NCT02522676

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 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).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
4.8 years until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

3 years

First QC Date

August 9, 2015

Last Update Submit

November 15, 2019

Conditions

Kidney Stones

Keywords

kidney stonepercutaneous nephrolithotripsyretrograde intrarenal surgeryextracorporeal shock wave lithotripsymini PCNLultra-mini PCNLmicro PCNL

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/procedure

Secondary Outcomes (6)

  • Complication rate

    Within the first 30 days after surgery/procedure

  • Blood Cystatin C level (mg/L)

    Within the first 48 hours after surgery/procedure

  • Blood Netrin-1 level (pg/mL)

    Within the first 48 hours after surgery/procedure

  • Urine NGAL level (ng/mL)

    Within the first 72 hours after surgery/procedure

  • Urine Cystatin C level (mg/L)

    Within the first 24 hours after surgery/procedure

  • +1 more secondary outcomes

Study Arms (6)

Conventional PCNL

ACTIVE COMPARATOR

Endoscopic kidney stone surgery: Patients will undergo conventional percutaneous nephrolithotripsy.

Procedure: Endoscopic kidney stone surgery

Mini PCNL

ACTIVE COMPARATOR

Endoscopic kidney stone surgery: Patients will undergo mini percutaneous nephrolithotripsy.

Procedure: Endoscopic kidney stone surgery

Ultra-mini PCNL

ACTIVE COMPARATOR

Endoscopic kidney stone surgery: Patients will undergo ultra-mini percutaneous nephrolithotripsy.

Procedure: Endoscopic kidney stone surgery

Micro PCNL

ACTIVE COMPARATOR

Endoscopic kidney stone surgery: Patients will undergo micro percutaneous nephrolithotripsy.

Procedure: Endoscopic kidney stone surgery

Retrograde intrarenal surgery

ACTIVE COMPARATOR

Endoscopic kidney stone surgery: Patients will undergo retrograde intrarenal surgery.

Procedure: Endoscopic kidney stone surgery

Extracorporeal shock wave lithotripsy

ACTIVE COMPARATOR

Non-invasive kidney stone treatment: Patients will undergo extracorporeal shock wave lithotripsy.

Procedure: Non-invasive kidney stone treatment

Interventions

Endoscopic kidney stone surgeryPROCEDURE

Conventional PCNL will be performed.

Conventional PCNL
Non-invasive kidney stone treatmentPROCEDURE

Extracorporeal shock wave will be performed.

Extracorporeal shock wave lithotripsy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, School of Medicine, Department of Urology

Konya, 42075, Turkey (Türkiye)

Location

Related Publications (17)

  • Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrik A, Turk 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.

    PMID: 25454613BACKGROUND

  • 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: 21247286BACKGROUND

  • 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.

    PMID: 25100624BACKGROUND

  • 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.

    PMID: 21477921BACKGROUND

  • 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.

    PMID: 21575966BACKGROUND

  • 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.

    PMID: 24337646BACKGROUND

  • 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.

    PMID: 23841665BACKGROUND

  • 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.

    PMID: 22840867BACKGROUND

  • Cepeda M, Amon JH, Mainez JA, Rodriguez V, Alonso D, Martinez-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.

    PMID: 24881777BACKGROUND

  • 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.

    PMID: 24892920BACKGROUND

  • Palmero JL, Miralles J, Garau C, Nuno 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.

    PMID: 24892394BACKGROUND

  • 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.

    PMID: 22642568BACKGROUND

  • 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.

    PMID: 23958507RESULT

  • 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. doi: 10.1016/j.eururo.2014.07.003. Epub 2014 Jul 23.

    PMID: 25064687RESULT

  • 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: 10.1007/s00240-013-0615-2. Epub 2013 Oct 27.

    PMID: 24162954RESULT

  • 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 stones. World J Urol. 2013 Dec;31(6):1581-6. doi: 10.1007/s00345-012-0991-1. Epub 2012 Nov 22.

    PMID: 23179732RESULT

  • 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. Epub 2013 Jun 28.

    PMID: 23816573RESULT

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Murat Akand, M.D.

    Selcuk University, School of Medicine, Department of Urology

    PRINCIPAL INVESTIGATOR

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
Assistant Professor, M.D.

Study Record Dates

First Submitted

August 9, 2015

First Posted

August 13, 2015

Study Start

June 1, 2020

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

November 19, 2019

Record last verified: 2019-11

Locations

TU(1)