Obstructive UropathyNCT03936673
Effect of Nephrostomy on Relative Function of Obstructed Kidney
A study testing Percutaneous nephrostomy in people with Obstructive Uropathy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Urinary tract obstruction is a serious health problem due to kidney damage. Relative renal function has an important role in the treatment of obstructed kidneys. Nephrectomy can be recommended when the relative renal function is 10% or less in radionuclide examinations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Uropathy
- What is being tested?
- Percutaneous nephrostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2014to 1 Jan 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral obstructed kidney with RRF 10% or less
- Unilateral obstructed kidney with grade 2 or more hydroureteronephrosis
- Defined etiology for unilateral obstructed kidney
- estimated glomerular filtration rate (GFR) ≥ 30ml/min
- Approving the nephrostomy procedure
Who cannot join
- Unilateral obstructed kidney with RRF above 10%
- Estimated GFR <30 ml/min
- diagnosis of bilateral obstructed kidneys
- not approving nephrostomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Urology, Ercieys University, Faculty Of Medicine,
Kayseri, 38039
About this study
Official title: The Effect of Percutaneous Nephrostomy Application on Obstructed Kidneys With Relative Function of 10% or Less In Technetium-99m Dimercaptosuccinic Acid (DMSA) Scintigraphy
Urinary tract obstruction is a serious health problem due to kidney damage. Relative renal function has an important role in the treatment of obstructed kidneys. Nephrectomy can be recommended when the relative renal function is 10% or less in radionuclide examinations. Recently, however, nephron sparing approaches have come to the fore. This indicated the need to evaluate the possibility of recovering the function of the kidney before nephrectomy. The aim of this study is to compare relative functions of obstructed kidneys in technetium 99m dimercaptosuccinic acid scintigraphy (DMSA) before and 2 weeks after nephrostomy tube.
Read the detailed description
Obstructive uropathy is one of the most important causes of acute renal injury and end-stage renal failure. obstruction of urine flow increases the intratubular pressure. This pressure increase causes decrease in renal blood flow and starts the inflammatory process. In the first few hours after total ureter obstruction, due to the increase in intratubular pressure glomerular filtration ceases and tubular transport is markedly decreased. Long lasting obstruction results in renal fibrosis and end stage renal damage. Basically obstructive uropathy leading to irreversible renal damage and loss of renal function is the main indication for simple nephrectomy. Serious renal parenchymal damage is defined as non-functioning kidney having relative renal function (RRF) 10% or less in the literature. But recently in some studies it was suggested that by applying the nephrostomy catheter, ability of kidney to regain function can be evaluated before nephrectomy. So, possibility of gaining function should be kept in mind. In this study effect of percutaneous nephrostomy tube on serum creatinine, blood urea nitrogen (BUN) and RRF in obstructed kidney with RRF 10% or less. Before and 2 weeks after percutaneous nephrostomy, serum creatinine, ure and RRF in DMSA was recorded and compared.
- Conditions
- Obstructive Uropathy
- Being tested
- Percutaneous nephrostomy
- Keywords
- obstructive uropathy, relative renal function, DMSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nephrostomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| atrophic kidney | Experimental | Patients diagnosed with unilateral obstructed kidney with RRF 10% or less underwent application of percutaneous nephrostomy tube on affected side. Receives: Procedure: Percutaneous nephrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine level 2 weeks after nephrostomy
serum creatinine level 2 weeks after nephrostomy
Measured: 2 weeks after nephrostomy
Serum BUN level 2 weeks after nephrostomy
Serum BUN level 2 weeks after nephrostomy
Measured: 2 weeks after nephrostomy
RRF in DMSA 2 weeks after nephrostomy
RRF in DMSA 2 weeks after nephrostomy
Measured: 2 weeks after nephrostomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Jul 2014
- Primary completion31 May 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obstructive UropathyStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Model description
- Patients diagnosed with unilateral obstructed kidney with RRF 10% or less underwent application of percutaneous nephrostomy tube on affected side.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Demirtas, TC Erciyes University
- Investigators
- Abdullah T Demirtas, Assoc Prof, Principal investigator, Erciyes University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936673
- Sponsor's protocol ID
- 2014/349
- Status last verified
- May 2019
- First submitted
- 1 May 2019
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thorup J, Jokela R, Cortes D, Nielsen OH. The results of 15 years of consistent strategy in treating antenatally suspected pelvi-ureteric junction obstruction. BJU Int. 2003 Jun;91(9):850-2. doi: 10.1046/j.1464-410x.2003.04228.x.
