Clinical trial NCT03822338: Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy
Official title: Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemia Reperfusion Injury
Keywords: Renal ischemia reperfusion injury
Pneumoperitoneum preconditioning
Laparoscopic partial nephrectomy
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study is designed to investigate the short-term and long-term renoprotective role of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The absolute change in glomerular filtration rate (GFR)
timeFrame: changes from baseline and postoperative 1, 6 months
measure: The absolute change in the level of serum Cystatin C (Cys C)
timeFrame: changes from baseline and 12, 24, 48 hours after desufflation
Secondary outcomes:
measure: The level of serum creatinine (SCr)
timeFrame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
measure: Estimated glomerular filtration rate (eGFR)
timeFrame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
measure: The level of alanine transaminase (ALT)
timeFrame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
measure: The level of serum amylase
timeFrame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
measure: The level of intestinal fatty acid binding protein (I-FABP)
timeFrame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Other outcomes:
measure: Duration of postoperative hospital stay
timeFrame: 6 months following surgery
measure: Incidence of adverse events
timeFrame: 6 months following surgery
measure: Rate of mortality
timeFrame: 6 months following surgery
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References:
citation: Zhou C, Xu L, Xu Z, Ge Y, Zhou L, Wang F, Liu J, Pan G, Yang T, Jia R. Pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy: protocol for a double-blind randomised controlled trial. BMJ Open. 2020 May 26;10(5):e032002. doi: 10.1136/bmjopen-2019-032002.