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

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

Sponsors

Lead sponsor: Changhai Hospital

Collaborator: 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

Source 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.

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.

Overall Status Recruiting
Start Date May 1, 2017
Completion Date December 2019
Primary Completion Date November 2019
Study Type Observational
Primary Outcome
Measure Time Frame
whether the f-URS could enter the low kidney calyx or not during the operation
Secondary Outcome
Measure Time Frame
stone clearance 4 weeks post-operatively
Enrollment 1100
Condition
Intervention

Intervention type: Procedure

Intervention name: Flexible Ureteroscopy

Description: the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope

Arm group label: Low Pole Renal Calculus

Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Gao Xiaofeng, MD Principal Investigator Changhai Hospital
Overall Contact

Last name: Gao Xiaofeng, MD

Phone: 086-13601600968

Email: [email protected]

Location
facility status contact contact_backup Changhai Hospital Gao Xiaofeng, MD 0086-13601600968 [email protected]
Location Countries

China

Verification Date

February 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Changhai Hospital

Investigator full name: Xiaofeng Gao

Investigator title: Changhai Hospital

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Low Pole Renal Calculus

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

Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov