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Not Yet Recruiting NCT07782580

Low-Pressure AirSeal Versus Conventional Insufflation in Major Minimally Invasive Hepatopancreatobiliary Surgery

Conditions: Hepato-Pancreato-Biliary Conditions Requiring Minimally Invasive Surgery

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: Juan Glinka

Summary

When performing minimally invasive (MIS) hepato-pancreato-biliary (HPB) surgery, an air seal is used for optimal space and visibility of the surgical field. This is typically done at a pressure of 10-15 mmHg, but can also come with risks of serious complications. HBP surgeries are high risk, prolonged, and complex, which all come with their own difficulties. Current pressure systems have shown pressure instability and leak conditions such as changing instruments and suctioning. When there is instability this can cause loss of visibility of the surgical field, which in complex surgeries, can lead to further complications. Lower pneumoperitoneum pressures may improve respiratory mechanics and early recovery but can be limited by poor exposure, smoke, and field instability. AirSeal's valveless system with continuous smoke evacuation may enable low-pressure surgery more reliably. Before a definitive efficacy trial, the investigators need to confirm feasibility of maintaining low pressure in major HPB cases and patient safety, while estimating effects on perioperative recovery and complications.

Eligibility Criteria

Inclusion Criteria: * Adults ≥18 years * Elective major minimally invasive HPB surgery (robotic or laparoscopic), including: Pancreaticoduodenectomy, Distal pancreatectomy, Major hepatectomy (≥3 segments) or complex liver resections as locally defined * Other major HPB MIS procedures per investigator definition Exclusion Criteria: * Emergency cases * Planned open surgery * Pregnancy * Unable to consent * Contraindication to pneumoperitoneum.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07782580). StuddyBuddy aggregates publicly available trial information.