The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury
NCT ID: NCT03112499
Last Updated: 2022-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
75 participants
INTERVENTIONAL
2018-06-05
2021-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Efficacy of Mini-PCNLversus RIRS for the Management of Upper Urinary Tract Calculus (1-2.5 cm)
NCT06031103
Prospective Assessment of Procedure-Related and Patient-Reported Outcomes After Retrograde Intrarenal Surgery (RIRS) for Renal Calculi Less Than 20 mm
NCT03719456
Mini-PNL, RIRS, and ESWL for Treatment of Medium-Sized, High-Density, Non-Lower Pole, Renal Stones
NCT04856722
Mini-PNCL vs fURS in Management of Nephrolithiasis
NCT04389853
Flexible Mini Percutaneous Nephrolithotomy Vs Retrograde Intra-renal Surgery
NCT06249100
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PCNL Group
Patients with renal calculi 10-30mm in maximal diameter in who percutaneous nephrolithotomy (PCNL) will be conducted
PCNL
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-PCNL Group
Patients with renal calculi 10-30mm in maximal diameter in who mini- percutaneous nephrolithotomy (mini-PCNL) will be conducted
mini-PCNL
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.
RIRS Group
Patients with renal calculi 10-30mm in maximal diameter in who retrograde intrarenal surgery (RIRS) will be conducted
RIRS
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PCNL
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-PCNL
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.
RIRS
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with renal stone or stones of 10-30 mm in maximal diameter measured in computed tomography scan.
3. Decision of the patient to receive surgical treatment
4. Ability to understand and provide a written informed consent to participate in the study.
Exclusion Criteria
2. Ureteral stone in the same system causing obstruction
3. Malignant tumor in the treated kidney
4. Stone in diverticulum
5. Diabetes or coronary heart disease.
6. History of surgery in the treated kidney
7. Recent intake of drugs that affect renal function or intravenous contrast agent
8. Concomitant urinary infection
9. Congenital anomalies of the urinary tract
10. Patients of whom incomplete clinical data or incomplete samples are available
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute for the Study of Urological Diseases, Greece
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dimitrios Hatzichristou
President
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dimitrios Hatzichristou, Prof.
Role: PRINCIPAL_INVESTIGATOR
Institute for the Study of Urological Diseases (ISUD)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
G.Gennimatas Hospital
Thessaloniki, , Greece
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Haase 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.
Vaidya 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.
Lin 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.
Dede 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.
Daggulli 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.
Balasar 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.
Soderberg 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1343/2017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.