Detection of Renal Malignancy of Complicated Renal Cysts

NCT ID: NCT01087060

Last Updated: 2010-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

269 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-01-31

Study Completion Date

2009-05-31

Brief Summary

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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

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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.

Conditions

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Kidney Neoplasm Cysts Carcinoma, Renal Cell

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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cysts surgically removed

partial or radical nephrectomy

Intervention Type PROCEDURE

cysts under surveillance

No interventions assigned to this group

Interventions

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partial or radical nephrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Cheol Kwak, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type RESULT
PMID: 19375094 (View on PubMed)

Other Identifiers

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Bosniak

Identifier Type: -

Identifier Source: org_study_id

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