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

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

Sponsors

Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Source 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.

Overall Status Not yet recruiting
Start Date 2019-08-06
Completion Date 2021-05-01
Primary Completion Date 2021-02-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The absolute change in glomerular filtration rate (GFR) changes from baseline and postoperative 1, 6 months
The absolute change in the level of serum Cystatin C (Cys C) changes from baseline and 12, 24, 48 hours after desufflation
Secondary Outcome
Measure Time Frame
The level of serum creatinine (SCr) Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Estimated glomerular filtration rate (eGFR) Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
The level of alanine transaminase (ALT) Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
The level of serum amylase Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
The level of intestinal fatty acid binding protein (I-FABP) Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Enrollment 86
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Pneumoperitoneum preconditioning

Description: 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.

Arm Group Label: Pneumoperitoneum preconditioning group

Intervention Type: Procedure

Intervention Name: Sham-Pneumoperitoneum preconditioning

Description: Sham-Pneumoperitoneum preconditioning consists of three cycles without insufflation and subsequent desufflation. The whole duration will also last 30 min.

Arm Group Label: Control group

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Nanjing First Hospital
Location Countries

China

Verification Date

2019-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Nanjing First Hospital, Nanjing Medical University

Investigator Full Name: Ruipeng Jia

Investigator Title: Study Chair

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Pneumoperitoneum preconditioning group

Type: Experimental

Description: 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.

Label: Control group

Type: Sham Comparator

Description: Participants in the control group will receive the same placement of the veress but without insufflation and subsequent desufflation.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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