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Evaluation of Different Treatment Modalities for Lower Pole and Renal Pelvis Stones

Primary Purpose

Kidney Stones

Status
Suspended
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Endoscopic kidney stone surgery
Endoscopic kidney stone surgery
Endoscopic kidney stone surgery
Endoscopic kidney stone surgery
Endoscopic kidney stone surgery
Non-invasive kidney stone treatment
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones focused on measuring kidney stone, percutaneous nephrolithotripsy, retrograde intrarenal surgery, extracorporeal shock wave lithotripsy, mini PCNL, ultra-mini PCNL, micro PCNL

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with unregulated diabetes mellitus and diabetic nephropathy
  • Patients with a blood pressure higher than 140/80 mmHg despite use of antihypertensive drug(s) regularly
  • Patients with chronic renal failure who need dialysis
  • Patients who had prerenal, renal or postrenal acute kidney failure during the last 6 months
  • Patients who had acute pyelonephritis during the last 6 months
  • Patients younger than 18 years old or older than 70 years old
  • Patients who had kidney surgery during the last 3 months and who have abnormal kidney functions
  • Patients with ureteral stone who are planned to undergo endoscopic stone treatment at the same time
  • Patients with a history of corticosteroid use during enrollment into the study or previous 3 months
  • Patients with uncontrolled thyroid disease
  • Patients who have a disease with rapid cell turn-over (like leukemia, lymphoma, etc.)
  • Patients in whom PCNL/RIRS/ESWL cannot be performed due to any reason and the procedure is terminated
  • Patients who are converted to open surgery due to any reason
  • Patients with missing data

Sites / Locations

  • Selcuk University, School of Medicine, Department of Urology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Conventional PCNL

Mini PCNL

Ultra-mini PCNL

Micro PCNL

Retrograde intrarenal surgery

Extracorporeal shock wave lithotripsy

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Stone-free rate
Determination of any residual stone in the collecting system by using one of imaging modalities.

Secondary Outcome Measures

Complication rate
Determination of any complications related to the 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.
Blood Netrin-1 level (pg/mL)
Determination of any impairment in renal function after the surgery/procedure by measuring blood Netrin-1 level.
Urine NGAL level (ng/mL)
Determination of any impairment in renal function after the surgery/procedure by measuring urine NGAL level.
Urine Cystatin C level (mg/L)
Determination of any impairment in renal function after the surgery/procedure by measuring urine Cystatin C level.
Urine Netrin-1 level (pg/mL)
Determination of any impairment in renal function after the surgery/procedure by measuring urine Netrin-1 level.

