Comparison Between Two Methods for Renal Stone Treatment Mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy With Suction Sheath (mini-PCNL/FANS)

December 13, 2025 updated by: Mohamed M Hasab Allah, Ain Shams University

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmed Higazy, Lecturer of Urology

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mini-PCNL

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, 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
Experimental: FURS with Tip-Bendable Suction Sheath
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one month postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of surgery until date of hospital discharge for 14 days (measured in days).
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
Measured intraoperatively, from procedure start to end (in minutes).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Ahmed M Tawfeek, assistant proffessor, Ain Shams University, Department Of Urology
  • Study Director: Ahmed Higazy, lecturer of urology, Ain Shams University, Department Of Urology
  • Study Director: Ashraf Satour, lecturer of urology, Ain Shams University, Department Of Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

December 13, 2025

First Posted (Actual)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS 725/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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