Mini‑PCNL versus flexible ureteroscopy with a suction sheath for 2–3 cm kidney stones
Official title: 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
Run by Ain Shams University · NCT07306819 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | August 15, 2026 |
| Study ends | September 15, 2026 |
| Registry record updated | December 29, 2025 |
| Trial ID | NCT07306819 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Effect of surgical position on kidney stone removal success
This study tests whether changing the way patients are positioned during kidney stone surgery can help doctors remove stones more successfully and with fewer complications.
-
Evaluating a new patient position for kidney stone surgery
This study is testing if a new way of positioning patients during kidney stone surgery can help them get rid of stones more effectively than the usual position.
-
Using 3D imaging to improve kidney stone surgery training
This study is testing if using 3D imaging can help doctors learn to perform kidney stone surgery better for patients with larger stones.
-
Improving kidney stone clearance after surgery with home exercises
This study tests if doing specific exercises at home can help people pass kidney stones more easily after surgery.
-
Self-posturotherapy to clear leftover fragments after lower-pole kidney stone treatment
This trial will test whether a simple home posturotherapy technique helps people treated with extracorporeal lithotripsy or flexible ureteroscopy for lower-pole kidney stones get rid of remaining fragments over three months.
-
Exploring the link between kidney stones, insulin resistance, and inflammation
This study is trying to see if people with kidney stones have more belly fat and inflammation compared to healthy individuals, to better understand how these factors are linked.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.