Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flexible Nephroscopy-Assisted Single-Tract PCNL, Conventional Multi-Tract PCNL.
- Who it may be relevant to
- Registry conditions: Percutaneous Nephrolithotomy. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones: A Prospective, Randomized, Non-Inferiority Trial
Overview
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.
Detailed description
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.
Interventions
- Procedure Flexible Nephroscopy-Assisted Single-Tract PCNL
Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed. - Procedure Conventional Multi-Tract PCNL
Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.
Primary outcome measures
- Stone-free rate at 3 months. [Time frame: 3 months after surgery.]
Secondary outcome measures (7)
- Operative time [Time frame: Intraoperative]
- Fluoroscopy time [Time frame: Intraoperative]
- Number of tracts [Time frame: Intraoperative]
- Hemoglobin drop [Time frame: From baseline to postoperative day 1.]
- Transfusion rate [Time frame: Perioperative/Periprocedural]
- Duration of Postoperative Hospitalization [Time frame: From the date of PCNL surgery until hospital discharge.]
- Complication rate [Time frame: Up to 3 months]
Eligibility criteria
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.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07753733 · UroAzhar_8_026