High Versus Low Pneumoperitoneum PressUre for Parenchymal Transection in Minimally Invasive Major Liver Surgery

NCT ID: NCT06770803

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2027-01-31

Brief Summary

Minimally invasive techniques in liver surgery gain popularity as they facilitate postoperative recovery while achieving comparable oncologic outcomes to the open approach. No consensus on the application of pneumoperitoneum pressure in minimal invasive liver resections (MILR) has been reached yet, as prospective clinical studies are scarce. The positive pressure of the CO2 pneumoperitoneum reduces intraoperative blood loss during MILR alongside the development of new transection devices and advancements in inflow control. Low-pressure pneumoperitoneum on the other hand has been shown to decrease postoperative pain scores and analgesic consumption in comparison to standard pneumoperitoneum, and international guidelines recommend the application of "the lowest intra-abdominal pressure allowing adequate exposure of the operative field rather than a routine pressure". Nevertheless, evidence for the application of low-pressure pneumoperitoneum is only moderate to low, requiring additional studies to better define its safety. To address this oxymoron, the investigators conduct a randomized non-inferiority trial to investigate the effect of low in comparison to high-pressure pneumoperitoneum during the transection phase of major MILR on intraoperative blood loss while also evaluating the risk of embolic complications.

Conditions

Liver Surgery; Minimal Invasive Surgery; Major Liver Resection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

High Pressure Pneumoperitoneum

Intraperitoneal insufflation pressures (IIP) during the parenchymal transection phase of liver resection will be different between the two study groups. Baseline IIP of the surgical procedure will be ≤10 mmHg. IIP will be elevated to ≥14 mmHg in the intervention group during the parenchymal transection phase of liver resection.

Group Type: ACTIVE_COMPARATOR

High Pressure Pneumoperitoneum

Intervention Type: PROCEDURE

The objective of this trial is to determine whether the maintenance of a low intraperitoneal insufflation pressure (IIP) of ≤10 mmHg during the parenchymal transection phase of conventional and robotic-assisted laparoscopic liver resection is non-inferior to a higher IIP of ≥14 mmHg in terms of intraoperative blood loss, gas embolisms, perioperative morbidity, and mortality.

Low Pressure Pneumoperitoneum

Intraperitoneal insufflation pressures (IIP) during the parenchymal transection phase of liver resection will be different between the two study groups. Baseline IIP of the surgical procedure will be ≤10 mmHg. IIP will be maintained at ≤10 mmHg in the control group.

Group Type: SHAM_COMPARATOR

Low Pressure Pneumoperitoneum

Intervention Type: PROCEDURE

The objective of this trial is to determine whether the maintenance of a low intraperitoneal insufflation pressure (IIP) of ≤10 mmHg during the parenchymal transection phase of conventional and robotic-assisted laparoscopic liver resection is non-inferior to a higher IIP of ≥14 mmHg in terms of intraoperative blood loss, gas embolisms, perioperative morbidity, and mortality.

Interventions

High Pressure Pneumoperitoneum

The objective of this trial is to determine whether the maintenance of a low intraperitoneal insufflation pressure (IIP) of ≤10 mmHg during the parenchymal transection phase of conventional and robotic-assisted laparoscopic liver resection is non-inferior to a higher IIP of ≥14 mmHg in terms of intraoperative blood loss, gas embolisms, perioperative morbidity, and mortality.

Intervention Type: PROCEDURE

Low Pressure Pneumoperitoneum

The objective of this trial is to determine whether the maintenance of a low intraperitoneal insufflation pressure (IIP) of ≤10 mmHg during the parenchymal transection phase of conventional and robotic-assisted laparoscopic liver resection is non-inferior to a higher IIP of ≥14 mmHg in terms of intraoperative blood loss, gas embolisms, perioperative morbidity, and mortality.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• age equal or older than 18 years and
• capacity of consent and
• planned elective conventional laparoscopic or da Vinci-assisted major liver resection or resections near the liver hilum or the hepatic venous vasculature. Major liver resections are defined as the resection of 3 liver segments or more (right and left partial hepatectomies, extended right and left hepatectomies, liver resections of 3 or more segments). Right posterior sectionectomies and mesohepatectomies of ≥2 liver segments are considered resections in proximity to the liver hilum or hepatic venous vasculature.

Exclusion Criteria

• the participation in another trial with interference of intervention and outcome of this study,
• being a woman who is pregnant or breast-feeding or planning to become pregnant,
• American Society of Anesthesiologists (AS) score >3,
• language barrier,
• any contraindication to a minimal invasive surgical approach or intolerance to pneumoperitoneum
• a patent foramen ovale (PFO) or any other structural cardiac defect that facilitates paradoxical gas embolisms,
• diagnosis of neuromuscular disease, heart failure NYHA > class II or chronic obstructive pulmonary disease (COPD)
• being on oral anticoagulation therapy other than Aspirin 100mg daily or any other condition known to increase the risk of bleeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: collaborator

University Hospital Dresden

OTHER

Sponsor Role: collaborator

Groeninge Hospital, Kortrijk, Belgium

UNKNOWN

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Arianeb Mehrabi, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Arianeb Mehrabi, Professor

Role: CONTACT

arianeb.mehrabi@med.uni-heidelberg.de

004962215636223

Other Identifiers

S-729/2024

Identifier Type: -

Identifier Source: org_study_id