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

The present study is designed to investigate the short-term and long-term renoprotective role of pneumoperitoneum preconditioning in patients undergoing laparoscopic partial nephrectomy.

Study Overview

• Status: Recruiting
• Conditions: Ischemia Reperfusion Injury
• Intervention / Treatment: Procedure: Pneumoperitoneum preconditioning; Procedure: Sham-Pneumoperitoneum preconditioning

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 Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruipeng Jia, MD, PHD; Phone Number: +86-02552271061; Email: [email protected]
• Study Contact Backup: Name: Changcheng Zhou, MD; Phone Number: +86-02552271048; Email: [email protected]

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital
      • Contact: Ruipeng Jia, MD, PHD; Phone Number: +86-02552271061; Email: [email protected]
      • Principal Investigator: Ruipeng Jia, MD, PHD
      • Sub-Investigator: Luwei Xu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Duration of postoperative hospital stay	6 months following surgery
Incidence of adverse events	6 months following surgery
Rate of mortality	6 months following surgery

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

General Publications

• Zhou C, Xu L, Xu Z, Ge Y, Zhou L, Wang F, Liu J, Pan G, Yang T, Jia R. Pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy: protocol for a double-blind randomised controlled trial. BMJ Open. 2020 May 26;10(5):e032002. doi: 10.1136/bmjopen-2019-032002.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Laparoscopic partial nephrectomy; Renal ischemia reperfusion injury; Pneumoperitoneum preconditioning
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Peritoneal Diseases; Postoperative Complications; Pneumoperitoneum; Ischemia; Reperfusion Injury
• Other Study ID Numbers: NFH20180205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No