Autosomal Dominant Polycystic Kidney Disease (ADPKD) Pain Study
Evaluation and Treatment of Chronic Pain in Autosomal Dominant Polycystic Kidney Disease
2 other identifiers
interventional
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 10, 2007
CompletedFirst Posted
Study publicly available on registry
December 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedOctober 20, 2017
October 1, 2017
8.7 years
December 10, 2007
October 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in pain control and quality of life
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.
3 years
Study Arms (1)
video thoracoscopic splanchnicectomy (VSPL)
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Polycystic Kidney Disease Foundationcollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie C. Hogan, M.D., Ph.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 10, 2007
First Posted
December 12, 2007
Study Start
May 1, 2007
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
October 20, 2017
Record last verified: 2017-10