An interventional study of Flexible Nephroscopy-Assisted Single-Tract PCNL and Conventional Multi-Tract PCNL in Percutaneous Nephrolithotomy, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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.
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.
324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.
This study's planned enrollment of 470 is above the median of 92 across 257 interventional studies indexed under Nephrolithiasis.
Browse Nephrolithiasis studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
Exclusion Criteria:
Solitary kidney.
Uncorrected coagulopathy.
Active urinary tract infection.
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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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.
Procedure: Flexible Nephroscopy-Assisted Single-Tract PCNL
Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.
Procedure: Conventional Multi-Tract PCNL
Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.
Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.
Stone-free rate at 3 months.
Proportion of patients with no residual stone fragments greater than 4 mm on non-contrast CT.
Time frame: 3 months after surgery.
Operative time
Time from skin incision or anesthesia induction to completion of the procedure.
Time frame: Intraoperative
Fluoroscopy time
Total duration of fluoroscopy exposure during the procedure.
Time frame: Intraoperative
Number of tracts
Total number of percutaneous renal access tracts used to complete stone clearance.
Time frame: Intraoperative
Hemoglobin drop
Difference between preoperative hemoglobin and postoperative day 1 hemoglobin.
Time frame: From baseline to postoperative day 1.
Transfusion rate
Proportion of patients requiring blood transfusion after surgery.
Time frame: Perioperative/Periprocedural
Duration of Postoperative Hospitalization
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.
Time frame: From the date of PCNL surgery until hospital discharge.
Complication rate
Postoperative complications classified according to the Clavien-Dindo grading system.
Time frame: Up to 3 months
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