Can lower pressure make complex surgery safer and speed recovery?

NCT ID NCT07782580

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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