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Pneumothorax Safety of Pleural-Depth-Trimmed Hookwires for Lung Nodule Localization

NCT07300072 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1072

Last updated 2025-12-23

No results posted yet for this study

Summary

The goal of this observational study is to learn about the pneumothorax risk associated with the Pleural-Depth-Trimmed Hookwire (PDTH) technique in patients undergoing Preoperative CT-Guided Lung Nodule Localization (POCTGL). The main question it aims to answer is: Does the specialized PDTH technique increase the risk of iatrogenic pneumothorax compared to dye-only localization in a setting utilizing advanced puncture guidance?. Participants were a retrospective cohort of patients who underwent POCTGL procedures between 2015 and 2022, and their procedural data and post-procedural complications were analyzed.

Conditions

  • Lung Nodules
  • Pneumothorax Iatrogenic Postprocedural
  • Propensity Score Matching

Interventions

PROCEDURE

Preoperative CT-Guided Lung Nodule Localization with Pleural-Depth-Trimmed Hookwire (PDTH) Technique

The PDTH Technique is a modified localization method using the U.S. FDA-regulated Hawkins II hookwire (Argon Medical Devices, US). The standard wire is pre-trimmed to only exceed the nodule-to-pleura depth by a minimal 5 mm to 10 mm. This crucial modification aims to reduce iatrogenic pneumothorax risk by preventing excessive wire length from protruding and causing pleural friction or trauma during the procedure. This technique is primarily used for deeper lesions (\>30 mm from the pleura) and is integrated with the Laser Angle Guide Assembly (LAGA) system to ensure precise needle insertion and a dual patent blue vital dye tattooing strategy.

PROCEDURE

Preoperative CTGuided Lung Nodule Localization with Patent Blue Vital Dye (PBVD) Localization Technique

This intervention serves as the comparison group for the Pleural-Depth-Trimmed Hookwire (PDTH) technique in the Propensity Score Matching (PSM) analysis. This localization method utilizes only a vital dye marker and is generally associated with a lower complication risk due to its non-solid nature. Localization Marker: Patent blue vital dye (PBVD; Guerbet, France, 2.5%). Indication: The dye-only method was typically used for target lesions located within 20 mm of the pleura. Procedure: Two dye tattoos were marked on the lung parenchyma using a thinner 23-gauge, 89 mm spinal needle or a 23-gauge, 70 mm spinal needle. Guidance: Procedures were conducted under CT guidance, utilizing the Laser Angle Guide Assembly (LAGA) system. Purpose: In the context of this study, this group provides the benchmark comparison to determine the non-inferiority of the PDTH technique regarding the risk of iatrogenic pneumothorax.

Sponsors & Collaborators

  • Chung Shan Medical University

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2022-01-31
Completion
2022-01-31
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300072 on ClinicalTrials.gov