Renal CalculiNCT03112499
The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury
A study testing PCNL, mini-PCNL and RIRS in people with Renal Calculi and Renal Insufficiency, run by Institute for the Study of Urological Diseases, Greece at 1 site in Greece.
Trial summary
The main aim of the study is to investigate and compare the possible acute effect of standard PCNL, mini-PCNL and RIRS on renal function. Secondary aims are to investigate the efficacy (stone-free rate), safety (complication rate, long-term kidney function) and other parameters (operation, fluoroscopy and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Calculi, Renal Insufficiency
- What is being tested?
- PCNL, mini-PCNL and RIRS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGreece
- Study dates
- 5 Jun 2018to 15 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged > 18 years old
- Patients with renal stone or stones of 10-30 mm in maximal diameter measured in computed tomography scan.
- Decision of the patient to receive surgical treatment
- Ability to understand and provide a written informed consent to participate in the study.
Who cannot join
- Solitary kidney (functional or organic)
- Ureteral stone in the same system causing obstruction
- Malignant tumor in the treated kidney
- Stone in diverticulum
- Diabetes or coronary heart disease.
- History of surgery in the treated kidney
Show all 10Show fewer
- Recent intake of drugs that affect renal function or intravenous contrast agent
- Concomitant urinary infection
- Congenital anomalies of the urinary tract
- Patients of whom incomplete clinical data or incomplete samples are available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury: a Prospective Randomized 3-arm Study.
The main aim of the study is to investigate and compare the possible acute effect of standard PCNL, mini-PCNL and RIRS on renal function. Secondary aims are to investigate the efficacy (stone-free rate), safety (complication rate, long-term kidney function) and other parameters (operation, fluoroscopy and hospitalization time) concerning the 3 endourological operations (PCNL, mini- PCNL, RIRS) for the treatment of renal calculi.
Read the detailed description
This is a 3-arm parallel group prospective randomized active-treatment clinical study. A total of 75 patients with renal calculi 10-30 mm in maximal diameter measured in abdominal CT scan will be recruited in this research protocol. Patient enrollment will be performed from patients referred to Urolithiasis Unit of the 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki. In all potentially eligible patients full medical history, as well as demographic characteristics and drug treatment will be recorded, followed by a detailed physical examination and standard laboratory tests.
Eligible patients will be randomized to receive one of the following endourological techniques of nephrolithotripsy: standard PCNL, mini- PCNL or RIRS. All eligible patients will be randomised to one of the 3 groups, consisting of 25 patients, with an equal allocation ratio (1:1). The randomization sequence will be computer generated by the study coordinating team.
The primary and secondary measurements of the study will be carried in prespecified time-points that are listed below:
Point 0(P0): Screening visit:
Potentially eligible patients will be asked to provide written informed consent. We will record full medical history, concomitant medication, clinical examination, demographic characteristics, body weight, height, body mass index (BMI).
Point 1(P1): 1st day of hospitalization (Monday or Thursday):
Admission of the patient to the hospital where a routine preoperative control is conducted including: routine hematological and biochemical laboratory parameters (Hct, Hb, WBC, PLT, fasting glucose, urea, creatinine, serum electrolytes, SGOT, SGPT), chest X-ray and anesthesiological preoperative evaluation. Patient is randomized to be treated with one of the 3 endourological operations.
Point 2(P2): Operation day (Tuesday or Friday), 2 hours before the operation:
Urine sample is collected for measurement of urine biomarkers (NGAL, KIM-1, IL-18) and creatinine (baseline values). Blood sample is collected for creatinine measurement and eGFR is calculated.
Point 3(P3): Operation (PCNL, mini-PCNL or RIRS):
Operation, fluoroscopy time and intraoperative complications are recorded
Point 4(P4): 2 hours after the operation:
Urine sample is collected for measurement of urine biomarkers (NGAL, KIM-1, IL-18) and creatinine. Blood sample is collected for creatinine measurement and eGFR is calculated. A VAS pain score is completed. Urine output is measured. Postoperative complications are recorded.
