Comparison of Ultra-mini PCNL and Micro PCNL
Comparison of Success Rates, Complication Rates and Injury to Kidneys of Ultra-mini PCNL and Micro PCNL in the Treatment of Kidney Stones
1 other identifier
interventional
60
1 country
1
Brief Summary
It is aimed to evaluate the treatment results, rates of success and complications, and injury given to the kidney by measuring preoperative and postoperative blood and Cystatin C levels in patients with kidney stones smaller than 2 cm who will undergo either ultra-mini percutaneous nephrolithotripsy (PCNL) or micro PCNL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
August 9, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedStudy Start
First participant enrolled
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedNovember 18, 2019
November 1, 2019
1.7 years
August 9, 2015
November 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stone-free rate
Determination of any residual stone in the collecting system by using one of imaging modalities.
Within the first 30 days after surgery.
Secondary Outcomes (3)
Complication rate
Within the first 30 days after surgery.
Blood Cystatin C level (mg/L)
Within the first 12 hours after surgery.
Urine Cystatin C level (mg/L)
Within the first 12 hours after surgery.
Study Arms (2)
Ultra-mini PCNL
ACTIVE COMPARATOREndoscopic kidney stone surgery: Patients will undergo ultra-mini percutaneous nephrolithotripsy.
Micro PCNL
ACTIVE COMPARATOREndoscopic kidney stone surgery: Patients will undergo micro percutaneous nephrolithotripsy.
Interventions
Eligibility Criteria
You may qualify if:
- Patients who are planned to undergo PCNL due to kidney stone
- Patients with a kidney stone \< 2 cm
- Patients between 18 and 65 years old
You may not qualify if:
- Patients with unregulated diabetes mellitus and diabetic nephropathy
- Patients with a blood pressure higher than 140/80 mmHg despite use of antihypertensive drug(s) regularly
- Patients with chronic renal failure who need dialysis
- Patients who had prerenal, renal or postrenal acute kidney failure during the last 6 months
- Patients who had acute pyelonephritis during the last 6 months
- Patients younger than 18 years old or older than 65 years old
- Patients who had kidney surgery during the last 3 months and who have abnormal kidney functions
- Patients with ureteral stone who are planned to undergo endoscopic stone treatment at the same time
- Patients with a history of corticosteroid use during enrollment into the study or previous 3 months
- Patients with uncontrolled thyroid disease
- Patients who have a disease with rapid cell turn-over (like leukemia, lymphoma, etc.)
- Patients whose operation terminated or converted to open surgery due to any reason
- Patients with missing data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Selcuk University, School of Medicine, Department of Urology
Konya, 42075, Turkey (Türkiye)
Related Publications (13)
de la Rosette J, Assimos D, Desai M, Gutierrez J, Lingeman J, Scarpa R, Tefekli A; CROES PCNL Study Group. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: indications, complications, and outcomes in 5803 patients. J Endourol. 2011 Jan;25(1):11-7. doi: 10.1089/end.2010.0424.
PMID: 21247286BACKGROUNDXu S, Shi H, Zhu J, Wang Y, Cao Y, Li K, Wang Y, Sun Z, Xia S. A prospective comparative study of haemodynamic, electrolyte, and metabolic changes during percutaneous nephrolithotomy and minimally invasive percutaneous nephrolithotomy. World J Urol. 2014 Oct;32(5):1275-80. doi: 10.1007/s00345-013-1204-2. Epub 2013 Nov 1.
PMID: 24177788BACKGROUNDWong KA, Sahai A, Patel A, Thomas K, Bultitude M, Glass J. Is percutaneous nephrolithotomy in solitary kidneys safe? Urology. 2013 Nov;82(5):1013-6. doi: 10.1016/j.urology.2013.06.034. Epub 2013 Aug 16.
PMID: 23958507BACKGROUNDKamphuis GM, Baard J, Westendarp M, de la Rosette JJ. Lessons learned from the CROES percutaneous nephrolithotomy global study. World J Urol. 2015 Feb;33(2):223-33. doi: 10.1007/s00345-014-1367-5. Epub 2014 Aug 7.