PubMed 12780846Gupta DK, Chandrasekharam VV, Srinivas M, Bajpai M. Percutaneous nephrostomy in children with ureteropelvic junction obstruction and poor renal function. Urology. 2001 Mar;57(3):547-50. doi: 10.1016/s0090-4295(00)01046-3.
PubMed 11248637Ismail A, Elkholy A, Zaghmout O, Alkadhi A, Elnaggar O, Khairat A, Elhassanat H, Mosleh A, Hamad B, Elzomer J, Elkaabi A. Postnatal management of antenatally diagnosed ureteropelvic junction obstruction. J Pediatr Urol. 2006 Jun;2(3):163-8. doi: 10.1016/j.jpurol.2005.07.005. Epub 2005 Aug 26.
PubMed 18947602Morduchowicz G, Winkler J, Zabludowski JR, Boner G. Effects of residual renal function in haemodialysis patients. Int Urol Nephrol. 1994;26(1):125-31. doi: 10.1007/BF02768252.
PubMed 8026917Wang AY, Wang M, Woo J, Law MC, Chow KM, Li PK, Lui SF, Sanderson JE. A novel association between residual renal function and left ventricular hypertrophy in peritoneal dialysis patients. Kidney Int. 2002 Aug;62(2):639-47. doi: 10.1046/j.1523-1755.2002.00471.x.
PubMed 12110029Bargman JM, Thorpe KE, Churchill DN. Relative contribution of residual renal function and peritoneal clearance to adequacy of dialysis: a reanalysis of the CANUSA study. J Am Soc Nephrol. 2001 Oct;12(10):2158-2162. doi: 10.1681/ASN.V12102158.
PubMed 11562415Zhang S, Zhang Q, Ji C, Zhao X, Liu G, Zhang S, Li X, Lian H, Zhang G, Guo H. Improved split renal function after percutaneous nephrostomy in young adults with severe hydronephrosis due to ureteropelvic junction obstruction. J Urol. 2015 Jan;193(1):191-5. doi: 10.1016/j.juro.2014.07.005. Epub 2014 Jul 9.
PubMed 25014578Aziz MA, Hossain AZ, Banu T, Karim MS, Islam N, Sultana H, Alam MI, Hanif A, Khan AR. In hydronephrosis less than 10 % kidney function is not an indication for nephrectomy in children. Eur J Pediatr Surg. 2002 Oct;12(5):304-7. doi: 10.1055/s-2002-35956.
PubMed 12469255
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Percutaneous Nephrostomy Application on Obstructed Kidneys With Relative Function of 10% or Less In Technetium-99m Dimercaptosuccinic Acid (DMSA) Scintigraphy
- ClinicalTrials.gov ID
- NCT03936673
- Acronym / sponsor ID
- 2014/349
- Conditions
- Obstructive Uropathy
- Keywords
- obstructive uropathy, relative renal function, DMSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 3 May 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.
Urinary tract obstruction is a serious health problem due to kidney damage. Relative renal function has an important role in the treatment of obstructed kidneys. Nephrectomy can be recommended when the relative renal function is 10% or less in radionuclide examinations. Recently, however, nephron sparing approaches have come to the fore. This indicated the need to evaluate the possibility of recovering the function of the kidney before nephrectomy. The aim of this study is to compare relative functions of obstructed kidneys in technetium 99m dimercaptosuccinic acid scintigraphy (DMSA) before and 2 weeks after nephrostomy tube.
Detailed description
Obstructive uropathy is one of the most important causes of acute renal injury and end-stage renal failure. obstruction of urine flow increases the intratubular pressure. This pressure increase causes decrease in renal blood flow and starts the inflammatory process. In the first few hours after total ureter obstruction, due to the increase in intratubular pressure glomerular filtration ceases and tubular transport is markedly decreased. Long lasting obstruction results in renal fibrosis and end stage renal damage. Basically obstructive uropathy leading to irreversible renal damage and loss of renal function is the main indication for simple nephrectomy. Serious renal parenchymal damage is defined as non-functioning kidney having relative renal function (RRF) 10% or less in the literature. But recently in some studies it was suggested that by applying the nephrostomy catheter, ability of kidney to regain function can be evaluated before nephrectomy. So, possibility of gaining function should be kept in mind. In this study effect of percutaneous nephrostomy tube on serum creatinine, blood urea nitrogen (BUN) and RRF in obstructed kidney with RRF 10% or less. Before and 2 weeks after percutaneous nephrostomy, serum creatinine, ure and RRF in DMSA was recorded and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients diagnosed with unilateral obstructed kidney with RRF 10% or less underwent application of percutaneous nephrostomy tube on affected side.