Full Information

First Posted
August 9, 2015
Last Updated
November 15, 2019
Sponsor
Selcuk University
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT02522676
Brief Title
Evaluation of Different Treatment Modalities for Lower Pole and Renal Pelvis Stones
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Suspended
Why Stopped
Due to surgeons' unwillingness to randomize patients into different treatments
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
Collaborators
The Scientific and Technological Research Council of Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It is aimed to evaluate the treatment results, rates of success and complications, and injury given to the kidney by measuring preoperative and postoperative blood urea, creatinine, Cystatin C and Netrin-1 levels and urine Cystatin C and Netrin-1 levels in patients with lower pole or renal pelvis stone(s) undergoing either one of the treatment modalities including conventional percutaneous nephrolithotripsy (PCNL), mini PCNL, ultra-mini PCNL, micro PCNL, retrograde intrarenal surgery (RIRS) and extracorporeal shock wave lithotripsy (ESWL).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
kidney stone, percutaneous nephrolithotripsy, retrograde intrarenal surgery, extracorporeal shock wave lithotripsy, mini PCNL, ultra-mini PCNL, micro PCNL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional PCNL
Arm Type
Active Comparator
Arm Description
Endoscopic kidney stone surgery: Patients will undergo conventional percutaneous nephrolithotripsy.
Arm Title
Mini PCNL
Arm Type
Active Comparator
Arm Description
Endoscopic kidney stone surgery: Patients will undergo mini percutaneous nephrolithotripsy.
Arm Title
Ultra-mini PCNL
Arm Type
Active Comparator
Arm Description
Endoscopic kidney stone surgery: Patients will undergo ultra-mini percutaneous nephrolithotripsy.
Arm Title
Micro PCNL
Arm Type
Active Comparator
Arm Description
Endoscopic kidney stone surgery: Patients will undergo micro percutaneous nephrolithotripsy.
Arm Title
Retrograde intrarenal surgery
Arm Type
Active Comparator
Arm Description
Endoscopic kidney stone surgery: Patients will undergo retrograde intrarenal surgery.
Arm Title
Extracorporeal shock wave lithotripsy
Arm Type
Active Comparator
Arm Description
Non-invasive kidney stone treatment: Patients will undergo extracorporeal shock wave lithotripsy.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic kidney stone surgery
Intervention Description
Conventional PCNL will be performed.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic kidney stone surgery
Intervention Description
Mini PCNL will be performed.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic kidney stone surgery
Intervention Description
Ultra-mini PCNL will be performed.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic kidney stone surgery
Intervention Description
Micro PCNL will be performed.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic kidney stone surgery
Intervention Description
Retrograde intrarenal surgery will be performed.
Intervention Type
Procedure
Intervention Name(s)
Non-invasive kidney stone treatment
Intervention Description
Extracorporeal shock wave will be performed.
Primary Outcome Measure Information:
Title
Stone-free rate
Description
Determination of any residual stone in the collecting system by using one of imaging modalities.
Time Frame
Within the first 30 days after surgery/procedure
Secondary Outcome Measure Information:
Title
Complication rate
Description
Determination of any complications related to the surgery/procedure.
Time Frame
Within the first 30 days after surgery/procedure
Title
Blood Cystatin C level (mg/L)
Description
Determination of any impairment in renal function after the surgery/procedure by measuring blood Cystatin C level.
Time Frame
Within the first 48 hours after surgery/procedure
Title
Blood Netrin-1 level (pg/mL)
Description
Determination of any impairment in renal function after the surgery/procedure by measuring blood Netrin-1 level.
Time Frame
Within the first 48 hours after surgery/procedure
Title
Urine NGAL level (ng/mL)
Description
Determination of any impairment in renal function after the surgery/procedure by measuring urine NGAL level.
Time Frame
Within the first 72 hours after surgery/procedure
Title
Urine Cystatin C level (mg/L)
Description
Determination of any impairment in renal function after the surgery/procedure by measuring urine Cystatin C level.
Time Frame
Within the first 24 hours after surgery/procedure
Title
Urine Netrin-1 level (pg/mL)
Description
Determination of any impairment in renal function after the surgery/procedure by measuring urine Netrin-1 level.
Time Frame
Within the first 24 hours after surgery/procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients with unregulated diabetes mellitus and diabetic nephropathy Patients with a blood pressure higher than 140/80 mmHg despite use of antihypertensive drug(s) regularly Patients with chronic renal failure who need dialysis Patients who had prerenal, renal or postrenal acute kidney failure during the last 6 months Patients who had acute pyelonephritis during the last 6 months Patients younger than 18 years old or older than 70 years old Patients who had kidney surgery during the last 3 months and who have abnormal kidney functions Patients with ureteral stone who are planned to undergo endoscopic stone treatment at the same time Patients with a history of corticosteroid use during enrollment into the study or previous 3 months Patients with uncontrolled thyroid disease Patients who have a disease with rapid cell turn-over (like leukemia, lymphoma, etc.) Patients in whom PCNL/RIRS/ESWL cannot be performed due to any reason and the procedure is terminated Patients who are converted to open surgery due to any reason Patients with missing data
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Akand, M.D.
Organizational Affiliation
Selcuk University, School of Medicine, Department of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University, School of Medicine, Department of Urology
City
Konya
ZIP/Postal Code
42075
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Evaluation of Different Treatment Modalities for Lower Pole and Renal Pelvis Stones

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