A Prospective Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy
A Prospective and Randomized Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy
1 other identifier
interventional
450
1 country
1
Brief Summary
Purpose: The aim of this present study is to compare the result of fluoroscopy, ultrasonography (US) and US combined with fluoroscopy in the guidance of minimally invasive percutaneous nephrolithotomy (MPCNL). Methods: The investigators will enroll 450 patients who are candidates for MPCNL in our study. By simple random sampling technique, patients will be assigned to three 150-patient groups (group 1, US-guided MPCNL, group 2, fluoroscopy-guided MPCNL and group 3, US combined with fluoroscopy-guided MPCNL). In addition to approaches in guidance of MPCNL, the rest of the procedure is the same in all three groups.The end point of the study is the comparison of outcome of procedure including stone free rate, transfusion rate, operation time, access time, length of stay and complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 13, 2014
CompletedFirst Posted
Study publicly available on registry
October 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
November 9, 2016
CompletedNovember 9, 2016
September 1, 2016
1 year
October 13, 2014
August 4, 2016
September 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stone Free Rate
Stone-free status is assessed by kidneys-ureter-bladder (KUB) or/ and noncontrast CT at day 1 after MPCNL. A stone-free state is defined as no residual stones of diameter \>4 mm.
one day after MPCNL
Secondary Outcomes (3)
Perioperative Complications
intraoperatively or ≤ 30 days postoperatively
Operation Time
intraoperatively
Change in Hemoglobin Concentration
within 24 hours after MPCNL
Study Arms (3)
US-guided group
OTHERPatients in US-guided group undergo MPCNL using only US-guided renal access.
Fluoroscopy-guided group
OTHERPatients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
Combined-guided group
OTHERPatients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Interventions
Patients undergo MPCNL using only US-guided renal access.
Patients undergo MPCNL using only fluoroscopy-guided renal access.
Patients undergo MPCNL using US combined with fluoroscopy-guided renal access
Eligibility Criteria
You may qualify if:
- Normal renal function.
- American society of Anesthesiology (ASA) score 1 and 2.
- Absence of congenital abnormalities.
- Kidney stones of diameter \> 2.0cm (including multiple and staghorn stones)
You may not qualify if:
- Patients with congenital anomalies, e.g. ectopic kidney, polycystic, horseshoe, or malrotated kidney.
- Patients who underwent transplant or urinary diversion.
- Patients with solitary kidney.
- Patients will be excluded from the study if they undergoing MPCNL have purulent fluid in the initial puncture.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230, China
Related Publications (9)
Lu MH, Pu XY, Gao X, Zhou XF, Qiu JG, Si-Tu J. A comparative study of clinical value of single B-mode ultrasound guidance and B-mode combined with color doppler ultrasound guidance in mini-invasive percutaneous nephrolithotomy to decrease hemorrhagic complications. Urology. 2010 Oct;76(4):815-20. doi: 10.1016/j.urology.2009.08.091. Epub 2010 Jun 25.
PMID: 20579695BACKGROUNDMozer P, Conort P, Leroy A, Baumann M, Payan Y, Troccaz J, Chartier-Kastler E, Richard F. Aid to percutaneous renal access by virtual projection of the ultrasound puncture tract onto fluoroscopic images. J Endourol. 2007 May;21(5):460-5. doi: 10.1089/end.2006.0168.
PMID: 17523896BACKGROUNDYan S, Xiang F, Yongsheng S. Percutaneous nephrolithotomy guided solely by ultrasonography: a 5-year study of >700 cases. BJU Int. 2013 Nov;112(7):965-71. doi: 10.1111/bju.12248. Epub 2013 Jul 26.
PMID: 23889729BACKGROUNDLi X, Long Q, Chen X, He D, He H. Real-time ultrasound-guided PCNL using a novel SonixGPS needle tracking system. Urolithiasis. 2014 Aug;42(4):341-6. doi: 10.1007/s00240-014-0671-2. Epub 2014 Jun 26.
PMID: 24965272BACKGROUNDAgarwal M, Agrawal MS, Jaiswal A, Kumar D, Yadav H, Lavania P. Safety and efficacy of ultrasonography as an adjunct to fluoroscopy for renal access in percutaneous nephrolithotomy (PCNL). BJU Int. 2011 Oct;108(8):1346-9. doi: 10.1111/j.1464-410X.2010.10002.x. Epub 2011 Jan 20.
PMID: 21251187BACKGROUNDOpondo D, Gravas S, Joyce A, Pearle M, Matsuda T, Sun YH, Assimos D, Denstedt J, de la Rosette J. Standardization of patient outcomes reporting in percutaneous nephrolithotomy. J Endourol. 2014 Jul;28(7):767-74. doi: 10.1089/end.2014.0057. Epub 2014 Apr 16.
PMID: 24571713BACKGROUNDBasiri A, Ziaee AM, Kianian HR, Mehrabi S, Karami H, Moghaddam SM. Ultrasonographic versus fluoroscopic access for percutaneous nephrolithotomy: a randomized clinical trial. J Endourol. 2008 Feb;22(2):281-4. doi: 10.1089/end.2007.0141.
PMID: 18294034BACKGROUNDDesai M, Jain P, Ganpule A, Sabnis R, Patel S, Shrivastav P. Developments in technique and technology: the effect on the results of percutaneous nephrolithotomy for staghorn calculi. BJU Int. 2009 Aug;104(4):542-8; discussion 548. doi: 10.1111/j.1464-410X.2009.08472.x. Epub 2009 Mar 6.
PMID: 19298409BACKGROUNDZhu W, Li J, Yuan J, Liu Y, Wan SP, Liu G, Chen W, Wu W, Luo J, Zhong D, Qi D, Lei M, Zhong W, Zhang Z, He Z, Zhao Z, Lu S, Wu Y, Zeng G. A prospective and randomised trial comparing fluoroscopic, total ultrasonographic, and combined guidance for renal access in mini-percutaneous nephrolithotomy. BJU Int. 2017 Apr;119(4):612-618. doi: 10.1111/bju.13703. Epub 2016 Nov 28.
PMID: 27862806DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Guohua Zeng
- Organization
- The First Affiliated Hospital of Guangzhou Medical University
Study Officials
- STUDY CHAIR
Guohua Zeng, PH.D and M.D
The First Affiliated Hospital of Guangzhou Medical University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President of the Hospital
Study Record Dates
First Submitted
October 13, 2014
First Posted
October 17, 2014
Study Start
July 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
November 9, 2016
Results First Posted
November 9, 2016
Record last verified: 2016-09