Percutaneous NephrolithotomyNCT07753733
Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones
A study testing Flexible Nephroscopy-Assisted Single-Tract PCNL and Conventional Multi-Tract PCNL in people with Percutaneous Nephrolithotomy, run by Al-Azhar University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Percutaneous Nephrolithotomy
- What is being tested?
- Flexible Nephroscopy-Assisted Single-Tract PCNL and Conventional Multi-Tract PCNL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Aug 2026to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Solitary kidney.
- Uncorrected coagulopathy.
- Active urinary tract infection.
- ASA grade IV or higher.
- Pregnancy.
- Previous ipsilateral PCNL or open renal surgery.
Show all 9Show fewer
- Stones less than 2 cm or simple calyceal stones.
- Refusal or inability to comply with follow-up.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
Cairo
Abul-fotouh Ahmed, +201001066756, abulfotouhahmed@yahoo.com
Ahmed S Elasy
About this study
Official title: Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones: A Prospective, Randomized, Non-Inferiority Trial
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.
Read the 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.
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- Flexible Nephroscopy-Assisted Single-Tract PCNL, Conventional Multi-Tract PCNL
- Keywords
- Renal stones, Flexible Nephroscopy, Multi-tract
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Nephroscopy-Assisted Single-Tract PCNLProcedure or surgery
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 PCNLProcedure or surgery
Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.
| Study group | Role | What they receive |
|---|---|---|
| Flexible Nephroscopy-Assisted Single-Tract PCNL | Experimental | Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed. Receives: Procedure: Flexible Nephroscopy-Assisted Single-Tract PCNL |
| Conventional Multi-Tract PCNL | Experimental | Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed. Receives: Procedure: Conventional Multi-Tract PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate at 3 months.
Proportion of patients with no residual stone fragments greater than 4 mm on non-contrast CT.
Measured: 3 months after surgery.
Secondary outcomes (7)
Operative time
Time from skin incision or anesthesia induction to completion of the procedure.
Measured: Intraoperative
Fluoroscopy time
Total duration of fluoroscopy exposure during the procedure.
Measured: Intraoperative
Number of tracts
Total number of percutaneous renal access tracts used to complete stone clearance.
Measured: Intraoperative
Hemoglobin drop
Difference between preoperative hemoglobin and postoperative day 1 hemoglobin.
Measured: From baseline to postoperative day 1.
Transfusion rate
Proportion of patients requiring blood transfusion after surgery.
Measured: 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.
Measured: From the date of PCNL surgery until hospital discharge.
Complication rate
Postoperative complications classified according to the Clavien-Dindo grading system.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start13 Aug 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abul-fotouh Ahmed, Al-Azhar University
- Investigators
- Abul-fotouh Ahmed, Principal investigator, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753733
- Sponsor's protocol ID
- UroAzhar_8_026
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones: A Prospective, Randomized, Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07753733
- Acronym / sponsor ID
- UroAzhar_8_026
- Conditions
- Percutaneous Nephrolithotomy
- Keywords
- Renal stones, Flexible Nephroscopy, Multi-tract
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible Nephroscopy-Assisted Single-Tract PCNL | Experimental | Procedure: Flexible Nephroscopy-Assisted Single-Tract PCNLSingle-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 | Experimental | Procedure: Conventional Multi-Tract PCNLMulti-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Solitary kidney.
- Uncorrected coagulopathy.
- Active urinary tract infection.
- ASA grade IV or higher.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible Nephroscopy-Assisted Single-Tract PCNLSingle-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed. | Procedure or surgery | Flexible Nephroscopy-Assisted Single-Tract PCNL |
| Conventional Multi-Tract PCNLMulti-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed. | Procedure or surgery | Conventional Multi-Tract PCNL |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
Related trials for Percutaneous Nephrolithotomy
Recruiting
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Kidney Stone
Recruiting
Supine vs. Prone Mini-PCNL in Children
Kidney Calculi (or Renal Calculi / Nephrolithiasis), Supine Mini Percutaneous Nephrolithotomy
Recruiting
Nephrostomy Tract Infiltration for Pain Control After PCNL
Postoperative Pain, Kidney Calculi
Recruiting
Safety and Efficacy of Papillary Versus NonPapillary Access During Percutaneous Nephrolithotomy
Safety, Efficacy
Not yet recruitingPhase 4
Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy
Nephrolithiasis, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abul-fotouh Ahmed principal investigator
Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible Nephroscopy-Assisted Single-Tract PCNL and Conventional Multi-Tract PCNL in people with Percutaneous Nephrolithotomy, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abul-fotouh Ahmed (00201001066756, abulfotouhahmed7070@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free rate at 3 months. (time frame: 3 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.