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

Guangzhou Medical University

Status: Unknown

Conditions: Renal Calculi

Treatments: Device: 18F Peel-Way Sheath; Device: 18F access sheath with a suction-evacuation function

Study type: Interventional

Funder types: Other

Identifiers

NCT03206515

MRER(17)2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Group 1

Other group

Description:

Patients in Group 1 undergo Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath group

Treatment:

Device: 18F Peel-Way Sheath

Group 2

Other group

Description:

Patients in Group 2 undergo Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function group

Treatment:

Device: 18F access sheath with a suction-evacuation function