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NCT Number: NCT07393178

Efficacy & Safety of High Power vs. Low Power Holmium Laser in Mini-PCNL for Large Renal Stones

The investigator will compare between holmium laser setting during miniPCNL for renal stones as regard safety & efficacy

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Renal Stones < 20 mm indicated for intervention (pain, infection, obstructing stone causing hydronephrosis or parenchymal affection)
  • Informed consent obtained

Exclusion criteria

  • Active urinary tract infection
  • Bleeding diathesis
  • Pregnancy
  • Anatomical anomalies impeding access e.g. ectopic malrotated kidneys, crossed fused kidneys...etc.)

Treatment and study plan

Mini Percutaneous Nephrolithotomy

Procedure

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.

Other names: miniperc, miniPCNL

Primary outcomes

  1. operative time

    Time frame: during mini-PCNL procedure (intraoperative )

    time from introduction of nephroscope till nephrostomy tube fixation

Secondary outcomes

  1. post operative complication

    Time frame: 2 days

    number of patients that will develop post operative fever, hematuria, or will require blood transfusion

  2. stone free rate at 3 month

    Time frame: 3 month

    presence of residual stones requiring reintervention

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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

Acronym: miniPCNL

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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