View Clinical Trial (Medical Research Study)
Evaluation and Treatment of Chronic Pain in Autosomal Dominant Polycystic Kidney Disease
| City: |
|
Rochester |
| State: |
|
Minnesota |
| Zip Code: |
|
55905 |
| Conditions: |
|
Kidney, Polycystic, Autosomal Dominant |
| Purpose: |
|
We will enroll 20 patients to evaluate the effectiveness of a new operation known as
videothoracoscopic splanchnicectomy (VSPL) for management of chronic kidney pain. This study
is being done to test if this procedure is effective in controlling chronic kidney pain.
|
| Study Summary: |
|
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.
|
| Criteria: |
|
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)
|
| NCT ID: |
|
NCT00571909 |
| Primary Contact: |
|
Principal Investigator
Marie C. Hogan, M.D., Ph.D.
Mayo Clinic
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Rochester, Minnesota 55905
United States
Marie C Hogan, MD, PhD
Phone: 507-266-1963
Email: hogan.marie@mayo.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 23, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|