Evaluation of Different Treatment Modalities for Lower Pole and Renal Pelvis Stones

Kidney Stones Clinical Trial

Official title:

Comparison of Success Rates, Complication Rates and Injury to Kidneys of Conventional PCNL, Mini PCNL, Ultra-mini PCNL, Micro PCNL, RIRS and ESWL in the Treatment of Lower Pole and Renal Pelvis Stone(s)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02522676
• Other study ID #: SU-PCNL-LPRPS-01
• Status: Suspended
• Phase: N/A
• Start date: June 2020
• Est. completion date: December 2023

Study information

• Verified date: November 2019
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 urea, creatinine, Cystatin C and Netrin-1 levels and urine Cystatin C and Netrin-1 levels in patients with lower pole or renal pelvis stone(s) undergoing either one of the treatment modalities including conventional percutaneous nephrolithotripsy (PCNL), mini PCNL, ultra-mini PCNL, micro PCNL, retrograde intrarenal surgery (RIRS) and extracorporeal shock wave lithotripsy (ESWL).

Description:

In this study, the demographic and preoperative data, imaging data, operative data and postoperative follow-up data will be prospectively recorded according to the patient information forms for the patients with lower pole and/or renal pelvis stone(s) who will undergo either one of the treatment modalities including conventional PCNL, mini PCNL, ultra-mini PCNL, micro PCNL, RIRS and ESWL.

A total of 300 (three hundred) patients, aging between 18 and 70 years, with similar stone size and location are being planned to be enrolled into the study; and will be prospectively randomized into one of six groups with a 1:1 ratio. By this means, conventional PCNL will performed to 50 (fifty) patients, mini PCNL will be performed to 50 (fifty) patients, ultra-mini PCNL will be performed to 50 (fifty) patients, micro PCNL will be performed to 50 (fifty) patients, while 50 (fifty) patients will undergo RIRS and 50 (fifty) patients will undergo ESWL.

Preoperatively, blood Cystatin C and Netrin-1, and urine Neutrophil gelatinase-associated lipocalin (NGAL), Cystatin C and Netrin-1 levels will be measured. After the treatments, blood Cystatin C and Netrin-1 levels at postoperative 6th, 12th, 24th and 48th hours will be recorded. Cystatin C and Netrin-1 levels in urine will be measured at postoperative 12th and 24th hours, while urine NGAL levels will be measured at postoperative 12th and 72nd hours. Besides these, classical kidney function tests, namely blood urea and creatinine levels, will be measured preoperatively and postoperatively at 24th and 48th hours.

Parameters listed below will be also recorded and evaluated:

1. Preoperative general evaluation data: Age, height, weight, body-mass index, concomitant comorbidities, prescriptions used, history of operation(s), American Society of Anesthesiologists (ASA) score

2. Preoperative urological evaluation data: History of ESWL/PCNL/ureterorenoscopy (URS)/RIRS/open surgery, whole blood count, kidney function tests, automatic urine test, urine culture, preoperative imaging modality (KUB, US, CT), number-dimensions-localization-composition of stone(s), existence of hydronephrosis

3. Operative data: Access fluoroscopy duration, total access duration, total fluoroscopy duration, operation duration, use of double-J stent, preoperative complications

4. Number of previous ESWL seance, total duration of ESWL, number of shots during ESWL (if any)

5. Follow-up data: Urethral catheterization time, hospitalization time, need of any other treatment for being stone-free, time to full stone-free, duration to removal of double-J stent, existence of residual stone(s), formation of new stone(s), complications in late time, medical prophylaxis

6. Stone analysis

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients planned to undergo either conventional PCNL, mini PCNL, ultra-mini PCNL, micro PCNL, RIRS or ESWL due to kidney stone(s)

• Patients between 18 and 70 years old

Exclusion Criteria:

• 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 70 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 in whom PCNL/RIRS/ESWL cannot be performed due to any reason and the procedure is terminated

• Patients who are converted to open surgery due to any reason

• Patients with missing data

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis

Intervention

Procedure:
• Endoscopic kidney stone surgery
Conventional PCNL will be performed.
• Endoscopic kidney stone surgery
Mini PCNL will be performed.
• Endoscopic kidney stone surgery
Ultra-mini PCNL will be performed.
• Endoscopic kidney stone surgery
Micro PCNL will be performed.
• Endoscopic kidney stone surgery
Retrograde intrarenal surgery will be performed.
• Non-invasive kidney stone treatment
Extracorporeal shock wave will be performed.

