Can lower pressure make complex surgery safer and speed recovery?
NCT ID NCT07782580
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial investigates whether using a lower gas pressure (6-10 mmHg) with a special AirSeal system during minimally invasive liver and pancreas surgery is feasible and safe, compared to the standard higher pressure (10-15 mmHg). The study will enroll 70 adults undergoing major minimally invasive hepatopancreatobiliary procedures. The goal is to see if the low-pressure approach can be maintained without frequent pressure increases, and to assess its effects on pain, recovery, and complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Low-pressure AirSeal insufflation (a device that maintains gas pressure in the abdomen during minimally invasive surgery)
- What this could lead to
- If low-pressure AirSeal proves feasible and safe, it could lead to a new standard for minimally invasive liver and pancreas surgery, potentially improving recovery and reducing complications.
- What could go wrong
- This is an early feasibility trial with only 70 participants, so results may not be definitive. Low pressure might not provide adequate surgical visibility or could increase complications, and the approach may not work for all patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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As listed by the trial registrant
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How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
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A doctor treating you
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