PMID: 25100624BACKGROUNDDe S, Autorino R, Kim FJ, Zargar H, Laydner H, Balsamo R, Torricelli FC, Di Palma C, Molina WR, Monga M, De Sio M. Percutaneous nephrolithotomy versus retrograde intrarenal surgery: a systematic review and meta-analysis. Eur Urol. 2015 Jan;67(1):125-137. doi: 10.1016/j.eururo.2014.07.003. Epub 2014 Jul 23.
PMID: 25064687BACKGROUNDBader MJ, Gratzke C, Seitz M, Sharma R, Stief CG, Desai M. The "all-seeing needle": initial results of an optical puncture system confirming access in percutaneous nephrolithotomy. Eur Urol. 2011 Jun;59(6):1054-9. doi: 10.1016/j.eururo.2011.03.026. Epub 2011 Apr 1.
PMID: 21477921BACKGROUNDDesai MR, Sharma R, Mishra S, Sabnis RB, Stief C, Bader M. Single-step percutaneous nephrolithotomy (microperc): the initial clinical report. J Urol. 2011 Jul;186(1):140-5. doi: 10.1016/j.juro.2011.03.029. Epub 2011 May 14.
PMID: 21575966BACKGROUNDHatipoglu NK, Tepeler A, Buldu I, Atis G, Bodakci MN, Sancaktutar AA, Silay MS, Daggulli M, Istanbulluoglu MO, Karatag T, Gurbuz C, Armagan A, Caskurlu T. Initial experience of micro-percutaneous nephrolithotomy in the treatment of renal calculi in 140 renal units. Urolithiasis. 2014 Apr;42(2):159-64. doi: 10.1007/s00240-013-0631-2. Epub 2013 Dec 13.
PMID: 24337646BACKGROUNDKaratag T, Tepeler A, Buldu I, Akcay M, Tosun M, Istanbulluoglu MO, Armagan A. Is micro-percutaneous nephrolithotomy surgery technically feasible and efficient under spinal anesthesia? Urolithiasis. 2015 Jun;43(3):249-54. doi: 10.1007/s00240-015-0752-x. Epub 2015 Jan 9.
PMID: 25572955BACKGROUNDDesai J, Solanki R. Ultra-mini percutaneous nephrolithotomy (UMP): one more armamentarium. BJU Int. 2013 Nov;112(7):1046-9. doi: 10.1111/bju.12193. Epub 2013 Jul 11.
PMID: 23841665BACKGROUNDShlipak MG, Mattes MD, Peralta CA. Update on cystatin C: incorporation into clinical practice. Am J Kidney Dis. 2013 Sep;62(3):595-603. doi: 10.1053/j.ajkd.2013.03.027. Epub 2013 May 20.
PMID: 23701892BACKGROUNDDelanaye P, Cavalier E, Morel J, Mehdi M, Maillard N, Claisse G, Lambermont B, Dubois BE, Damas P, Krzesinski JM, Lautrette A, Mariat C. Detection of decreased glomerular filtration rate in intensive care units: serum cystatin C versus serum creatinine. BMC Nephrol. 2014 Jan 13;15:9. doi: 10.1186/1471-2369-15-9.
PMID: 24410757BACKGROUNDKrawczeski CD, Vandevoorde RG, Kathman T, Bennett MR, Woo JG, Wang Y, Griffiths RE, Devarajan P. Serum cystatin C is an early predictive biomarker of acute kidney injury after pediatric cardiopulmonary bypass. Clin J Am Soc Nephrol. 2010 Sep;5(9):1552-7. doi: 10.2215/CJN.02040310. Epub 2010 Jun 10.
PMID: 20538834BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ozcan Kilic, M.D.
Selcuk University, School of Medicine, Department of Urology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Assoc. Prof. Dr.
Study Record Dates
First Submitted
August 9, 2015
First Posted
August 13, 2015
Study Start
October 8, 2019
Primary Completion
July 1, 2021
Study Completion
September 1, 2021
Last Updated
November 18, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share