Kidney StonesNCT02522676
Evaluation of Different Treatment Modalities for Lower Pole and Renal Pelvis Stones
A study testing Endoscopic kidney stone surgery and Non-invasive kidney stone treatment in people with Kidney Stones, run by Selcuk University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Endoscopic kidney stone surgery and Non-invasive kidney stone treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, School of Medicine, Department of Urology
Konya, 42075
About this study
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)
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).
Read the detailed 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:
- Preoperative general evaluation data: Age, height, weight, body-mass index, concomitant comorbidities, prescriptions used, history of operation(s), American Society of Anesthesiologists (ASA) score
- 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
- Operative data: Access fluoroscopy duration, total access duration, total fluoroscopy duration, operation duration, use of double-J stent, preoperative complications
- Number of previous ESWL seance, total duration of ESWL, number of shots during ESWL (if any)
- 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
- Stone analysis
- Conditions
- Kidney Stones
- Being tested
- Endoscopic kidney stone surgery, Non-invasive kidney stone treatment
- Keywords
- kidney stone, percutaneous nephrolithotripsy, retrograde intrarenal surgery, extracorporeal shock wave lithotripsy, mini PCNL, ultra-mini PCNL, micro PCNL
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic kidney stone surgeryProcedure or surgery
Conventional PCNL will be performed.
Endoscopic kidney stone surgeryProcedure or surgery
Mini PCNL will be performed.
Endoscopic kidney stone surgeryProcedure or surgery
Ultra-mini PCNL will be performed.
Endoscopic kidney stone surgeryProcedure or surgery
Micro PCNL will be performed.
Endoscopic kidney stone surgeryProcedure or surgery
Retrograde intrarenal surgery will be performed.
Non-invasive kidney stone treatmentProcedure or surgery
Extracorporeal shock wave will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Conventional PCNL | Active comparator | Endoscopic kidney stone surgery: Patients will undergo conventional percutaneous nephrolithotripsy. Receives: Procedure: Endoscopic kidney stone surgery |
| Mini PCNL | Active comparator | Endoscopic kidney stone surgery: Patients will undergo mini percutaneous nephrolithotripsy. Receives: Procedure: Endoscopic kidney stone surgery |
| Ultra-mini PCNL | Active comparator | Endoscopic kidney stone surgery: Patients will undergo ultra-mini percutaneous nephrolithotripsy. Receives: Procedure: Endoscopic kidney stone surgery |
| Micro PCNL | Active comparator | Endoscopic kidney stone surgery: Patients will undergo micro percutaneous nephrolithotripsy. Receives: Procedure: Endoscopic kidney stone surgery |
| Retrograde intrarenal surgery | Active comparator | Endoscopic kidney stone surgery: Patients will undergo retrograde intrarenal surgery. Receives: Procedure: Endoscopic kidney stone surgery |
| Extracorporeal shock wave lithotripsy | Active comparator | Non-invasive kidney stone treatment: Patients will undergo extracorporeal shock wave lithotripsy. Receives: Procedure: Non-invasive kidney stone treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate
Determination of any residual stone in the collecting system by using one of imaging modalities.
Measured: Within the first 30 days after surgery/procedure
Secondary outcomes (6)
Complication rate
Determination of any complications related to the surgery/procedure.
Measured: Within the first 30 days after surgery/procedure
Blood Cystatin C level (mg/L)
Determination of any impairment in renal function after the surgery/procedure by measuring blood Cystatin C level.
Measured: Within the first 48 hours after surgery/procedure
Blood Netrin-1 level (pg/mL)
Determination of any impairment in renal function after the surgery/procedure by measuring blood Netrin-1 level.
Measured: Within the first 48 hours after surgery/procedure
Urine NGAL level (ng/mL)
Determination of any impairment in renal function after the surgery/procedure by measuring urine NGAL level.
Measured: Within the first 72 hours after surgery/procedure
Urine Cystatin C level (mg/L)
Determination of any impairment in renal function after the surgery/procedure by measuring urine Cystatin C level.
Measured: Within the first 24 hours after surgery/procedure
Urine Netrin-1 level (pg/mL)
Determination of any impairment in renal function after the surgery/procedure by measuring urine Netrin-1 level.
Measured: Within the first 24 hours after surgery/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJun 2020 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Due to surgeons' unwillingness to randomize patients into different treatments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Murat AKAND, Selcuk University
- Investigators
- Murat Akand, M.D., Principal investigator, Selcuk University, School of Medicine, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522676
- Sponsor's protocol ID
- SU-PCNL-LPRPS-01
- Status last verified
- Nov 2019
- First submitted
- 9 Aug 2015
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25454613de 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.
PubMed 21247286Kamphuis 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.
PubMed 25100624Bader 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.
PubMed 21477921Desai 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.
PubMed 21575966Hatipoglu 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.
