Liver TumorNCT06060899
Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection.
A study testing Pneumoperitoneum 14mmHg and Pneumoperitoneum 10mmHg in people with Liver Tumor, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Commonly the pressure of about 14 mmHg is applied during laparoscopic liver resection (LLR) with moderate neuromuscular blockade. Lowering the pneumoperitoneum pressure combined with deep neuromuscular blockade may sustain optimal operating space with providing better short-term postoperative results. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Tumor
- What is being tested?
- Pneumoperitoneum 14mmHg and Pneumoperitoneum 10mmHg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2023to 30 Jul 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to perform elective laparoscopic major liver resection
- Age of 18 years or older
- Signed informed consent
Who cannot join
- Severe cardiopulmonary disease
- Severe renal disease
- Liver cirrhosis
- Emergency surgery
- Pregnancy
- Patient's refusal of participation
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of General, Transplant and Liver Surgery, Medical University of Warsaw
Warsaw
About this study
Official title: Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection: Study Protocol for a Randomized Controlled Trial
Commonly the pressure of about 14 mmHg is applied during laparoscopic liver resection (LLR) with moderate neuromuscular blockade. Lowering the pneumoperitoneum pressure combined with deep neuromuscular blockade may sustain optimal operating space with providing better short-term postoperative results. It has been proved in randomized controlled trials in colorectal or bariatric patients, however there is lack of similar data for laparoscopic liver resection. Doubts about lowering the pneumoperitoneum pressure too hasty are supported by apprehension of worse bleeding control during liver parenchyma transection and its impact on postoperative results.
The aim of the trial is to assess the impact of standard (14 mmHg; arm 1) versus low (10 mmHg; arm 2) pneumoperitoneum pressure on intraoperative blood loss, what will be the primary outcome. As secondary endpoints following outcomes will be measured: quality of operating space, intraoperative adverse events, quality of recovery, postoperative renal function, 30-day postoperative complications rate, length of hospital stay. The investigators assume that lower pneumoperitoneum provides non-inferior blood loss control during laparoscopic liver resection with better postoperative results.
Read the detailed description
After signing the informed consent patients will be randomized into 2 groups. Randomization will be conducted by investigators via drawing a sealed envelope with computer-generated intervention code at the Department just before patient transfer to the operating theatre. There will be two study arms with 1:1 fashion
For both trial arms additional routine elements of perioperative anesthesia care will be defined:
- low central vein pressure, aimed for 5 ± 2 mmHg with restrictive fluid therapy
- ventilation in a volume-controlled mode without intraoperative high positive end-expiratory pressure (PEEP)
- invasive arterial blood pressure monitoring with maintaining mean arterial pressure ≥ 60 mmHg
- maintaining hemoglobin concentration > 8g/dl
- maintaining normothermia and normoglycemia
- maintaining oxygenation >94%, in case of hypercapnia with respiratory acidosis, the respiratory rate and tidal volume will be stepwise increased
The surgeon will be blinded to the study arm and level of pneumoperitoneum pressure.
The blood loss during liver parenchyma transection and total procedure blood loss will be reported based on the amount of sucked outside intraperitoneal fluids after liver transection and after procedure without volume inserted for intraperitoneal irrigation. The estimated blood loss will be measured in milliliters. Patients who are converted to open surgery are excluded from the analysis of the primary end-point.
During the procedure, the surgeon will be asked regularly to rate the quality of operating space in accordance to the Leiden Surgical Rating Scale. In case of inadequate operating space, pneumoperitoneum pressure may be increased by 2 mmHg (with maximum of 16 mmHg in arm 1. and 12 mmHg in arm 2.). Intraoperative adverse events will be assessed in accordance to ClassIntra classification. Quality of recovery (QoR) will be measured on postoperative day 1, 3 and 5 with patient reported QoR-40 questionnaire, 30-day postoperative complication rate will be assessed in accordance to Clavien-Dindo classification. Length of hospital stay will be counted from the date of surgery to the discharge day. All patients will be followed up by researchers who are blinded to the intraoperative grouping.
