Detection of Renal Malignancy of Complicated Renal Cysts

Carcinoma, Renal Cell Clinical Trial

Official title:

Does Hounsfield Unit (HU) Predict the Detection of Cystic Renal Malignancy of Complicated Renal Cysts?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087060
• Other study ID #: Bosniak
• Status: Completed
• Phase: N/A
• First received: March 10, 2010
• Last updated: March 12, 2010
• Start date: January 1997
• Est. completion date: May 2009

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: May 2009
• Est. primary completion date: March 2008
• 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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Cysts
• Kidney Neoplasm
• Kidney Neoplasms

Intervention

Procedure:
• partial or radical nephrectomy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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

Outcome

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