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Autosomal Dominant Polycystic Kidney Disease (ADPKD) Pain Study
This study is currently recruiting participants.
Verified by Mayo Clinic, September 2008
Sponsored by: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00571909
  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.


Condition Intervention Phase
Kidney, Polycystic, Autosomal Dominant
Procedure: Videothoracoscopic Splanchnectomy (VSPL)
Phase II

Genetics Home Reference related topics: polycystic kidney disease
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Evaluation and Treatment of Chronic Pain in Autosomal Dominant Polycystic Kidney Disease

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Improvement in pain control and quality of life [ Time Frame: 2 yrs ]

Secondary Outcome Measures:
  • Changes in urine biomarkers compared to pre-operation values within patients will be compared. Changes in kidney volume, kidney cyst volume, and kidney blood flow before and after the operation will be studied. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2007
Detailed Description:

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 hosptial 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 18 years 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571909

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States
Contact: Bev Tietje     507-255-0401     tietje.beverly@mayo.edu    
Principal Investigator: Marie C. Hogan, M.D., Ph.D.            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Marie C. Hogan, M.D., Ph.D. Mayo Clinic
  More Information

Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

Responsible Party: Mayo Clinic ( Marie C. Hogan, M.D., Ph.D. )
Study ID Numbers: 06-009690, PDK#14
Study First Received: December 10, 2007
Last Updated: September 30, 2008
ClinicalTrials.gov Identifier: NCT00571909  
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Polycystic Kidney Disease
Chronic Kidney Pain
Autosomal Dominant Polycystic Kidney
Kidney Cyst
VSPL
Videothoracoscopic
Splanchnectomy
Splanchiectomy
Splanchnicectomy

Study placed in the following topic categories:
Urologic Diseases
Polycystic Kidney, Autosomal Dominant
Kidney Diseases, Cystic
Polycystic Kidney Diseases
Pain
Kidney Diseases
Cysts

ClinicalTrials.gov processed this record on January 13, 2009