Renal StonesNCT07464717
Standard Versus Mini Percutaneous Nephrolithotomy for Renal Stones
A study testing Mini Percutaneous Nephrolithotomy and Standard Percutaneous Nephrolithotomy in people with Renal Stones, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
Renal stone disease is a common urological condition associated with significant morbidity. Percutaneous nephrolithotomy (PCNL) is the standard treatment for renal stones larger than 2 cm. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Renal Stones
- What is being tested?
- Mini Percutaneous Nephrolithotomy and Standard Percutaneous Nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Aug 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 20 to 60 years
- Both male and female participants
- Single renal pelvic stone less than 30 mm in size
- Diagnosis confirmed by intravenous urography and ultrasonography
Who cannot join
- Coagulopathy (INR > 1.5)
- Active urinary tract infection
- Staghorn calculus
- Renal structural anomalies
- Polycystic kidney disease
- Ectopic or transplanted kidney
Show all 9Show fewer
- Renal malignancy
- Uncontrolled pyonephrosis
- Chronic renal failure or chronic liver disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Khyber Teaching Hospital Peshawar
Peshawar, KhyberPakhtunkhwa, 25000
About this study
Official title: Comparison of the Outcome of Mini-Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in Renal Stones
Renal stone disease is a common urological condition associated with significant morbidity. Percutaneous nephrolithotomy (PCNL) is the standard treatment for renal stones larger than 2 cm. Although standard PCNL (Percutaneous nephrolithotomy) is associated with high stone-free rates, it carries a risk of complications such as bleeding and prolonged hospital stay. Mini percutaneous nephrolithotomy has been introduced as a less invasive alternative with the potential to reduce morbidity. However, evidence comparing outcomes between mini-PCNL (Percutaneous nephrolithotomy) and standard PCNL (Percutaneous nephrolithotomy) remains inconsistent, particularly in the local population. This randomized controlled trial aims to compare operative and postoperative outcomes of mini-PCNL versus standard PCNL in patients with renal stones.
Read the detailed description
Percutaneous nephrolithotomy is the preferred surgical intervention for large renal calculi. Despite its effectiveness, standard PCNL is associated with complications including hemorrhage, postoperative pain, and prolonged hospitalization. Mini-PCNL utilizes a smaller tract size, potentially reducing parenchymal injury and blood loss while maintaining adequate stone clearance. Previous studies have reported conflicting results regarding operative time, stone-free rates, and complications between the two techniques. Additionally, limited data are available from Pakistan. This randomized controlled trial will compare operative time, hemoglobin drop, stone clearance, postoperative fever, and length of hospital stay between mini-PCNL and standard PCNL, with the aim of identifying the safer and more effective approach for renal stone management.
- Conditions
- Renal Stones
- Being tested
- Mini Percutaneous Nephrolithotomy, Standard Percutaneous Nephrolithotomy
- Keywords
- o Mean operative time, o Mean drop in hemoglobin, o Stone Clearance, o Fever, o Mean hospital stay
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Percutaneous NephrolithotomyProcedure or surgery
Mini-PCNL (Percutaneous nephrolithotomy) performed under general anesthesia using small-caliber tract dilation and Pneumatic lithotripsy.
Standard Percutaneous NephrolithotomyProcedure or surgery
Standard PCNL performed under general anesthesia using conventional tract dilation and Nephroscope-assisted stone removal.
| Study group | Role | What they receive |
|---|---|---|
| Mini Percutaneous Nephrolithotomy | Experimental | Patients will undergo Mini Percutaneous Nephrolithotomy using an 11-13 Fr Amplatz sheath and Semi-rigid Ureteroscope for stone fragmentation and removal. Receives: Procedure: Mini Percutaneous Nephrolithotomy |
| Standard Percutaneous Nephrolithotomy | Active comparator | Patients will undergo Standard Percutaneous Nephrolithotomy using a 30 Fr Amplatz sheath and Standard Nephroscope. Receives: Procedure: Standard Percutaneous Nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Duration of operative time measured in minutes from renal puncture to skin closure.
Measured: From renal puncture to skin closure during the index surgical procedure
Stone Clearance Rate
Absence of residual stones on X-ray KUB ( Kidney, Ureter, Bladder) or ultrasonography at the time of discharge.
Measured: Assessed at 1 week post-procedure.
Secondary outcomes (3)
Hemoglobin Drop
Difference between preoperative and postoperative hemoglobin levels (g/dL).
Measured: Preoperqtively and 24 hours post-procedure.
Postoperative Fever
Body temperature >101°F.
Measured: Post procedure up to 24 hours.
Length of Hospital Stay
Measured in days.
