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

Renal Calculi Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03206515
• Other study ID #: MRER(17)2016
• Status: Recruiting
• Phase: N/A
• First received: October 27, 2016
• Last updated: June 29, 2017
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Guohua Zeng, PH.D and M.D
• Phone: +86 13802916676
• Email: gzgyzgh[@]vip.tom.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients consent for percutaneous renal stone removal

• Age 18 to 70 years

• Normal renal function

• ASA score ? and ?

• 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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Renal Calculi

Intervention

Device:
• 18F Peel-Way Sheath
Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath
• 18F access sheath with a suction-evacuation function
Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function

Locations

Country	Name	City	State
China	epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The renal pelvic pressure	To measure the renal pelvic pressure during mini-PCNL procedure	During the procedure
Secondary	Perioperative complications	Invaluate perioperative complications by modified Clavien system	Intraoperatively or = 1 month postoperatively