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Mini- Percutaneous Nephrolithotomy, Retrograde Intrarenal Surgery, and Extracorporeal Shock Wave Lithotripsy for Treatment of Medium-Sized, High-Density, Non-Lower Pole, Renal Stones

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ClinicalTrials.gov Identifier: NCT04856722
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Abul-fotouh Ahmed, Al-Azhar University

Study Description
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Brief Summary:
The optimal management of medium-sized renal stones remains quite challenging and continues to be contested. In the present study, the investigators will compare mini-PNL, RIRS and SWL in the treatment of non- lower pole, medium size, high dense renal stones regarding the stone-free rate, the safety of the procedures, cost, and patients' and surgeon's satisfaction. Eligible patients will be randomly allocated into three equal groups (mini-PNL, RIRS, and SWL). Postoperative, patients will be followed-up by regularly for 3 months. The study parameters will be compared between groups.

Condition or disease Intervention/treatment Phase
Renal Stone Percutaneous Nephrolithotomy Retrograde Intrarenal Surgery Extracorporeal Shockwave Lithotripsy Procedure: mini-PNL Procedure: RIRS Procedure: SWL Not Applicable

Detailed Description:

The treatment options for renal stones 10-20 mm include either extracorporeal shock wave lithotripsy (SWL) or endourology (retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL).

SWL is an attractive treatment option for renal stones because it is non-invasive and more acceptable for the patient and can be done under analgesia, sedation, or minimal anaesthesia. However, the limitation of SWL includes a relatively lower stone-free rate (SFR) and the need for repeated sessions and auxiliary procedures. The SFR after SWL is affected by several factors, including body mass index (BMI), stone size, intrarenal stone location, skin-to-stone distance (SSD), and stone density.

The EAU guidelines put endourology and SWL as two equal options in medium-sized non-lower pole renal stones and did not give special attention to the stone density, which is an important predictor for SWL outcome. Several studies reported that the number of SWL sessions increased with increased stone attenuation value (SAV) and SFR decreased significantly in high-density renal stone.

PNL and RIRS have good SFR compared to SWL but might entail a significant risk of morbidity. The improved fURS instrumentation and lithotripsy technology, and development of the miniaturized PNL technique, may lower the procedure-related complications and mPNL and RIRS an alternative and excellent option for medium-sized and even large renal stones The investigators hypothesize that addressing the stone density factor may give a clear recommendation for medium-sized, high-density renal stones. They expected the superiority for either mPNL or RIRS, regarding SFR, without increased morbidity.

The study aims to compare the outcome of mPNL, RIRS, and SWL for treatment of non-lower pole, high-density renal stones of 10 to 20 mm size.

The study will include adult patients with non-lower pole, high-density (>1000 HU) renal stones of 10 to 20 mm size.

Pre-operatively, patients will be evaluated by medical history taking, physical examination. urinalysis, urine culture, complete blood cell count (CBC), liver function tests, coagulation profile, blood urea nitrogen (BUN), serum creatinine, plain abdominal X-ray and computed tomography for urinary tract (CT-UT), Eligible patients will be randomly divided into 3 equal groups. PNL group, in which PNL procedures will be performed using miniature nephroscope, RIRS group, in which RIRS will be performed using flexible ureteroscope and SWL group, in which SWL procedures will be performed using Dornier Lithotripter.

post-operatively, patients will be followed up regularly, for 3 months. The SFR, complication rate, cost, patients' and surgeon's satisfaction will be evaluated and compared between the three groups using the appropriate statistical tests and analytical program.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mini- Percutaneous Nephrolithotomy (mPNL), Retrograde Intrarenal Surgery (RIRS), and Extracorporeal Shock Wave Lithotripsy (SWL) for Treatment of Medium-Sized, High-Density, Non-Lower Pole, Renal Stones: A Prospective, Randomized, Comparative Study
Actual Study Start Date : April 5, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones Shock

Arms and Interventions
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Arm Intervention/treatment
Experimental: mini-PNL group
In which PCNL will be performed using miniature nephroscope
 Procedure: mini-PNL
PCNL using miniature nephroscope. The procedure will be performed under general or regional anaesthesia under fluoroscopy guidance.
Experimental: RIRS group
In which RIRS will be performed using a flexible ureteroscope
 Procedure: RIRS
RIRS using flexible ureteroscope. The procedure will be performed under general or regional anaesthesia under fluoroscopy guidance. Holmium Laser lithotripter will be used for stone fragmentation.
Experimental: SWL group
In which extracorporeal shock wave lithotripsy will be performed using Dornier lithotripter SII
 Procedure: SWL
SWL using Dornier SII lithotripter. the procedure will be performed under sedoanalgesia, and fluoroscopy will be used for stone localization; for a maximum of 3 SWL session.


Outcome Measures
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Primary Outcome Measures :
  1. Stone-free rate [ Time Frame: as detected by non-contrasted computed tomography 3 months after the intervention procedures. ]
    Stone free status is defined as no residual renal stone or residual fragment(s) less than 4 mm size.

  2. Complication rate [ Time Frame: up to 3 months. ]

Secondary Outcome Measures :
  1. Cost of treatment [ Time Frame: throughout the study procedure, up to 3 months post-operative. ]
    The cost of each treatment methods will be estimated, Including the devices, disposable instruments, operating room, bed stay, imaging, laboratory, medications, retreatment and ancillary procedures.

  2. Patients satisfaction [ Time Frame: throughout the study procedure, up to 3 months post-operative ]
    A 5-point scale will be used to assess satisfaction, where 1 is unsatisfied and 5 fully satisfied.

  3. Surgeon's satisfaction. [ Time Frame: throughout the study procedure, up to 3 months post-operative ]
    A 5-point scale will be used to assess satisfaction, where 1 is unsatisfied and 5 fully satisfied.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (both genders)
  • Single non-lower pole renal stone.
  • Stone size: 10-20 mm.
  • Stone density: > 1000 HU.

Exclusion Criteria:

  • Pregnant women.
  • Morbid obesity.
  • Severe orthopaedic deformities.
  • Co-morbidities precluding general anaesthesia or prone positioning.
  • Uncorrectable coagulation disorders.
  • Active urinary tract infection (UTI).
  • Stone in a calyceal diverticulum.
  • Abnormal renal anatomy.
  • Urinary tract obstruction distal to the stone.
  • Concomitant pathology that needs intervention in the same setting.
  • Advanced hydronephrosis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856722


Contacts
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Contact: Abul-fotouh Ahmed, MD 00201001066756 abulfotouhahmed@yahoo.com

Locations
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Egypt
Urology Department, Al-Azhar University Hospital Recruiting
Cairo, Egypt, 11633
Contact: Ahmed Fahim, MD    002025107333    urologyhospital@gmail.com   
Sub-Investigator: Hassan Abdelazeim, MD         
Sponsors and Collaborators
Al-Azhar University
More Information
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Responsible Party: Abul-fotouh Ahmed, Professor of Urology and Andrology, Al-Azhar University
ClinicalTrials.gov Identifier: NCT04856722    
Other Study ID Numbers: Uro_Azhar_11_021
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
 Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi