Clinical trial NCT01087060: Detection of Renal Malignancy of Complicated Renal Cysts
Official title: Does Hounsfield Unit (HU) Predict the Detection of Cystic Renal Malignancy of Complicated Renal Cysts?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Neoplasm
Cysts
Carcinoma, Renal Cell
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-03-15
Enrollment: 269
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All 2,992 patients who were diagnosed as renal cysts in this institute

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.

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.

Eligibility 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

Primary outcomes:
measure: additional diagnostic criteria of CT to diagnose and predict the detection and recurrence of cystic RCC in the patients with complicated renal cysts
Secondary outcomes:
measure: informative to determine the time of operation and which is better for a patient with a complicated cyst between partial or radical nephrectomy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Cheol Kwak, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.