Jean de la Rosette, Stavros Gravas, Sonja van Rees Vellinga

At the World Congress of Endourology (WCE) in Istanbul, Turkey, in September, there was a strong representation of the Clinical Research Office of the Endourological Society (CROES). At the plenary sessions, an update was given on the different projects and especially the lessons learned from the percutaneous nephrolithotomy (PCNL) study.

Furthermore, there were meetings with the Steering Committees of all studies to discuss the progress of the studies but most importantly to timely identify problems and solve them with the ultimate goal to achieve the high quality standards set by CROES. In accordance with its commitment for transparency and communication with all the participants in the global studies, CROES presents the key points from the last Steering Committee meetings that took place at the WCE meeting.

General key points from the meetings

a. CROES Renal Mass Steering Committee Meeting

Present: Pilar Laguna (chairman), Benjamin Lee, Adrian Joyce, Stavros Gravas, Jean de la Rosette, Jeffrey Cadeddu, Jaime Landman, Helmut Wehrstein, Jochen Cramer, Sonja van Rees Vellinga.

The Renal Mass study is currently audited. Data quality is one of the major points of interest and therefore all centers have to successfully pass the audit. The data will be cleaned afterward, and the first analyses should be ready at the end of the year. At the moment, there are 107 centers participating in the Renal Mass study with more than 6000 patients included. The participants are located in approximately 35 countries worldwide.

Two new members were proposed and approved by the Steering Committee. CROES welcomes Dr. Gueglio (Buenos Aires) and Prof. Hohenfellner (Heidelberg) as new committee members.

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Picture 1.

PCNL update.

The first article prepared will be a descriptive one authored by all the members of the Steering Committee. The initial articles will be submitted to the Journal of Endourology; later articles can be submitted to other journals. The members of the Steering Committee can put forward their ideas for proposals, and 6 months after closing the study, all contributors may propose to the Steering Committee topics for analysis. Although the participants have signed a data transfer agreement, this does not keep them from publishing their own data at their own discretion.

b. CROES PCNL Steering Committee Meeting

Present: Jean de la Rosette (chairman), Stavros Gravas, Ahmet Tefekli, John Denstedt, Dean Assimos, Susanne Stahlkopf, Dedan Opondo, Sonja van Rees Vellinga.

The study closed at the end of 2009, and the data have been analyzed centrally at the CROES office. The members of the Steering Committee were presented with an update on all publications. Currently, 22 articles have been published in the Journal of Endourology, Journal of Urology, World Journal of Urology, British Journal of Urology International, European Urology, and Canadian Urological Association Journal. In total, the Global PCNL Study will result in approximately 30 articles. For a complete overview, please visit www.croesoffice.org. The call for proposals has been closed, and this meeting was the final meeting for the PCNL Study. CROES would like to continue the collaboration with Olympus and conduct a second study that will fill in the gaps on PCNL that were not investigated in the first study.

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Picture 2.

Meeting of Renal Mass Steering Committee.

c. CROES Narrow Band Imaging (NBI) Steering Committee Meeting

Present: Seiji Naito (chairman), Jean de la Rosette, Koji Shimomura, Scott Goldstein, Sonja van Rees Vellinga.

The study was initiated at the beginning of August 2010. There is an active involvement, mainly from centers in Asia and Europe. At the moment, 24 centers are actively including patients. The first milestone of 500 patients has been reached. Dr. Luc Valiquette from Montreal has been proposed and accepted as a member of the NBI Steering Committee. CROES is still recruiting new centers and aims also to collaborate with United Kingdom and French centers on this project. A few new centers have signed up at the WCE, and we expect the inclusion to further increase within the next few months. We invite all other centers that are interested to contact the CROES office through info@croesoffice.org.

d. CROES Ureteroscopy (URS) Steering Committee Meeting

Present: Jean de la Rosette (chairman), Stavros Gravas, Tadashi Matsuda, Margaret Pearle, Dave Dyer, Evan Brasington, Dedan Opondo, Sonja van Rees Vellinga.

The URS study is also undergoing an audit. It is commonplace that all participating centers contribute their data on a voluntary basis; however, monitoring, validation, and quality control of the data are of great importance to safeguard that the conclusions coming from the studies are accurate. At the moment, there are 150 centers actively participating with more than 12,000 patients included. We expect the first publications at the beginning of next year. As an extra service, CROES offers the centers that have contributed to the URS and Renal Mass studies the opportunity to keep on collecting data after the 1-year recruitment has passed.

e. CROES Green Light Laser Steering Committee Meeting

Present: Jean de la Rosette (chairman), Gerasimos Alivizatos, Sonja van Rees Vellinga.

All participating centers of the Greenlight Laser study were audited. Each center received 10 audit queries to confirm the validity of data that were entered in the CROES data management system (DMS). Responses to the queries in the form of laboratory reports, radiologic images, and text reports were compared with data in the DMS. For cases in which discrepancies arose, centers were asked to verify specific patient data.

In total, there are 27 centers that have successfully passed the audit. The data of two centers were excluded because the data failed the audit. After cleaning the data, 1066 patients are included. Of these 1066 patients, 744 have been treated with Greenlight Laser. The number of patients treated with the different powered lasers was as follows: 80 W (n=247), 120 W (n=356), and 180 W (n=110). The first descriptive article is currently being written and will be authored by the Steering Committee.

Last but not least, there were five poster presentations at the WCE on the outcomes of the PCNL study. We would like to thank Dr. Cormio, Dr. Anastadiadis, Dr. Astroza, Dr. Tefekli, and Dr. Opondo for presenting the results. To view all posters, please visit our website.

CROES is well aware that without the altruistic support from all the investigators, this would not have been made possible. Approximately 350 centers and 720 investigators are dedicated to CROES and working with us to improve research and eventually healthcare. CROES welcomes the suggestion of new projects and specifically encourages American investigators to take the lead for that. At present, to start a new project, funding has to be secured by the investigator, who then will become the chairman of the Steering Committee. CROES is you; therefore, send us your feedback or suggestions to further improve our common effort. The time is now—with CROES, the ability is yours. ¹

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Picture 3.

Poster of PCNL study: Staghorn stones and positioning