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

NCT07291271 | Completed FDA Device

• 1 other identifier: METc-number: 2024.0386
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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 (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. 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.

Conditions

Ventilation; Ablation Techniques

Keywords

Flow controlled ventilation; Volume controlled ventilation; Liver tumor; Percutaneous ablation; CT-guided ablation

Outcome Measures

Primary Outcomes (1)

• Switch from flow controlled ventilation to volume controlled ventilation

  Switch if deemed necessary by the anesthesiologist performing the ventilation.

  During the CT-guided percutaneous ablation procedure

Secondary Outcomes (2)

• Image-based analyses

  During the ablation procedure

• Modified five-point Surgical Rating Scale

  Directly after the ablation procedure

Study Arms (2)

Flow controlled ventilation

Patients recieving CT-guided percutaneous ablation, ventilated with flow controlled ventilation

Device: Flow controlled ventilation

Volume controlled ventilation

Patients recieving CT-guided percutaneous ablation, ventilated with volume controlled ventilation

Interventions

Flow controlled ventilation DEVICE

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

Flow controlled ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for CT-guided percutaneous ablation of liver tumors

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, 1081HV, Netherlands

Location

MeSH Terms

Conditions

Respiratory Aspiration; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drs, MD.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 18, 2025
• Study Start: August 20, 2024
• Primary Completion: May 20, 2025
• Study Completion: November 20, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

NL (1)