IRB Number:

06-009690

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This study will evaluate the effectiveness of Videothoracoscopic Splanchnicectomy(VSLP)procedure for pain management in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). We will enroll 20 patients to evaluate the effectiveness of Videothoracoscopic Splanchnicectomy (VSLP) for pain management. This study should improve understanding of the molecular mechanisms and mediators of kidney pain and provide the prospect of a definitive palliative procedure to these patients.

Who is Eligible to Participate in the Study?

-18year or older
-Diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
-History of debilitating kidney pain
-Patient fit for general anesthesia
-Must be able to travel to Mayo Clinic Rochester for 3 visits
-Must be responsible to cover the cost of the surgery and post operative care.

Minimum Age:

18

Maximum Age:

100

What is Involved With this Study?

Baseline Visit - At this visit the patient will have an Iothalamate Clearance to measure the kidney's filtration rate. The patient will wake up at 6 AM and remain standing for two hours. Weight will be measured. A urine sample will be collected. Blood pressure will be measured. A small plastic tube will be inserted into one of the veins in the arm of the patient. This is to allow repeat blood samples to be taken. Blood samples will be drawn 5 times during the next 3 hours. At about 9 AM,a renal function test will begin. The patient will be asked to go to the toilet to empty the bladder. Then, every time urine is passed it will be collected in a special container provided by the study staff. A about 11 AM a Magnetic Resonance Imaging (MRI) test will be performed. MRI is a test that uses a magnetic field and radio frequency waves to create images of the patient's body. When you have the MRI, you will lie still in the scanner (a hollow tube) for up to 45 minutes. While you are in the scanner, the table you are on will be moved slowly and pictures of your kidneys will be made. You will be asked to hold your breath for 30 seconds when each picture is taken. There is no radiation exposure associated with this procedure. You will hear tapping, thumping sounds or other noises during the test. The Patient will also have a complete physical exam. Temperature, blood pressure, breathing and heart rate will be measured. A blood sample will be collected to measure blood chemicals and the patient will be asked to give a urine sample.The patient will also be asked to complete Quality of Life questionnaire (QOL), HALT Pain questionnaire, and Depression Score questionnaire. These will take approximately 15 minutes to complete.
Videothoracoscopic Splanchnicectomy?VSPL
The VSPL operation will be done within approximately 1 week of your Baseline Visit and is considered part of your clinical care and not part of the research.
1 Month Visit-You will be asked to return to the Mayo Clinic one month after your VSLP procedure for a physical exam and completion of the QOL questionnaire, HALT Pain questionnaire and the Depression Score questionnaires.

3 Month Visit
The 3 Month Visit will be identical to the Baseline visit. You will have a physical exam, blood and urine samples, MRI of your kidneys, Iothalamate Clearance, and the three questionnaires to complete.

6 Month Visit
The QOL questionnaire, HALT Pain questionnaire and the Depression Score questionnaire are the only items required at this visit. The questionnaires will be mailed to you for completion.

12 Month Visit
The 12 Month Visit is identical to the 1 Month visit. You will be asked to return to the Mayo Clinic 1 year after your VSLP procedure for a physical exam and completion of the three questionnaires.

2 Year Visit
The 2 Year Visit will be identical to the Baseline visit. You will have a physical exam, blood and urine samples, MRI of your kidneys, Iothalamate Clearance, and the three questionnaires to complete.

How long will the Study run?

2 Years

Who can I Contact for Additional Information on this Trial?

Mark Manemann
manemann.mark@mayo.edu
507-266-3088

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 10/09/2009