HydronephrosisPunctureNCT04090255
Us vs Fluoroscopic Guided Renal Access
A study testing Renal puncture in people with Hydronephrosis, run by Assiut University at 1 site in Egypt.
Trial summary
this present study is to compare the result of fluoroscopy, ultrasonography (US) in the guidance of percutaneous nephrostomy pcn . Read more about this study
- Who is it for?
- Ages 6 to 90 years
- Conditions the study is for
- Hydronephrosis
- What is being tested?
- Renal puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2019to 1 Apr 2021
- 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 6 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- infected hydronephrotic kidney onen's grade 2-3
- obstructed good cortex with backpressure changes onen's grade 2-3 .
- Evaluation of function of asymptomatic hydronephrotic kidney thin cortex onen's grade 4
Who cannot join
- congenital anomalies of kidney
- patient underwent transplant or urinary diversion
- solitary kidney
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mostafs Kamel Abdel Rahman
Asyut, Sedfa, 11775
mostafa k abdel rahman, resident, +201061133200, mostafa075@gmail.com
About this study
Official title: Ultrasonography Versus Fluoroscopic Guided Renal Access
this present study is to compare the result of fluoroscopy, ultrasonography (US) in the guidance of percutaneous nephrostomy pcn .
Read the detailed description
investigators will enroll 100 patients who are candidates for PCN in the study. By simple random sampling technique, patients will be assigned to two patient groups (group 1, US-guided approach , group 2, fluoroscopy-guided approach.The end point of the study is the comparison of outcome of procedure including stone free rate, transfusion rate, operation time, access time, length of stay and complications.
- Conditions
- Hydronephrosis
- Being tested
- Renal puncture
- Medical subject headings
- Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal punctureProcedure or surgery
The use of a needle for entering pelvicalyceal system of the kidney and put a guide wire for further pcn
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonographic guided renal access | Experimental | The use of ultrasound to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine Receives: Procedure: Renal puncture |
| Fluoroscopic guided renal access | Experimental | The use of fluoroscopy to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine Receives: Procedure: Renal puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of puncture
The time taken for make a puncture
Measured: Within the operation
duration of operation
time taken from patient putted on table until end of operation
Measured: withen the operation
Rate of success
the rate success of intervention by u/s or by fluoroscopy
Measured: withen the operation
Secondary outcomes (2)
rate of Perioperative complication
numbers of patients with Adverse effects occures intra operative ,bleeding ,extravasation
Measured: withen the operation
Haemoglobin concentration change
Compare preoperative and post operative Hg concentration
Measured: 24 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start10 Sep 2019
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (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 HydronephrosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa kamel abdel rahman abdel aal, Assiut University
- Investigators
- Fathy G Elanany, Prof, Study director, AssiutMohamed A Sayed, Prof, Study director, AssiutHosney M Bahnasawy, Ass Prof, Study director, Assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090255
- Sponsor's protocol ID
- Renal puncture
- Acronym
- Puncture
- Status last verified
- Oct 2020
- First submitted
- 11 Sep 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen X, Peng PX, He YH, Ding ZS, Wang JF, Tan YW, Zhou XF. [Evaluation and Comparison of SHA.LIN,S.T.O.N.E.Nephrolithometry Scoring System,and Clinical Research Office of the Endourological Society Nephrolithometry Nomogram for Predicting Stone Free Rate and Postoperative Outcomes after Percutaneous Nephrolithotomy]. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2019 Aug 30;41(4):492-500. doi: 10.3881/j.issn.1000-503X.10767. Chinese.
PubMed 31484611Zanetti SP, Boeri L, Gallioli A, Talso M, Montanari E. Minimally invasive PCNL-MIP. Arch Esp Urol. 2017 Jan;70(1):226-234.
PubMed 28221157Gulati M, Cheng J, Loo JT, Skalski M, Malhi H, Duddalwar V. Pictorial review: Renal ultrasound. Clin Imaging. 2018 Sep-Oct;51:133-154. doi: 10.1016/j.clinimag.2018.02.012. Epub 2018 Feb 16.