- Conditions
- Liver Tumor
- Being tested
- Pneumoperitoneum 14mmHg, Pneumoperitoneum 10mmHg
- Keywords
- laparoscopic liver resection, pneumoperitoneum pressure, blood loss
- Medical subject headings
- Carcinoma, Hepatocellular, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumoperitoneum 14mmHgProcedure or surgery
Performing surgery in 14mmHg pneumoperitoneum pressure
Pneumoperitoneum 10mmHgProcedure or surgery
Performing surgery in 10mmHg pneumoperitoneum pressure
| Study group | Role | What they receive |
|---|---|---|
| Standard pneumoperitoneum pressure | Active comparator | Laparoscopic liver resection performed in standard (14mmHg) pneumoperitoneum pressure Receives: Procedure: Pneumoperitoneum 14mmHg |
| Low pneumoperitoneum pressure | Experimental | Laparoscopic liver resection performed in low (10mmHg) pneumoperitoneum pressure Receives: Procedure: Pneumoperitoneum 10mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Intraoperative blood loss in ml
Measured: Intraoperative
Secondary outcomes (5)
Quality of the operating space
Expressed in accordance to Leiden scale (L-SRS) and the rate of need for increase of pneumoperitoneum pressure
Score 1-5 (where 1 means extremely poor conditions; 5- optimal conditions)
From multiple measurements, value submitted for analysis will be the lowest reported during the surgery.
Measured: Intraoperative
Intraoperative adverse events
Expressed in accordance to ClassIntra scale
Grades 0-V (where 0 means no deviation; V- intraoperative death of the patient)
Measured: Intraoperative
Quality of postoperative rehabilitation
Expressed in accordance to questionaire QoR-40
40 questions with 1-5 points each (total score minimum 40 points; maximum 200 points)
Measured: Postoperative day 1, Postoperative day 3, Postoperative day 5
Risk of postoperative complications
Expressed in accordance to Clavien-Dindo classification in 30-day postoperative period
Measured: 30 postoperative days
Length of hospital stay
Expressed in days
Measured: From date of surgery until the date of disscharge or date of death from any cause, whichever came first, assessed up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Jan 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University, Regional Oncology Center, Białystok, Poland
- Responsible party
- Principal investigator, Wacław Hołówko, Medical University of Warsaw
- Investigators
- Wacław Hołówko, MD, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060899
- Sponsor's protocol ID
- KB/160/2022
- Status last verified
- Sep 2024
- First submitted
- 26 Aug 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol will be published in a journal
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06060899
- Acronym / sponsor ID
- KB/160/2022
- Conditions
- Liver Tumor
- Keywords
- laparoscopic liver resection, pneumoperitoneum pressure, blood loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Jagiellonian University, Regional Oncology Center, Białystok, Poland
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 29 Sep 2023 (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.
Commonly the pressure of about 14 mmHg is applied during laparoscopic liver resection (LLR) with moderate neuromuscular blockade. Lowering the pneumoperitoneum pressure combined with deep neuromuscular blockade may sustain optimal operating space with providing better short-term postoperative results. It has been proved in randomized controlled trials in colorectal or bariatric patients, however there is lack of similar data for laparoscopic liver resection. Doubts about lowering the pneumoperitoneum pressure too hasty are supported by apprehension of worse bleeding control during liver parenchyma transection and its impact on postoperative results.
The aim of the trial is to assess the impact of standard (14 mmHg; arm 1) versus low (10 mmHg; arm 2) pneumoperitoneum pressure on intraoperative blood loss, what will be the primary outcome. As secondary endpoints following outcomes will be measured: quality of operating space, intraoperative adverse events, quality of recovery, postoperative renal function, 30-day postoperative complications rate, length of hospital stay. The investigators assume that lower pneumoperitoneum provides non-inferior blood loss control during laparoscopic liver resection with better postoperative results.
