SafetyNCT07855354
Safety and Efficacy of Papillary Versus NonPapillary Access During Percutaneous Nephrolithotomy
A study testing Papillary access puncture and Non-papillary access puncture in people with Safety and Efficacy, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to evaluate and compare the safety, efficacy, and clinical outcomes of papillary and non-papillary renal access during percutaneous nephrolithotomy (PCNL), and to determine whether non-papillary puncture can be considered a safe and effective alternative to the conventional papillary approach in… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Papillary access puncture and Non-papillary access puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to 30 Oct 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
- Age ≥ 18 years
- Solitary or multiple renal calculi ≥2 cm
- Ability to provide informed consent
Who cannot join
- Bleeding diathesis or uncorrected coagulopathy
- Active urinary tract infection at the time of surgery
- Congenital anomalies severely distorting renal anatomy (e.g., horseshoe kidney, ectopic kidney)
- Morbid obesity [body mass index (BMI) ≥ 40] limiting safe positioning
- Pregnancy
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
Ain Shams University
Cairo, 11591
Mohamed I El-Sayed, MBBCH, 00201068569307, 29709041800133@med.asu.edu.eg
Mohamed K Tolba, MD
About this study
Official title: Evaluation of Safety and Efficacy of Papillary Versus NonPapillary Access During Percutaneous Nephrolithotomy: A Prospective Randomized Study
This study aims to evaluate and compare the safety, efficacy, and clinical outcomes of papillary and non-papillary renal access during percutaneous nephrolithotomy (PCNL), and to determine whether non-papillary puncture can be considered a safe and effective alternative to the conventional papillary approach in selected patients.
Read the detailed description
The choice between papillary and non-papillary access during percutaneous nephrolithotomy (PCNL) continues to influence procedural outcomes and surgical preferences. The papillary Access puncture, which targets the tip of the renal pyramid, aligns with the natural flow of the collecting system and is traditionally associated with minimal bleeding and parenchymal damage, thus being considered the standard approach in PCNL. It allows optimal tract dilation and access to stones with reduced complication rates when performed correctly.
- Conditions
- Safety, Efficacy, Papillary, NonPapillary, Percutaneous Nephrolithotomy
- Being tested
- Papillary access puncture, Non-papillary access puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papillary access punctureProcedure or surgery
Patients will undergo papillary access puncture (Control group)
Non-papillary access punctureProcedure or surgery
Patients will undergo non-papillary access puncture
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients will undergo papillary access puncture (Control group) Receives: Procedure: Papillary access puncture |
| Group B | Experimental | Patients will undergo non-papillary access puncture Receives: Procedure: Non-papillary access puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate
Stone-free rate will be assessed at 4 weeks postoperatively using non-contrast computed tomography (CT). It will be defined as the absence of residual stones or the presence of clinically insignificant residual fragments (asymptomatic, non-obstructive fragments 2:3mm).
Measured: 4 weeks postoperatively
Secondary outcomes (6)
Incidence of complication
Incidence of complication will be assessed using ClavienDindo classification. Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Allowed treatments include antiemetics, antipyretics, analgesics, diuretics, electrolytes, physiotherapy, and opening wound infections at the bedside.
Grade II: Requiring pharmacological treatment with drugs other than those allowed for Grade I complications. Blood transfusions and total parenteral nutrition (TPN) are also included in this grade.
Grade III: Requiring surgical, endoscopic, or radiological intervention. Grade IV: Life-threatening complication (including central nervous system complications) requiring intermediate Grade V: Death of the patient.
Measured: 4 weeks postoperatively
Operative time
Operative time will be recorded from start of the surgery till the end of surgery.
Measured: Intraoperatively
Fluoroscopy time
Total fluoroscopy time during the procedure will be measured.
Measured: Intraoperatively
Hemoglobin drop
Difference in hemoglobin level between the preoperative and postoperative measurements will be recorded.
Measured: 24 hours after the procedure
Need for blood transfusion
Requirement for blood transfusion during the perioperative period will be recorded
Measured: 24 hours after the procedure
Length of hospital stay
Length of hospital stay will be recorded from admission till discharge from hospital.
Measured: Till discharge from hospital (Up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Nov 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahem, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855354
- Sponsor's protocol ID
- FMASU MS 480/2026
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Papillary Versus NonPapillary Access During Percutaneous Nephrolithotomy: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07855354
- Acronym / sponsor ID
- FMASU MS 480/2026
- Conditions
- Safety, Efficacy, Papillary, NonPapillary, Percutaneous Nephrolithotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 2 Oct 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 study aims to evaluate and compare the safety, efficacy, and clinical outcomes of papillary and non-papillary renal access during percutaneous nephrolithotomy (PCNL), and to determine whether non-papillary puncture can be considered a safe and effective alternative to the conventional papillary approach in selected patients.
Detailed description
The choice between papillary and non-papillary access during percutaneous nephrolithotomy (PCNL) continues to influence procedural outcomes and surgical preferences. The papillary Access puncture, which targets the tip of the renal pyramid, aligns with the natural flow of the collecting system and is traditionally associated with minimal bleeding and parenchymal damage, thus being considered the standard approach in PCNL. It allows optimal tract dilation and access to stones with reduced complication rates when performed correctly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Papillary access puncturePatients will undergo papillary access puncture (Control group) |
| Group B | Experimental | Procedure: Non-papillary access puncturePatients will undergo non-papillary access puncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Solitary or multiple renal calculi ≥2 cm
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Bleeding diathesis or uncorrected coagulopathy
- Active urinary tract infection at the time of surgery
- Congenital anomalies severely distorting renal anatomy (e.g., horseshoe kidney, ectopic kidney)
- Morbid obesity [body mass index (BMI) ≥ 40] limiting safe positioning
- 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 |
|---|---|---|
| Papillary access puncturePatients will undergo papillary access puncture (Control group) | Procedure or surgery | Group A |
| Non-papillary access puncturePatients will undergo non-papillary access puncture | Procedure or surgery | Group B |
Primary outcome
Stone-free rate
Time frame: 4 weeks postoperatively
Stone-free rate will be assessed at 4 weeks postoperatively using non-contrast computed tomography (CT). It will be defined as the absence of residual stones or the presence of clinically insignificant residual fragments (asymptomatic, non-obstructive fragments 2:3mm).
6 secondary outcomes
Incidence of complication
Time frame: 4 weeks postoperatively
Operative time
Time frame: Intraoperatively
Fluoroscopy time
Time frame: Intraoperatively
Hemoglobin drop
Time frame: 24 hours after the procedure
Need for blood transfusion
Time frame: 24 hours after the procedure
Length of hospital stay
Time frame: Till discharge from hospital (Up to 2 weeks)
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 2 Oct 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Papillary access puncture and Non-papillary access puncture in people with Safety and Efficacy, run by Ain Shams 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 5 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 2 Oct 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 Mohamed I El-Sayed, MBBCH (00201068569307, 29709041800133@med.asu.edu.eg), 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: 4 weeks postoperatively). 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 2 Oct 2026.