Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Procedure: Pneumoperitoneum preconditioning
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 Comparator: Control group Participants in the control group will receive the same placement of the veress but without insufflation and subsequent desufflation. |
Procedure: Sham-Pneumoperitoneum preconditioning
Sham-Pneumoperitoneum preconditioning consists of three cycles without insufflation and subsequent desufflation. The whole duration will also last 30 min.
|
Outcome Measures
Primary Outcome Measures
- The absolute change in glomerular filtration rate (GFR) [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) [changes from baseline and 12, 24, 48 hours after desufflation]
The absolute change in the level of serum Cys C after desufflation.
Secondary Outcome Measures
- The level of serum creatinine (SCr) [Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation]
The absolute change in the level of serum SCr after desufflation.
- Estimated glomerular filtration rate (eGFR) [Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation]
eGFR will be calculated by a combined formula.
- The level of alanine transaminase (ALT) [Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation]
Serum markers for detecting the insults of the liver.
- The level of serum amylase [Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation]
Serum markers for detecting the insults of the pancreas.
- The level of intestinal fatty acid binding protein (I-FABP) [Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation]
Serum markers for detecting the insults of the intestine.
Other Outcome Measures
- Duration of postoperative hospital stay [6 months following surgery]
- Incidence of adverse events [6 months following surgery]
- Rate of mortality [6 months following surgery]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female patients aged 18 years and older;
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Patients with renal tumours (whether benign or malignant) and accept laparoscopic partial nephrectomy as the surgical method;
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The renal tumor must be stage T1a (assessed by MRI/CT), and tumor≤4cm in diameter;
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Unilateral renal tumour, and another contralateral renal function reveal normal (renal function >40% as determined by radionuclide scintigraphy);
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Patients volunteer for this study and provided written informed consent.
Exclusion Criteria:
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Large tumour (tumor>4cm in diameter);
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Severe renal insufficiency (glomerular filtration rate, GFR<30 ml/min/1.73m2) or needing preoperative dialysis (hemodialysis or peritoneal dialysis);
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Patients severe cardiopulmonary dysfunction;
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Pregnancy Women;
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Patients with other malignant tumours;
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Patients who have had a renal transplantation;
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Patients with a history of other abdominal viscera operations within one year (open or under laparoscope);
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American Society of Anesthesiologists (ASA)>Ⅲ.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanjing First Hospital | Nanjing | Jiangsu | China | 210006 |
Sponsors and Collaborators
- Nanjing First Hospital, Nanjing Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NFH20180205