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NCT Number: NCT07594834

Clinical Study on the Effects of Pulmonary Vessels on Cryoablation and Preventive Embolization Strategies

This study targeted high-risk individuals with incomplete ablation and performed selective pulmonary artery embolization before lung cryoablation, which could enhance the therapeutic effect and reduce the risk of intraoperative bleeding. Previous studies have shown that selective pulmonary artery embolization before ablation has no adverse reactions related to embolization. In this study, gelatin sponge particles were used for selective pulmonary artery embolization. Gelatin sponge is an absorbable embolic material that can be absorbed and degraded in the human body within about 7 days, which has high safety and a low probability of adverse reactions. The surgical risks are detailed in the surgical protocol. The study aims to optimize the lung cryoablation strategy for high-risk individuals with incomplete ablation, aiming to improve the prognosis of high-risk recurrent patients. The two groups of patients underwent lung CT reexamination every three months after surgery to observe the tumor ablation situation.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals at high risk of incomplete ablation (for example, there are vessels with a diameter greater than 3mm within 1cm around the pulmonary nodule);
  • Scheduled for lung cryoablation, meeting the surgical indications and without any specific contraindications;
  • The long diameter of the lung tumor is less than 3cm;
  • The single cryoablation needle will be used. -

Exclusion criteria

  • Postoperative complications such as massive pneumothorax and bleeding occurred, which affected the observation of the ice ball's shape;
  • Poor image quality or incomplete images. -

Treatment and study plan

Pulmonary artery embolization

Procedure

In this study, using DSA guidance, gelatin sponge particles were used to artificially embolize the thicker pulmonary arteries around the tumor, thereby reducing the heat sink effect and complications, and improving the efficacy of lung cryoablation.

Primary outcomes

  1. ablation zone

    Time frame: Immediately assess the extent of the ablation after the ablation needle is withdrawn.

    The CT images obtained during the operation are subjected to three-dimensional reconstruction, and the ROI is delineated. The long diameter, short diameter and volume of the ablation area are measured.Compare the values of various aspects of the smiling areas between the experimental group and the control group.

Sponsors and collaborators

Lead sponsor

Haibo Shao

Other

Registry information

Official study title

This Study Aims to Provide New Evidence for Optimizing the Lung Cryoablation Strategy by Targeting High-risk Individuals With Incomplete Ice Ball Morphology in Lung Cryoablation. This is Achieved Through the Use of Selective Pulmonary Artery Embolization.

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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