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
Primary Purpose
Renal Calculi
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F Peel-Way Sheath
18F access sheath with a suction-evacuation function
Sponsored by
About this trial
This is an interventional other trial for Renal Calculi focused on measuring Renal Pelvic Pressure
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
Sites / Locations
- epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1
Group 2
Arm Description
Patients in Group 1 undergo Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath group
Patients in Group 2 undergo Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function group
Outcomes
Primary Outcome Measures
The renal pelvic pressure
To measure the renal pelvic pressure during mini-PCNL procedure
Secondary Outcome Measures
Perioperative complications
Invaluate perioperative complications by modified Clavien system
Full Information
NCT ID
NCT03206515
First Posted
October 27, 2016
Last Updated
June 29, 2017
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03206515
Brief 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
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Calculi
Keywords
Renal Pelvic Pressure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Description
Patients in Group 1 undergo Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath group
Arm Title
Group 2
Arm Type
Other
Arm Description
Patients in Group 2 undergo Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function group
Intervention Type
Device
Intervention Name(s)
18F Peel-Way Sheath
Intervention Description
Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath
Intervention Type
Device
Intervention Name(s)
18F access sheath with a suction-evacuation function
Intervention Description
Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function
Primary Outcome Measure Information:
Title
The renal pelvic pressure
Description
To measure the renal pelvic pressure during mini-PCNL procedure
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Perioperative complications
Description
Invaluate perioperative complications by modified Clavien system
Time Frame
Intraoperatively or ≤ 1 month postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guohua Zeng, PH.D and M.D
Phone
+86 13802916676
Email
gzgyzgh@vip.tom.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guangming Chen
Phone
+8613246888213
Email
1172676107@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, PH.D and M.D
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510230
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, Ph.D and M.D
Phone
+86 13802916676
Email
gzgyzgh@vip.tom.com
12. IPD Sharing Statement
Learn more about this trial
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
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