Point 5(P5): 6 hours after the operation:
Urine sample is collected for measurement of urine biomarkers (NGAL, KIM-1, IL-18) and creatinine. Blood sample is collected for creatinine measurement and eGFR is calculated. A VAS pain score is completed. Urine output is measured. Postoperative complications are recorded.
Point 6(P6): 24 hours after the operation:
Urine sample is collected for measurement of urine biomarkers (NGAL, KIM-1, IL-18) and creatinine. Blood sample is collected for creatinine measurement and eGFR is calculated. A VAS pain score is completed. Urine output is measured. Postoperative complications are recorded.
Point 7(P7): 48 hours after the operation:
Urine sample is collected for measurement of urine biomarkers (NGAL, KIM-1, IL-18) and creatinine. Blood sample is collected for creatinine measurement and eGFR is calculated. A VAS pain score is completed. Urine output is measured. Potential postoperative complications are recorded.
Point 8(P8): 1 month after the operation:
CT scan is conducted for confirmation of treatment success and stone free status or not. Blood sample is collected for creatinine measurement and eGFR is calculated. Potential postoperative complications are recorded.
Point9(P9): 3 months after the operation:
Blood sample is collected for creatinine measurement and eGFR is calculated. Potential postoperative complications are recorded.
- Conditions
- Renal Calculi, Renal Insufficiency
- Being tested
- PCNL, mini-PCNL, RIRS
- Keywords
- Acute Kidney Injury, PCNL, mini-PCNL, RIRS, urine biomarkers
- Medical subject headings
- Kidney Calculi, Renal Insufficiency, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCNLProcedure or surgery
Under general anesthesia and patient in prone position, with the use of a flexible cystoscope an open-ended ureteral catheter 5F / 70cm is positioned to the proximal ureter. Retrograde pyelography is performed and the most appropriate calyx is accessed with the use of ultrasound, under fluoroscopic guidance. A 0.035 guide wire is inserted into the ureter and then replaced with an extra stiff wire. Using either balloon (20 atm) or Amplatz serial dilators a 30F access channel is created. Lithotripsy is performed using ultrasound lithotripter and stone fragments are removed by grasping forceps. At the end of the operation a 18F Council type catheter is placed into the kidney for drainage of urine and an indwelling JJ catheter is inserted in the ipsilateral ureter. Council and JJ catheter are removed,in the absence of complications, the second and tenth postoperative day, respectively.
mini-PCNLProcedure or surgery
Under general anesthesia and patient in prone position, with the use of a flexible cystoscope an open-ended ureteral catheter 5F / 70cm is positioned to the proximal ureter. Retrograde pyelography is performed and the most appropriate calyx is accessed with the use of ultrasound, under fluoroscopic guidance. A 0.035 guide wire is inserted into the ureter and then replaced with an extra stiff wire. Using Amplatz serial dilators a 16F access channel is created. Lithotripsy is performed using using 270mm Ho: YAG laser fiber and stone fragments are removed by grasping forceps. At the end of the operation a 10F nephrostomy tube is placed into the kidney for drainage of urine and an indwelling JJ catheter is inserted in the ipsilateral ureter. Nephrostomy tube and JJ catheter are removed, in the absence of complications, the second and tenth postoperative day, respectively.
RIRSProcedure or surgery
Under general anesthesia and patient in lithotomy position, a 0.035 hydrophilic safety wire is inserted in the ureter under fluoroscopic guidance. Subsequently 8-10 F dilators are used for dilation of the ureter.Insertion of a second working wire follows above which a 14F ureteral sheath is placed. Lithotripsy with a flexible ureteroscope using 270mm Ho: YAG laser fiber follows.Remaining stone fragments are removed by a 2,2F nitinol basket. At the end of the operation a JJ indwelling ureteral catheter is placed over the safety wire. Discharge is performed in the absence of complications, the first postoperative day while JJ catheter is removed on the 10th postoperative day.
| Study group | Role | What they receive |
|---|---|---|
| PCNL Group | Active comparator | Patients with renal calculi 10-30mm in maximal diameter in who percutaneous nephrolithotomy (PCNL) will be conducted Receives: Procedure: PCNL |
| mini-PCNL Group | Active comparator | Patients with renal calculi 10-30mm in maximal diameter in who mini- percutaneous nephrolithotomy (mini-PCNL) will be conducted Receives: Procedure: mini-PCNL |
| RIRS Group | Active comparator | Patients with renal calculi 10-30mm in maximal diameter in who retrograde intrarenal surgery (RIRS) will be conducted Receives: Procedure: RIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in urine NGAL/Cr value
Urine NGAL/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique.
