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

Primary Purpose

Ischemia Reperfusion Injury

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pneumoperitoneum preconditioning
Sham-Pneumoperitoneum preconditioning
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemia Reperfusion Injury focused on measuring Renal ischemia reperfusion injury, Pneumoperitoneum preconditioning, Laparoscopic partial nephrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Pneumoperitoneum preconditioning group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

The absolute change in glomerular filtration rate (GFR)
Unilateral and overall GFR detected by 99mTc-DTPA renal scintigraphy.
The absolute change in the level of serum Cystatin C (Cys C)
The absolute change in the level of serum Cys C after desufflation.

Secondary Outcome Measures

The level of serum creatinine (SCr)
The absolute change in the level of serum SCr after desufflation.
Estimated glomerular filtration rate (eGFR)
eGFR will be calculated by a combined formula.
The level of alanine transaminase (ALT)
Serum markers for detecting the insults of the liver.
The level of serum amylase
Serum markers for detecting the insults of the pancreas.
The level of intestinal fatty acid binding protein (I-FABP)
Serum markers for detecting the insults of the intestine.

Full Information

First Posted
January 19, 2019
Last Updated
September 30, 2022
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03822338
Brief Title
Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy
Official Title
Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy: a Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia Reperfusion Injury
Keywords
Renal ischemia reperfusion injury, Pneumoperitoneum preconditioning, Laparoscopic partial nephrectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pneumoperitoneum preconditioning group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Participants in the control group will receive the same placement of the veress but without insufflation and subsequent desufflation.
Intervention Type
Procedure
Intervention Name(s)
Pneumoperitoneum preconditioning
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Sham-Pneumoperitoneum preconditioning
Intervention Description
Sham-Pneumoperitoneum preconditioning consists of three cycles without insufflation and subsequent desufflation. The whole duration will also last 30 min.
Primary Outcome Measure Information:
Title
The absolute change in glomerular filtration rate (GFR)
Description
Unilateral and overall GFR detected by 99mTc-DTPA renal scintigraphy.
Time Frame
changes from baseline and postoperative 1, 6 months
Title
The absolute change in the level of serum Cystatin C (Cys C)
Description
The absolute change in the level of serum Cys C after desufflation.
Time Frame
changes from baseline and 12, 24, 48 hours after desufflation
Secondary Outcome Measure Information:
Title
The level of serum creatinine (SCr)
Description
The absolute change in the level of serum SCr after desufflation.
Time Frame
Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Title
Estimated glomerular filtration rate (eGFR)
Description
eGFR will be calculated by a combined formula.
Time Frame
Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Title
The level of alanine transaminase (ALT)
Description
Serum markers for detecting the insults of the liver.
Time Frame
Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Title
The level of serum amylase
Description
Serum markers for detecting the insults of the pancreas.
Time Frame
Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Title
The level of intestinal fatty acid binding protein (I-FABP)
Description
Serum markers for detecting the insults of the intestine.
Time Frame
Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Other Pre-specified Outcome Measures:
Title
Duration of postoperative hospital stay
Time Frame
6 months following surgery
Title
Incidence of adverse events
Time Frame
6 months following surgery
Title
Rate of mortality
Time Frame
6 months following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruipeng Jia, MD, PHD
Phone
+86-02552271061
Email
urojiarp@njmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Changcheng Zhou, MD
Phone
+86-02552271048
Email
zhoucc@njmu.edu.cn
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruipeng Jia, MD, PHD
Phone
+86-02552271061
Email
urojiarp@njmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Ruipeng Jia, MD, PHD
First Name & Middle Initial & Last Name & Degree
Luwei Xu, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32461289
Citation
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.
Results Reference
derived

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

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