Liver SurgeryPPULSNCT06770803
High Versus Low Pneumoperitoneum PressUre for Parenchymal Transection in Minimally Invasive Major Liver Surgery
A study testing High Pressure Pneumoperitoneum and Low Pressure Pneumoperitoneum in people with Liver Surgery and Minimal Invasive Surgery, run by University Hospital Heidelberg.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Surgery, Minimal Invasive Surgery, Major Liver Resection
- What is being tested?
- High Pressure Pneumoperitoneum and Low Pressure Pneumoperitoneum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: High Versus Low Pneumoperitoneum PressUre for Parenchymal Transection in Minimally Invasive Major Liver Surgery - a Non-inferiority, Multicenter, Randomized, Controlled Trial
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.
- Being tested
- High Pressure Pneumoperitoneum, Low Pressure Pneumoperitoneum
- Keywords
- Pneumoperitoneum, minimal-invasive liver surgery, intraoperative blood loss
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Pressure PneumoperitoneumProcedure or surgery
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 PneumoperitoneumProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| High Pressure Pneumoperitoneum | Active comparator | 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. Receives: Procedure: High Pressure Pneumoperitoneum |
| Low Pressure Pneumoperitoneum | Sham comparator | 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. Receives: Procedure: Low Pressure Pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Measured: From the time of randomization until the completion of the liver surgery, assessed up to 24 hours.
Secondary outcomes (3)
Incidence of CO2 embolisms
Incidence of CO2 embolisms in the right atrioventricular system detected by intraoperative transesophageal echocardiography
Measured: intraoperative
Morbidity rate
Postoperative complication rate
Measured: 90 days postoperative
Mortality rate
Postoperative mortality
Measured: 90 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (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 Liver SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Model description
- This trial is a multicenter, randomized, controlled, non-inferiority trial with a two-arm parallel-group design. Patients will be randomized to either the LPP or HPP group during the parenchymal transection phase of MILR. Study interventions include intraoperative measures such as blood sampling, peritoneal biopsies, and liver tissue collection to assess intraoperative tissue damage. Transesophageal echocardiography will be employed to detect CO2 embolisms, while the quality of the surgical field will be evaluated using the Leiden Surgical Rating Scale (L-SRS). Follow-up and data collection involves gathering postoperative data on morbidity, complications, and recovery quality, alongside analyzing blood and biopsy samples for cytokine and molecular markers. The study will also monitor long-term outcomes, including hospital readmission, survival rates, and histopathological findings in cases of malignancy.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulm, University Hospital Dresden, Groeninge Hospital, Kortrijk, Belgium
- Responsible party
- Principal investigator, Arianeb Mehrabi, MD, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770803
- Sponsor's protocol ID
- S-729/2024
- Acronym
- PPULS
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request, the data generated by the current research that supports our future article, would be made available as soon as possible, wherever legally and ethically possible.
Publications
Giehl-Brown E, Khajeh E, Dehne S, Czigany Z, Gutzeit O, Neuhaus C, Riediger C, Birgin E, Rahbari N, D'Hondt M, Lurje G, Weigand M, Michalski C, Mehrabi A, Kahlert C. High versus low pneumoperitoneum PressUre for parenchymal transection in minimally invasive major liver surgery (PPULS)-a non-inferiority, multicenter, randomized, controlled trial. Trials. 2025 Dec 1;26(1):556. doi: 10.1186/s13063-025-09269-9.
PubMed 41327288
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Versus Low Pneumoperitoneum PressUre for Parenchymal Transection in Minimally Invasive Major Liver Surgery - a Non-inferiority, Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06770803
- Acronym / sponsor ID
- PPULS / S-729/2024
- Keywords
- Pneumoperitoneum, minimal-invasive liver surgery, intraoperative blood loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- University of Ulm, University Hospital Dresden, Groeninge Hospital, Kortrijk, Belgium
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Jan 2025 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is a multicenter, randomized, controlled, non-inferiority trial with a two-arm parallel-group design. Patients will be randomized to either the LPP or HPP group during the parenchymal transection phase of MILR. Study interventions include intraoperative measures such as blood sampling, peritoneal biopsies, and liver tissue collection to assess intraoperative tissue damage. Transesophageal echocardiography will be employed to detect CO2 embolisms, while the quality of the surgical field will be evaluated using the Leiden Surgical Rating Scale (L-SRS). Follow-up and data collection involves gathering postoperative data on morbidity, complications, and recovery quality, alongside analyzing blood and biopsy samples for cytokine and molecular markers. The study will also monitor long-term outcomes, including hospital readmission, survival rates, and histopathological findings in cases of malignancy.
| Arm | Type | Receives |
|---|---|---|
| High Pressure Pneumoperitoneum | Active comparator | Procedure: High Pressure PneumoperitoneumIntraperitoneal 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. |
| Low Pressure Pneumoperitoneum | Sham comparator | Procedure: Low Pressure PneumoperitoneumIntraperitoneal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| High Pressure PneumoperitoneumThe 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. | Procedure or surgery | High Pressure Pneumoperitoneum |
| Low Pressure PneumoperitoneumThe 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. | Procedure or surgery | Low Pressure Pneumoperitoneum |
Primary outcome
Intraoperative blood loss
Time frame: From the time of randomization until the completion of the liver surgery, assessed up to 24 hours.
3 secondary outcomes
Incidence of CO2 embolisms
Time frame: intraoperative
Morbidity rate
Time frame: 90 days postoperative
Mortality rate
Time frame: 90 days postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Derived from this study: PubMed 41327288Giehl-Brown E, Khajeh E, Dehne S, Czigany Z, Gutzeit O, Neuhaus C, Riediger C, Birgin E, Rahbari N, D'Hondt M, Lurje G, Weigand M, Michalski C, Mehrabi A, Kahlert C. High versus low pneumoperitoneum PressUre for parenchymal transection in minimally invasive major liver surgery (PPULS)-a non-inferiority, multicenter, randomized, controlled trial. Trials. 2025 Dec 1;26(1):556. doi: 10.1186/s13063-025-09269-9.
- Individual participant dataSharing planned: Yes. Upon reasonable request, the data generated by the current research that supports our future article, would be made available as soon as possible, wherever legally and ethically possible.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing High Pressure Pneumoperitoneum and Low Pressure Pneumoperitoneum in people with Liver Surgery and Minimal Invasive Surgery, run by University Hospital Heidelberg.
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 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: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arianeb Mehrabi, Professor (004962215636223, arianeb.mehrabi@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: From the time of randomization until the completion of the liver surgery, assessed up to 24 hours.). 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 NCT06770803, 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 13 Jan 2025.