Evaluation and Treatment of Chronic Pain in Autosomal Dominant Polycystic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Improvement in pain control and quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
video thoracoscopic splanchnicectomy (VSPL)
干预措施: video thorascopic splanchnicectomy (VSPL) (Procedure)
结局指标
主要结局
Improvement in pain control and quality of life
时间窗: 2 yrs
次要结局
- 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)