| Arm | Type | Receives |
|---|---|---|
| atrophic kidney | Experimental | Procedure: Percutaneous nephrostomyPatients diagnosed with unilateral obstructed kidney with RRF 10% or less underwent application of percutaneous nephrostomy tube on affected side. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral obstructed kidney with RRF 10% or less
- Unilateral obstructed kidney with grade 2 or more hydroureteronephrosis
- Defined etiology for unilateral obstructed kidney
- estimated glomerular filtration rate (GFR) ≥ 30ml/min
- Approving the nephrostomy procedure
Key exclusion criteria (4 listed)
- Unilateral obstructed kidney with RRF above 10%
- Estimated GFR <30 ml/min
- diagnosis of bilateral obstructed kidneys
- not approving nephrostomy
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 nephrostomy | Procedure or surgery | atrophic kidney |
Primary outcome
serum creatinine level 2 weeks after nephrostomy
Time frame: 2 weeks after nephrostomy
serum creatinine level 2 weeks after nephrostomy
Serum BUN level 2 weeks after nephrostomy
Time frame: 2 weeks after nephrostomy
Serum BUN level 2 weeks after nephrostomy
RRF in DMSA 2 weeks after nephrostomy
Time frame: 2 weeks after nephrostomy
RRF in DMSA 2 weeks after nephrostomy
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 3 May 2019.
- Background: PubMed 12780846Thorup J, Jokela R, Cortes D, Nielsen OH. The results of 15 years of consistent strategy in treating antenatally suspected pelvi-ureteric junction obstruction. BJU Int. 2003 Jun;91(9):850-2. doi: 10.1046/j.1464-410x.2003.04228.x.
- Background: PubMed 11248637Gupta DK, Chandrasekharam VV, Srinivas M, Bajpai M. Percutaneous nephrostomy in children with ureteropelvic junction obstruction and poor renal function. Urology. 2001 Mar;57(3):547-50. doi: 10.1016/s0090-4295(00)01046-3.
- Background: PubMed 18947602Ismail A, Elkholy A, Zaghmout O, Alkadhi A, Elnaggar O, Khairat A, Elhassanat H, Mosleh A, Hamad B, Elzomer J, Elkaabi A. Postnatal management of antenatally diagnosed ureteropelvic junction obstruction. J Pediatr Urol. 2006 Jun;2(3):163-8. doi: 10.1016/j.jpurol.2005.07.005. Epub 2005 Aug 26.
- Background: PubMed 8026917Morduchowicz G, Winkler J, Zabludowski JR, Boner G. Effects of residual renal function in haemodialysis patients. Int Urol Nephrol. 1994;26(1):125-31. doi: 10.1007/BF02768252.
- Background: PubMed 12110029Wang AY, Wang M, Woo J, Law MC, Chow KM, Li PK, Lui SF, Sanderson JE. A novel association between residual renal function and left ventricular hypertrophy in peritoneal dialysis patients. Kidney Int. 2002 Aug;62(2):639-47. doi: 10.1046/j.1523-1755.2002.00471.x.
- Background: PubMed 11562415Bargman JM, Thorpe KE, Churchill DN. Relative contribution of residual renal function and peritoneal clearance to adequacy of dialysis: a reanalysis of the CANUSA study. J Am Soc Nephrol. 2001 Oct;12(10):2158-2162. doi: 10.1681/ASN.V12102158.
- Results publication: PubMed 25014578Zhang S, Zhang Q, Ji C, Zhao X, Liu G, Zhang S, Li X, Lian H, Zhang G, Guo H. Improved split renal function after percutaneous nephrostomy in young adults with severe hydronephrosis due to ureteropelvic junction obstruction. J Urol. 2015 Jan;193(1):191-5. doi: 10.1016/j.juro.2014.07.005. Epub 2014 Jul 9.
- Results publication: PubMed 12469255Aziz MA, Hossain AZ, Banu T, Karim MS, Islam N, Sultana H, Alam MI, Hanif A, Khan AR. In hydronephrosis less than 10 % kidney function is not an indication for nephrectomy in children. Eur J Pediatr Surg. 2002 Oct;12(5):304-7. doi: 10.1055/s-2002-35956.
- 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.
Abdullah T Demirtas, Assoc Prof principal investigator
Erciyes University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous nephrostomy in people with Obstructive Uropathy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 3 May 2019. 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 Turkey (Türkiye). 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?
serum creatinine level 2 weeks after nephrostomy (time frame: 2 weeks after nephrostomy). 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 NCT03936673, which also lists 8 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 3 May 2019.