Trial record 37 of 97 for:    polycystic kidney disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Pain Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Marie Hogan, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00571909
First received: December 10, 2007
Last updated: May 13, 2014
Last verified: May 2014
  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: video thorascopic splanchnicectomy (VSPL)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation and Treatment of Chronic Pain in Autosomal Dominant Polycystic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Improvement in pain control and quality of life [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]

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
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: video thoracoscopic splanchnicectomy (VSPL) Procedure: video thorascopic splanchnicectomy (VSPL)
VSPL is a minimally invasive technique using 1-2cm incisions through which a camera and surgical tools are placed inside the thoracic cavity and the idea of the procedure is to cut the pain pathway linking the splanchnic ganglion with pain centers in the hypothalamus

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571909

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Marie C Hogan, MD, PhD    507-266-1963    hogan.marie@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

Additional Information:
No publications provided

Responsible Party: Marie Hogan, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00571909     History of Changes
Other Study ID Numbers: 06-009690, PDK#14
Study First Received: December 10, 2007
Last Updated: May 13, 2014
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
video thoracoscopic splanchnicectomy

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Multicystic Dysplastic Kidney
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Urogenital Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 29, 2014