Percutaneous Nephrolithotomy (PCNL)NCT07279389
Comparative Study Between One-Shot Dilatation Versus Serial Dilatation Techniques for Access in Percutaneous Nephrolithotomy in Adult Patients
A study testing renal dilatation by one-shot dilatation technique, renal dilatation by metallic telescopic dilators (Alken). and renal dilatation by sequential fascial dilators (Amplatz) in people with Percutaneous Nephrolithotomy (PCNL) and Renal Stone Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
This comparative study aims to compare and assess the safety, efficacy, outcome, feasibility, intraoperative and postoperative complications of one-shot dilatation versus serial dilatation techniques for access during percutaneous nephrolithotomy for management of renal stone disease in adult patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Percutaneous Nephrolithotomy (PCNL), Renal Stone Disease
- What is being tested?
- renal dilatation by one-shot dilatation technique, renal dilatation by metallic telescopic dilators (Alken). and renal dilatation by sequential fascial dilators (Amplatz)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Feb 2022to 5 Aug 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 70 years.
- Patients with renal stones which their size in maximum diameter is more than 2cm and indicated for percutaneous nephrolithotomy.
- Patients clinically fit for surgery.
- Patients with normal anatomy of urinary tract.
- Patients able to understand the procedure and accept to sign the informed consent.
Who cannot join
- Patients aged below 18 or above 70 years.
- Patients with renal stones which their size in maximum diameter is less than 2cm or contraindicated for endoscopic management.
- Patients with urinary tract infection, abnormal coagulopathy state or clinically unfit for surgery.
- Patients with nephrostomy tube in situ.
- Patients with more than single access tract.
- Patients undergoing simultaneous bilateral stone procedures.
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- Patients with urinary tract abnormalities or history of renal transplantation.
- Renal insufficiency with serum creatinine above 3.0mg/dL
- Patients unable to understand the procedure or refuse to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
This comparative study aims to compare and assess the safety, efficacy, outcome, feasibility, intraoperative and postoperative complications of one-shot dilatation versus serial dilatation techniques for access during percutaneous nephrolithotomy for management of renal stone disease in adult patients.
- Being tested
- renal dilatation by one-shot dilatation technique, renal dilatation by metallic telescopic dilators (Alken)., renal dilatation by sequential fascial dilators (Amplatz)
- Keywords
- Percutaneous Nephrolithotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal dilatation by one-shot dilatation techniqueProcedure or surgery
renal dilatation was done by one-shot dilatation technique using 30Fr Amplatz dilator directly over the central Alken rod.
renal dilatation by metallic telescopic dilators (Alken).Procedure or surgery
insertion of the Alken guide followed by a telescopic dilator between 9Fr to 30Fr, then an Amplatz sheath 30Fr was advanced over the dilator which was then removed, leaving the Amplatz sheath in the collecting system
renal dilatation by sequential fascial dilators (Amplatz)Procedure or surgery
sequential renal dilatation with Amplatz dilator set was used
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving renal dilatation by one-shot dilatation technique | Active comparator | renal dilatation was done by one-shot dilatation technique using 30Fr Amplatz dilator directly over the central Alken rod. Receives: Procedure: renal dilatation by one-shot dilatation technique |
| Patients receiving renal dilatation by metallic telescopic dilators (Alken). | Active comparator | Not described Receives: Procedure: renal dilatation by metallic telescopic dilators (Alken). |
| Patients receiving renal dilatation by sequential fascial dilators (Amplatz). | Active comparator | Not described Receives: Procedure: renal dilatation by sequential fascial dilators (Amplatz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Fluoroscopy time
Measured: From enrollment to the end of treatment at 8 weeks
Mean access time
Measured: From enrollment to the end of treatment at 8 weeks
Stone free rate
Measured: From enrollment to the end of treatment at 8 weeks
Hospitalization Period
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start27 Feb 2022
- Primary completion27 Aug 2022
- Study completion5 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Nephrolithotomy (PCNL)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hisham Arafa, Consultant, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279389
- Sponsor's protocol ID
- FMASU MS133/2022
- Status last verified
- Aug 2022
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Alken P, Hutschenreiter G, Gunther R, Marberger M. Percutaneous stone manipulation. J Urol. 1981 Apr;125(4):463-6. doi: 10.1016/s0022-5347(17)55073-9.
