UrolithiasisPhase 4NCT06350045
High Supracostal Versus Subcostal Puncture in Adult PCNL
A Phase 4 study testing PCNL in people with Urolithiasis, run by Assiut University at 1 site in Egypt.
Trial summary
as the supra eleventh puncture PCNL is not well investigated in the literature we will conduct that randomised trial in comparison to the subcostal one Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis
- What is being tested?
- PCNL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Apr 2028
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Patients amenable for PCNL with stone burden between 2 cm - 4 cm (guy score 1-2-3)
Who cannot join
- Ectopic kidney.
- Single middle calyceal stone.
- Skeletal anomalies.
- Bleeding diathesis.
- Active urinary tract infection.
- Patient refusing participation.
- Patients with active pulmonary and pleural disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal Puncture Above the Eleventh Rib (High Supracostal Approach) Versus Subcostal Puncture in Percutaneous Nephrolithotomy for Treatment of Renal Stones in Adults: A Prospective Randomized Trial
as the supra eleventh puncture PCNL is not well investigated in the literature we will conduct that randomised trial in comparison to the subcostal one
Read the detailed description
The use of percutaneous nephrolithotomy (PCNL) was first reported by Fernström and Johansson in 1976. Percutaneous nephrolithotomy (PCNL) is the accepted treatment for staghorn stones, large renal stones, and some upper ureteric stones. Achieving suitable access to the appropriate calyx is one of the most important steps during the PCNL procedure. Effective puncture is key for the success of PCNL. An ideal percutaneous nephrolithotomy (PCNL) puncture has been described as one that provides the shortest and straightest access to all calculi, avoids major vessels, bowel and lung, lies along the axis of the calyx and causes minimal parenchymal damage.
Many studies have reported that supracostal access for PCNL is advantageous over infracostal access. By creating a straight path along the kidney's long axis, the upper-pole method guarantees access to the majority of the collecting system and makes it simpler to manipulate the rigid nephroscope and other rigid devices. Therefore, supracostal puncture is perhaps the greatest method for gaining access to the upper pole calyx, where staghorn and big, complicated renal stones are most likely to be located. Although pneumothorax, hydrothorax, and lung damage (1-10%) can result after a supracostal puncture, this injury can now be handled with minimal morbidity thanks to advances in surgical technique and understanding of pleural and diaphragmatic architecture.
- Conditions
- Urolithiasis
- Being tested
- PCNL
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCNLCombination product
percutaneous nephrolithotomy
| Study group | Role | What they receive |
|---|---|---|
| subcostal puncture PCNL | Experimental | puncturing the subcostal region to reach the kidney Receives: Combination Product: PCNL |
| supracostal puncture PCNL | Experimental | puncturing the supra eleventh rib Receives: Combination Product: PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complications
Clavien -Dindo classification.
Measured: within 3 months post operative
Stone free rate
the patient being either completely stone-free or there are residual fragments (less than 4 mm).
Measured: within 3 months post operative
Secondary outcomes (2)
duration of Hospital stay.
post operative hospital stay
Measured: Postoperativly
Operative time
from the puncture until withdrawal of the endoscope at the end of the operation
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Gaber, Assiut University
- Investigators
- ayman assem, dr, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350045
- Sponsor's protocol ID
- supra 11th puncture PCNL
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernstrom I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. doi: 10.1080/21681805.1976.11882084.
PubMed 1006190Galvin DJ, Pearle MS. The contemporary management of renal and ureteric calculi. BJU Int. 2006 Dec;98(6):1283-8. doi: 10.1111/j.1464-410X.2006.06514.x. No abstract available.
PubMed 17125486He Z, Tang F, Lu Z, He Y, Wei G, Zhong F, Zeng G, Wu W, Yan L, Li Z. Comparison of Supracostal and Infracostal Access For Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Urol J. 2019 May 5;16(2):107-114. doi: 10.22037/uj.v0i0.4727.
PubMed 30882159Sampaio FJ. Renal anatomy. Endourologic considerations. Urol Clin North Am. 2000 Nov;27(4):585-607, vii. doi: 10.1016/s0094-0143(05)70109-9.
PubMed 11098758Sinha M, Krishnappa P, Subudhi SK, Krishnamoorthy V. Supracostal percutaneous nephrolithotomy: A prospective comparative study. Indian J Urol. 2016 Jan-Mar;32(1):45-9. doi: 10.4103/0970-1591.173121.
PubMed 26941494Mousavi-Bahar SH, Mehrabi S, Moslemi MK. The safety and efficacy of PCNL with supracostal approach in the treatment of renal stones. Int Urol Nephrol. 2011 Dec;43(4):983-7. doi: 10.1007/s11255-011-9916-y. Epub 2011 Mar 11.
