An interventional study of mini-percutaneous nephrolithotomy and Flexible Uerteroscopy with Tip-Bendable Suction Sheath in Stone;Renal, Stone, Urinary and Stone, Kidney, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
This study aims to compare the efficacy and safety of two modern, minimally invasive surgical techniques for the removal of kidney stones: Mini-Percutaneous Nephrolithotomy (Mini-PCNL) and Flexible Ureteroscopy (FURS) with Flexible and navigable suction sheath
The primary objective is to determine which procedure results in a higher stone-free rate, as measured by post-operative imaging. Secondary objectives include comparing operative time, hospitalization length andcomplication rates between the two treatment groups.
Patients with two to three centimeter kidney stones who are candidates for either procedure will be randomly assigned to undergo either Mini-PCNL or suctioning FURS. The outcomes will be critically assessed to help establish a higher level of evidence for guiding surgical management of kidney stones.
Mini-PCNL involves creating a small tract from the skin on the back directly into the kidney, through which a miniature nephroscope is passed to visualize and remove stones. Flexible Ureteroscopy is performed by passing a thin, flexible scope through the natural urinary passage (urethra and ureter) into the kidney. The specific FURS technique in this study utilizes a specialized scope with integrated suction, which is theorized to improve stone fragment clearance.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 120 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Kidney Calculi, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Nephrolithiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Under general anesthesia, a 6 Fr ureteral catheter will be placed into the target ureter via cystoscopy, and bladder drainage will be achieved with a 16 Fr Foley catheter. The patient will then be repositioned to the prone position. Percutaneous renal access will be obtained by puncturing the selected calyx with an 18-gauge coaxial needle under fluoroscopic or ultrasound guidance. Tract dilation will be performed using fascial dilators up to 20 Fr then the mini-PCNL sheath (mini-Amplatz sheath) will be inserted and the mini nephroscope 12 to 15 Fr will be used. If multiple nephrostomy tracts are required for stone removal, the same approach will be repeated for each tract. Stone fragmentation will be carried out with a pneumatic lithotripter. At the end of the procedure, a 6 Fr double-J ureteral stent will be inserted for 4 weeks, and whether to place a nephrostomy tube will be determined at the discretion of the operating surgeon.
Procedure: mini-percutaneous nephrolithotomy
under general anesthesia with the patient in the lithotomy position. A 6 Fr ureteral catheter will first be placed into the ureter, followed by retrograde pyelography to assess the upper urinary tract. A guidewire will then be advanced into the renal pelvis. either a 12/14 Fr or 11/13 Fr tip-bendable S-UAS will be inserted. If insertion is not possible due to ureteral narrowing, a smaller 10/12 Fr UAS will be attempted. if failed, a double-J stent will be placed and the procedure terminated, with a second session scheduled 4 weeks later. fURS will be performed using digital flexible ureteroscopes either 8.5 Fr or 7.5 Fr according to UAS size; an 8.5-Fr scope for a 12/14 Fr UAS, and a 7.5-Fr scope for an 11/13-Fr or 10/12-Fr UAS. Stone fragmentation will be performed using a holmium laser (Ho: YAG) with a 272-μm fiber and an energy setting below 30 W. Irrigation will be maintained at 50-100 ml/min and suction pressure at 80-120 mmHg. at the end a 6 Fr JJ will be inserted for 4 weeks.
Procedure: Flexible Uerteroscopy with Tip-Bendable Suction Sheath
Under general anesthesia, a 6 Fr ureteral catheter will be placed into the target ureter via cystoscopy, and bladder drainage will be achieved with a 16 Fr Foley catheter. The patient will then be repositioned to the prone position. Percutaneous renal access will be obtained by puncturing the selected calyx with an 18-gauge coaxial needle under fluoroscopic or ultrasound guidance. Tract dilation will be performed using fascial dilators up to 20 Fr then the mini-PCNL sheath (mini-Amplatz sheath) will be inserted and the mini nephroscope 12 to 15 Fr will be used. If multiple nephrostomy tracts are required for stone removal, the same approach will be repeated for each tract. Stone fragmentation will be carried out with a pneumatic lithotripter. At the end of the procedure, a 6 Fr double-J ureteral stent will be inserted for 4 weeks, and whether to place a nephrostomy tube will be determined at the discretion of the operating surgeon.
Also known as: Mini-PCNL, mPCNL
under general anesthesia with the patient in the lithotomy position. A 6 Fr ureteral catheter will first be placed into the ureter, followed by retrograde pyelography to assess the upper urinary tract. A guidewire will then be advanced into the renal pelvis. either a 12/14 Fr or 11/13 Fr tip-bendable S-UAS will be inserted. If insertion is not possible due to ureteral narrowing, a smaller 10/12 Fr UAS will be attempted. if failed, a double-J stent will be placed and the procedure terminated, with a second session scheduled 4 weeks later. fURS will be performed using digital flexible ureteroscopes either 8.5 Fr or 7.5 Fr according to UAS size; an 8.5-Fr scope for a 12/14 Fr UAS, and a 7.5-Fr scope for an 11/13-Fr or 10/12-Fr UAS. Stone fragmentation will be performed using a holmium laser (Ho: YAG) with a 272-μm fiber and an energy setting below 30 W. Irrigation will be maintained at 50-100 ml/min and suction pressure at 80-120 mmHg. at the end a 6 Fr JJ will be inserted for 4 weeks.
Also known as: FANS, FURS with Suction Sheath
stone free rate
The proportion of participants in each treatment arm who are completely free of any stone fragments in the treated kidney, following the initial procedure and without the need for any secondary surgical interventions. Status will be determined by a blinded central radiologist.
Time frame: one month postoperative
length of hospital stay
The total duration of inpatient hospitalization following the procedure, calculated from the day of surgery to the day of discharge
Time frame: From date of surgery until date of hospital discharge for 14 days (measured in days).
operative time
The total time from the initiation of the procedure to the final removal of all endoscopic equipment and placement/completion of any necessary stents
Time frame: Measured intraoperatively, from procedure start to end (in minutes).
Plan to share: No
Started Oct 2025 (actual). Primary completion is estimated for Aug 2026, 10 months after the start.
Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 10 months is below that.
Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
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