NCT03936673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

3.9 years

First QC Date

May 1, 2019

Last Update Submit

May 1, 2019

Conditions

Keywords

obstructive uropathyrelative renal functionDMSA

Outcome Measures

Primary Outcomes (3)

  • serum creatinine level 2 weeks after nephrostomy

    serum creatinine level 2 weeks after nephrostomy

    2 weeks after nephrostomy

  • Serum BUN level 2 weeks after nephrostomy

    Serum BUN level 2 weeks after nephrostomy

    2 weeks after nephrostomy

  • RRF in DMSA 2 weeks after nephrostomy

    RRF in DMSA 2 weeks after nephrostomy

    2 weeks after nephrostomy

Study Arms (1)

atrophic kidney

EXPERIMENTAL

Patients diagnosed with unilateral obstructed kidney with RRF 10% or less underwent application of percutaneous nephrostomy tube on affected side.

Procedure: Percutaneous nephrostomy

Interventions

atrophic kidney

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unilateral obstructed kidney with RRF above 10%
  • Estimated GFR \<30 ml/min
  • diagnosis of bilateral obstructed kidneys
  • not approving nephrostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Ercieys University, Faculty Of Medicine,

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 12780846BACKGROUND
  • 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.

    PMID: 11248637BACKGROUND
  • 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.

    PMID: 18947602BACKGROUND
  • 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.

    PMID: 8026917BACKGROUND
  • 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.

    PMID: 12110029BACKGROUND
  • 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.

    PMID: 11562415BACKGROUND
  • 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.

MeSH Terms

Interventions

Nephrostomy, Percutaneous

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, UrologicalDiagnostic Techniques and ProceduresDiagnosisOstomySurgical Procedures, OperativeNephrotomyUrologic Surgical ProceduresUrogenital Surgical ProceduresUrinary Diversion

Study Officials

  • Abdullah T Demirtas, Assoc Prof

    Erciyes University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients diagnosed with unilateral obstructed kidney with RRF 10% or less underwent application of percutaneous nephrostomy tube on affected side.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md, Assoc Prof

Study Record Dates

First Submitted

May 1, 2019

First Posted

May 3, 2019

Study Start

July 1, 2014

Primary Completion

May 31, 2018

Study Completion

January 1, 2019

Last Updated

May 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations