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

Not Applicable

• Conditions: Renal Calculi

• Registration Number: NCT03206515
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-10-27
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-29
• Last Update Submitted: 2017-06-29
• Study First Posted: 2017-07-02
• Last Update Posted: 2017-07-02
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The renal pelvic pressure	During the procedure	To measure the renal pelvic pressure during mini-PCNL procedure

Secondary Outcome Measures

Name	Time	Method
Perioperative complications	Intraoperatively or ≤ 1 month postoperatively	Invaluate perioperative complications by modified Clavien system

Trial Locations

Locations (1)

epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China