A Multicenter Prospective Research on the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope

Renal Calculus Clinical Trial

Official title:

A Multicenter Prospective Research on the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03105206
• Other study ID #: SHOT-20161208
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Changhai Hospital
• Contact: Gao Xiaofeng, MD
• Phone: 086-13601600968
• Email: gxfdoc[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Renal Calculus

Intervention

Procedure:
• Flexible Ureteroscopy
the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (11)

Lead Sponsor	Collaborator
Changhai Hospital	Jiangsu Provincial People's Hospital, Renmin Hospital of Wuhan University, Shanghai Changzheng Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Xiamen University, The Second People's Hospital of GuangDong Province, Tongji Hospital, West China Hospital, Zhejiang Provincial People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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. Review. — View 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. Review. — View 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. — View Citation

Knoll T, Musial A, Trojan L, Ptashnyk T, Michel MS, Alken P, Köhrmann 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	whether the f-URS could enter the low kidney calyx or not	Following conditions are regarded as failures: 1. the f-URS couldn't enter the low kidney calyx 2. Though the f-URS has entered the low kidney calyx, it cannot crush the stone.	during the operation
Secondary	stone clearance	Check NECT(nonenhanced CT), no residual or residual stones are smaller than 2mm in total refers to clear success.Number of participants undergo f-URS surgeries without residual calculus/Total number of participants in each group *100%=stone clearance	4 weeks post-operatively

External Links

•   Do new generation flexible ureterorenoscopes offer a higher treatment success than their predecessors?
•   Flexible ureterorenoscopy for lower pole stones: influence of the collecting system's anatomy
•   Impact of lower pole renal anatomy on stone clearance after shock wave lithotripsy: fact or fiction
•   Measurement of renal anatomy for prediction of lower-pole caliceal stone clearance: reproducibility of different parameters
•   Predictive factors of lower calyceal stone clearance after extracorporeal shockwave lithotripsy (ESWL): the impact of radiological anatomy
•   Pushing the boundaries of ureteroscopy: current status and future perspectives
•   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