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

Not Applicable

Recruiting

• Conditions: Ischemia Reperfusion Injury
• Interventions: Procedure: Pneumoperitoneum preconditioning; Procedure: Sham-Pneumoperitoneum preconditioning

• Registration Number: NCT03822338
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2019-01-19
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-30
• Study Start: 2021-01-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-03
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pneumoperitoneum preconditioning group	Pneumoperitoneum preconditioning	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.
Control group	Sham-Pneumoperitoneum preconditioning	Participants in the control group will receive the same placement of the veress but without insufflation and subsequent desufflation.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
Estimated glomerular filtration rate (eGFR)	Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation	eGFR will be calculated by a combined formula.

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China