Locations

Country	Name	City	State
Turkey	Selcuk University, School of Medicine, Department of Urology	Konya

Sponsors (2)

Lead Sponsor	Collaborator
Selcuk University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (17)

Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK. Flexible ureteroscopy and laser lithotripsy for stones >2 cm: a systematic review and meta-analysis. J Endourol. 2012 Oct;26(10):1257-63. doi: 10.1089/end.2012.0217. Epub 2012 Jul 30. Review. — View Citation

Bader 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. — View Citation

Bas O, Bakirtas H, Sener NC, Ozturk U, Tuygun C, Goktug HN, Imamoglu MA. Comparison of shock wave lithotripsy, flexible ureterorenoscopy and percutaneous nephrolithotripsy on moderate size renal pelvis stones. Urolithiasis. 2014 Apr;42(2):115-20. doi: 10. — View Citation

Cepeda M, Amón JH, Mainez JA, Rodríguez V, Alonso D, Martínez-Sagarra JM. Flexible ureteroscopy for renal stones. Actas Urol Esp. 2014 Nov;38(9):571-5. doi: 10.1016/j.acuro.2014.03.014. Epub 2014 Jun 2. English, Spanish. — View Citation

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. — View Citation

De 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. — View Citation

Desai 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. — View Citation

Desai 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. — View Citation

Gao X, Peng Y, Shi X, Li L, Zhou T, Xu B, Sun Y. Safety and efficacy of retrograde intrarenal surgery for renal stones in patients with a solitary kidney: a single-center experience. J Endourol. 2014 Nov;28(11):1290-4. doi: 10.1089/end.2014.0295. Epub 2014 Aug 6. — View Citation

Hatipoglu 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. — View Citation

Kamphuis 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. — View Citation

Ozturk U, Sener NC, Goktug HN, Nalbant I, Gucuk A, Imamoglu MA. Comparison of percutaneous nephrolithotomy, shock wave lithotripsy, and retrograde intrarenal surgery for lower pole renal calculi 10-20 mm. Urol Int. 2013;91(3):345-9. doi: 10.1159/000351136 — View Citation

Palmero JL, Miralles J, Garau C, Nuño de la Rosa I, Amoros A, Benedicto A. Retrograde intrarenal surgery (RIRS) in the treatment of calyceal diverticulum with lithiasis. Arch Esp Urol. 2014 May;67(4):331-6. English, Spanish. — View Citation

Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26. — View Citation

Resorlu B, Unsal A, Ziypak T, Diri A, Atis G, Guven S, Sancaktutar AA, Tepeler A, Bozkurt OF, Oztuna D. Comparison of retrograde intrarenal surgery, shockwave lithotripsy, and percutaneous nephrolithotomy for treatment of medium-sized radiolucent renal st — View Citation

Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrík A, Türk C. Metabolic evaluation and recurrence prevention for urinary stone patients: EAU guidelines. Eur Urol. 2015 Apr;67(4):750-63. doi: 10.1016/j.eururo.2014.10.029. Epub 2014 Nov 20. — View Citation

Wong 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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/procedure
Secondary	Complication rate	Determination of any complications related to the surgery/procedure.	Within the first 30 days after surgery/procedure
Secondary	Blood Cystatin C level (mg/L)	Determination of any impairment in renal function after the surgery/procedure by measuring blood Cystatin C level.	Within the first 48 hours after surgery/procedure
Secondary	Blood Netrin-1 level (pg/mL)	Determination of any impairment in renal function after the surgery/procedure by measuring blood Netrin-1 level.	Within the first 48 hours after surgery/procedure
Secondary	Urine NGAL level (ng/mL)	Determination of any impairment in renal function after the surgery/procedure by measuring urine NGAL level.	Within the first 72 hours after surgery/procedure
Secondary	Urine Cystatin C level (mg/L)	Determination of any impairment in renal function after the surgery/procedure by measuring urine Cystatin C level.	Within the first 24 hours after surgery/procedure
Secondary	Urine Netrin-1 level (pg/mL)	Determination of any impairment in renal function after the surgery/procedure by measuring urine Netrin-1 level.	Within the first 24 hours after surgery/procedure