9 The risk of ureteral injury and steinstrasse with RIRS compared with urine leak, pelvic perforation, embolization, and pleural injury with PCNL were again highlighted. Minimally invasive PCNL has been developed to minimize the parenchymal injury that results in bleeding and morbidity associated with standard PCNL that uses larger 24F to 30F sheaths.10 Mini
384
PCNL was initially described using smaller tracts up to 20F and a 12F miniscope.11 This has the advantage of causing less bleeding with reduced analgesic requirement and hospital stay, but the visibility is less and the increased operative time needed means the technique is not suitable for a larger stone burden. In a comparative study between mini and standard PCNL, the SFR (96%–100%) was similar for stones 1 to 2 cm.12 Using a smaller tract also led to a lower hemoglobin drop, analgesic requirement, and hospital stay. The boundaries were pushed even further when the micro PCNL was described in which a 4.85F allseeing needle was used in an initial series of 10 patients with a mean stone size of 14.3 cm and SFR of 80%.13 This technique allows for a single step access directly into the relevant calix without the need for multiple maneuvers that leads to significantly less morbidity. The need to completely vaporize the stone because the fragments cannot be retrieved means there is a limit to the size of stone and operative times are invariably longer. To overcome these issues, the most recent development is the UMP where an even smaller 3.5F scope is used but with a 13F sheath.14 The flow of irrigation in this technique seemed to provide the right balance of pressure needed to flush out the fragments without the need for using graspers. The study with 62 patients, mean stone size of 16.8 cm, and SFR of 86.6% showed that the procedure was as safe and effective and that improved on the operative times while minimizing morbidity. Furthermore, a recent study comparing UMP and RIRS of 30 patients found no significant difference between operative times, hospital stay, and complications.8 It is clear from the evidence so far that minimally invasive PCNL seems to be the answer to minimizing the trauma and the resulting morbidity while maintaining the efficacy associated with standard PCNL. While there have been small studies demonstrating the benefits of minimally invasive PCNL, the initial CROES PCNL study will need updating in the near future in view of these current trends and a randomized study is desperately needed to assess how the different techniques compare. This should also put in perspective the CROES Global Ureteroscopy Study and an urgently needed update on SWL within the armamentarium for stone management. CROES is committed to provide data that enable us to deliver the best possible care to our patients. References
1. de la Rosette JJ, Laguna MP, Rassweiler JJ, Conort P. Training in percutaneous nephrolithotomy—a critical review. Eur Urol 2008;54:994–1001. 2. Fernstro¨m I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol 1976;10:257– 259. 3. Tu¨rk C, Knoll T, Petrik A, et al. Guidelines on urolithiasis. European Urological Association Web site. http://www.uroweb.org/ gls/pdf/ 22%20Urolithiasis_LR.pdf Updated 2014. 4. Michel M, Trojan L, Rassweiler J. Complications in percutaneous nephrolithotomy. Eur Urol 2007;51:899–906. 5. 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. 6. 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. 7. Landman J, Lee DI, Lee C, Monga M. Evaluation of overall costs of currently available small flexible ureteroscopes. Urology 2003;62:218–222. 8. Schoenthaler M, Wilhelm K, Hein S, et al. Ultra-mini PCNL versus flexible ureteroscopy: A matched analysis of treatment costs (endoscopes and disposables) in patients with renal stones 10–20 mm. World J Urol 2015. Epub ahead of print. 9. De S, Autorino R, Kim FJ, et al. Percutaneous nephrolithotomy versus retrograde intrarenal surgery: A systematic review and meta-analysis. Eur Urol 2015;67:125–137. 10. Kukreja R, Desai M, Patel S, et al. Factors affecting blood loss during percutaneous nephrolithotomy: Prospective study. J Endourol 2004;18:715–722. 11. Jackman SV, Docimo SG, Cadeddu JA, et al. The ‘‘mini-perc’’ technique: A less invasive alternative to percutaneous nephrolithotomy. World J Urol 1998;16:371–374. 12. Mishra S, Sharma R, Garg C, et al. Prospective comparative study of miniperc and standard PNL for treatment of 1 to 2 cm size renal stone. BJU Int 2011;108:896–900.
385
13. Desai M, Sharma R, Mishra S, et al. Single-step percutaneous nephrolithotomy (microperc): The initial clinical report. J Urol 2011;186:140–145. 14. Desai J, Solanki R. Ultra-mini percutaneous nephrolithotomy (UMP): One more armamentarium. BJU Int 2013;112:1046– 1049.
