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

NCT07782580 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-24

No results posted yet for this study

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.

Conditions

  • Hepato-Pancreato-Biliary Conditions Requiring Minimally Invasive Surgery

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.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    collaborator OTHER

  • Juan Glinka

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-03-01
Completion
2028-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07782580 on ClinicalTrials.gov