Clinical trial NCT03206515: The 18F Peel-way Sheath Versus the 18F Access Sheath With a Suction-evacuation Function MPCNL for the Management of 2-5cm Size Kidney Stones
Official title: The 18F Peel-way Sheath Versus the 18F Access Sheath With a Suction-evacuation Function MPCNL for the Management of 2-5cm Size Kidney Stones: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Calculi
Keywords: Renal Pelvic Pressure
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the management of \>20mm kidney stones. Microchannel percutaneous nephrolithotomy (Mini PCNL) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications. At present, the use of percutaneous renal surgery in our country is more than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by Guohua Zeng and so on. But there is still a lack of high quality evidence of Evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness. Therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.

Detailed description: Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the management of \>20mm kidney stones. Microchannel percutaneous nephrolithotomy (Mini PCNL) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications. At present, the use of percutaneous renal surgery in our country is more than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by Guohua Zeng and so on. But there is still a lack of high quality evidence of Evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness. Therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.

Eligibility criteria: Inclusion Criteria:

* Patients consent for percutaneous renal stone removal
* Age 18 to 70 years
* Normal renal function
* ASA score Ⅰ and Ⅱ
* Renal stones 20-50mm

Exclusion Criteria:

* Patients with solitary kidney
* Uncorrected coagulopathy and active urinary tract infection (UTI)
* Morbid obese patients
* Patients who underwent transplant or urinary diversion
* Congenital abnormalities
* Patients will be excluded from the study if the undergoing standard PNL/mini-perc have purulent fluid in the initial puncture

Primary outcomes:
measure: The renal pelvic pressure
timeFrame: During the procedure
Secondary outcomes:
measure: Perioperative complications
timeFrame: Intraoperatively or ≤ 1 month postoperatively
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Guohua Zeng, PH.D and M.D
role: STUDY_CHAIR
References: