Effect of Nephrostomy on Relative Function of Obstructed Kidney
Primary Purpose
Obstructive Uropathy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Percutaneous nephrostomy
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Uropathy focused on measuring obstructive uropathy, relative renal function, DMSA
Eligibility Criteria
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
Sites / Locations
- Department of Urology, Ercieys University, Faculty Of Medicine,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
atrophic kidney
Arm Description
Patients diagnosed with unilateral obstructed kidney with RRF 10% or less underwent application of percutaneous nephrostomy tube on affected side.
Outcomes
Primary Outcome Measures
serum creatinine level 2 weeks after nephrostomy
serum creatinine level 2 weeks after nephrostomy
Serum BUN level 2 weeks after nephrostomy
Serum BUN level 2 weeks after nephrostomy
RRF in DMSA 2 weeks after nephrostomy
RRF in DMSA 2 weeks after nephrostomy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03936673
Brief Title
Effect of Nephrostomy on Relative Function of Obstructed Kidney
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2014 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Uropathy
Keywords
obstructive uropathy, relative renal function, DMSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
atrophic kidney
Arm Type
Experimental
Arm Description
Patients diagnosed with unilateral obstructed kidney with RRF 10% or less underwent application of percutaneous nephrostomy tube on affected side.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous nephrostomy
Primary Outcome Measure Information:
Title
serum creatinine level 2 weeks after nephrostomy
Description
serum creatinine level 2 weeks after nephrostomy
Time Frame
2 weeks after nephrostomy
Title
Serum BUN level 2 weeks after nephrostomy
Description
Serum BUN level 2 weeks after nephrostomy
Time Frame
2 weeks after nephrostomy
Title
RRF in DMSA 2 weeks after nephrostomy
Description
RRF in DMSA 2 weeks after nephrostomy
Time Frame
2 weeks after nephrostomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdullah T Demirtas, Assoc Prof
Organizational Affiliation
Erciyes University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Ercieys University, Faculty Of Medicine,
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12780846
Citation
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.
Results Reference
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PubMed Identifier
11248637
Citation
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.
Results Reference
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PubMed Identifier
18947602
Citation
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.
Results Reference
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PubMed Identifier
8026917
Citation
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.
Results Reference
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PubMed Identifier
12110029
Citation
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.
Results Reference
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PubMed Identifier
11562415
Citation
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.
Results Reference
background
PubMed Identifier
25014578
Citation
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.
Results Reference
result
PubMed Identifier
12469255
Citation
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.
Results Reference
result
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Effect of Nephrostomy on Relative Function of Obstructed Kidney
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