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

Primary Purpose

Renal Stone, Extracorporeal Shockwave Lithotripsy, Percutaneous Nephrolithotomy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mini-PNL
SWL
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Urology Department, Al-Azhar University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

mini-PNL group

SWL group

Arm Description

In which percutaneous nephrolithotomy will be performed using miniature nephroscope.

In which extracorporeal shock wave lithotripsy will be performed using Dornier lithotripter SII

Outcomes

Primary Outcome Measures

Stone Free Rate
No residual renal stone or residual fragment(s) less than 4 mm size

Secondary Outcome Measures

Complications

Full Information

First Posted
April 13, 2020
Last Updated
February 4, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT04346134
Brief Title
Mini- Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy for High Density Renal Stones
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone, Extracorporeal Shockwave Lithotripsy, Percutaneous Nephrolithotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-arm, prospective, Randomized, intervention study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mini-PNL group
Arm Type
Experimental
Arm Description
In which percutaneous nephrolithotomy will be performed using miniature nephroscope.
Arm Title
SWL group
Arm Type
Experimental
Arm Description
In which extracorporeal shock wave lithotripsy will be performed using Dornier lithotripter SII
Intervention Type
Procedure
Intervention Name(s)
mini-PNL
Intervention Description
Percutaneous nephrolithotomy using miniature nephroscope. The procedure will be performed under general or spinal anesthesia under fluoroscopy guidance.
Intervention Type
Procedure
Intervention Name(s)
SWL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stone Free Rate
Description
No residual renal stone or residual fragment(s) less than 4 mm size
Time Frame
as detected by non-contrasted computed tomography 3 months after the intervention procedures.
Secondary Outcome Measure Information:
Title
Complications
Time Frame
Intra- and 3 months post-operative complications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Urology Department, Al-Azhar University Hospital
City
Cairo
ZIP/Postal Code
11633
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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