Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy: a Double-blind Randomized Controlled Trial

Conditions
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Ischemia Reperfusion Injury

Intervention / Treatment
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* Procedure: Pneumoperitoneum preconditioning
* Procedure: Sham-Pneumoperitoneum preconditioning


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumoperitoneum preconditioning group<br>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. | Procedure: Pneumoperitoneum preconditioning<br>* 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.<br>|
| Sham Comparator: Control group<br>Participants in the control group will receive the same placement of the veress but without insufﬂation and subsequent desufﬂation. | Procedure: Sham-Pneumoperitoneum preconditioning<br>* Sham-Pneumoperitoneum preconditioning consists of three cycles without insufﬂation and subsequent desufﬂation. The whole duration will also last 30 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute change in glomerular filtration rate (GFR) | Unilateral and overall GFR detected by 99mTc-DTPA renal scintigraphy. | 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. | changes from baseline and 12, 24, 48 hours after desufflation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of serum creatinine (SCr) | The absolute change in the level of serum SCr after desufflation. | Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation | 
| Estimated glomerular filtration rate (eGFR) | eGFR will be calculated by a combined formula. | 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. | 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. | 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. | Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal ischemia reperfusion injury, Pneumoperitoneum preconditioning, Laparoscopic partial nephrectomy