Ultra Mini Percutaneous Nephrolithotomy VS Stented Extracorporeal Shock Wave Lithotripsy for Stone Management

NCT05697341 | Completed

• 1 other identifier: YRS0001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Nephrolithiasis is the third most common disease of the urinary tract. As minimally invasive technologies develop, shock wave lithotripsy (SWL), retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotomy (PCNL) are different surgeries to treat renal stones. Aim of the Study is to compare results, safety and outcome of Ultra mini PCNL versus stented extracorporeal shock wave lithotripsy (SWL) for the management of renal calculi from 10 - 20 mm. Patients were randomized to either Ultra-Mini-Percutaneous nephrolithotomy group or stented SWL group via the closed envelope method. Patient data was collected preoperatively, immediately postoperatively and 2 and 4 weeks postoperatively to assess operative time, hospital stay, complications regarding fever, hematuria and need for blood transfusion, residual stones and need for retreatment.

Conditions

Renal Stone

Keywords

Nephrolithiasis; Ultra-Mini-PCNL; Stented SWL

Outcome Measures

Primary Outcomes (1)

• Stone-free status

  The complete stone clearance or presence of clinically insignificant residual fragments (\<4 mm) 2 or 4 weeks after the final procedure was regarded as stone-free

  at 2 or 4 weeks after ultra-mini-PCNL or stented SWL

Study Arms (2)

Ultra-Mini-PCNL Group (A)

ACTIVE COMPARATOR

In The Ultra-Mini-percutaneous nephrolithotomy group, a 5 Fr open-ended ureteral catheter was introduced and a retrograde pyelogram was performed in the Lithotomy position after the induction of general anesthesia. Patients were then repositioned to the prone position. Ultra-mini-PCNLs were done in a prone position by a single consultant. The desired calyx was punctured with a Cook diamond tip 18G puncture needle under fluoroscopy guidance using standard bull's eye technique. Single tract dilatation with One Step Dilator (11Fr), with central channel for guide wires with its Operating Sheath (Storzz Dilator and Operating Sheaths for MIP XS) under fluoroscopy guidance. Storzz Nephroscope for MIP XS / S along with Swiss Lithoclast master pneumatic lithotripter with 1/0.8 mm probe was used for stone fragmentation. Stone fragments are flushed out on rapid removal of the endoscope, due to a 'vortex' effect and with wash through the operating sheath using a 6 Fr. nelaton catheter.

Procedure: Ultra-Mini-PCNL

Stented SWL Group (B)

ACTIVE COMPARATOR

In the stented ESWL group, a 5 Fr open-ended ureteral catheter was introduced in the renal pelvis, and a retrograde pyelogram was performed in the Lithotomy position after the induction of general anathesia. JJ is applied either 5-26 or 5-28 accorging to the patient. Extracorporeal shock wave lithotripsy ESWL was administered with an electromagnetic shockwave lithotripter (Siemens electromagnetic lithotripters devices). Patients were positioned supine with the shock head from the back. Fluoroscopy was used for the localization and monitoring of stone fragmentation. All patients received shocks at a frequency of 60/min. An average of approximately 2500-3000 shocks was targeted in all patients.

Procedure: Stented SWL

Interventions

Ultra-Mini-PCNL PROCEDURE

treatment to extract or disintegrate renal stones

Ultra-Mini-PCNL Group (A)

Stented SWL PROCEDURE

treatment to disintegrate renal stones in the presence of a JJ

Stented SWL Group (B)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients between 18 and 60 years
• complaining of radioopaque renal stones ranging from 10-20 mm.
• BMI not exceeding 40

You may not qualify if:

• radiolucent stones,
• smaller than 10 mm or larger than 20 mm stones
• congenital renal anomalies or spinal deformity
• BMI exceeding 40.
• Patients with uncorrected bleeding diathesis
• pregnant females
• untreated UTI.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University, Faculty of medicine

Cairo, Abbassia, 1181, Egypt

Location

Related Publications (4)

• Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrik A, Turk C. Metabolic evaluation and recurrence prevention for urinary stone patients: EAU guidelines. Eur Urol. 2015 Apr;67(4):750-63. doi: 10.1016/j.eururo.2014.10.029. Epub 2014 Nov 20.

  PMID: 25454613 BACKGROUND

• Kim CH, Chung DY, Rha KH, Lee JY, Lee SH. Effectiveness of Percutaneous Nephrolithotomy, Retrograde Intrarenal Surgery, and Extracorporeal Shock Wave Lithotripsy for Treatment of Renal Stones: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2020 Dec 30;57(1):26. doi: 10.3390/medicina57010026.

  PMID: 33396839 BACKGROUND

• Gao XS, Liao BH, Chen YT, Feng SJ, Gao R, Luo DY, Liu JM, Wang KJ. Different Tract Sizes of Miniaturized Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery: A Systematic Review and Meta-Analysis. J Endourol. 2017 Nov;31(11):1101-1110. doi: 10.1089/end.2017.0547. Epub 2017 Oct 30.

  PMID: 28950716 BACKGROUND

• Bozzini G, Verze P, Arcaniolo D, Dal Piaz O, Buffi NM, Guazzoni G, Provenzano M, Osmolorskij B, Sanguedolce F, Montanari E, Macchione N, Pummer K, Mirone V, De Sio M, Taverna G. A prospective randomized comparison among SWL, PCNL and RIRS for lower calyceal stones less than 2 cm: a multicenter experience : A better understanding on the treatment options for lower pole stones. World J Urol. 2017 Dec;35(12):1967-1975. doi: 10.1007/s00345-017-2084-7. Epub 2017 Sep 5.

  PMID: 28875295 BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Ahmed Radwan, MD

  Assisstant Professof of Urology, Faculty of medicine, Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of medicine

Model Details: 90 Patients were enrolled from the outpatient urology clinic of Ain Shams University hospital (Demredash Hospital) randomized to either Group A Ultra-Mini-Percutaneous nephrolithotomy group or Group B stented SWL group via the closed envelope method.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)