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NOT YET RECRUITING
NCT07782580
NA

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

Sponsor: Juan Glinka

View on ClinicalTrials.gov

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.

Official title: Low-Pressure AirSeal Versus Conventional Insufflation in Major Minimally Invasive Hepatopancreatobiliary Surgery - A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-08-31

Completion Date

2028-03-01

Last Updated

2026-08-24

Healthy Volunteers

No

Interventions

PROCEDURE

Low Pressure AirSeal Insufflation

Standard insufflation in minimally invasive HPB surgeries is maintained at 10-15mmHg. Low pressure AirSeal insufflation will maintain pressure at 6-10mmHg, using the AirSeal system.