PubMed 21394440
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Puncture Above the Eleventh Rib (High Supracostal Approach) Versus Subcostal Puncture in Percutaneous Nephrolithotomy for Treatment of Renal Stones in Adults: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06350045
- Acronym / sponsor ID
- supra 11th puncture PCNL
- Conditions
- Urolithiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 5 Apr 2024 (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.
as the supra eleventh puncture PCNL is not well investigated in the literature we will conduct that randomised trial in comparison to the subcostal one
Detailed description
The use of percutaneous nephrolithotomy (PCNL) was first reported by Fernström and Johansson in 1976. Percutaneous nephrolithotomy (PCNL) is the accepted treatment for staghorn stones, large renal stones, and some upper ureteric stones. Achieving suitable access to the appropriate calyx is one of the most important steps during the PCNL procedure. Effective puncture is key for the success of PCNL. An ideal percutaneous nephrolithotomy (PCNL) puncture has been described as one that provides the shortest and straightest access to all calculi, avoids major vessels, bowel and lung, lies along the axis of the calyx and causes minimal parenchymal damage.
Many studies have reported that supracostal access for PCNL is advantageous over infracostal access. By creating a straight path along the kidney's long axis, the upper-pole method guarantees access to the majority of the collecting system and makes it simpler to manipulate the rigid nephroscope and other rigid devices. Therefore, supracostal puncture is perhaps the greatest method for gaining access to the upper pole calyx, where staghorn and big, complicated renal stones are most likely to be located. Although pneumothorax, hydrothorax, and lung damage (1-10%) can result after a supracostal puncture, this injury can now be handled with minimal morbidity thanks to advances in surgical technique and understanding of pleural and diaphragmatic architecture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subcostal puncture PCNL | Experimental | Combination Product: PCNLpuncturing the subcostal region to reach the kidney |
| supracostal puncture PCNL | Experimental | Combination Product: PCNLpuncturing the supra eleventh rib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years old.
- Patients amenable for PCNL with stone burden between 2 cm - 4 cm (guy score 1-2-3)
Key exclusion criteria (7 listed)
- Ectopic kidney.
- Single middle calyceal stone.
- Skeletal anomalies.
- Bleeding diathesis.
- Active urinary tract infection.
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 |
|---|---|---|
| PCNLpercutaneous nephrolithotomy | Combination product | subcostal puncture PCNL, supracostal puncture PCNL |
Primary outcome
Rate of complications
Time frame: within 3 months post operative
Clavien -Dindo classification.
Stone free rate
Time frame: within 3 months post operative
the patient being either completely stone-free or there are residual fragments (less than 4 mm).
2 secondary outcomes
duration of Hospital stay.
Time frame: Postoperativly
Operative time
Time frame: intraoperative
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 5 Apr 2024.
- Background: PubMed 1006190Fernstrom I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. doi: 10.1080/21681805.1976.11882084.
- Background: PubMed 17125486Galvin DJ, Pearle MS. The contemporary management of renal and ureteric calculi. BJU Int. 2006 Dec;98(6):1283-8. doi: 10.1111/j.1464-410X.2006.06514.x. No abstract available.
- Background: PubMed 30882159He Z, Tang F, Lu Z, He Y, Wei G, Zhong F, Zeng G, Wu W, Yan L, Li Z. Comparison of Supracostal and Infracostal Access For Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Urol J. 2019 May 5;16(2):107-114. doi: 10.22037/uj.v0i0.4727.
- Background: PubMed 11098758Sampaio FJ. Renal anatomy. Endourologic considerations. Urol Clin North Am. 2000 Nov;27(4):585-607, vii. doi: 10.1016/s0094-0143(05)70109-9.
- Background: PubMed 26941494Sinha M, Krishnappa P, Subudhi SK, Krishnamoorthy V. Supracostal percutaneous nephrolithotomy: A prospective comparative study. Indian J Urol. 2016 Jan-Mar;32(1):45-9. doi: 10.4103/0970-1591.173121.
- Background: PubMed 21394440Mousavi-Bahar SH, Mehrabi S, Moslemi MK. The safety and efficacy of PCNL with supracostal approach in the treatment of renal stones. Int Urol Nephrol. 2011 Dec;43(4):983-7. doi: 10.1007/s11255-011-9916-y. Epub 2011 Mar 11.
- Individual participant dataSharing planned: No
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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.
ayman assem, dr study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCNL in people with Urolithiasis, run by Assiut 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 2 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Apr 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Rate of complications (time frame: within 3 months post operative). 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?
On the ClinicalTrials.gov record for NCT06350045, which also lists 6 linked publications.
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 5 Apr 2024.