PubMed 24337646Desai 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.
PubMed 23841665Resorlu 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.
PubMed 22840867Cepeda 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.
PubMed 24881777Gao 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.
PubMed 24892920Palmero 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.
PubMed 24892394Aboumarzouk 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.
PubMed 22642568Wong 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.
PubMed 23958507De 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.
PubMed 25064687Bas 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.
PubMed 24162954
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02522676
- Acronym / sponsor ID
- SU-PCNL-LPRPS-01
- Conditions
- Kidney Stones
- Keywords
- kidney stone, percutaneous nephrolithotripsy, retrograde intrarenal surgery, extracorporeal shock wave lithotripsy, mini PCNL, ultra-mini PCNL, micro PCNL
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to surgeons' unwillingness to randomize patients into different treatments
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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:
- Preoperative general evaluation data: Age, height, weight, body-mass index, concomitant comorbidities, prescriptions used, history of operation(s), American Society of Anesthesiologists (ASA) score
- 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
- Operative data: Access fluoroscopy duration, total access duration, total fluoroscopy duration, operation duration, use of double-J stent, preoperative complications
- Number of previous ESWL seance, total duration of ESWL, number of shots during ESWL (if any)
- 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
- Stone analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Conventional PCNL | Active comparator | Procedure: Endoscopic kidney stone surgeryEndoscopic kidney stone surgery: Patients will undergo conventional percutaneous nephrolithotripsy. |
| Mini PCNL | Active comparator | Procedure: Endoscopic kidney stone surgeryEndoscopic kidney stone surgery: Patients will undergo mini percutaneous nephrolithotripsy. |
| Ultra-mini PCNL | Active comparator | Procedure: Endoscopic kidney stone surgeryEndoscopic kidney stone surgery: Patients will undergo ultra-mini percutaneous nephrolithotripsy. |
| Micro PCNL | Active comparator | Procedure: Endoscopic kidney stone surgeryEndoscopic kidney stone surgery: Patients will undergo micro percutaneous nephrolithotripsy. |
| Retrograde intrarenal surgery | Active comparator | Procedure: Endoscopic kidney stone surgeryEndoscopic kidney stone surgery: Patients will undergo retrograde intrarenal surgery. |
| Extracorporeal shock wave lithotripsy | Active comparator | Procedure: Non-invasive kidney stone treatmentNon-invasive kidney stone treatment: Patients will undergo extracorporeal shock wave lithotripsy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic kidney stone surgeryConventional PCNL will be performed. | Procedure or surgery | Conventional PCNL |
| Endoscopic kidney stone surgeryMini PCNL will be performed. | Procedure or surgery | Mini PCNL |
| Endoscopic kidney stone surgeryUltra-mini PCNL will be performed. | Procedure or surgery | Ultra-mini PCNL |
| Endoscopic kidney stone surgeryMicro PCNL will be performed. | Procedure or surgery | Micro PCNL |
| Endoscopic kidney stone surgeryRetrograde intrarenal surgery will be performed. | Procedure or surgery | Retrograde intrarenal surgery |
| Non-invasive kidney stone treatmentExtracorporeal shock wave will be performed. | Procedure or surgery | Extracorporeal shock wave lithotripsy |
Primary outcome
Stone-free rate
Time frame: Within the first 30 days after surgery/procedure
Determination of any residual stone in the collecting system by using one of imaging modalities.
6 secondary outcomes
Complication rate
Time frame: Within the first 30 days after surgery/procedure
Blood Cystatin C level (mg/L)
Time frame: Within the first 48 hours after surgery/procedure
Blood Netrin-1 level (pg/mL)
Time frame: Within the first 48 hours after surgery/procedure
Urine NGAL level (ng/mL)
Time frame: Within the first 72 hours after surgery/procedure
Urine Cystatin C level (mg/L)
Time frame: Within the first 24 hours after surgery/procedure
Urine Netrin-1 level (pg/mL)
Time frame: Within the first 24 hours after surgery/procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Background: PubMed 25454613Skolarikos 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.
- Background: PubMed 21247286de 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.
- Background: PubMed 25100624Kamphuis 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.
- Background: PubMed 21477921Bader 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.
- Background: PubMed 21575966Desai 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.
- Background: PubMed 24337646Hatipoglu 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.
- Background: PubMed 23841665Desai 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.
- Background: PubMed 22840867Resorlu 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.
- Background: PubMed 24881777Cepeda 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.
- Background: PubMed 24892920Gao 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.
- Background: PubMed 24892394Palmero 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.
- Background: PubMed 22642568Aboumarzouk 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murat Akand, M.D. principal investigator
Selcuk University, School of Medicine, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic kidney stone surgery and Non-invasive kidney stone treatment in people with Kidney Stones, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free rate (time frame: Within the first 30 days after surgery/procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02522676, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.