PubMed 7218439
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between One-Shot Dilatation Versus Serial Dilatation Techniques for Access in Percutaneous Nephrolithotomy in Adult Patients
- ClinicalTrials.gov ID
- NCT07279389
- Acronym / sponsor ID
- FMASU MS133/2022
- Keywords
- Percutaneous Nephrolithotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 27 Feb 2022 (actual)
- Primary completion
- 27 Aug 2022 (actual)
- Study completion
- 5 Aug 2023 (actual)
- First posted
- 12 Dec 2025 (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 comparative study aims to compare and assess the safety, efficacy, outcome, feasibility, intraoperative and postoperative complications of one-shot dilatation versus serial dilatation techniques for access during percutaneous nephrolithotomy for management of renal stone disease in adult patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients receiving renal dilatation by one-shot dilatation technique | Active comparator | Procedure: renal dilatation by one-shot dilatation techniquerenal dilatation was done by one-shot dilatation technique using 30Fr Amplatz dilator directly over the central Alken rod. |
| Patients receiving renal dilatation by metallic telescopic dilators (Alken). | Active comparator | Procedure: renal dilatation by metallic telescopic dilators (Alken). |
| Patients receiving renal dilatation by sequential fascial dilators (Amplatz). | Active comparator | Procedure: renal dilatation by sequential fascial dilators (Amplatz) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged between 18 and 70 years.
- Patients with renal stones which their size in maximum diameter is more than 2cm and indicated for percutaneous nephrolithotomy.
- Patients clinically fit for surgery.
- Patients with normal anatomy of urinary tract.
- Patients able to understand the procedure and accept to sign the informed consent.
Key exclusion criteria (9 listed)
- Patients aged below 18 or above 70 years.
- Patients with renal stones which their size in maximum diameter is less than 2cm or contraindicated for endoscopic management.
- Patients with urinary tract infection, abnormal coagulopathy state or clinically unfit for surgery.
- Patients with nephrostomy tube in situ.
- Patients with more than single access tract.
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 |
|---|---|---|
| renal dilatation by one-shot dilatation techniquerenal dilatation was done by one-shot dilatation technique using 30Fr Amplatz dilator directly over the central Alken rod. | Procedure or surgery | Patients receiving renal dilatation by one-shot dilatation technique |
| renal dilatation by metallic telescopic dilators (Alken).insertion of the Alken guide followed by a telescopic dilator between 9Fr to 30Fr, then an Amplatz sheath 30Fr was advanced over the dilator which was then removed, leaving the Amplatz sheath in the collecting system | Procedure or surgery | Patients receiving renal dilatation by metallic telescopic dilators (Alken). |
| renal dilatation by sequential fascial dilators (Amplatz)sequential renal dilatation with Amplatz dilator set was used | Procedure or surgery | Patients receiving renal dilatation by sequential fascial dilators (Amplatz). |
Primary outcome
Mean Fluoroscopy time
Time frame: From enrollment to the end of treatment at 8 weeks
Mean access time
Time frame: From enrollment to the end of treatment at 8 weeks
Stone free rate
Time frame: From enrollment to the end of treatment at 8 weeks
Hospitalization Period
Time frame: From enrollment to the end of treatment at 8 weeks
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 12 Dec 2025.
- Background: PubMed 7218439Alken P, Hutschenreiter G, Gunther R, Marberger M. Percutaneous stone manipulation. J Urol. 1981 Apr;125(4):463-6. doi: 10.1016/s0022-5347(17)55073-9.
- Individual participant dataSharing planned: Yes
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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.
Hisham Arafa, Consultant principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing renal dilatation by one-shot dilatation technique, renal dilatation by metallic telescopic dilators (Alken). and renal dilatation by sequential fascial dilators (Amplatz) in people with Percutaneous Nephrolithotomy (PCNL) and Renal Stone Disease, 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 5 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 12 Dec 2025. 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?
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?
Mean Fluoroscopy time (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07279389, which also lists 1 linked publication.
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 12 Dec 2025.