Staghorn CalculiPCNLNCT05291702
Multitract Percutaneous Nephrolithotomy(PCNL) in Large Renal Stones.
A study testing PCNL in people with Staghorn Calculi, run by Assiut University.
Trial summary
Investigator aimed to analyze the clinical efficacy and safety of multiple tracts PCNL as one step therapy to treat the staghorn stones or multiple calyceal calculi which are inaccessible by single tract Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staghorn Calculi
- What is being tested?
- PCNL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients more than 18 years old.
- Patients with staghorn stone (partial, complete).
- Patients with multiple calyceal calculi which are inaccessible by single tract.
Who cannot join
- Patients under 18 years old.
- Patients with renal anomalies.
- Patients with only function kidney.
- Patients with distal ureteric obstruction.
- Patients with radiolucent stone.
- Patients with febrile urinary tract infection.
Show all 10Show fewer
- Patients with abnormal coagulopathy state.
- Patients refused to participate in this study.
- pregnancy.
- Musculoskeletal deformity.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Multitract PCNL as One Step for Management of Large Renal Stones
Investigator aimed to analyze the clinical efficacy and safety of multiple tracts PCNL as one step therapy to treat the staghorn stones or multiple calyceal calculi which are inaccessible by single tract
Read the detailed description
Staghorn calculi are branched stones either partial or complete occupying the pelvis and one or more of the renal caliceal system that is detected by non contrast computrized tomography (NCCT) and plain on kidney, ureter, urinary bladder (KUB). An untreated staghorn calculus over time can damage the kidney and deteriorate its function and /or cause life threatening sepsis.
Total stone clearance is an important goal to eradicate any infective focus, relieve obstruction and preserve the kidney function.
Based on American Urological Association (AUA) guideline, PCNL is the most effective, safest and minimally invasive treatment option compared to open surgery
- Conditions
- Staghorn Calculi
- Being tested
- PCNL
- Keywords
- PCNL
- Medical subject headings
- Staghorn Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCNLProcedure or surgery
Percutaneous nephrolithotomy ( Extraction of the renal stones using the nephroscope/ Ureteroscope )
| Study group | Role | What they receive |
|---|---|---|
| Multitract PCNL patients | Other | Assessment of the multitract PCNL procedure in removal of large renal stones using pneumatic or laser lithotripsy. Receives: Procedure: PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Assessment of the instant postoperative stone free rate and after one month from the procedure for all 40 participants using the postoperative non contrast computerized tomography (NCCT )and plain on kidney , ureter, urinary bladder (KUB )
Measured: The participants will be followed for one month after the procedure
Secondary outcomes (4)
Postoperative complications
Measuring the postoperative complications rates, classification of the severity of the complications will assess the safety of the procedure.
Measured: From the start of the operation and till one month after the patient discharge.
Operative time
Measurment of the time from start of the operation till fixation of nephrostomy tube
Measured: Average of three hours
Postoperative pain
Measurment of the postoperative pain score using the Visual analogue scale(VAS) that is divided into mild(1-3), moderate(4-6) and sever(7-10) according to the severity of the pain.
Measured: Within 24 hours postoperative and till the patient discharge
Hospital stay
Postoperative hospital stay of the participants till thier discharge
Measured: Average of six days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Staghorn CalculiStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Mahmoud Ali Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291702
- Sponsor's protocol ID
- Multitract PCNL
- Acronym
- PCNL
- Status last verified
- Mar 2022
- First submitted
- 30 Jan 2022
- Last updated
- 23 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Romero V, Akpinar H, Assimos DG. Kidney stones: a global picture of prevalence, incidence, and associated risk factors. Rev Urol. 2010 Spring;12(2-3):e86-96.
PubMed 20811557Turk C, Petrik A, Sarica K, et al. Urolithiassis. European Association of Urolgy. Accessed: August 23,2019.
Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.
PubMed 27238616Zhu W, Liu Y, Liu L, Lei M, Yuan J, Wan SP, Zeng G. Minimally invasive versus standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. 2015 Nov;43(6):563-70. doi: 10.1007/s00240-015-0808-y. Epub 2015 Aug 5.
PubMed 26242465
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multitract PCNL as One Step for Management of Large Renal Stones
- ClinicalTrials.gov ID
- NCT05291702
- Acronym / sponsor ID
- PCNL / Multitract PCNL
- Conditions
- Staghorn Calculi
- Keywords
- PCNL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 23 Mar 2022 (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.
Investigator aimed to analyze the clinical efficacy and safety of multiple tracts PCNL as one step therapy to treat the staghorn stones or multiple calyceal calculi which are inaccessible by single tract
Detailed description
Staghorn calculi are branched stones either partial or complete occupying the pelvis and one or more of the renal caliceal system that is detected by non contrast computrized tomography (NCCT) and plain on kidney, ureter, urinary bladder (KUB). An untreated staghorn calculus over time can damage the kidney and deteriorate its function and /or cause life threatening sepsis.
Total stone clearance is an important goal to eradicate any infective focus, relieve obstruction and preserve the kidney function.
Based on American Urological Association (AUA) guideline, PCNL is the most effective, safest and minimally invasive treatment option compared to open surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multitract PCNL patients | Other | Procedure: PCNLAssessment of the multitract PCNL procedure in removal of large renal stones using pneumatic or laser lithotripsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients more than 18 years old.
- Patients with staghorn stone (partial, complete).
- Patients with multiple calyceal calculi which are inaccessible by single tract.
Key exclusion criteria (10 listed)
- Patients under 18 years old.
- Patients with renal anomalies.
- Patients with only function kidney.
- Patients with distal ureteric obstruction.
- Patients with radiolucent stone.
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 ( Extraction of the renal stones using the nephroscope/ Ureteroscope ) | Procedure or surgery | Multitract PCNL patients |
Primary outcome
Stone free rate
Time frame: The participants will be followed for one month after the procedure
Assessment of the instant postoperative stone free rate and after one month from the procedure for all 40 participants using the postoperative non contrast computerized tomography (NCCT )and plain on kidney , ureter, urinary bladder (KUB )
4 secondary outcomes
Postoperative complications
Time frame: From the start of the operation and till one month after the patient discharge.
Operative time
Time frame: Average of three hours
Postoperative pain
Time frame: Within 24 hours postoperative and till the patient discharge
Hospital stay
Time frame: Average of six days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Background: PubMed 20811557Romero V, Akpinar H, Assimos DG. Kidney stones: a global picture of prevalence, incidence, and associated risk factors. Rev Urol. 2010 Spring;12(2-3):e86-96.
- BackgroundTurk C, Petrik A, Sarica K, et al. Urolithiassis. European Association of Urolgy. Accessed: August 23,2019.
- Background: PubMed 27238616Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.
- Background: PubMed 26242465Zhu W, Liu Y, Liu L, Lei M, Yuan J, Wan SP, Zeng G. Minimally invasive versus standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. 2015 Nov;43(6):563-70. doi: 10.1007/s00240-015-0808-y. Epub 2015 Aug 5.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PCNL in people with Staghorn Calculi, run by Assiut University.
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 10 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: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed Mahmoud Abbas, M.Sc (+2001009377858, Dr_walidws@yahoo.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: The participants will be followed for one month after the procedure). 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 NCT05291702, which also lists 4 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 23 Mar 2022.