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

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ClinicalTrials.gov Identifier: NCT03105206
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
Shanghai Changzheng Hospital
The First Affiliated Hospital of Anhui Medical University
Tongji Hospital
Renmin Hospital of Wuhan University
The Second People's Hospital of GuangDong Province
Jiangsu Provincial People's Hospital
The First Affiliated Hospital of Nanchang University
West China Hospital
The First Affiliated Hospital of Xiamen University
Zhejiang Provincial People’s Hospital
Information provided by (Responsible Party):
Xiaofeng Gao, Changhai Hospital

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.

Condition or disease Intervention/treatment
Renal Calculus Procedure: Flexible Ureteroscopy

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.

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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter Prospective Research on the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Group/Cohort Intervention/treatment
Low Pole Renal Calculus
patients with low pole renal calculus who are suitable to treat by flexible ureteroscopy
Procedure: Flexible Ureteroscopy
the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope




Primary Outcome Measures :
  1. whether the f-URS could enter the low kidney calyx or not [ Time Frame: during the operation ]
    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.


Secondary Outcome Measures :
  1. stone clearance [ Time Frame: 4 weeks post-operatively ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
low pole renal calculus patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105206


Contacts
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Contact: Gao Xiaofeng, MD 086-13601600968 gxfdoc@hotmail.com
Contact: Peng Yonghan, MD 086-13917386896 yonghanyhtl@163.com

Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Gao Xiaofeng, MD    0086-13601600968    gxfdoc@hotmail.com   
Contact: Peng Yonghan, MD    0086-13917386896    yonghanyhtl@163.com   
Sponsors and Collaborators
Changhai Hospital
Shanghai Changzheng Hospital
The First Affiliated Hospital of Anhui Medical University
Tongji Hospital
Renmin Hospital of Wuhan University
The Second People's Hospital of GuangDong Province
Jiangsu Provincial People's Hospital
The First Affiliated Hospital of Nanchang University
West China Hospital
The First Affiliated Hospital of Xiamen University
Zhejiang Provincial People’s Hospital
Investigators
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Principal Investigator: Gao Xiaofeng, MD Changhai Hospital

Additional Information:
Publications of Results:

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Responsible Party: Xiaofeng Gao, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03105206     History of Changes
Other Study ID Numbers: SHOT-20161208
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Keywords provided by Xiaofeng Gao, Changhai Hospital:
lowl pole renal calculus
anatomical parameters
flexible ureteroscopy
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi