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VentilationEVOLVENCT07291271

Use of Flow-Controlled Ventilation During CT-Guided Percutaneous Liver Tumor Ablation

An observational study of Ventilation and Ablation Techniques, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Tumors in the liver can be treated using percutaneous ablation. At the Amsterdam UMC, this procedure is often performed under CT guidance by an interventional radiologist. The available ablation techniques include thermal ablation (microwave ablation (MWA) and radiofrequency ablation (RFA)) and non-thermal ablation… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventilation, Ablation Techniques
Type of treatment
Medical device
How many people
41 participants
Where
1 siteNetherlands
Study dates
20 Aug 2024to 20 Nov 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients eligible for CT-guided percutaneous ablation of liver tumors

Who may be able to join

  • Clinical indication for CT-guided percutaneous ablation of one or more liver tumours
  • Approval for general anaesthesia

Who cannot join

  • Procedures performed under procedural sedation
  • Uncontrolled asthma, and (4) COPD classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage III or IV
  • No signed informed consent form

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Amsterdam UMC, location VUmc

    Amsterdam, 1081HV

Other trials in Netherlands

About this study

Official title: Flow-controlled Ventilation During Percutaneous CT-guided Liver Tumor Ablation

Tumors in the liver can be treated using percutaneous ablation. At the Amsterdam UMC, this procedure is often performed under CT guidance by an interventional radiologist. The available ablation techniques include thermal ablation (microwave ablation (MWA) and radiofrequency ablation (RFA)) and non-thermal ablation (irreversible electroporation (IRE)). Thermal ablation is performed under general anesthesia or deep sedation, whereas non-thermal ablation is always performed under general anesthesia.

Flow-controlled ventilation (FCV) is a ventilation technique in which increased diaphragm stability is observed due to a continuous flow during both inspiration and expiration. This contrasts with volume- or pressure-controlled ventilation, where active inspiration is followed by passive expiration through an increase in pressure or flow, leading to greater diaphragm movement during the ventilation cycle. With volume- or pressure-controlled ventilation, diaphragm position fluctuates between inspiration and expiration, requiring temporary pauses in ventilation (apnea; allowing the diaphragm to become motionless) during ablation needle positioning.

Read more

During volume- or pressure-controlled ventilation and the associated apnea periods, increased formation of atelectasis is often observed. This results in changes in diaphragm position during and after each apnea, which can complicate accurate needle placement. With FCV, apnea is not necessary-the continuous flow results in minimal diaphragm excursion and can be maintained throughout the entire procedure without interruption.

Both ventilation modes are currently used during CT-guided percutaneous ablation of liver and pancreatic tumors. However, the choice of ventilation technique presently lies with the attending anesthesiologist. In practice, some anesthesiologists prefer volume- or pressure-controlled ventilation, as these are traditionally the most commonly used modes. Others opt for FCV due to its minimal effect on diaphragm excursion and its potentially beneficial effects on atelectasis formation and intraprocedural image quality.

Given the subdiaphragmatic location of both organs and the presence of critical surrounding structures that must be preserved during the procedure, interventional radiologists find FCV particularly advantageous. Moreover, continuous ventilation without apnea is preferred by anesthesiologists, as it avoids periods of reduced oxygenation.

FCV is an already approved ventilation technique at Amsterdam UMC and is used during percutaneous ablations, surgeries performed by ENT and pulmonary specialists, and in the intensive care unit for critically ill patients. Through this study, the investigators aim to evaluate the use of FCV as a ventilation technique during CT-guided percutaneous ablations of liver tumors and to compare it with volume- or pressure-controlled ventilation.

Being tested
Flow controlled ventilation
Keywords
Flow controlled ventilation, Volume controlled ventilation, Liver tumor, Percutaneous ablation, CT-guided ablation
Medical subject headings
Respiratory Aspiration, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flow controlled ventilationDevice

    Flow controlled ventilation will be investigated during CT-guided percutaneous ablation of liver tumors

Study groups in NCT07291271
Study groupRoleWhat they receive
Flow controlled ventilationPatients recieving CT-guided percutaneous ablation, ventilated with flow controlled ventilation
Receives: Device: Flow controlled ventilation
Volume controlled ventilationPatients recieving CT-guided percutaneous ablation, ventilated with volume controlled ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Switch from flow controlled ventilation to volume controlled ventilation

    Switch if deemed necessary by the anesthesiologist performing the ventilation.

    Measured: During the CT-guided percutaneous ablation procedure

Secondary outcomes (2)
  1. Image-based analyses

    Comparison of diaphragm movement by segmenting the pulmonary bases in pre- and post-ablation images and assessment of intra-procedural atelectasis formation.

    Measured: During the ablation procedure

  2. Modified five-point Surgical Rating Scale

    Completed by the interventional radiologist to assess the suitability of FCV for the procedure.

    Score can vary from 0-25, where 25 is the highest score.

    Measured: Directly after the ablation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start20 Aug 2024
  3. Primary completion20 May 2025
  4. Study completion20 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07291271
Sponsor's protocol ID
METc-number: 2024.0386
Acronym
EVOLVE
Status last verified
Dec 2025
First submitted
25 Nov 2025
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ventilation and Ablation Techniques, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Switch from flow controlled ventilation to volume controlled ventilation (time frame: During the CT-guided percutaneous ablation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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