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

NCT03105206 | Unknown

• 1 other identifier: SHOT-20161208
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Calculus

Keywords

lowl pole renal calculus; anatomical parameters; flexible ureteroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• stone clearance

  4 weeks post-operatively

Study Arms (1)

Low Pole Renal Calculus

patients with low pole renal calculus who are suitable to treat by flexible ureteroscopy

Procedure: Flexible Ureteroscopy

Interventions

Flexible Ureteroscopy PROCEDURE

the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope

Low Pole Renal Calculus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

low pole renal calculus patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead
• Shanghai Changzheng Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Tongji Hospital: collaborator
• Renmin Hospital of Wuhan University: collaborator
• The Second People's Hospital of GuangDong Province: collaborator
• Jiangsu Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• West China Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Zhejiang Provincial People's Hospital: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 24083332 RESULT

• 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.

  PMID: 21855968 RESULT

• 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.

  PMID: 20968209 RESULT

• 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.

  PMID: 11342888 RESULT

• 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.

  PMID: 18955183 RESULT

• 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.

  PMID: 14565873 RESULT

• 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.

  PMID: 21052986 RESULT

• 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.

  PMID: 24890883 RESULT

Related Links

• 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

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gao Xiaofeng, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao Xiaofeng, MD

CONTACT

086-13601600968; gxfdoc@hotmail.com

Peng Yonghan, MD

CONTACT

086-13917386896; yonghanyhtl@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Changhai Hospital

Study Record Dates

• First Submitted: April 2, 2017
• First Posted: April 7, 2017
• Study Start: May 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

CN (1)