The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury

Sponsor

Institute for the Study of Urological Diseases, Greece (Other)

Overall Status

Completed

CT.gov ID

NCT03112499

Collaborator

(none)

Enrollment

Location

Arms

36.3

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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 hospitalization time) concerning the 3 endourological operations (PCNL, mini- PCNL, RIRS) for the treatment of renal calculi.

Condition or Disease	Intervention/Treatment	Phase
Renal Calculi Renal Insufficiency	Procedure: PCNL Procedure: mini-PCNL Procedure: RIRS	N/A

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:

Point 6(P6): 24 hours after the operation:

Point 7(P7): 48 hours after the operation:

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

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury: a Prospective Randomized 3-arm Study.

Actual Study Start Date :

Jun 5, 2018

Actual Primary Completion Date :

Mar 15, 2021

Actual Study Completion Date :

Jun 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PCNL Group Patients with renal calculi 10-30mm in maximal diameter in who percutaneous nephrolithotomy (PCNL) will be conducted	Procedure: 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.
Active Comparator: mini-PCNL Group Patients with renal calculi 10-30mm in maximal diameter in who mini- percutaneous nephrolithotomy (mini-PCNL) will be conducted	Procedure: 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.
Active Comparator: RIRS Group Patients with renal calculi 10-30mm in maximal diameter in who retrograde intrarenal surgery (RIRS) will be conducted	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: PCNL Group

Patients with renal calculi 10-30mm in maximal diameter in who percutaneous nephrolithotomy (PCNL) will be conducted

Procedure: 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.

Active Comparator: mini-PCNL Group

Patients with renal calculi 10-30mm in maximal diameter in who mini- percutaneous nephrolithotomy (mini-PCNL) will be conducted

Procedure: 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.

Active Comparator: RIRS Group

Patients with renal calculi 10-30mm in maximal diameter in who retrograde intrarenal surgery (RIRS) will be conducted

Procedure: 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.

Outcome Measures

Primary Outcome Measures

The change in urine NGAL/Cr value [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.

Secondary Outcome Measures

The change in urine NGAL/Cr value [2 hours preoperative and 6, 24, 48 hours postoperatively]
Urine NGAL/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique.
The change in urine KIM-1/Cr value [2 hours preoperative and 2, 6, 24, 48 hours postoperatively]
Urine KIM-1/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique.
The change in urine IL-18/Cr value [2 hours preoperative and 2, 6, 24, 48 hours postoperatively]
Urine IL-18/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique.
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 [2, 6, 24, 48 hours postoperatively]
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.
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 [2, 6, 24, 48 hours postoperatively]
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.
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 [2, 6, 24, 48 hours postoperatively]
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.
The presence of Acute Kidney Injury(AKI) in patients undergoing PCNL, mini-PCNL or RIRS [from the time of operation until 48 hours postoperatively]
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
The change in serum creatinine and eGFR values postoperatively in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. [1 month and 3 months postoperatively]
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
Percent of patients achieving treatment success and stone-free state in after undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. [4 weeks postoperatively]
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
Overall complications rates in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. [from the time of operation until the 3 month follow up visit]
Complications will be recorded according the Clavien Dindo grading system
Operation time in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. [- 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]
Operation time will be recorded in minutes
Fluoroscopy time in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. [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 will be recorded in minutes automatically by the fluoroscopic machine
Hospital stay duration in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. [From the day of operation until the day of discharge, up to 7 days]
Hospitalization time will be recorded in days
Postoperative pain, in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. [Immediately after the operation and in 2, 6, 24, 48 hours postoperatively.]
Postoperative pain will be measured by a visual analog scale (VAS) pain score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.