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

Ischemia Reperfusion Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03822338
• Other study ID #: NFH20180205
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Ruipeng Jia, MD, PHD
• Phone: +86-02552271061
• Email: urojiarp[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)>?.

Related Conditions & MeSH terms

• Ischemia
• Ischemia Reperfusion Injury
• Pneumoperitoneum
• Reperfusion Injury

Intervention

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-Pneumoperitoneum preconditioning
Sham-Pneumoperitoneum preconditioning consists of three cycles without insuf?ation and subsequent desuf?ation. The whole duration will also last 30 min.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of postoperative hospital stay		6 months following surgery
Other	Incidence of adverse events		6 months following surgery
Other	Rate of mortality		6 months following surgery
Primary	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
Primary	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	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
Secondary	Estimated glomerular filtration rate (eGFR)	eGFR will be calculated by a combined formula.	Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Secondary	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
Secondary	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
Secondary	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