The Global Ureteroscopy Study, Global GreenLightÔ Laser Study, and the Global Renal Mass Study were closed in 2012. The first six articles on ureteroscopy and the first one on the Renal Mass Study have been published. The first two articles of the GreenLightÔ Laser Study are under review. The randomized study on Narrow Band Imaging vs White Light Imaging closed in 2013. The first results are being analyzed. Ongoing project: The Irreversible Electroporation Study for Focal Therapy, including a pilot study, a randomized controlled trial, and a registry. New project: The randomized study on SPIES vs White Light Imaging New project: The Global Upper Tract-Transitional-Cell Carcinoma Study. For further information please visit: www.croesoffice.org or contact the Executive Director of CROES, Mrs. Sonja van Rees Vellinga ([email protected]).
386
JOIN THE PREMIER RESEARCH OFFICE IN THE FIELD OF ENDOUROLOGY
Stavros Gravas, M.D. Larissa (Greece) Jorge Gutierrez-Aceves, M.D. Winston Salem (USA) Dean Assimos, M.D. Birmingham (USA) Ying-Hao Sun, M.D. Shanghai (China) Tadashi Matsuda, M.D. Osaka ( Japan)
Take part in publications and presentations that offer exposure to your institution Become a member of the global research network of Endourologists Be recognized as a centre of excellence in the field of Endourology
TREASURER John Denstedt, M.D. London (Canada)
EXECUTIVE DIRECTOR Sonja van Rees Vellinga Amsterdam (The Netherlands) [email protected]
383
THE CROES GLOBAL PERCUTANEOUS NEPHROLITHOTOMY STUDY REVISITED Janak Desai, Alleemudder Adam, and Sam Dutta
Percutaneous nephrolithotomy (PCNL), shockwave lithotripsy (SWL) and retrograde intrarenal surgery (RIRS) are currently the three main interventions available for stone disease, which accounts for a third of the workload in a typical urology department, that has virtually eliminated the need for open surgery.1 Since first described, PCNL has become the standard of care for stones greater than 2 cm and has the highest stone-free rate (SFR).2,3 It is also associated with the highest morbidity, which led initially to a fall in its use because of the emergence of SWL and then a subsequent rise as the technique became refined and the equipment was improved and miniaturized.4 The global Clinical Research Office of the Endourological Society (CROES) study, published by de la Rosette and associates5 in 2011, described the current indications, perioperative morbidity, and SFR of standard PCNL in 5803 patients from 96 centers in 26 countries. In the majority of procedures, the stones were in the lower pole (44.8%), access was achieved by the urologist (90.1%), the patient was in the prone position (80.3%), and the subcostal route was preferred (83.3%). The procedure was uneventful in most cases (85.5%) but was associated with a risk of bleeding (7.8%) and necessitating transfusion (5.7%), fever (10.5%), renal pelvis perforation (3.4%), hydrothorax (1.8%), and failure to complete the procedure (1.7%). The SFR was 75.7% and a large proportion needed no further treatment (84.5%). A similar study from the United Kingdom with 987 patients, with a slightly higher proportion of staghorn stones (30%), also found the complication rate was low but with a SFR of 68% that was still more than with RIRS and SWL.6 Although generally regarded as a safe and effective procedure, PCNL is increasingly being challenged by RIRS and minimally invasive PCNL using miniaturized instruments. The use of RIRS has traditionally been reserved for lower pole stones when SWL has failed but is now being attempted with increased confidence for larger stones as technology moves on through the use of flexible, digital, and smaller caliber scopes. The downside to this technique includes the size of fragments that can be removed and the higher cost associated with disposable materials such as access sheaths, guidewires, laser fibers, and baskets.7 For example, the cost is almost double compared with ultra-mini PCNL (UMP), which has implications in financial-conscious developing countries.8 A recent meta-analysis comparing standard PCNL with RIRS found the operative times were similar, but PCNL was associated with a significantly higher SFR at the expense of more blood loss, complications, and admission stay.9 The risk of ureteral injury and steinstrasse with RIRS compared with urine leak, pelvic perforation, embolization, and pleural injury with PCNL were again highlighted. Minimally invasive PCNL has been developed to minimize the parenchymal injury that results in bleeding and morbidity associated with standard PCNL that uses larger 24F to 30F sheaths.10 Mini
384
