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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Renal Calculus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Changzheng Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

The Second People's Hospital of GuangDong Province

OTHER

Sponsor Role collaborator

Jiangsu Provincial People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role collaborator

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaofeng Gao

Changhai Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Gao Xiaofeng, MD

Role: CONTACT

086-13601600968

Peng Yonghan, MD

Role: CONTACT

086-13917386896

Facility Contacts

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Gao Xiaofeng, MD

Role: primary

0086-13601600968

Peng Yonghan, MD

Role: backup

0086-13917386896

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.

Reference Type RESULT
PMID: 24083332 (View on PubMed)

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.

Reference Type RESULT
PMID: 21855968 (View on PubMed)

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.

Reference Type RESULT
PMID: 20968209 (View on PubMed)

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.

Reference Type RESULT
PMID: 11342888 (View on PubMed)

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.

Reference Type RESULT
PMID: 18955183 (View on PubMed)

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.

Reference Type RESULT
PMID: 14565873 (View on PubMed)

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.

Reference Type RESULT
PMID: 21052986 (View on PubMed)

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.

Reference Type RESULT
PMID: 24890883 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/24083332

Flexible ureterorenoscopy for lower pole stones: influence of the collecting system's anatomy

http://www.ncbi.nlm.nih.gov/pubmed/21855968

The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stones

http://www.ncbi.nlm.nih.gov/pubmed/20968209

Ureteroscopy--an essential modern approach in upper urinary tract diagnosis and treatment

http://www.ncbi.nlm.nih.gov/pubmed/11342888

Impact of lower pole renal anatomy on stone clearance after shock wave lithotripsy: fact or fiction

http://www.ncbi.nlm.nih.gov/pubmed/18955183

Predictive factors of lower calyceal stone clearance after extracorporeal shockwave lithotripsy (ESWL): the impact of radiological anatomy

http://www.ncbi.nlm.nih.gov/pubmed/14565873

Measurement of renal anatomy for prediction of lower-pole caliceal stone clearance: reproducibility of different parameters

http://www.ncbi.nlm.nih.gov/pubmed/21052986

Do new generation flexible ureterorenoscopes offer a higher treatment success than their predecessors?

http://www.ncbi.nlm.nih.gov/pubmed/24890883

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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