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Detection of Renal Malignancy of Complicated Renal Cysts

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ClinicalTrials.gov Identifier: NCT01087060
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : March 15, 2010
Sponsor:
Information provided by:
Seoul National University Hospital

Brief Summary:
The aim of this study was to show additional diagnostic criteria of computed tomography (CT) scan to diagnose and predict the detection and recurrence of cystic renal cell carcinoma in the patients with complicated renal cysts. Furthermore, we would demonstrate the relationship between complicated renal cysts diagnosed by Bosniak system and some parameters of pathological results. The analysis about detection time of renal malignancy would help determine the practical guidelines of follow-up plan for complicated renal cysts.

Condition or disease Intervention/treatment
Kidney Neoplasm Cysts Carcinoma, Renal Cell Procedure: partial or radical nephrectomy

Detailed Description:
Even though there have been many trials and errors to enhance the diagnostic accuracy of CT scans for complicated cysts, the trial to obtain the enhanced accuracy using CT scan would be still valuable, when we consider its widespread use. A previous study demonstrated that the enhancement of HU with intravenous administration of contrast material on CT scan by 15 HU would be "almost always indicative of a pathologic process although not always a malignancy", another study showed the cut-off as 42 or 47 HU gap would be helpful in the prediction of renal malignancy.

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Study Type : Observational
Actual Enrollment : 269 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Does Hounsfield Unit (HU) Predict the Detection of Cystic Renal Malignancy of Complicated Renal Cysts?
Study Start Date : January 1997
Actual Primary Completion Date : March 2008
Actual Study Completion Date : May 2009

Group/Cohort Intervention/treatment
cysts surgically removed Procedure: partial or radical nephrectomy
cysts under surveillance



Primary Outcome Measures :
  1. additional diagnostic criteria of CT to diagnose and predict the detection and recurrence of cystic RCC in the patients with complicated renal cysts

    First, the primary outcomes is to determine cut-off values of maximal HU and the maximal gap of HU (HU of early excretory phase minus that of non-enhanced phase in CT scan)to predict the detection of renal malignancy. Some clinical factors (age, height, body weight, etc) were also included in the analysis.

    Second, the above-mentioned factors were included in the analysis of risk factors for recurrence of complicated renal cysts to determine the cut-off values.



Secondary Outcome Measures :
  1. informative to determine the time of operation and which is better for a patient with a complicated cyst between partial or radical nephrectomy
    The cut-off values would show a guideline to determine the time of operation for a patient with complicated renal cysts, namely, the nephrectomy should be performed earlier if the patient is included in the high-risk group. Furthermore, the cut-off value would be helpful in the determination in what operation would be proper to the patient. A partial nephrectomy would be more beneficial to every patient than radical nephrectomy, however, if the patient is in the high-risk group for early recurrence, the patient should undergo 'radical' nephrectomy first for complicated renal cysts.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All 2,992 patients who were diagnosed as renal cysts in this institute
Criteria

Inclusion Criteria:

  • All patients who were diagnosed as renal cysts
  • available serial follow-up data of CT scan
  • all CT imaging included non-enhanced (NEP), corticomedullary (CMP), and early excretory phase (EEP) scans. The scan delay times should range from 30 to 40 seconds for CMP scans and from 120 to 180 seconds for EEP scans.

Exclusion Criteria:

  • cases diagnosed by only US/MR
  • no serial CT images
  • cysts of autosomal dominant adult polycystic kidney disease
  • cysts less than 1cm in diameter (difficult to evaluate accurately)
  • follow-up period less than 1 yr in the patients who had no surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087060


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Cheol Kwak, M.D.,Ph.D. Seoul National University Hospital

Publications of Results:
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ClinicalTrials.gov Identifier: NCT01087060    
Other Study ID Numbers: Bosniak
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: March 15, 2010
Last Verified: March 2010
Additional relevant MeSH terms:
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Cysts
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms
Pathological Conditions, Anatomical
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases