Renal StonesNCT07322471
Efficacy and Safety of Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy in Management of Staghorn Stones
A study testing Percutaneous nephrolithotomy and Flexible ureteroscopy in people with Renal Stones, run by Menoufia University at 1 site in Egypt.
Trial summary
Percutaneous nephrolithotomy (PCNL) is considered the treatment of choice for management of large renal calculi larger than 2 cm based on the yearly updated European Association of Urology (EAU) guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stones
- What is being tested?
- Percutaneous nephrolithotomy and Flexible ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years.
- Diagnosis of complete staghorn renal stones confirmed by non-contrast CT.
- Negative urine culture.
Who cannot join
- Congenital renal anomalies (e.g., horseshoe kidney, malrotation).
- Coagulopathy or uncorrected bleeding disorder.
- Pregnancy.
- Previous ipsilateral renal surgery.
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
Menoufia Faculty of Medicine
Shebin El-Kom, Menoufia, 32511
Baher Salman, +201069973254, Bahersalman@yahoo.com
About this study
Official title: Efficacy and Safety of Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy in Management of Staghorn Stones: A Randomized Controlled Trial
Percutaneous nephrolithotomy (PCNL) is considered the treatment of choice for management of large renal calculi larger than 2 cm based on the yearly updated European Association of Urology (EAU) guidelines. However, PCNL is a challenging procedure which may be associated with several complications ranging from mild complications, such as urinary extravasation, leakage, infection and bleeding requiring transfusion to sever complications, such as sepsis, injury to surrounding organs, persistent hematuria and renal function impairment. The overall complication rate varies based on patient factors and surgical expertise.
Not only serious complications that defer some endourologists from performing PCNL but also such procedure is contraindicated and avoided by surgeons in cases of retrorenal colon, morbidly obese patients, spinal abnormalities and bleeding diathesis. Therefore, retrograde intrarenal surgery (RIRS) or flexible ureteroscopy (FURS) is increasingly recognized as an effective alternative, particularly for patients seeking a minimally invasive approach with a lower risk of complications.
Read more
The best practice in dealing with renal stones using FURS can be achieved via preoperative stenting for 2-4 weeks, negative urine culture, ureteral access sheath (UAS) usage and optimizing laser settings. Compared to PCNL, FURS is a less challenging procedure with low learning curve, less invasive and less bleeding. However, the high cost, including laser usage cost, presenting costs and multisession costs, in addition to the high risk of postoperative infection are considered as major drawbacks of FURS.
RIRS is emerging as an effective, safe, minimally invasive alternative to PCNL. Yet, the success of RIRS in comparison to PCNL, especially in a single session, is still questionable and there is no consensus about it.
- Conditions
- Renal Stones
- Being tested
- Percutaneous nephrolithotomy, Flexible ureteroscopy
- Keywords
- PCNL, RIRS, staghorn stone, renal stone
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrolithotomyProcedure or surgery
This intervention includes percutaneous nephrolithotomy for lithotripsy of staghorn stone
Flexible ureteroscopyProcedure or surgery
This intervention includes Flexible ureteroscopy for lithotripsy of staghorn stone
| Study group | Role | What they receive |
|---|---|---|
| PCNL group | Active comparator | patients of this group will undergo percutanous nephrolithotomy Receives: Procedure: Percutaneous nephrolithotomy |
| FURS group | Active comparator | Patients of this group will undergo flexible ureteroscopy Receives: Procedure: Flexible ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Stone-free rate (SFR), defined as no clinically significant residual stones on non-contrast 3-mm-cuts CT, measured as yes or no.
Measured: 1 Month
Secondary outcomes (3)
Operative time
Operative time is defined as time between starting the procedure and termination of it measured in minutes
Measured: During the surgery
Complications
Intra and postoperative complications, defined as complications happens intraoperative and postoperatively, graded by modified clavien-dindo classification
Measured: 1 month
Radiation time
Radiation time, defined as time in which ionizing radiation used intraoperatively, measured in minutes
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Fathi Mohamed AlOrabi, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322471
- Sponsor's protocol ID
- PCNL vs FURS in staghorn stone
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 9 Jan 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy in Management of Staghorn Stones: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07322471
- Acronym / sponsor ID
- PCNL vs FURS in staghorn stone
- Conditions
- Renal Stones
- Keywords
- PCNL, RIRS, staghorn stone, renal stone
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 7 Jan 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.
Percutaneous nephrolithotomy (PCNL) is considered the treatment of choice for management of large renal calculi larger than 2 cm based on the yearly updated European Association of Urology (EAU) guidelines. However, PCNL is a challenging procedure which may be associated with several complications ranging from mild complications, such as urinary extravasation, leakage, infection and bleeding requiring transfusion to sever complications, such as sepsis, injury to surrounding organs, persistent hematuria and renal function impairment. The overall complication rate varies based on patient factors and surgical expertise.
Not only serious complications that defer some endourologists from performing PCNL but also such procedure is contraindicated and avoided by surgeons in cases of retrorenal colon, morbidly obese patients, spinal abnormalities and bleeding diathesis. Therefore, retrograde intrarenal surgery (RIRS) or flexible ureteroscopy (FURS) is increasingly recognized as an effective alternative, particularly for patients seeking a minimally invasive approach with a lower risk of complications.
The best practice in dealing with renal stones using FURS can be achieved via preoperative stenting for 2-4 weeks, negative urine culture, ureteral access sheath (UAS) usage and optimizing laser settings. Compared to PCNL, FURS is a less challenging procedure with low learning curve, less invasive and less bleeding. However, the high cost, including laser usage cost, presenting costs and multisession costs, in addition to the high risk of postoperative infection are considered as major drawbacks of FURS.
RIRS is emerging as an effective, safe, minimally invasive alternative to PCNL. Yet, the success of RIRS in comparison to PCNL, especially in a single session, is still questionable and there is no consensus about it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCNL group | Active comparator | Procedure: Percutaneous nephrolithotomypatients of this group will undergo percutanous nephrolithotomy |
| FURS group | Active comparator | Procedure: Flexible ureteroscopyPatients of this group will undergo flexible ureteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥18 years.
- Diagnosis of complete staghorn renal stones confirmed by non-contrast CT.
- Negative urine culture.
Key exclusion criteria (4 listed)
- Congenital renal anomalies (e.g., horseshoe kidney, malrotation).
- Coagulopathy or uncorrected bleeding disorder.
- Pregnancy.
- Previous ipsilateral renal surgery.
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 |
|---|---|---|
| Percutaneous nephrolithotomyThis intervention includes percutaneous nephrolithotomy for lithotripsy of staghorn stone | Procedure or surgery | PCNL group |
| Flexible ureteroscopyThis intervention includes Flexible ureteroscopy for lithotripsy of staghorn stone | Procedure or surgery | FURS group |
Primary outcome
Stone free rate
Time frame: 1 Month
Stone-free rate (SFR), defined as no clinically significant residual stones on non-contrast 3-mm-cuts CT, measured as yes or no.
3 secondary outcomes
Operative time
Time frame: During the surgery
Complications
Time frame: 1 month
Radiation time
Time frame: During the surgery
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 9 Jan 2026.
Related trials for Renal Stones
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous nephrolithotomy and Flexible ureteroscopy in people with Renal Stones, run by Menoufia 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Jan 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 Ammar Alorabi (+201067608011, ammar.alorabi95@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 (time frame: 1 Month). 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 9 Jan 2026.