Detailed description
After signing the informed consent patients will be randomized into 2 groups. Randomization will be conducted by investigators via drawing a sealed envelope with computer-generated intervention code at the Department just before patient transfer to the operating theatre. There will be two study arms with 1:1 fashion
For both trial arms additional routine elements of perioperative anesthesia care will be defined:
- low central vein pressure, aimed for 5 ± 2 mmHg with restrictive fluid therapy
- ventilation in a volume-controlled mode without intraoperative high positive end-expiratory pressure (PEEP)
- invasive arterial blood pressure monitoring with maintaining mean arterial pressure ≥ 60 mmHg
- maintaining hemoglobin concentration > 8g/dl
- maintaining normothermia and normoglycemia
- maintaining oxygenation >94%, in case of hypercapnia with respiratory acidosis, the respiratory rate and tidal volume will be stepwise increased
The surgeon will be blinded to the study arm and level of pneumoperitoneum pressure.
The blood loss during liver parenchyma transection and total procedure blood loss will be reported based on the amount of sucked outside intraperitoneal fluids after liver transection and after procedure without volume inserted for intraperitoneal irrigation. The estimated blood loss will be measured in milliliters. Patients who are converted to open surgery are excluded from the analysis of the primary end-point.
During the procedure, the surgeon will be asked regularly to rate the quality of operating space in accordance to the Leiden Surgical Rating Scale. In case of inadequate operating space, pneumoperitoneum pressure may be increased by 2 mmHg (with maximum of 16 mmHg in arm 1. and 12 mmHg in arm 2.). Intraoperative adverse events will be assessed in accordance to ClassIntra classification. Quality of recovery (QoR) will be measured on postoperative day 1, 3 and 5 with patient reported QoR-40 questionnaire, 30-day postoperative complication rate will be assessed in accordance to Clavien-Dindo classification. Length of hospital stay will be counted from the date of surgery to the discharge day. All patients will be followed up by researchers who are blinded to the intraoperative grouping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard pneumoperitoneum pressure | Active comparator | Procedure: Pneumoperitoneum 14mmHgLaparoscopic liver resection performed in standard (14mmHg) pneumoperitoneum pressure |
| Low pneumoperitoneum pressure | Experimental | Procedure: Pneumoperitoneum 10mmHgLaparoscopic liver resection performed in low (10mmHg) pneumoperitoneum pressure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled to perform elective laparoscopic major liver resection
- Age of 18 years or older
- Signed informed consent
Key exclusion criteria (6 listed)
- Severe cardiopulmonary disease
- Severe renal disease
- Liver cirrhosis
- Emergency surgery
- Pregnancy
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 14mmHgPerforming surgery in 14mmHg pneumoperitoneum pressure | Procedure or surgery | Standard pneumoperitoneum pressure |
| Pneumoperitoneum 10mmHgPerforming surgery in 10mmHg pneumoperitoneum pressure | Procedure or surgery | Low pneumoperitoneum pressure |
Primary outcome
Intraoperative blood loss
Time frame: Intraoperative
Intraoperative blood loss in ml
5 secondary outcomes
Quality of the operating space
Time frame: Intraoperative
Intraoperative adverse events
Time frame: Intraoperative
Quality of postoperative rehabilitation
Time frame: Postoperative day 1, Postoperative day 3, Postoperative day 5
Risk of postoperative complications
Time frame: 30 postoperative days
Length of hospital stay
Time frame: From date of surgery until the date of disscharge or date of death from any cause, whichever came first, assessed up to 100 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. Protocol will be published in a journal
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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.
Wacław Hołówko, MD, PhD principal investigator
Medical University of Warsaw
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 14mmHg and Pneumoperitoneum 10mmHg in people with Liver Tumor, run by Medical University of Warsaw at 1 site in Poland.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 Poland. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.