PubMed 29477809Qiu Z, Yang Y, Zhang Y, Sun YC. Modified biological training model for percutaneous renal surgery with ultrasound and fluroscopy guidance. Chin Med J (Engl). 2011 May;124(9):1286-9.
PubMed 21740734
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography Versus Fluoroscopic Guided Renal Access
- ClinicalTrials.gov ID
- NCT04090255
- Acronym / sponsor ID
- Puncture / Renal puncture
- Conditions
- Hydronephrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 16 Sep 2019 (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 present study is to compare the result of fluoroscopy, ultrasonography (US) in the guidance of percutaneous nephrostomy pcn .
Detailed description
investigators will enroll 100 patients who are candidates for PCN in the study. By simple random sampling technique, patients will be assigned to two patient groups (group 1, US-guided approach , group 2, fluoroscopy-guided approach.The end point of the study is the comparison of outcome of procedure including stone free rate, transfusion rate, operation time, access time, length of stay and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonographic guided renal access | Experimental | Procedure: Renal punctureThe use of ultrasound to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine |
| Fluoroscopic guided renal access | Experimental | Procedure: Renal punctureThe use of fluoroscopy to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine |
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- infected hydronephrotic kidney onen's grade 2-3
- obstructed good cortex with backpressure changes onen's grade 2-3 .
- Evaluation of function of asymptomatic hydronephrotic kidney thin cortex onen's grade 4
Key exclusion criteria (3 listed)
- congenital anomalies of kidney
- patient underwent transplant or urinary diversion
- solitary kidney
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 punctureThe use of a needle for entering pelvicalyceal system of the kidney and put a guide wire for further pcn | Procedure or surgery | Fluoroscopic guided renal access, Ultrasonographic guided renal access |
Primary outcome
Duration of puncture
Time frame: Within the operation
The time taken for make a puncture
duration of operation
Time frame: withen the operation
time taken from patient putted on table until end of operation
Rate of success
Time frame: withen the operation
the rate success of intervention by u/s or by fluoroscopy
2 secondary outcomes
rate of Perioperative complication
Time frame: withen the operation
Haemoglobin concentration change
Time frame: 24 hours post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 31484611Chen X, Peng PX, He YH, Ding ZS, Wang JF, Tan YW, Zhou XF. [Evaluation and Comparison of SHA.LIN,S.T.O.N.E.Nephrolithometry Scoring System,and Clinical Research Office of the Endourological Society Nephrolithometry Nomogram for Predicting Stone Free Rate and Postoperative Outcomes after Percutaneous Nephrolithotomy]. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2019 Aug 30;41(4):492-500. doi: 10.3881/j.issn.1000-503X.10767. Chinese.
- Background: PubMed 28221157Zanetti SP, Boeri L, Gallioli A, Talso M, Montanari E. Minimally invasive PCNL-MIP. Arch Esp Urol. 2017 Jan;70(1):226-234.
- Background: PubMed 29477809Gulati M, Cheng J, Loo JT, Skalski M, Malhi H, Duddalwar V. Pictorial review: Renal ultrasound. Clin Imaging. 2018 Sep-Oct;51:133-154. doi: 10.1016/j.clinimag.2018.02.012. Epub 2018 Feb 16.
- Background: PubMed 21740734Qiu Z, Yang Y, Zhang Y, Sun YC. Modified biological training model for percutaneous renal surgery with ultrasound and fluroscopy guidance. Chin Med J (Engl). 2011 May;124(9):1286-9.
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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.
Fathy G Elanany, Prof study director
Assiut
Mohamed A Sayed, Prof study director
Assiut
Hosney M Bahnasawy, Ass Prof study director
Assiut
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 puncture in people with Hydronephrosis, 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 3 inclusion and 3 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 19 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa K Abdel rahman, A lecturer (+201061133200, Mostafa075@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of puncture (time frame: Within the operation). The study lists 3 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 NCT04090255, 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 19 Oct 2020.