Mini‑PCNL versus flexible ureteroscopy with a suction sheath for 2–3 cm kidney stones
Flexible Ureteroscopy Using a Tip-Bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for the Treatment of 2-3 cm Renal Stones: A Randomized Controlled Trial
This tests whether mini‑PCNL or flexible ureteroscopy with a suction sheath better clears 2–3 cm kidney stones and leads to fewer complications in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07306819 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial assigns adults with 2–3 cm renal stones to either mini‑percutaneous nephrolithotomy (mini‑PCNL) or flexible ureteroscopy (FURS) using a navigable suction sheath. Mini‑PCNL creates a small tract through the back into the kidney to directly visualize and remove stones with a miniature nephroscope. FURS is performed through the urinary tract using a thin flexible scope that incorporates suction to help capture and remove fragments and limit retropulsion. The primary outcome is stone‑free rate on post‑operative imaging, with secondary outcomes including operative time, length of hospital stay, and complication rates.
Who should consider this trial
Good fit: Adults aged 18 or older with kidney stones measuring 2–3 cm on CT who are eligible for either mini‑PCNL or flexible ureteroscopy and meet the study's inclusion/exclusion criteria.
Not a fit: Patients with uncontrolled diabetes, hypertension, hepatic dysfunction, renal failure, active urinary infection, bleeding disorders, pregnancy, prior ureteric injury, or certain congenital renal anomalies are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could guide patients and surgeons to the procedure that achieves higher stone‑free rates with fewer complications and shorter hospital stays.
How similar studies have performed: Prior comparisons generally show higher stone‑free rates for percutaneous approaches with larger stones, while suction‑enabled ureteroscopes have promising early results but limited randomized evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aging 18 years old or more. * Patients with renal stones between 2-3 cm in size confirmed by CT scan. Exclusion Criteria: * Patients with previous ureteric injury. * Patients with uncontrolled diabetes mellitus or hypertension. * Patients with uncontrolled hepatic dysfunction. * Patients with uremia or renal failure. * Pregnant patients. * patients with active urinary tract infection. * Patients with bleeding tendency or uncontrolled coagulopathy. * Patients with congenital anomalies as horse-shoe kidney and pelvi-ureteric junction obstruction.
Where this trial is running
Cairo
- Ain shams university hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed M Hasab Allah, resident
- Email: Mohamed-Hasaballah@med.asu.edu.eg
- Phone: +201012663766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.