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

February 10, 2019 updated by: Xiaofeng Gao, Changhai Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

low pole renal calculus patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

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

Investigators

  • Principal Investigator: Gao Xiaofeng, MD, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 2, 2017

First Submitted That Met QC Criteria

April 2, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 10, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHOT-20161208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Calculus

Clinical Trials on Flexible Ureteroscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe