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NCT Number: NCT07753733

Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones

This randomized, parallel-group, non-inferiority trial will compare flexible nephroscopy-assisted single-tract percutaneous nephrolithotomy with conventional multi-tract percutaneous nephrolithotomy in patients with complex unilateral renal stones. The primary outcome is stone-free rate at 3 months, and secondary outcomes include operative time, fluoroscopy time, hemoglobin drop, transfusion rate, hospital stay, complications, need for auxiliary procedures, and cost-effectiveness.

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Key information

Conditions

Percutaneous Nephrolithotomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This prospective randomized non-inferiority trial will enroll adults aged 18-70 years with complex unilateral renal stones anticipated to require multiple accesses. Participants will be randomized in a 1:1 ratio to either flexible nephroscopy-assisted single-tract PCNL or conventional multi-tract PCNL. The study aims to determine whether the single-tract approach is not inferior to the multi-tract approach with respect to stone-free rate at 3 months, while potentially reducing perioperative morbidity, including bleeding, transfusion, operative time, and length of hospital stay. Secondary analyses will evaluate complication profiles using Clavien-Dindo classification, need for auxiliary procedures, cost-effectiveness, and the predictive value of Guy's Stone Score and S.T.O.N.E. score.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-70 years.

Unilateral complex renal stones defined by one or more of the following: Guy's Stone Score III-IV, S.T.O.N.E. score ≥9, staghorn or partial staghorn calculus, or stones involving at least 3 calyces on NCCT.

Preoperative expectation of multiple accesses by the surgeon.

Written informed consent.

Exclusion criteria

Solitary kidney.

Uncorrected coagulopathy.

Active urinary tract infection.

ASA grade IV or higher.

Pregnancy.

Previous ipsilateral PCNL or open renal surgery.

Stones less than 2 cm or simple calyceal stones.

Refusal or inability to comply with follow-up.

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Treatment and study plan

Flexible Nephroscopy-Assisted Single-Tract PCNL

Procedure

Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.

Conventional Multi-Tract PCNL

Procedure

Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.

Primary outcomes

  1. Stone-free rate at 3 months.

    Time frame: 3 months after surgery.

    Proportion of patients with no residual stone fragments greater than 4 mm on non-contrast CT.

Secondary outcomes

  1. Operative time

    Time frame: Intraoperative

    Time from skin incision or anesthesia induction to completion of the procedure.

  2. Fluoroscopy time

    Time frame: Intraoperative

    Total duration of fluoroscopy exposure during the procedure.

  3. Number of tracts

    Time frame: Intraoperative

    Total number of percutaneous renal access tracts used to complete stone clearance.

  4. Hemoglobin drop

    Time frame: From baseline to postoperative day 1.

    Difference between preoperative hemoglobin and postoperative day 1 hemoglobin.

  5. Transfusion rate

    Time frame: Perioperative/Periprocedural

    Proportion of patients requiring blood transfusion after surgery.

  6. Duration of Postoperative Hospitalization

    Time frame: From the date of PCNL surgery until hospital discharge.

    Duration of postoperative hospitalization will be calculated as the number of days from the date of PCNL surgery until the date of hospital discharge. The date of surgery will be counted as Day 0. The reason for prolonged hospitalization, when applicable, will be documented.

  7. Complication rate

    Time frame: Up to 3 months

    Postoperative complications classified according to the Clavien-Dindo grading system.

Study contacts

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

Abul-fotouh Ahmed

CONTACT

[email protected]

00201001066756

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones: A Prospective, Randomized, Non-Inferiority Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

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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