Renal StonesminiPCNLNCT07393178
Efficacy & Safety of High Power vs. Low Power Holmium Laser in Mini-PCNL for Large Renal Stones
A study testing mini percutaneous nephrolithotomy in people with Renal Stones and Renal Calculi > 2 cm, run by Mansoura University.
Trial summary
The investigator will compare between holmium laser setting during miniPCNL for renal stones as regard safety \& efficacy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stones, Renal Calculi > 2 cm
- What is being tested?
- mini percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 30 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Renal Stones < 20 mm indicated for intervention (pain, infection, obstructing stone causing hydronephrosis or parenchymal affection)
- Informed consent obtained
Who cannot join
- Active urinary tract infection
- Bleeding diathesis
- Pregnancy
- Anatomical anomalies impeding access e.g. ectopic malrotated kidneys, crossed fused kidneys...etc.)
About this study
Official title: High Pulse Power vs. Low Pulse Power Holmium: YAG Laser in Mini-Percutaneous Nephrolithotomy for Management of Renal Stones > 20 mm: A Randomized Controlled Trial
The investigator will compare between holmium laser setting during miniPCNL for renal stones as regard safety \& efficacy
Read the detailed description
The first 80 consecutive Patients presented to the department of urology, Mansoura Urology and Nephrology Center and fulfilling the inclusion criteria will be included in the present study.
Preoperatively, all patients will be thoroughly evaluated by medical history and physical examination including body mass index (BMI), laboratory assessment (including urine analysis/culture, serum biochemistry, CBC, bleeding profile).
Radiological assessment will include plain X-ray Kidney-Ureter-Bladder (KUB), abdominal ultrasound and non-contrast computed tomography (NCCT).
NCCT images will be obtained from above the kidneys through the bladder base. For each renal stone, location, largest diameter, burden and density will be assessed.
Culture based antibiotic is given. Under spinal anaesthesia, the patient is initially placed in lithotomy position for retrograde ureteral catheter placement, then repositioned to prone or modified supine position for percutaneous access.
Under fluoroscopic guidance, an 18G Chiba needle is used to access a posterior calyx or the appropriate target calyx). Contrast confirms the collecting system entry.
Dilation is performed, typically up to 14-20 Fr. A mini-nephroscope (15 Fr) is inserted through an appropriate sheath. Irrigation is maintained using gravity or low-pressure systems.
Holmium: YAG laser is used for lithotripsy. high pulse power will be capped at 40 W, while low pulse power settings will remain between 10-20 W. Fragments are evacuated via vacuum cleaner effect or basket through the sheath.
Depending on intraoperative findings, a nephrostomy tube and/or double-J stent may be placed. Tubeless approach may be considered.
- Conditions
- Renal Stones, Renal Calculi > 2 cm
- Being tested
- mini percutaneous nephrolithotomy
- Keywords
- mini-PCNL, holmium-YAG, laser lithotripsy
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini percutaneous nephrolithotomyProcedure or surgery
Also called miniperc, miniPCNL
Under fluoroscopic guidance, an 18G Chiba needle is used to access a posterior calyx or the appropriate target calyx). Contrast confirms the collecting system entry.
Dilation is performed, typically up to 14-20 Fr. A mini-nephroscope (15 Fr) is inserted through an appropriate sheath. Irrigation is maintained using gravity or low-pressure systems.
Holmium: YAG laser is used for lithotripsy. high pulse power will be capped at 40 W, while low pulse power settings will remain between 10-20 W. Fragments are evacuated via vacuum cleaner effect or basket through the sheath.
| Study group | Role | What they receive |
|---|---|---|
| high power arm | Experimental | will undergo miniPCNL will high power laser setting Receives: Procedure: mini percutaneous nephrolithotomy |
| low power group | Placebo comparator | will undergo miniPCNL will low power laser setting Receives: Procedure: mini percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
time from introduction of nephroscope till nephrostomy tube fixation
Measured: during mini-PCNL procedure (intraoperative )
Secondary outcomes (2)
post operative complication
number of patients that will develop post operative fever, hematuria, or will require blood transfusion
Measured: 2 days
stone free rate at 3 month
presence of residual stones requiring reintervention
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elghamry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393178
- Sponsor's protocol ID
- MS.25.08.3291
- Acronym
- miniPCNL
- Status last verified
- Nov 2025
- First submitted
- 2 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No