Measured: through hospital discharge, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start16 Aug 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
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.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Murad Ali, Khyber Teaching Hospital
- Investigators
- Dr Hazrat Ullah, MBBS, FCPS, Study director, Khyber Teaching Hospital Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464717
- Sponsor's protocol ID
- KMC-IREB-547
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing plans have not been finalized . However, Individual participant data might not be shared due to institutional policy and absence of a formal data-sharing framework. But this will depend on journal requirements, funding agency policies.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Outcome of Mini-Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in Renal Stones
- ClinicalTrials.gov ID
- NCT07464717
- Acronym / sponsor ID
- KMC-IREB-547
- Conditions
- Renal Stones
- Keywords
- o Mean operative time, o Mean drop in hemoglobin, o Stone Clearance, o Fever, o Mean hospital stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 16 Aug 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 11 Mar 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.
Renal stone disease is a common urological condition associated with significant morbidity. Percutaneous nephrolithotomy (PCNL) is the standard treatment for renal stones larger than 2 cm. Although standard PCNL (Percutaneous nephrolithotomy) is associated with high stone-free rates, it carries a risk of complications such as bleeding and prolonged hospital stay. Mini percutaneous nephrolithotomy has been introduced as a less invasive alternative with the potential to reduce morbidity. However, evidence comparing outcomes between mini-PCNL (Percutaneous nephrolithotomy) and standard PCNL (Percutaneous nephrolithotomy) remains inconsistent, particularly in the local population. This randomized controlled trial aims to compare operative and postoperative outcomes of mini-PCNL versus standard PCNL in patients with renal stones.
Detailed description
Percutaneous nephrolithotomy is the preferred surgical intervention for large renal calculi. Despite its effectiveness, standard PCNL is associated with complications including hemorrhage, postoperative pain, and prolonged hospitalization. Mini-PCNL utilizes a smaller tract size, potentially reducing parenchymal injury and blood loss while maintaining adequate stone clearance. Previous studies have reported conflicting results regarding operative time, stone-free rates, and complications between the two techniques. Additionally, limited data are available from Pakistan. This randomized controlled trial will compare operative time, hemoglobin drop, stone clearance, postoperative fever, and length of hospital stay between mini-PCNL and standard PCNL, with the aim of identifying the safer and more effective approach for renal stone management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini Percutaneous Nephrolithotomy | Experimental | Procedure: Mini Percutaneous NephrolithotomyPatients will undergo Mini Percutaneous Nephrolithotomy using an 11-13 Fr Amplatz sheath and Semi-rigid Ureteroscope for stone fragmentation and removal. |
| Standard Percutaneous Nephrolithotomy | Active comparator | Procedure: Standard Percutaneous NephrolithotomyPatients will undergo Standard Percutaneous Nephrolithotomy using a 30 Fr Amplatz sheath and Standard Nephroscope. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 20 to 60 years
- Both male and female participants
- Single renal pelvic stone less than 30 mm in size
- Diagnosis confirmed by intravenous urography and ultrasonography
Key exclusion criteria (9 listed)
- Coagulopathy (INR > 1.5)
- Active urinary tract infection
- Staghorn calculus
- Renal structural anomalies
- Polycystic kidney disease
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 |
|---|---|---|
| Mini Percutaneous NephrolithotomyMini-PCNL (Percutaneous nephrolithotomy) performed under general anesthesia using small-caliber tract dilation and Pneumatic lithotripsy. | Procedure or surgery | Mini Percutaneous Nephrolithotomy |
| Standard Percutaneous NephrolithotomyStandard PCNL performed under general anesthesia using conventional tract dilation and Nephroscope-assisted stone removal. | Procedure or surgery | Standard Percutaneous Nephrolithotomy |
Primary outcome
Operative Time
Time frame: From renal puncture to skin closure during the index surgical procedure
Duration of operative time measured in minutes from renal puncture to skin closure.
Stone Clearance Rate
Time frame: Assessed at 1 week post-procedure.
Absence of residual stones on X-ray KUB ( Kidney, Ureter, Bladder) or ultrasonography at the time of discharge.
3 secondary outcomes
Hemoglobin Drop
Time frame: Preoperqtively and 24 hours post-procedure.
Postoperative Fever
Time frame: Post procedure up to 24 hours.
Length of Hospital Stay
Time frame: through hospital discharge, an average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided. Data sharing plans have not been finalized . However, Individual participant data might not be shared due to institutional policy and absence of a formal data-sharing framework. But this will depend on journal requirements, funding agency policies.
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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. This study is not recruiting at the moment.
Dr Hazrat Ullah, MBBS, FCPS study director
Khyber Teaching Hospital Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini Percutaneous Nephrolithotomy and Standard Percutaneous Nephrolithotomy in people with Renal Stones, run by Khyber Teaching Hospital at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 11 Mar 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Time (time frame: From renal puncture to skin closure during the index surgical procedure). The study lists 2 primary outcomes in all. 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 11 Mar 2026.