The present study is designed to investigate the short-term and long-term renoprotective role of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
86
Pneumoperitoneum preconditioning consists of three cycles of 5 min insufflation and 5 min desufflation, after complete anesthesia and successfully implanting the veress. This process will be induced by pneumoperitoneum machine, and the utilized gas will be carbon dioxide to maintain the intra-abdominal pressure at 15 mmHg. The whole duration will last 30 min.
Sham-Pneumoperitoneum preconditioning consists of three cycles without insufflation and subsequent desufflation. The whole duration will also last 30 min.
Nanjing First Hospital
Nanjing, Jiangsu, China
RECRUITINGThe absolute change in glomerular filtration rate (GFR)
Unilateral and overall GFR detected by 99mTc-DTPA renal scintigraphy.
Time frame: changes from baseline and postoperative 1, 6 months
The absolute change in the level of serum Cystatin C (Cys C)
The absolute change in the level of serum Cys C after desufflation.
Time frame: changes from baseline and 12, 24, 48 hours after desufflation
The level of serum creatinine (SCr)
The absolute change in the level of serum SCr after desufflation.
Time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Estimated glomerular filtration rate (eGFR)
eGFR will be calculated by a combined formula.
Time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
The level of alanine transaminase (ALT)
Serum markers for detecting the insults of the liver.
Time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
The level of serum amylase
Serum markers for detecting the insults of the pancreas.
Time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
The level of intestinal fatty acid binding protein (I-FABP)
Serum markers for detecting the insults of the intestine.
Time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
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