HydronephrosisNCT03695991
Effect of Per-cutaneous Nephrosotomy Drainage on Radioisotope Imaging of Hydronephrotic Kidneys
An observational study of Hydronephrosis, run by Assiut University.
Trial summary
Hydronephrosis describes a condition of urine-filled dilation of the collecting system. Normally, urine flows through the urinary tract with minimal or low pressure. If the build-up of excess fluid in the urinary collecting system continues, there will be an increase in pressure and atrophy of renal cortex. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydronephrosis
- What is being tested?
- percutaneous nephrostomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Dec 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be recruited from out-patient clinics and in-patient sectors of Assiut Urology and Nephrology hospital
Who may be able to join
- 1) Patients for whom a percutaneous nephrostomy is indicated provided that the hydronephrosis is advanced ( parenchymal thickness not more than 5 mm ) 2) Patients for whom a nephrectomy is planned for a seemingly poorly functioning kidney along with either
Who cannot join
- Target kidney is the only functioning or better functioning kidney or otherwise substantially contributing to the total renal function, so nephrectomy is not likely.
- Emergency cases where the general condition of the patient cannot withstand the logistics of undergoing a radioisotope study eg
- Malignancy in the target kidney
- Patients unlikely to undergo a nephrectomy
About this study
Hydronephrosis describes a condition of urine-filled dilation of the collecting system. Normally, urine flows through the urinary tract with minimal or low pressure. If the build-up of excess fluid in the urinary collecting system continues, there will be an increase in pressure and atrophy of renal cortex. If hydronephrosis is left untreated for a long time, renal damage with permanent loss of function occurs
- Conditions
- Hydronephrosis
- Being tested
- percutaneous nephrostomy
- Medical subject headings
- Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous nephrostomyProcedure or surgery
The percutaneous nephrostomy will be done under sonographic or fluoroscopic guidance. Establishment of intravenous access and antibiotics will be performed half an hour prior to procedure particularly in patients presenting with urinary tract infection. The procedure will be done under local anesthesia but general anesthesia may be used for uncooperative patients. percutaneous nephrostomy will be performed in the prone position, however, in case of relative contraindication to prone position
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients will be recruited from out-patient clinics and in-patient sectors of Assiut Urology and Nephrology hospital Receives: Procedure: percutaneous nephrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of increase in glomerular filtration rate after intervention
the radioisotope measurement of glomerular filtration rate will be done before and after insertion of percutaneous nephrostomy tube
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study startMay 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Atef Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695991
- Sponsor's protocol ID
- PCNHK
- Status last verified
- Apr 2019
- First submitted
- 3 Oct 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Per-cutaneous Nephrosotomy Drainage on Radioisotope Imaging of Hydronephrotic Kidneys
- ClinicalTrials.gov ID
- NCT03695991
- Acronym / sponsor ID
- PCNHK
- Conditions
- Hydronephrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Oct 2018 (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.
Hydronephrosis describes a condition of urine-filled dilation of the collecting system. Normally, urine flows through the urinary tract with minimal or low pressure. If the build-up of excess fluid in the urinary collecting system continues, there will be an increase in pressure and atrophy of renal cortex. If hydronephrosis is left untreated for a long time, renal damage with permanent loss of function occurs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: percutaneous nephrostomyPatients will be recruited from out-patient clinics and in-patient sectors of Assiut Urology and Nephrology hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited from out-patient clinics and in-patient sectors of Assiut Urology and Nephrology hospital
Key inclusion criteria (1 listed)
- 1) Patients for whom a percutaneous nephrostomy is indicated provided that the hydronephrosis is advanced ( parenchymal thickness not more than 5 mm ) 2) Patients for whom a nephrectomy is planned for a seemingly poorly functioning kidney along with either
Key exclusion criteria (4 listed)
- Target kidney is the only functioning or better functioning kidney or otherwise substantially contributing to the total renal function, so nephrectomy is not likely.
- Emergency cases where the general condition of the patient cannot withstand the logistics of undergoing a radioisotope study eg
- Malignancy in the target kidney
- Patients unlikely to undergo a nephrectomy
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 |
|---|---|---|
| percutaneous nephrostomyThe percutaneous nephrostomy will be done under sonographic or fluoroscopic guidance. Establishment of intravenous access and antibiotics will be performed half an hour prior to procedure particularly in patients presenting with urinary tract infection. The procedure will be done under local anesthesia but general anesthesia may be used for uncooperative patients. percutaneous nephrostomy will be performed in the prone position, however, in case of relative contraindication to prone position | Procedure or surgery | Study group |
Primary outcome
The rate of increase in glomerular filtration rate after intervention
Time frame: 3 weeks
the radioisotope measurement of glomerular filtration rate will be done before and after insertion of percutaneous nephrostomy tube
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydronephrosis, 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 1 inclusion and 4 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 16 Apr 2019. 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?
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?
The rate of increase in glomerular filtration rate after intervention (time frame: 3 weeks). 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 16 Apr 2019.