Phase-I Feasibility Trial To Study The Safety Of Laser Tissue Welding For Sealing Resected Kidney Surfaces After Laparoscopic Partial Nephrectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Operative Blood Loss
研究概览
简要总结
The objective of this pilot study will be to obtain a clinical safety and efficacy endpoint profile of laser tissue welding therapy for sealing the resected kidney surface after laparoscopic partial nephrectomy required for removal of resectable benign or malignant renal tumors in 10 patients.
详细描述
SCIENTIFIC RATIONALE:
The use of partial nephrectomy to treat small newly diagnosed kidney tumors is vastly under-used as per NCI statistics (http://www.cancer.gov/cancertopics/treatment/partial-nephrectomy0208).
As per the Surveillance, Epidemiology and End Results (SEER) Program, (http://seer.cancer.gov/statfacts/html/kidrp.html), the prevalence of cancer of the kidney and renal pelvis is 296,074 while the estimated new cases are 46,410 and deaths 13,040 in the United States in 2010 (www.cancer.gov/cancertopics/types/kidney).
There has been an increase in detection of incidental small renal mass (≤ 4cm) cases (TNM staging T1a) due to widespread use of ultrasound and abdominal cross sectional imaging (CT, MRI) and thus an increase in the amount of renal surgery performed. Current surgical practice for nephron sparing surgery allows at least 1 cm margin of normal tissue around the tumor3. This is the stage when curative resections are possible.
During a partial nephrectomy, the renal artery is clamped to minimize bleeding while resecting the tumor. Since a major reconstruction is required with suturing, clamp time can be significant, anywhere between 15 and 45 minutes. It has been repeatedly shown that reducing clamp time preserves renal function and that there is significant damage to the kidney if the renal artery is clamped for more than 30 minutes. This is especially crucial when dealing with patients with hypertension, diabetes, chronic renal failure or a tumor in a single kidney. Extended clamp time can result in decreased renal function and ultimately the need for dialysis at some point. Because of the inherent difficulties of laparoscopic suturing, this has not been widely used particularly in view of the risk of prolonged warm ischemia time. Many patients therefore undergo a radical nephrectomy instead of a nephron sparing procedure. Hemorrhage 9.5% (1) , is the major complication following partial nephrectomy. Besides bleeding (1) urinary fistula (4.5%), ureteral obstruction, and renal insufficiency due to prolonged warm ischemia times are further complications of partial nephrectomy.
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
- •T1a (< 4 cm). All resectable benign, primary or secondary malignant tumors of one kidney. No bi-lateral disease.
- •Serum creatinine: ≤ 2.5 mg/dL
- •Glomerular filtration rate greater than ≥ 50 ml/min/m2
- •Platelet count ≥ 50,000/mm3
- •Prothrombin time < 18 seconds
- •Partial thromboplastin time (PTT) ≤ 1.5 times control
- •Serum albumin levels > 3g/dL (Normal range 3.5 to 5 g/dL)
排除标准
- •Age younger than 18 years old
- •Severe uncorrected hypertension
- •Uncorrectable coagulopathies
- •Active urinary tract infection
- •T1b (>4 cm) lesion and above
- •Systemic or local infection
- •Subject has known allergy or intolerance to iodine or human serum albumin
- •Recent febrile illness that precludes or delays participation pre-operatively
- •Treatment with another investigational drug or other intervention during the study and follow-up period.
结局指标
主要结局
Operative Blood Loss
时间窗: Day 1
Operative blood loss is defined by: Volume of blood in the suction bottles, volume of blood clots, and weight of surgical towels before and after use. Clinical assessment of the blood loss: Clinical drop in hemoglobin (1 gm. % = 300 ml) without hemo-dilution. Therefore is correlated with blood products transfused to compensate for the blood lost during surgery.
Postoperative Blood Loss
时间窗: Up to 30 days
Clinical assessment of the blood loss: 1. Clinical drop in hemoglobin (1 gm. % = 300 ml) without hemodilution. Therefore is correlated with blood products transfused to compensate for the blood lost post-operatively. 2. Correlated to post-operative JP tube drainage, amount and type.
次要结局
- Urinary stone formation (safety issue no. 4)(Up to 12 months)
- Secondary hemorrhage or hematoma (safety issue no. 1)(Up to 12 months)
- Post-operative urinary leakage/ urinoma (safety issue no. 2)(Up to 12 months)
- Secondary infection, intra-abdominal abscess formation and septicemia (safety issue no. 3)(Up to 12 months)