Ischemia Reperfusion InjuryNCT03822338
Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy
A study testing Pneumoperitoneum preconditioning in people with Ischemia Reperfusion Injury, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia Reperfusion Injury
- What is being tested?
- Pneumoperitoneum preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Ruipeng Jia, MD, PHD, +86-02552271061, urojiarp@njmu.edu.cn
Ruipeng Jia, MD, PHD
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemia Reperfusion Injury
- Being tested
- Pneumoperitoneum preconditioning, Sham-Pneumoperitoneum preconditioning
- Keywords
- Renal ischemia reperfusion injury, Pneumoperitoneum preconditioning, Laparoscopic partial nephrectomy
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumoperitoneum preconditioningProcedure or surgery
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 preconditioningProcedure or surgery
Sham-Pneumoperitoneum preconditioning consists of three cycles without insufflation and subsequent desufflation. The whole duration will also last 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Pneumoperitoneum preconditioning group | Experimental | 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. Receives: Procedure: Pneumoperitoneum preconditioning |
| Control group | Sham comparator | Participants in the control group will receive the same placement of the veress but without insufflation and subsequent desufflation. Receives: Procedure: Sham-Pneumoperitoneum preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute change in glomerular filtration rate (GFR)
Unilateral and overall GFR detected by 99mTc-DTPA renal scintigraphy.
Measured: 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.
Measured: changes from baseline and 12, 24, 48 hours after desufflation
Secondary outcomes (5)
The level of serum creatinine (SCr)
The absolute change in the level of serum SCr after desufflation.
Measured: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Estimated glomerular filtration rate (eGFR)
eGFR will be calculated by a combined formula.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Jan 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemia Reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruipeng Jia, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822338
- Sponsor's protocol ID
- NFH20180205
- Status last verified
- Sep 2022
- First submitted
- 19 Jan 2019
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32461289
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumoperitoneum Preconditioning for the Prevention of Renal Function After Laparoscopic Partial Nephrectomy: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03822338
- Acronym / sponsor ID
- NFH20180205
- Conditions
- Ischemia Reperfusion Injury
- Keywords
- Renal ischemia reperfusion injury, Pneumoperitoneum preconditioning, Laparoscopic partial nephrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumoperitoneum preconditioning group | Experimental | Procedure: Pneumoperitoneum preconditioningParticipant 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 comparator | Procedure: Sham-Pneumoperitoneum preconditioningParticipants in the control group will receive the same placement of the veress but without insufflation and subsequent desufflation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumoperitoneum preconditioningPneumoperitoneum 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. | Procedure or surgery | Pneumoperitoneum preconditioning group |
| Sham-Pneumoperitoneum preconditioningSham-Pneumoperitoneum preconditioning consists of three cycles without insufflation and subsequent desufflation. The whole duration will also last 30 min. | Procedure or surgery | Control group |
Primary outcome
The absolute change in glomerular filtration rate (GFR)
Time frame: 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)
Time frame: changes from baseline and 12, 24, 48 hours after desufflation
The absolute change in the level of serum Cys C after desufflation.
5 secondary outcomes
The level of serum creatinine (SCr)
Time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Estimated glomerular filtration rate (eGFR)
Time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
The level of alanine transaminase (ALT)
Time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
The level of serum amylase
Time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
The level of intestinal fatty acid binding protein (I-FABP)
Time frame: Baseline; 12, 24, 48 hours, and 1, 6 months after desufflation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Derived from this study: PubMed 32461289Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumoperitoneum preconditioning in people with Ischemia Reperfusion Injury, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruipeng Jia, MD, PHD (+86-02552271061, urojiarp@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absolute change in glomerular filtration rate (GFR) (time frame: changes from baseline and postoperative 1, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03822338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.