Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The absolute change in glomerular filtration rate (GFR)
研究概览
简要总结
The present study is designed to investigate the short-term and long-term renoprotective role of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy.
详细描述
Renal ischemia reperfusion injury (IRI) is an inevitable event in patients undergoing laparoscopic partial nephrectomy (LPN), which can obviously affect the post-operational renal function. Pneumoperitoneum preconditioning (PP) is a promising strategy to render a protective effect on kidney, which has been already confirmed in some clinical settings. This study is designed as a randomized, prospective, double-blind and parallel controlled clinical trial to assess the short-term and long-term renoprotective role of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy, and observe its effect on the other abdominal organs. Patients with renal tunours and willing to accept elective LPN will be screened as eligible participants. The investigators aim to enroll 86 subjects. Patients randomized to the treatment arm will receive PP consisted of three cycles of 5 min insufflation and 5 min desufflation before PLN, while the control arm receive a sham operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Male and female patients aged 18 years and older;
- •Patients with renal tumours (whether benign or malignant) and accept laparoscopic partial nephrectomy as the surgical method;
- •The renal tumor must be stage T1a (assessed by MRI/CT), and tumor≤4cm in diameter;
- •Unilateral renal tumour, and another contralateral renal function reveal normal (renal function >40% as determined by radionuclide scintigraphy);
- •Patients volunteer for this study and provided written informed consent.
排除标准
- •Large tumour (tumor>4cm in diameter);
- •Severe renal insufficiency (glomerular filtration rate, GFR<30 ml/min/1.73m2) or needing preoperative dialysis (hemodialysis or peritoneal dialysis);
- •Patients severe cardiopulmonary dysfunction;
- •Pregnancy Women;
- •Patients with other malignant tumours;
- •Patients who have had a renal transplantation;
- •Patients with a history of other abdominal viscera operations within one year (open or under laparoscope);
- •American Society of Anesthesiologists (ASA)>Ⅲ.
研究组 & 干预措施
Pneumoperitoneum preconditioning group
Participant assigned to the this group will receive a treatment consisting of three cycles of 5 min insufflation (intra-abdominal pressure at 15 mmHg) and 5 min desufflation, after complete anesthesia and successfully implanting the veress.
干预措施: Pneumoperitoneum preconditioning (Procedure)
Control group
Participants in the control group will receive the same placement of the veress but without insufflation and subsequent desufflation.
干预措施: Sham-Pneumoperitoneum preconditioning (Procedure)
结局指标
主要结局
The absolute change in glomerular filtration rate (GFR)
时间窗: changes from baseline and postoperative 1, 6 months
Unilateral and overall GFR detected by 99mTc-DTPA renal scintigraphy.
The absolute change in the level of serum Cystatin C (Cys C)
时间窗: changes from baseline and 12, 24, 48 hours after desufflation
The absolute change in the level of serum Cys C after desufflation.
次要结局
- The level of serum creatinine (SCr)(Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation)
- The level of alanine transaminase (ALT)(Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation)
- The level of serum amylase(Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation)
- Estimated glomerular filtration rate (eGFR)(Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation)
- The level of intestinal fatty acid binding protein (I-FABP)(Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation)
研究者
Ruipeng Jia
Study Chair
Nanjing First Hospital, Nanjing Medical University