A Multicenter Prospective Research on the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope
NCT ID: NCT03105206
Last Updated: 2019-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1100 participants
OBSERVATIONAL
2017-05-01
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Low Pole Renal Calculus
patients with low pole renal calculus who are suitable to treat by flexible ureteroscopy
Flexible Ureteroscopy
the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope
Interventions
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Flexible Ureteroscopy
the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope
Eligibility Criteria
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Inclusion Criteria
* Subject is 18-70 yrs of age
* Subject can be either male or female
* Subject has a diagnosis of low pole renal stones according to CT urography(CTU) or intravenous pyelogram (IVP) results
* Subject has a single stone 1\~2cm in size (KUB), or multiple stones 1\~2cm in cumulative size (KUB), and is a surgical candidate for the ureteroscopic approach
Exclusion Criteria
* Subject has been diagnosed with a urethral stricture or bladder neck contracture
* Subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks
* Subject has severe hematuria that might blur the vision of the endoscopy
* Subject is pregnant or in monthly period
* Subject has coexistent disease like systemic disease, heart disease, lung disfunction or other diseases that could not tolerate the endoscopic surgery or anesthesia.
* Subject has unadjusted diabetes or high blood pressure
* Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
* Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (2 weeks)
* Subject has been diagnosed with hydronephrosis larger than 3cm according to the B-scan ultrasonography examination
* Subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Changzheng Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Tongji Hospital
OTHER
Renmin Hospital of Wuhan University
OTHER
The Second People's Hospital of GuangDong Province
OTHER
Jiangsu Provincial People's Hospital
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
West China Hospital
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Zhejiang Provincial People's Hospital
OTHER
Changhai Hospital
OTHER
Responsible Party
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Xiaofeng Gao
Changhai Hospital
Principal Investigators
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Gao Xiaofeng, MD
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Jessen JP, Honeck P, Knoll T, Wendt-Nordahl G. Flexible ureterorenoscopy for lower pole stones: influence of the collecting system's anatomy. J Endourol. 2014 Feb;28(2):146-51. doi: 10.1089/end.2013.0401. Epub 2013 Nov 19.
Resorlu B, Oguz U, Resorlu EB, Oztuna D, Unsal A. The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stones. Urology. 2012 Jan;79(1):61-6. doi: 10.1016/j.urology.2011.06.031.
Geavlete P, Jecu M, Geavlete B, Multescu R, Nita G, Georgescu D. Ureteroscopy--an essential modern approach in upper urinary tract diagnosis and treatment. J Med Life. 2010 Apr-Jun;3(2):193-9.
Madbouly K, Sheir KZ, Elsobky E. Impact of lower pole renal anatomy on stone clearance after shock wave lithotripsy: fact or fiction? J Urol. 2001 May;165(5):1415-8.
Lin CC, Hsu YS, Chen KK. Predictive factors of lower calyceal stone clearance after extracorporeal shockwave lithotripsy (ESWL): the impact of radiological anatomy. J Chin Med Assoc. 2008 Oct;71(10):496-501. doi: 10.1016/S1726-4901(08)70157-6.
Knoll T, Musial A, Trojan L, Ptashnyk T, Michel MS, Alken P, Kohrmann KU. Measurement of renal anatomy for prediction of lower-pole caliceal stone clearance: reproducibility of different parameters. J Endourol. 2003 Sep;17(7):447-51. doi: 10.1089/089277903769013577.
Wendt-Nordahl G, Mut T, Krombach P, Michel MS, Knoll T. Do new generation flexible ureterorenoscopes offer a higher treatment success than their predecessors? Urol Res. 2011 Jun;39(3):185-8. doi: 10.1007/s00240-010-0331-0. Epub 2010 Nov 5.
Geavlete P, Multescu R, Geavlete B. Pushing the boundaries of ureteroscopy: current status and future perspectives. Nat Rev Urol. 2014 Jul;11(7):373-82. doi: 10.1038/nrurol.2014.118. Epub 2014 Jun 3.
Related Links
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Flexible ureterorenoscopy for lower pole stones: influence of the collecting system's anatomy
The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stones
Ureteroscopy--an essential modern approach in upper urinary tract diagnosis and treatment
Impact of lower pole renal anatomy on stone clearance after shock wave lithotripsy: fact or fiction
Predictive factors of lower calyceal stone clearance after extracorporeal shockwave lithotripsy (ESWL): the impact of radiological anatomy
Measurement of renal anatomy for prediction of lower-pole caliceal stone clearance: reproducibility of different parameters
Do new generation flexible ureterorenoscopes offer a higher treatment success than their predecessors?
Pushing the boundaries of ureteroscopy: current status and future perspectives
Other Identifiers
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SHOT-20161208
Identifier Type: -
Identifier Source: org_study_id
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