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

NCT07393178 | Not Yet Recruiting

• 1 other identifier: MS.25.08.3291
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Renal Stones; Renal Calculi > 2 cm

Keywords

mini-PCNL; holmium-YAG; laser lithotripsy

Outcome Measures

Primary Outcomes (1)

• operative time

  time from introduction of nephroscope till nephrostomy tube fixation

  during mini-PCNL procedure (intraoperative )

Secondary Outcomes (2)

• post operative complication

  2 days

• stone free rate at 3 month

  3 month

Study Arms (2)

high power arm

EXPERIMENTAL

will undergo miniPCNL will high power laser setting

Procedure: mini percutaneous nephrolithotomy

low power group

PLACEBO COMPARATOR

will undergo miniPCNL will low power laser setting

Procedure: mini percutaneous nephrolithotomy

Interventions

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.

Also known as: miniperc, miniPCNL

high power arm; low power group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in urology

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: February 6, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: February 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share