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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Renal Calculi

Intervention / Treatment
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* Device: 18F Peel-Way Sheath
* Device: 18F access sheath with a suction-evacuation function


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Patients in Group 1 undergo Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath group | Device: 18F Peel-Way Sheath<br>* Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath<br>|
| Other: Group 2<br>Patients in Group 2 undergo Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function group | Device: 18F access sheath with a suction-evacuation function<br>* Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The renal pelvic pressure | To measure the renal pelvic pressure during mini-PCNL procedure | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complications | Invaluate perioperative complications by modified Clavien system | Intraoperatively or ≤ 1 month postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Pelvic Pressure