Mini- Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy for High Density Renal Stones

Miniaturized Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy in Treatment of Non- Lower Polar, High-Density, Renal Stone of 10 to 20 mm Size: A Prospective, Randomized Study

Several studies were conducted to compare extracorporeal shockwave lithotripsy (SWL) and percutaneous nephrolithotomy (PNL) as treatment options for medium size lower caliceal high dense stones. However, no studies compared these options for non- lower polar stones.

In the present study the investigators will compare mini-PNL and SWL in treatment of non- lower polar, medium size, high dense renal stones in reference to the stone free rate and safety of the procedures.

Pre-operative evaluation including abdominal non-contrasted computed tomography will be performed for all patients. Patients will be randomly allocated into two equal groups and will be treated by either mini-PNL or SWL. postoperative, patients will be followed by regularly for 3 months. the outcome of the procedures will be evaluated and compared between groups.

Study Overview

• Status: Completed
• Conditions: Percutaneous Nephrolithotomy; Renal Stone; Extracorporeal Shockwave Lithotripsy
• Intervention / Treatment: Procedure: mini-PNL; Procedure: SWL

Detailed Description

The European guidelines put SWL and PNL as an equal treatment options for non- lower polar renal stones from 10 to 20 mm size regardless of density. However, several studies reported markedly reduced SFR after SWL with increased density. Also, in practice, the investigators noticed a high failure rate in renal stones with high density regardless of stone size. Several studies were conducted to compare SWL and PNL as treatment options for medium size lower caliceal stones. However, no studies compared these options for non- lower polar stones.

In the present study the investigators will compare mini-PNL and SWL in treatment of non- lower polar, medium size, high dense renal stones in reference to the SFR and safety of the procedures.

Adult patients with renal stones who agree to participate in the study will evaluated evaluated by full medical history taking and thorough physical examination, urinalysis, urine culture and antibiogram, complete blood cell count (CBC), serum creatinine, liver function tests and coagulation profile. Plain abdominal X-ray for kidney, ureters and urinary bladders (KUB), abdominal ultrasonography and abdominal non-contrasted computed tomography (NCCT). Preoperative assessment of renal anatomy and stone characteristics will be based on the findings of abdominal NCCT.

patients with high density (>1000 HU), non-lower polar, single renal stone of 10 to 20 mm size will be randomly divided into 2 equal groups. mini-PNL group, in which PNL procedures will be performed using miniature nephroscope and SWL group, in which SWL procedures will be performed using Dornier Lithotripter. SWL will be performed for a maximum of 3 sessions.

Patients will be followed up regularly, post-operatively for 3 months. NCCT will be performed after 3 months for detection of stone free status. Baseline data, intra-operative and post-operative parameters will be compared between groups.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11633
    • Urology Department, Al-Azhar University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients with high density (>1000 HU), non-lower polar, single renal stone of 10 to 20 mm size

Exclusion Criteria:

• Pregnant women, morbid obesity, severe orthopaedic deformities, any co-morbidities precluding general anaesthesia or prone positioning, uncorrectable coagulation disorders, active urinary tract infection (UTI), stone in calyceal diverticulum, abnormal renal anatomy and urinary tract obstruction distal to the stone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SWL group; In which extracorporeal shock wave lithotripsy will be performed using Dornier lithotripter SII	Procedure: SWL; Extracorporal shockwave lithotripsy 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.
Experimental: mini-PNL group; In which percutaneous nephrolithotomy will be performed using miniature nephroscope.	Procedure: mini-PNL; Percutaneous nephrolithotomy using miniature nephroscope. The procedure will be performed under general or spinal anesthesia under fluoroscopy guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone Free Rate	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.

Secondary Outcome Measures

Outcome Measure	Time Frame
Complications	Intra- and 3 months post-operative complications

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: Uro_Azhar_16_019

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