Mini-PNL, RIRS, and ESWL for Treatment of Medium-Sized, High-Density, Non-Lower Pole, Renal Stones

Renal Stone Clinical Trial

Official title:

Mini-PNL, RIRS, and ESWL for Treatment of Medium-Sized, High-Density, Non-Lower Pole, Renal Stones: A Prospective, Randomized, Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04856722
• Other study ID #: Uro_Azhar_11_021
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: February 2023
• Source: Al-Azhar University
• Contact: Abul-fotouh Ahmed, MD
• Phone: 00201001066756
• Email: abulfotouhahmed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Extracorporeal Shockwave Lithotripsy
• Kidney Calculi
• Nephrolithiasis
• Percutaneous Nephrolithotomy
• Renal Stone
• Retrograde Intrarenal Surgery

Intervention

Procedure:
• mini-PNL
PCNL using miniature nephroscope. The procedure will be performed under general or regional anaesthesia under fluoroscopy guidance.
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Urology Department, Al-Azhar University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone-free rate	Stone free status is defined as no residual renal stone or residual fragment(s) less than 4 mm size.	as detected by non-contrasted computed tomography 3 months after the intervention procedures.
Primary	Complication rate	intra- and post-operative complications	up to 3 months.
Secondary	Cost of treatment	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.	throughout the study procedure, up to 3 months post-operative.
Secondary	Patients satisfaction	A 5-point scale will be used to assess satisfaction, where 1 is unsatisfied and 5 fully satisfied.	throughout the study procedure, up to 3 months post-operative
Secondary	Surgeon's satisfaction.	A 5-point scale will be used to assess satisfaction, where 1 is unsatisfied and 5 fully satisfied.	throughout the study procedure, up to 3 months post-operative