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High versus low pneumoperitoneum PressUre for parenchymal transection in minimally invasive major liver surgery
Esther Giehl-Brown1, Elias Khajeh1, Sarah Dehne2
1Department of General, Visceral and Transplant Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 420, Heidelberg, 69120, Germany.
Background:
Low pneumoperitoneum pressure (LPP) lowers the incidence of CO2 embolisms in minimally invasive liver resections (MILR), while higher pneumoperitoneum pressure (HPP) reduces intraoperative blood loss. This contradiction necessitates careful pressure management especially in major liver resections where intraoperative blood loss greatly impacts postoperative outcome.
Methods:
In this randomized non-inferiority trial, adults undergoing elective MILR for any indication will be recruited in alignment with inclusion and exclusion criteria. After given informed consent, eligible patients will be randomized to either low (≤10 mmHg) or high (≥14 mmHg) pneumoperitoneum pressure during parenchymal transection. Blood, peritoneal biopsies, and liver tissue will be sampled to evaluate intraoperative tissue damage. Sample size (n = 66 patients per group) is calculated based on the current literature. The primary study endpoint is intraoperative blood loss during the parenchymal transection phase. Secondary endpoints include CO2 embolisms, intraoperative tissue damage, operation time, morbidity, mortality, and duration of hospitalization.
Discussion:
Minimizing intraoperative blood loss in MILR is a clinically relevant problem, which greatly impacts the procedure's safety and influences the patient's morbidity and mortality. HPP, exerting counter pressure to the vascular pressure, serves for bleeding control in MILR. The risk of CO2 embolism, arising from the combination of high intra-abdominal pressure and low central venous pressure, favors the use of LPP. The proposed trial aims to assess the non-inferiority of LPP compared to HPP during the parenchymal transection phase of MILR.
Trial Registration:
ClinicalTrials.gov NCT06770803. First Submitted: 2024-12-30, First Submitted that Met QC Criteria: 2025-01-07, First Posted: 2025-01-13.
Insights
This study compares low versus high pneumoperitoneum pressure in minimally invasive liver resections. It aims to determine if lower pressure is non-inferior for reducing blood loss while managing CO2 embolism risks.
Area of Science:
- Minimally invasive surgery
- Hepatobiliary surgery
- Surgical safety and outcomes
Background:
- Minimally invasive liver resections (MILR) present a challenge in balancing pneumoperitoneum pressure for optimal outcomes.
- Low pneumoperitoneum pressure (LPP) is associated with reduced CO2 embolism risk, while higher pneumoperitoneum pressure (HPP) is linked to decreased intraoperative blood loss.
- Managing pneumoperitoneum pressure is critical in major liver resections due to its impact on postoperative results.
Purpose of the Study:
- To assess the non-inferiority of LPP compared to HPP during the parenchymal transection phase of MILR.
- To evaluate the trade-offs between CO2 embolism risk and intraoperative blood loss in MILR.
- To optimize surgical safety and patient outcomes in complex liver resections.
Main Methods:
- A randomized non-inferiority trial involving adult patients undergoing elective MILR.
- Patients will be randomized to LPP (≤10 mmHg) or HPP (≥14 mmHg) during parenchymal transection.
- Primary endpoint: intraoperative blood loss; Secondary endpoints: CO2 embolisms, tissue damage, operation time, morbidity, mortality, and hospitalization duration. Sample size: 66 patients per group.
Main Results:
- The primary outcome is intraoperative blood loss during parenchymal transection.
- Secondary outcomes include CO2 embolism incidence, intraoperative tissue damage, operative time, and patient morbidity and mortality.
- Data on peritoneal biopsies and liver tissue will be analyzed to assess tissue damage.
Conclusions:
- Minimizing intraoperative blood loss is crucial for MILR safety and patient outcomes.
- HPP may aid bleeding control by exerting counter-vascular pressure.
- LPP is favored due to lower CO2 embolism risk, but its non-inferiority in blood loss control needs evaluation.
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