Measured: 2 hours preoperative and 2 hours postoperatively
Secondary outcomes (14)
The change in urine NGAL/Cr value
Urine NGAL/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique.
Measured: 2 hours preoperative and 6, 24, 48 hours postoperatively
The change in urine KIM-1/Cr value
Urine KIM-1/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique.
Measured: 2 hours preoperative and 2, 6, 24, 48 hours postoperatively
The change in urine IL-18/Cr value
Urine IL-18/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique.
Measured: 2 hours preoperative and 2, 6, 24, 48 hours postoperatively
The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with standard PCNL and those undergone nephrolithotripsy with mini - PCNL technique
Urine NGAL/Cr, KIM1/Cr and IL-18/Cr values in all patients undergone nephrolithotripsy with standard PCNL or mini-PCNL technique will be measured using Elisa technique.
Measured: 2, 6, 24, 48 hours postoperatively
The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with standard PCNL and those undergone nephrolithotripsy with RIRS technique
Urine NGAL/Cr, KIM1/Cr and IL-18/Cr values in all patients undergone nephrolithotripsy with standard PCNL or RIRS technique will be measured using Elisa technique.
Measured: 2, 6, 24, 48 hours postoperatively
The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with mini -PCNL and those undergone nephrolithotripsy with RIRS technique
Urine NGAL/Cr, KIM1/Cr and IL-18/Cr values in all patients undergone nephrolithotripsy with mini-PCNL or RIRS technique will be measured using Elisa technique.
Measured: 2, 6, 24, 48 hours postoperatively
The presence of Acute Kidney Injury(AKI) in patients undergoing PCNL, mini-PCNL or RIRS
Potential presence of AKI in patients undergoing PCNL or mini-PCNL or RIRS for the treatment of renal stones of 10-30mm in maximal diameter according to the KDIGO criteria, defined as: Serum Cr rise of 0,3mg/dl (≥26μmol/L) within 48 hours or 50-99% Cr rise from baseline within 7 days (1, 50-1, 99 x baseline) or urine output <0, 5/kg/h for more than 6 hours
Measured: from the time of operation until 48 hours postoperatively
The change in serum creatinine and eGFR values postoperatively in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
- Serum creatinine levels will be measured using autoanalyzer
- Calculation of eGFR will be done according to the equation CKD-EPI:
GFR = 141 * min(Scr/κ,1)α * max(Scr/κ, 1)-1.209 * 0.993Age * 1.018 [if female] * 1.159 [if black]
*Scr is serum creatinine (mg/dL), κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1
Measured: 1 month and 3 months postoperatively
Percent of patients achieving treatment success and stone-free state in after undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
- Treatments success (considered as absence of any stone or presence of residual stone fragment 4mm)
- Stone-free rate (considered as absence of any stone) in CT scan
Measured: 4 weeks postoperatively
Overall complications rates in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
Complications will be recorded according the Clavien Dindo grading system
Measured: from the time of operation until the 3 month follow up visit
Operation time in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
Operation time will be recorded in minutes
Measured: - from the renal puncture until the placement of the renal tube in the end of the PCNL or mini-PCNL operations/- From the insertion of the resectoscope into the bladder until the placement of the urethra catheter in the end of the RIRS operation
Fluoroscopy time in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
Fluoroscopy time will be recorded in minutes automatically by the fluoroscopic machine
Measured: from the renal puncture until the placement of the renal tube in the end of the PCNL or mini-PCNL operations/- From the insertion of the resectoscope into the bladder until the placement of the urethra catheter in the end of the RIRS operation
Hospital stay duration in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
Hospitalization time will be recorded in days
Measured: From the day of operation until the day of discharge, up to 7 days
Postoperative pain, in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
Postoperative pain will be measured by a visual analog scale (VAS) pain score
Measured: Immediately after the operation and in 2, 6, 24, 48 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start5 Jun 2018
- Primary completion15 Mar 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Renal CalculiStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for the Study of Urological Diseases, Greece
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Hatzichristou, Institute for the Study of Urological Diseases, Greece
- Investigators
- Dimitrios Hatzichristou, Prof., Principal investigator, Institute for the Study of Urological Diseases (ISUD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112499
- Sponsor's protocol ID
- 1343/2017
- Status last verified
- May 2022
- First submitted
- 28 Mar 2017
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
PubMed 22890468Haase M, Bellomo R, Devarajan P, Schlattmann P, Haase-Fielitz A; NGAL Meta-analysis Investigator Group. Accuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Dec;54(6):1012-24. doi: 10.1053/j.ajkd.2009.07.020. Epub 2009 Oct 21.
