Carcinoma, Renal Cell Clinical Trial
Official title:
Does Hounsfield Unit (HU) Predict the Detection of Cystic Renal Malignancy of Complicated Renal Cysts?
Verified date | March 2010 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 269 |
Est. completion date | May 2009 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Song C, Min GE, Song K, Kim JK, Hong B, Kim CS, Ahn H. Differential diagnosis of complex cystic renal mass using multiphase computerized tomography. J Urol. 2009 Jun;181(6):2446-50. doi: 10.1016/j.juro.2009.01.111. Epub 2009 Apr 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
No | |
Secondary | 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. | No |
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