Detection of Renal Malignancy of Complicated Renal Cysts

March 12, 2010 updated by: Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

269

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All 2,992 patients who were diagnosed as renal cysts in this institute

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Outcome Measure
Measure Description
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

March 10, 2010

First Submitted That Met QC Criteria

March 12, 2010

First Posted (Estimate)

March 15, 2010

Study Record Updates

Last Update Posted (Estimate)

March 15, 2010

Last Update Submitted That Met QC Criteria

March 12, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bosniak

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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