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| Name | Class |
|---|---|
| University of Ulm | OTHER |
| University Hospital Dresden | OTHER |
| Groeninge Hospital, Kortrijk, Belgium | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative blood loss | From the time of randomization until the completion of the liver surgery, assessed up to 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CO2 embolisms | Incidence of CO2 embolisms in the right atrioventricular system detected by intraoperative transesophageal echocardiography | intraoperative |
| Morbidity rate | Postoperative complication rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arianeb Mehrabi, Professor | Contact | 004962215636223 | arianeb.mehrabi@med.uni-heidelberg.de |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41327288 | Derived | 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. |
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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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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.
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| 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. |
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| 90 days postoperative |
| Mortality rate | Postoperative mortality | 90 days postoperative |
| ID | Term |
|---|---|
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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