PubMed 19850388Vaidya VS, Waikar SS, Ferguson MA, Collings FB, Sunderland K, Gioules C, Bradwin G, Matsouaka R, Betensky RA, Curhan GC, Bonventre JV. Urinary biomarkers for sensitive and specific detection of acute kidney injury in humans. Clin Transl Sci. 2008 Dec;1(3):200-8. doi: 10.1111/j.1752-8062.2008.00053.x.
PubMed 19212447Lin X, Yuan J, Zhao Y, Zha Y. Urine interleukin-18 in prediction of acute kidney injury: a systemic review and meta-analysis. J Nephrol. 2015 Feb;28(1):7-16. doi: 10.1007/s40620-014-0113-9. Epub 2014 Jun 5.
PubMed 24899123Dede O, Dagguli M, Utangac M, Yuksel H, Bodakci MN, Hatipoglu NK, Sancaktutar AA, Penbegul N. Urinary expression of acute kidney injury biomarkers in patients after RIRS: it is a prospective, controlled study. Int J Clin Exp Med. 2015 May 15;8(5):8147-52. eCollection 2015.
PubMed 26221383Daggulli M, Utangac MM, Dede O, Bodakci MN, Hatipoglu NK, Penbegul N, Sancaktutar AA, Bozkurt Y, Soylemez H. Potential biomarkers for the early detection of acute kidney injury after percutaneous nephrolithotripsy. Ren Fail. 2016;38(1):151-6. doi: 10.3109/0886022X.2015.1073494. Epub 2015 Oct 19.
PubMed 26481764Balasar M, Piskin MM, Topcu C, Demir LS, Gurbilek M, Kandemir A, Ozturk A. Urinary kidney injury molecule-1 levels in renal stone patients. World J Urol. 2016 Sep;34(9):1311-6. doi: 10.1007/s00345-016-1765-y. Epub 2016 Jan 21.
PubMed 26795762Soderberg L, Ergun O, Ding M, Parker R, Borofsky MS, Pais V, Dahm P. Percutaneous nephrolithotomy versus retrograde intrarenal surgery for treatment of renal stones in adults. Cochrane Database Syst Rev. 2023 Nov 13;11(11):CD013445. doi: 10.1002/14651858.CD013445.pub2.
PubMed 37955353
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury: a Prospective Randomized 3-arm Study.
- ClinicalTrials.gov ID
- NCT03112499
- Acronym / sponsor ID
- 1343/2017
- Conditions
- Renal Calculi, Renal Insufficiency
- Keywords
- Acute Kidney Injury, PCNL, mini-PCNL, RIRS, urine biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Institute for the Study of Urological Diseases, GreeceUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 13 Apr 2017 (actual)
- 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.
The main aim of the study is to investigate and compare the possible acute effect of standard PCNL, mini-PCNL and RIRS on renal function. Secondary aims are to investigate the efficacy (stone-free rate), safety (complication rate, long-term kidney function) and other parameters (operation, fluoroscopy and hospitalization time) concerning the 3 endourological operations (PCNL, mini- PCNL, RIRS) for the treatment of renal calculi.
