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NCT Number: NCT06770803

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

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.

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Key information

Conditions

Liver Surgery Digestive System Diseases Major Liver Resection Minimal Invasive Surgery Peritoneal Diseases Pneumoperitoneum

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Pressure Pneumoperitoneum

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

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.

Primary outcomes

  1. Intraoperative blood loss

    Time frame: From the time of randomization until the completion of the liver surgery, assessed up to 24 hours.

Secondary outcomes

  1. Incidence of CO2 embolisms

    Time frame: intraoperative

    Incidence of CO2 embolisms in the right atrioventricular system detected by intraoperative transesophageal echocardiography

  2. Morbidity rate

    Time frame: 90 days postoperative

    Postoperative complication rate

  3. Mortality rate

    Time frame: 90 days postoperative

    Postoperative mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Arianeb Mehrabi, Professor

CONTACT

[email protected]

004962215636223

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • Groeninge Hospital, Kortrijk, Belgium
  • University Hospital Dresden
  • University of Ulm

Registry information

Official study title

High Versus Low Pneumoperitoneum PressUre for Parenchymal Transection in Minimally Invasive Major Liver Surgery - a Non-inferiority, Multicenter, Randomized, Controlled Trial

Acronym: PPULS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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