PCNL was initially described using smaller tracts up to 20F and a 12F miniscope.11 This has the advantage of causing less bleeding with reduced analgesic requirement and hospital stay, but the visibility is less and the increased operative time needed means the technique is not suitable for a larger stone burden. In a comparative study between mini and standard PCNL, the SFR (96%–100%) was similar for stones 1 to 2 cm.12 Using a smaller tract also led to a lower hemoglobin drop, analgesic requirement, and hospital stay. The boundaries were pushed even further when the micro PCNL was described in which a 4.85F allseeing needle was used in an initial series of 10 patients with a mean stone size of 14.3 cm and SFR of 80%.13 This technique allows for a single step access directly into the relevant calix without the need for multiple maneuvers that leads to significantly less morbidity. The need to completely vaporize the stone because the fragments cannot be retrieved means there is a limit to the size of stone and operative times are invariably longer. To overcome these issues, the most recent development is the UMP where an even smaller 3.5F scope is used but with a 13F sheath.14 The flow of irrigation in this technique seemed to provide the right balance of pressure needed to flush out the fragments without the need for using graspers. The study with 62 patients, mean stone size of 16.8 cm, and SFR of 86.6% showed that the procedure was as safe and effective and that improved on the operative times while minimizing morbidity. Furthermore, a recent study comparing UMP and RIRS of 30 patients found no significant difference between operative times, hospital stay, and complications.8 It is clear from the evidence so far that minimally invasive PCNL seems to be the answer to minimizing the trauma and the resulting morbidity while maintaining the efficacy associated with standard PCNL. While there have been small studies demonstrating the benefits of minimally invasive PCNL, the initial CROES PCNL study will need updating in the near future in view of these current trends and a randomized study is desperately needed to assess how the different techniques compare. This should also put in perspective the CROES Global Ureteroscopy Study and an urgently needed update on SWL within the armamentarium for stone management. CROES is committed to provide data that enable us to deliver the best possible care to our patients. References
1. de la Rosette JJ, Laguna MP, Rassweiler JJ, Conort P. Training in percutaneous nephrolithotomy—a critical review. Eur Urol 2008;54:994–1001. 2. Fernstro¨m I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol 1976;10:257– 259. 3. Tu¨rk C, Knoll T, Petrik A, et al. Guidelines on urolithiasis. European Urological Association Web site. http://www.uroweb.org/ gls/pdf/ 22%20Urolithiasis_LR.pdf Updated 2014. 4. Michel M, Trojan L, Rassweiler J. Complications in percutaneous nephrolithotomy. Eur Urol 2007;51:899–906. 5. 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. 6. 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. 7. Landman J, Lee DI, Lee C, Monga M. Evaluation of overall costs of currently available small flexible ureteroscopes. Urology 2003;62:218–222. 8. Schoenthaler M, Wilhelm K, Hein S, et al. Ultra-mini PCNL versus flexible ureteroscopy: A matched analysis of treatment costs (endoscopes and disposables) in patients with renal stones 10–20 mm. World J Urol 2015. Epub ahead of print. 9. De S, Autorino R, Kim FJ, et al. Percutaneous nephrolithotomy versus retrograde intrarenal surgery: A systematic review and meta-analysis. Eur Urol 2015;67:125–137. 10. Kukreja R, Desai M, Patel S, et al. Factors affecting blood loss during percutaneous nephrolithotomy: Prospective study. J Endourol 2004;18:715–722. 11. Jackman SV, Docimo SG, Cadeddu JA, et al. The ‘‘mini-perc’’ technique: A less invasive alternative to percutaneous nephrolithotomy. World J Urol 1998;16:371–374. 12. Mishra S, Sharma R, Garg C, et al. Prospective comparative study of miniperc and standard PNL for treatment of 1 to 2 cm size renal stone. BJU Int 2011;108:896–900.
385
13. Desai M, Sharma R, Mishra S, et al. Single-step percutaneous nephrolithotomy (microperc): The initial clinical report. J Urol 2011;186:140–145. 14. Desai J, Solanki R. Ultra-mini percutaneous nephrolithotomy (UMP): One more armamentarium. BJU Int 2013;112:1046– 1049.
The Global Ureteroscopy Study, Global GreenLightÔ Laser Study, and the Global Renal Mass Study were closed in 2012. The first six articles on ureteroscopy and the first one on the Renal Mass Study have been published. The first two articles of the GreenLightÔ Laser Study are under review. The randomized study on Narrow Band Imaging vs White Light Imaging closed in 2013. The first results are being analyzed. Ongoing project: The Irreversible Electroporation Study for Focal Therapy, including a pilot study, a randomized controlled trial, and a registry. New project: The randomized study on SPIES vs White Light Imaging New project: The Global Upper Tract-Transitional-Cell Carcinoma Study. For further information please visit: www.croesoffice.org or contact the Executive Director of CROES, Mrs. Sonja van Rees Vellinga ([email protected]).
386
