NCT07594834

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
49mo left

Started Jun 2026

Typical duration for not_applicable lung-cancer

Status
not yet recruiting

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

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 30, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

May 19, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 12, 2026

Last Update Submit

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

EXPERIMENTAL
Procedure: Pulmonary artery embolization

control group

NO INTERVENTION

Interventions

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.

experimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

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