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NCT Number: NCT07306819

Comparison Between Two Methods for Renal Stone Treatment Mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy With Suction Sheath

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.

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Key information

Conditions

Stone;Renal Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stone Clearance Stone, Kidney Stone, Urinary Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university hospitals

Cairo, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

mini-percutaneous nephrolithotomy

Procedure

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.

Other names: Mini-PCNL, mPCNL

Flexible Uerteroscopy with Tip-Bendable Suction Sheath

Procedure

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.

Other names: FANS, FURS with Suction Sheath

Primary outcomes

  1. stone free rate

    Time frame: one month postoperative

    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.

Secondary outcomes

  1. length of hospital stay

    Time frame: From date of surgery until date of hospital discharge for 14 days (measured in days).

    The total duration of inpatient hospitalization following the procedure, calculated from the day of surgery to the day of discharge

  2. operative time

    Time frame: Measured intraoperatively, from procedure start to end (in minutes).

    The total time from the initiation of the procedure to the final removal of all endoscopic equipment and placement/completion of any necessary stents

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Higazy, Lecturer of Urology

CONTACT

Mohamed M Hasab Allah, resident

CONTACT

[email protected]

+201012663766

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Acronym: mini-PCNL/FANS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

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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