Investigating a Novel Modifiable Factor Affecting Renal Function After Partial Nephrectomy: Cortical Renorrhaphy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- %Loss renal volume
研究概览
简要总结
Preserving kidney function during removal of a kidney tumor is becoming increasingly important as rates of chronic kidney disease increase. A novel modifiable factor (suture closure of the defect caused by tumor removal) was discovered on retrospective studies to account for nearly two-thirds of the 15% volume loss commonly seen in operated kidneys. We hypothesize that a randomized controlled surgical trial will show that omitting the suture closure both preserves renal function and will not lead to unreasonable postoperative complications.
详细描述
Purpose: To evaluate a never before studied modifiable factor affecting renal function after partial nephrectomy: the suture closure of the renal cortex after tumor removal (renorrhaphy).
Background:
There is increasing interest in preserving renal function when removing renal tumors. This is partly due to studies that link chronic kidney disease with cardiovascular events and overall survival. There is an approximate loss of 10% overall renal function after partial nephrectomy along with a loss of 15% of the volume in the operated kidney. Studies point to 3 factors leading to this loss in renal function after partial nephrectomy: 1) Poor preoperative renal function, 2) Ischemia time (clamping the renal blood vessels to decrease bleeding during surgery, and 3) Loss in renal volume from the surgery.
The only factor that is considered modifiable is ischemia time, especially when over 20-25-minutes in duration. Modern techniques now aid in keeping the ischemia time below the 25-minute cutoff. Leading experts from institutions such as the Cleveland Clinic, The University of Southern California, and The Mayo Clinic have concluded that the most important factor in preserving renal function, renal volume loss, is not modifiable.
Specific Aims: Our question is: if we are removing non-functional tissue (tumor) then why is there a loss in renal volume (15%) and function (10%)? We hypothesize that by omitting one particular step during surgery, sewing closed the defect caused by tumor removal, we will be able to improve renal volume loss and function (RENORRHAPHY CLIP http://youtu.be/NXOtUHdigj4). Indiana University is in a unique position to study this hypothesis as two of our surgeons have routinely omitted closing the defect left after tumor removal (NO RENORRHAPHY CLIP http://youtu.be/ZisMjrm85s8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •3.0 INCLUSION/
排除标准
- •3.1 Inclusion criteria:
- •≥ 18 years of age.
- •Must provide written informed consent
- •Presence of cT1 renal mass by diagnostic CT assessment.
- •Scheduled for partial nephrectomy of renal mass.
- •Expected survival of at least 3 months.
- •Negative serum/urine pregnancy test within 24 hours for females of child bearing age prior to surgery
- •Recovered from toxicity of any prior therapy to grade 1 or better
- •If biopsy of mass has been done, pathology must be consistent with RCC.
- •3.2 Exclusion criteria:
- •Solitary kidney
- •Multiple or bilateral renal masses when more than one mass is operated on at the same time or within 4-months of each other.
- •Hepatic or renal toxicity (GFR <30) greater than or equal to Grade 2 (using CTCAE version 4 standard definitions)
- •Bleeding diathesis or inability to hold anticoagulation for surgery
- •Participation in another investigational trial concurrently or within 30 days
- •Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
研究组 & 干预措施
Cortical renorrhaphy
Cortical renorrhaphy is performed after partial nephrectomy using a running barbed suture on MH (36mm) needle. Polymer locking clips are used to maintain tension. A base layer running stitch is performed prior to the cortical renorrhaphy.
干预措施: Renorrhaphy (Procedure)
Non-renorrhaphy
The suture closure of the renal cortex after tumor removal is omitted. A base layer running stitch only is performed for hemostasis and urine leak prevention.
干预措施: Non-renorrhaphy (Procedure)
结局指标
主要结局
%Loss renal volume
时间窗: 4months
% loss in renal volume (cm3) of the operated kidney (post-operative CT at 4 mo vs. - pre-operative CT) using Phillips IntelliSpace portal semi-automated segmentation algorithm.
次要结局
- Adverse events as defined by the Clavien-Dindo classification system.(Through 4months)
- Surgeon survey(immediately after surgery is complete)
- Operative and postoperative complications(through 4months)
- Resistive index(In the operating room prior to resection (baseline) and immediately after resection of tumor)
- Predicted volume loss(4months)
- %Loss in GFR(4months)
研究者
Chandru Sundaram
Professor of Urology
Indiana University