Clinical Study on the Effects of Pulmonary Vessels on Cryoablation and Preventive Embolization Strategies
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.
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Jun 2026
Typical duration for not_applicable lung-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2026
CompletedFirst Posted
Study publicly available on registry
May 19, 2026
CompletedStudy Start
First participant enrolled
June 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
Study Completion
Last participant's last visit for all outcomes
June 30, 2030
May 19, 2026
April 1, 2026
1 year
April 12, 2026
May 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
ablation zone
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.
Immediately assess the extent of the ablation after the ablation needle is withdrawn.
Study Arms (2)
experimental group
EXPERIMENTALcontrol group
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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. -
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haibo Shaolead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- offices director
Study Record Dates
First Submitted
April 12, 2026
First Posted
May 19, 2026
Study Start (Estimated)
June 30, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2030
Last Updated
May 19, 2026
Record last verified: 2026-04