Evaluation and Treatment of Chronic Pain in Autosomal Dominant Polycystic Kidney Disease

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

Some patients with autosomal dominant polycystic kidney disease (ADPKD) have intractable disabling chronic kidney pain. Among methods used to manage these patients, removal of the nerve supply to the kidney by Videothoracoscopic excision of Splanchnic nerve (videothoracoscopic splanchnicectomy — VSPL) is one of the most promising procedures. Few of these procedures have been performed in ADPKD patients (and in only one patient using the less invasive thoracic approach). We recently performed VSPL on two patients who had chronic pain. Both had initial improvement but have had very short follow up. This study should improve understanding of the molecular mechanisms and mediators of kidney pain and provide the hope of an effective procedure to ADPKD patients with chronic kidney pain. We are now enrolling patients to study the effectiveness of the VSPL operation, collecting information on pain intensity, quality of life, kidney blood flow, kidney/cyst volume and also to study the involved pain pathways. Baseline Visit - The patient will also have a complete physical exam and have the kidney's filtration rate measured. Urine and blood tests are performed at each evaluation. You will have an MRI performed of your kidneys. There is no radiation exposure associated with this procedure. You will also be asked to complete Quality of Life (QOL), HALT Pain, and Depression Score questionnaires. These will take approximately 15 minutes to complete and will be repeated at each evaluation. 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.In this procedure the surgeon approaches the nerves supplying the kidneys through the chest wall, using 3 small incisions. He locates these nerves, then cuts a piece of them and removes it from the chest cavity.You will be released from the hospital when your pain is controlled on oral medications. 1 Month Visit-You will be asked to return to the Mayo Clinic one month after your VSPL procedure for a physical exam and completion of the questionnaires.If unable to return to the Mayo Clinic this evaluation can be done with your local doctor. 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 Months: 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 for a physical exam and completion of the 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, measurement of kidney filtration and complete the three questionnaires.

Who is eligible to participate?

Inclusion Criteria: - 18 years or older - Diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD) - History of debilitating kidney pain for at least 6 month. Other methods of pain management will have been appropriately considered and used when feasible and indicated. - Patient fit for general anesthesia - Must be able to travel to Mayo Clinic Rochester for 3 visits - Must be able to cover the cost of the surgery and post operative care. Exclusion Criteria: - Pregnant women (must have a confirmed negative pregnancy test) - Nursing women - Creatinine > 3mg/dl, or hemodialysis dependent - Cancer and other major systemic diseases that could prevent follow-up or data interpretation - Neurologic or psychologic conditions preventing appropriate informed consent - Uncontrolled hypertension(SBP > 160; DBP >100)

What is involved?

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 is the study?

2 Years

Last updated:

5/13/2014

NCT ID:

NCT00571909

IRB Number:

06-009690