- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03936673
Effect of Nephrostomy on Relative Function of Obstructed Kidney
May 1, 2019 updated by: Abdullah Demirtas, TC Erciyes University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kayseri, Turkey, 38039
- Department of Urology, Ercieys University, Faculty Of Medicine,
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unilateral obstructed kidney with RRF above 10%
- Estimated GFR <30 ml/min
- diagnosis of bilateral obstructed kidneys
- not approving nephrostomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: atrophic kidney
Patients diagnosed with unilateral obstructed kidney with RRF 10% or less underwent application of percutaneous nephrostomy tube on affected side.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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serum creatinine level 2 weeks after nephrostomy
Time Frame: 2 weeks after nephrostomy
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serum creatinine level 2 weeks after nephrostomy
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2 weeks after nephrostomy
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Serum BUN level 2 weeks after nephrostomy
Time Frame: 2 weeks after nephrostomy
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Serum BUN level 2 weeks after nephrostomy
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2 weeks after nephrostomy
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RRF in DMSA 2 weeks after nephrostomy
Time Frame: 2 weeks after nephrostomy
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RRF in DMSA 2 weeks after nephrostomy
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2 weeks after nephrostomy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abdullah T Demirtas, Assoc Prof, Erciyes University Faculty of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Gupta 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.
- Ismail 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.
- Morduchowicz 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.
- Wang 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.
- Bargman 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.
- Zhang 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.
- Aziz 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2014
Primary Completion (Actual)
May 31, 2018
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
May 1, 2019
First Submitted That Met QC Criteria
May 1, 2019
First Posted (Actual)
May 3, 2019
Study Record Updates
Last Update Posted (Actual)
May 3, 2019
Last Update Submitted That Met QC Criteria
May 1, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/349
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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