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

May 17, 2026 updated by: Haibo Shao

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Procedure: Pulmonary artery embolization
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.
No Intervention: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately assess the extent of the ablation after the ablation needle is withdrawn.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haibo Shao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

April 12, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026GSlungcryo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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