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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03936673
Other study ID # 2014/349
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2014
Est. completion date January 1, 2019

Study information

Verified date May 2019
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date January 1, 2019
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Percutaneous nephrostomy


Locations

Country Name City State
Turkey Department of Urology, Ercieys University, Faculty Of Medicine, Kayseri

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View Citation

Bargman JM, Thorpe KE, Churchill DN; CANUSA Peritoneal Dialysis Study Group. 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):2158-62. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary serum creatinine level 2 weeks after nephrostomy serum creatinine level 2 weeks after nephrostomy 2 weeks after nephrostomy
Primary Serum BUN level 2 weeks after nephrostomy Serum BUN level 2 weeks after nephrostomy 2 weeks after nephrostomy
Primary RRF in DMSA 2 weeks after nephrostomy RRF in DMSA 2 weeks after nephrostomy 2 weeks after nephrostomy
See also
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