Detailed description
This is a 3-arm parallel group prospective randomized active-treatment clinical study. A total of 75 patients with renal calculi 10-30 mm in maximal diameter measured in abdominal CT scan will be recruited in this research protocol. Patient enrollment will be performed from patients referred to Urolithiasis Unit of the 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki. In all potentially eligible patients full medical history, as well as demographic characteristics and drug treatment will be recorded, followed by a detailed physical examination and standard laboratory tests.
Eligible patients will be randomized to receive one of the following endourological techniques of nephrolithotripsy: standard PCNL, mini- PCNL or RIRS. All eligible patients will be randomised to one of the 3 groups, consisting of 25 patients, with an equal allocation ratio (1:1). The randomization sequence will be computer generated by the study coordinating team.
The primary and secondary measurements of the study will be carried in prespecified time-points that are listed below:
Point 0(P0): Screening visit:
Potentially eligible patients will be asked to provide written informed consent. We will record full medical history, concomitant medication, clinical examination, demographic characteristics, body weight, height, body mass index (BMI).
Point 1(P1): 1st day of hospitalization (Monday or Thursday):
Admission of the patient to the hospital where a routine preoperative control is conducted including: routine hematological and biochemical laboratory parameters (Hct, Hb, WBC, PLT, fasting glucose, urea, creatinine, serum electrolytes, SGOT, SGPT), chest X-ray and anesthesiological preoperative evaluation. Patient is randomized to be treated with one of the 3 endourological operations.
Point 2(P2): Operation day (Tuesday or Friday), 2 hours before the operation:
Urine sample is collected for measurement of urine biomarkers (NGAL, KIM-1, IL-18) and creatinine (baseline values). Blood sample is collected for creatinine measurement and eGFR is calculated.
Point 3(P3): Operation (PCNL, mini-PCNL or RIRS):
Operation, fluoroscopy time and intraoperative complications are recorded
Point 4(P4): 2 hours after the operation:
Urine sample is collected for measurement of urine biomarkers (NGAL, KIM-1, IL-18) and creatinine. Blood sample is collected for creatinine measurement and eGFR is calculated. A VAS pain score is completed. Urine output is measured. Postoperative complications are recorded.
Point 5(P5): 6 hours after the operation:
Urine sample is collected for measurement of urine biomarkers (NGAL, KIM-1, IL-18) and creatinine. Blood sample is collected for creatinine measurement and eGFR is calculated. A VAS pain score is completed. Urine output is measured. Postoperative complications are recorded.
Point 6(P6): 24 hours after the operation:
Urine sample is collected for measurement of urine biomarkers (NGAL, KIM-1, IL-18) and creatinine. Blood sample is collected for creatinine measurement and eGFR is calculated. A VAS pain score is completed. Urine output is measured. Postoperative complications are recorded.
Point 7(P7): 48 hours after the operation:
Urine sample is collected for measurement of urine biomarkers (NGAL, KIM-1, IL-18) and creatinine. Blood sample is collected for creatinine measurement and eGFR is calculated. A VAS pain score is completed. Urine output is measured. Potential postoperative complications are recorded.
Point 8(P8): 1 month after the operation:
CT scan is conducted for confirmation of treatment success and stone free status or not. Blood sample is collected for creatinine measurement and eGFR is calculated. Potential postoperative complications are recorded.
Point9(P9): 3 months after the operation:
Blood sample is collected for creatinine measurement and eGFR is calculated. Potential postoperative complications are recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCNL Group | Active comparator | Procedure: PCNLPatients with renal calculi 10-30mm in maximal diameter in who percutaneous nephrolithotomy (PCNL) will be conducted |
| mini-PCNL Group | Active comparator | Procedure: mini-PCNLPatients with renal calculi 10-30mm in maximal diameter in who mini- percutaneous nephrolithotomy (mini-PCNL) will be conducted |
| RIRS Group | Active comparator | Procedure: RIRSPatients with renal calculi 10-30mm in maximal diameter in who retrograde intrarenal surgery (RIRS) will be conducted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged > 18 years old
- Patients with renal stone or stones of 10-30 mm in maximal diameter measured in computed tomography scan.
