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Research Proposal
1.
Trial Synopsis
Simon Hein, M.D.
Department of Urology, University Medical Centre Freiburg
Hugstetter Str. 55, D-79106 Freiburg, Germany
Coordinating
investigator
Tel.:
Fax:
Email:
+49/761/270-28910
+49/761/270-28780
simon.hein@uniklinik-freiburg.de
Title of trial
Clinical Significance of Residual Fragments in 2015: Impact, Detection and How
to Avoid Them
Objective
Review of the literature concerning outcome parameters relevant to patients with persisting residual fragments after active stone treatment and techniques to detect and
avoid them
Inclusion criteria:
Inclusion and
clusion criteria
ex-
Clinical studies, including systematic reviews (SR), RCTs, cohort studies, case-control
studies, case series, EAU and AUA guidelines on urolithiasis
Exclusion criteria:
Case reports, epidemiological studies, cross-sectional studies, cadaveric studies,
animal studies
Primary endpoint:
Stone-related clinical events (medical treatment, retreatment)
Secondary endpoint(s):
Outcome(s)
Sensitivity and specificity of different imaging modes
Radiation exposure of imaging modes
Stone free rate of SWL and endourology (URS/ PNL)
Complications of SWL and endourology
Frequency of ancillary procedures in SWL and endourology
Current and future techniques to avoid residual fragments
Trial type
Cross-sectional, comprehensive review (non-systematic)
Statistical analysis
Descriptive analyses of primary and secondary endpoints.
Sample size
Max. 60 references to be included
Trial duration
Time for preparation of the trial (months): 3
Data acquisition (months): 3
Statistical analysis (months): 0
Manuscript drafting (months): 3
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2.
The Medical Problem
The treatment of urolithiasis has changed dramatically with minimally invasive techniques gradually
replacing open surgery since the beginning of the 1970s. In the era of open surgery, complete stone
clearance defined a successful treatment [1]. With the introduction of extracorporeal shock wave lithotripsy (SWL), fragments of targeted stones and subsequent expulsion came into focus [2]. ‘Clinically
insignificant residual fragments’ (CIRF) were defined as asymptomatic residual fragments of 4 mm or
less after SWL [3]. Indeed, occurrence of residual fragments (RF) is not restricted to SWL of renal
stones. RF may as well remain after percutaneous nephrolithotomy (PNL) and (flexible) ureteroscopy
(fURS) of the kidney and ureter [1, 4]. However, the impact of residual fragments on subsequent stone
associated incidents, reoccurrence and growth, remains a subject of discussion [5]. In this review we
address various issues concerning the fate of residual fragments (and the patients carrying them),
their detection and current and future techniques to avoid them.
3.
Justification of Design Aspects
3.1
Inclusion and exclusion criteria
Inclusion criteria:
Clinical studies including systematic reviews (SR), RCTs, cohort studies, case-control studies, case
series, non-systematic reviews and EAU and AUA guidelines on urolithiasis
Exclusion criteria:
Case reports, epidemiological studies, cross-sectional studies, cadaveric studies, animal studies
Assessment of clinical outcome parameters of clinical trials (best available evidence) to answer identified problems relevant to the patient.
3.2
Search Method
Databases:
PubMed®, MEDLINE®, Embase™, Ovid®, Google Scholar™, and the Cochrane Library.
Search term:
Boolean searching will be performed using following terms:
“shock wave lithotripsy”, “ureteroscopy”, “percutaneous nephrolithotomy”, “imaging”, “computed tomography”, “clinically insignificant residual fragments”, “CIRF”, and “residual fragments”.
Terms will be linked by Boolean operators AND and OR.
EAU/AUA guidelines will be assessed concerning recommendations and cited references.
3.3
Outcome measures
Results will be evaluated concerning primary and secondary endpoints.
Primary endpoint:
Stone-related clinical events (medical treatment, retreatment)
Secondary endpoint(s):
Sensitivity and specificity of different imaging modes
Radiation exposure of imaging modes
Stone free rate of SWL and endourology (URS/ PNL)
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Complications of SWL and endourology
Frequency of ancillary procedures in SWL and endourology
Current and future techniques to avoid residual fragments
3.4
Methods against bias
Evaluation and rating of extracted article by 2 independent reviewers (S.H. and M.S.). In cases of divergent ratings, results will be verified by a third independent reviewer (A.M.).
4.
Statistical Analysis
Results will be described using descriptive statistics. No further statistical analysis will be performed.
5.
Trial Management
5.1
Key participants
#
Name
Affiliation
Responsibility/Role
1
Simon Hein, M.D.
Dept. of Urology, University Medical Centre Freiburg
Principal investigator
2
Arkadisz Miernik, M.D., Ph.D.
Dept. of Urology, University Medical Centre Freiburg
Co-Investigator
3
Konrad Wilhelm, M.D
Dept. of Urology, University Medical Centre Freiburg
Co-Investigator
Fabian Adams, M.D.
Dept. of Urology, University Medical Centre Freiburg
Co-Investigator
Daniel Schlager, M.D.
Dept. of Urology, University Medical Centre Freiburg
Co-Investigator
4
5
6
Thomas Herrmann, M.D., Ph.D.
7
Jens Rassweiler, M.D., Ph.D., Dr.
h.c., Prof.
8
Martin Schoenthaler, M.D., Ph.D.
5.2
Department of Urology and
Urooncology, Hanover Medical
School (MHH)
SLK Kliniken Heilbronn
Department of Urology and Pediatric Urology
Dept. of Urology, University Medical Centre Freiburg
Co-Investigator
Co-Investigator
Co-Investigator
Supporting facilities
None.
6.
Financing
Institutional funding (Department of Urology, University Medical Centre Freiburg)
6.1
Co-financing of the trial by a company: None
7.
References
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1.
2.
3.
4.
5.
Altunrende, F., et al., Clinically insignificant residual fragments after percutaneous
nephrolithotomy: medium-term follow-up. J Endourol, 2011. 25(6): p. 941-5.
Osman, M.M., et al., 5-year-follow-up of patients with clinically insignificant residual
fragments after extracorporeal shockwave lithotripsy. Eur Urol, 2005. 47(6): p. 860-4.
Rassweiler, J.J., et al., Treatment of renal stones by extracorporeal shockwave lithotripsy: an
update. Eur Urol, 2001. 39(2): p. 187-99.
Ozgor, F., et al., Clinically insignificant residual fragments after flexible ureterorenoscopy:
medium-term follow-up results. Urolithiasis, 2014. 42(6): p. 533-8.
Tan, Y.H. and M. Wong, How significant are clinically insignificant residual fragments
following lithotripsy? Curr Opin Urol, 2005. 15(2): p. 127-31.