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

November 15, 2019 updated by: Murat AKAND, Selcuk University

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).

Study Overview

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:

  1. Preoperative general evaluation data: Age, height, weight, body-mass index, concomitant comorbidities, prescriptions used, history of operation(s), American Society of Anesthesiologists (ASA) score
  2. 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
  3. Operative data: Access fluoroscopy duration, total access duration, total fluoroscopy duration, operation duration, use of double-J stent, preoperative complications
  4. Number of previous ESWL seance, total duration of ESWL, number of shots during ESWL (if any)
  5. 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
  6. Stone analysis

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Konya, Turkey, 42075
        • Selcuk University, School of Medicine, Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional PCNL
Endoscopic kidney stone surgery: Patients will undergo conventional percutaneous nephrolithotripsy.
Conventional PCNL will be performed.
Mini PCNL will be performed.
Ultra-mini PCNL will be performed.
Micro PCNL will be performed.
Retrograde intrarenal surgery will be performed.
Active Comparator: Mini PCNL
Endoscopic kidney stone surgery: Patients will undergo mini percutaneous nephrolithotripsy.
Conventional PCNL will be performed.
Mini PCNL will be performed.
Ultra-mini PCNL will be performed.
Micro PCNL will be performed.
Retrograde intrarenal surgery will be performed.
Active Comparator: Ultra-mini PCNL
Endoscopic kidney stone surgery: Patients will undergo ultra-mini percutaneous nephrolithotripsy.
Conventional PCNL will be performed.
Mini PCNL will be performed.
Ultra-mini PCNL will be performed.
Micro PCNL will be performed.
Retrograde intrarenal surgery will be performed.
Active Comparator: Micro PCNL
Endoscopic kidney stone surgery: Patients will undergo micro percutaneous nephrolithotripsy.
Conventional PCNL will be performed.
Mini PCNL will be performed.
Ultra-mini PCNL will be performed.
Micro PCNL will be performed.
Retrograde intrarenal surgery will be performed.
Active Comparator: Retrograde intrarenal surgery
Endoscopic kidney stone surgery: Patients will undergo retrograde intrarenal surgery.
Conventional PCNL will be performed.
Mini PCNL will be performed.
Ultra-mini PCNL will be performed.
Micro PCNL will be performed.
Retrograde intrarenal surgery will be performed.
Active Comparator: Extracorporeal shock wave lithotripsy
Non-invasive kidney stone treatment: Patients will undergo extracorporeal shock wave lithotripsy.
Extracorporeal shock wave will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first 30 days after surgery/procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: Within the first 30 days after surgery/procedure
Determination of any complications related to the surgery/procedure.
Within the first 30 days after surgery/procedure
Blood Cystatin C level (mg/L)
Time Frame: Within the first 48 hours after surgery/procedure
Determination of any impairment in renal function after the surgery/procedure by measuring blood Cystatin C level.
Within the first 48 hours after surgery/procedure
Blood Netrin-1 level (pg/mL)
Time Frame: Within the first 48 hours after surgery/procedure
Determination of any impairment in renal function after the surgery/procedure by measuring blood Netrin-1 level.
Within the first 48 hours after surgery/procedure
Urine NGAL level (ng/mL)
Time Frame: Within the first 72 hours after surgery/procedure
Determination of any impairment in renal function after the surgery/procedure by measuring urine NGAL level.
Within the first 72 hours after surgery/procedure
Urine Cystatin C level (mg/L)
Time Frame: Within the first 24 hours after surgery/procedure
Determination of any impairment in renal function after the surgery/procedure by measuring urine Cystatin C level.
Within the first 24 hours after surgery/procedure
Urine Netrin-1 level (pg/mL)
Time Frame: Within the first 24 hours after surgery/procedure
Determination of any impairment in renal function after the surgery/procedure by measuring urine Netrin-1 level.
Within the first 24 hours after surgery/procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Murat Akand, M.D., Selcuk University, School of Medicine, Department of Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 9, 2015

First Submitted That Met QC Criteria

August 11, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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