- Decision of the patient to receive surgical treatment
- Ability to understand and provide a written informed consent to participate in the study.
Key exclusion criteria (10 listed)
- Solitary kidney (functional or organic)
- Ureteral stone in the same system causing obstruction
- Malignant tumor in the treated kidney
- Stone in diverticulum
- Diabetes or coronary heart disease.
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 |
|---|---|---|
| PCNLUnder general anesthesia and patient in prone position, with the use of a flexible cystoscope an open-ended ureteral catheter 5F / 70cm is positioned to the proximal ureter. Retrograde pyelography is performed and the most appropriate calyx is accessed with the use of ultrasound, under fluoroscopic guidance. A 0.035 guide wire is inserted into the ureter and then replaced with an extra stiff wire. Using either balloon (20 atm) or Amplatz serial dilators a 30F access channel is created. Lithotripsy is performed using ultrasound lithotripter and stone fragments are removed by grasping forceps. At the end of the operation a 18F Council type catheter is placed into the kidney for drainage of urine and an indwelling JJ catheter is inserted in the ipsilateral ureter. Council and JJ catheter are removed,in the absence of complications, the second and tenth postoperative day, respectively. | Procedure or surgery | PCNL Group |
| mini-PCNLUnder general anesthesia and patient in prone position, with the use of a flexible cystoscope an open-ended ureteral catheter 5F / 70cm is positioned to the proximal ureter. Retrograde pyelography is performed and the most appropriate calyx is accessed with the use of ultrasound, under fluoroscopic guidance. A 0.035 guide wire is inserted into the ureter and then replaced with an extra stiff wire. Using Amplatz serial dilators a 16F access channel is created. Lithotripsy is performed using using 270mm Ho: YAG laser fiber and stone fragments are removed by grasping forceps. At the end of the operation a 10F nephrostomy tube is placed into the kidney for drainage of urine and an indwelling JJ catheter is inserted in the ipsilateral ureter. Nephrostomy tube and JJ catheter are removed, in the absence of complications, the second and tenth postoperative day, respectively. | Procedure or surgery | mini-PCNL Group |
| RIRSUnder general anesthesia and patient in lithotomy position, a 0.035 hydrophilic safety wire is inserted in the ureter under fluoroscopic guidance. Subsequently 8-10 F dilators are used for dilation of the ureter.Insertion of a second working wire follows above which a 14F ureteral sheath is placed. Lithotripsy with a flexible ureteroscope using 270mm Ho: YAG laser fiber follows.Remaining stone fragments are removed by a 2,2F nitinol basket. At the end of the operation a JJ indwelling ureteral catheter is placed over the safety wire. Discharge is performed in the absence of complications, the first postoperative day while JJ catheter is removed on the 10th postoperative day. | Procedure or surgery | RIRS Group |
Primary outcome
The change in urine NGAL/Cr value
Time frame: 2 hours preoperative and 2 hours postoperatively
Urine NGAL/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique.
14 secondary outcomes
The change in urine NGAL/Cr value
Time frame: 2 hours preoperative and 6, 24, 48 hours postoperatively
The change in urine KIM-1/Cr value
Time frame: 2 hours preoperative and 2, 6, 24, 48 hours postoperatively
The change in urine IL-18/Cr value
Time frame: 2 hours preoperative and 2, 6, 24, 48 hours postoperatively
The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with standard PCNL and those undergone nephrolithotripsy with mini - PCNL technique
Time frame: 2, 6, 24, 48 hours postoperatively
The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with standard PCNL and those undergone nephrolithotripsy with RIRS technique
Time frame: 2, 6, 24, 48 hours postoperatively
The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with mini -PCNL and those undergone nephrolithotripsy with RIRS technique
Time frame: 2, 6, 24, 48 hours postoperatively
The presence of Acute Kidney Injury(AKI) in patients undergoing PCNL, mini-PCNL or RIRS
Time frame: from the time of operation until 48 hours postoperatively
The change in serum creatinine and eGFR values postoperatively in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
Time frame: 1 month and 3 months postoperatively
Percent of patients achieving treatment success and stone-free state in after undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
Time frame: 4 weeks postoperatively
Overall complications rates in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
Time frame: from the time of operation until the 3 month follow up visit
Operation time in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
Time frame: - from the renal puncture until the placement of the renal tube in the end of the PCNL or mini-PCNL operations/- From the insertion of the resectoscope into the bladder until the placement of the urethra catheter in the end of the RIRS operation
Fluoroscopy time in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
Time frame: from the renal puncture until the placement of the renal tube in the end of the PCNL or mini-PCNL operations/- From the insertion of the resectoscope into the bladder until the placement of the urethra catheter in the end of the RIRS operation
Hospital stay duration in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
Time frame: From the day of operation until the day of discharge, up to 7 days
Postoperative pain, in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique.
