Kidney, Polycystic, Autosomal DominantNCT00571909
Autosomal Dominant Polycystic Kidney Disease (ADPKD) Pain Study
A study testing video thorascopic splanchnicectomy (VSPL) in people with Kidney, Polycystic, Autosomal Dominant, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney, Polycystic, Autosomal Dominant
- What is being tested?
- video thorascopic splanchnicectomy (VSPL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Treatment of Chronic Pain in Autosomal Dominant Polycystic Kidney Disease
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.
Read the 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.
- Conditions
- Kidney, Polycystic, Autosomal Dominant
- Being tested
- video thorascopic splanchnicectomy (VSPL)
- Keywords
- Polycystic Kidney Disease, Chronic Kidney Pain, Autosomal Dominant Polycystic Kidney, Kidney Cyst, VSPL, video thoracoscopic splanchnicectomy
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Polycystic Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video thorascopic splanchnicectomy (VSPL)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| video thoracoscopic splanchnicectomy (VSPL) | Experimental | Not described Receives: Procedure: video thorascopic splanchnicectomy (VSPL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pain control and quality of life
Measured: 2 yrs
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney, Polycystic, Autosomal DominantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Polycystic Kidney Disease Foundation
- Responsible party
- Principal investigator, Marie Hogan, Mayo Clinic
- Investigators
- Marie C. Hogan, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571909
- Sponsor's protocol ID
- 06-009690
- Other IDs
- PDK#14
- Status last verified
- Oct 2017
- First submitted
- 10 Dec 2007
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Treatment of Chronic Pain in Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT00571909
- Acronym / sponsor ID
- 06-009690
- Conditions
- Kidney, Polycystic, Autosomal Dominant
- Keywords
- Polycystic Kidney Disease, Chronic Kidney Pain, Autosomal Dominant Polycystic Kidney, Kidney Cyst, VSPL, video thoracoscopic splanchnicectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Polycystic Kidney Disease Foundation
- Study start
- May 2007
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| video thoracoscopic splanchnicectomy (VSPL) | Experimental | Procedure: video thorascopic splanchnicectomy (VSPL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | video thoracoscopic splanchnicectomy (VSPL) |
Primary outcome
Improvement in pain control and quality of life
Time frame: 2 yrs
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie C. Hogan, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video thorascopic splanchnicectomy (VSPL) in people with Kidney, Polycystic, Autosomal Dominant, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in pain control and quality of life (time frame: 2 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.