Clinical trial NCT03105206: A Multicenter Prospective Research on the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope
Official title: A Multicenter Prospective Research on the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Calculus
Keywords: lowl pole renal calculus
anatomical parameters
flexible ureteroscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Changzheng Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Tongji Hospital
name: Renmin Hospital of Wuhan University
name: The Second People's Hospital of GuangDong Province
name: Jiangsu Provincial People's Hospital
name: The First Affiliated Hospital of Nanchang University
name: West China Hospital
name: The First Affiliated Hospital of Xiamen University
name: Zhejiang Provincial People's Hospital
First posted: 2017-04-07
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: low pole renal calculus patients

Brief summary: This study centers on the treatment of low pole renal stones by flexible ureteroscope and intends to find the key anatomical parameters using a prospective, randomized multi-center trial design and to make a more appropriate standard for flexible ureteroscopy of low pole renal stones.

Detailed description: With the development of manufacturing technique, new generation of flexible ureteroscopes have great initiative and passive bending capacity and have greatly expanded its application. In our clinical practice, we have found that IPA (Infundibulopelvic angle) is no longer a decisive factor for the success of f-URS（flexible ureteroscope） surgeries. Thus, we think it is necessary to have further study on the effect of anatomy of renal collecting system for f-URS surgeries.

Eligibility criteria: Inclusion Criteria:

* • Subject has provided informed consent and indicated a willingness to comply with study treatments

  * 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 an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)

  * 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

Primary outcomes:
measure: whether the f-URS could enter the low kidney calyx or not
timeFrame: during the operation
Secondary outcomes:
measure: stone clearance
timeFrame: 4 weeks post-operatively
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Gao Xiaofeng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.