Time frame: Immediately after the operation and in 2, 6, 24, 48 hours postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Background: PubMed 22890468Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
- Background: PubMed 19850388Haase M, Bellomo R, Devarajan P, Schlattmann P, Haase-Fielitz A; NGAL Meta-analysis Investigator Group. Accuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Dec;54(6):1012-24. doi: 10.1053/j.ajkd.2009.07.020. Epub 2009 Oct 21.
- Background: PubMed 19212447Vaidya VS, Waikar SS, Ferguson MA, Collings FB, Sunderland K, Gioules C, Bradwin G, Matsouaka R, Betensky RA, Curhan GC, Bonventre JV. Urinary biomarkers for sensitive and specific detection of acute kidney injury in humans. Clin Transl Sci. 2008 Dec;1(3):200-8. doi: 10.1111/j.1752-8062.2008.00053.x.
- Background: PubMed 24899123Lin X, Yuan J, Zhao Y, Zha Y. Urine interleukin-18 in prediction of acute kidney injury: a systemic review and meta-analysis. J Nephrol. 2015 Feb;28(1):7-16. doi: 10.1007/s40620-014-0113-9. Epub 2014 Jun 5.
- Background: PubMed 26221383Dede O, Dagguli M, Utangac M, Yuksel H, Bodakci MN, Hatipoglu NK, Sancaktutar AA, Penbegul N. Urinary expression of acute kidney injury biomarkers in patients after RIRS: it is a prospective, controlled study. Int J Clin Exp Med. 2015 May 15;8(5):8147-52. eCollection 2015.
- Background: PubMed 26481764Daggulli M, Utangac MM, Dede O, Bodakci MN, Hatipoglu NK, Penbegul N, Sancaktutar AA, Bozkurt Y, Soylemez H. Potential biomarkers for the early detection of acute kidney injury after percutaneous nephrolithotripsy. Ren Fail. 2016;38(1):151-6. doi: 10.3109/0886022X.2015.1073494. Epub 2015 Oct 19.
- Background: PubMed 26795762Balasar M, Piskin MM, Topcu C, Demir LS, Gurbilek M, Kandemir A, Ozturk A. Urinary kidney injury molecule-1 levels in renal stone patients. World J Urol. 2016 Sep;34(9):1311-6. doi: 10.1007/s00345-016-1765-y. Epub 2016 Jan 21.
- Derived from this study: PubMed 37955353Soderberg L, Ergun O, Ding M, Parker R, Borofsky MS, Pais V, Dahm P. Percutaneous nephrolithotomy versus retrograde intrarenal surgery for treatment of renal stones in adults. Cochrane Database Syst Rev. 2023 Nov 13;11(11):CD013445. doi: 10.1002/14651858.CD013445.pub2.
- Individual participant dataSharing planned: No
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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.
Dimitrios Hatzichristou, Prof. principal investigator
Institute for the Study of Urological Diseases (ISUD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCNL, mini-PCNL and RIRS in people with Renal Calculi and Renal Insufficiency, run by Institute for the Study of Urological Diseases, Greece at 1 site in Greece.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 5 May 2022. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in urine NGAL/Cr value (time frame: 2 hours preoperative and 2 hours postoperatively). 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 NCT03112499, which also lists 8 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 5 May 2022.