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

Chung Shan Medical University

Status: Completed

Conditions: Pneumothorax Iatrogenic Postprocedural; Propensity Score Matching; Lung Nodules

Treatments: Procedure: Preoperative CTGuided Lung Nodule Localization with Patent Blue Vital Dye (PBVD) Localization Technique; Procedure: Preoperative CT-Guided Lung Nodule Localization with Pleural-Depth-Trimmed Hookwire (PDTH) Technique

Study type: Observational

Funder types: Other

Identifiers

NCT07300072

CS2-25160

Details and patient eligibility

About

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.

Full description

The unique contribution of this retrospective cohort study lies in its rigorous evaluation of an institutional, multi-component protocol for Preoperative CT-Guided Lung Nodule Localization (POCTGL), specifically focusing on the safety of the Pleural-Depth-Trimmed Hookwire (PDTH) technique when used in conjunction with the Laser Angle Guide Assembly (LAGA) system.

Specialized Intervention Technique Pleural-Depth-Trimmed Hookwire (PDTH)

Technical Rationale: The PDTH technique was developed to mitigate the high pneumothorax risk (historically reported up to 35%) associated with standard hookwires. This risk is hypothesized to result from the excessive length of the traditional hookwire protruding from the chest wall, causing friction and pleural trauma during patient movement and respiration.

Execution: The standard localization hookwire (Hawkins II) is pre-trimmed prior to insertion. Its length is adjusted to only exceed the measured distance from the pleural surface to the target nodule by a minimal margin (5 mm∼10 mm), effectively eliminating the long, protruding segment.

Combined Approach: For deep lesions (typically >30 mm from the pleura), the PDTH is used in combination with a dual patent blue vital dye (PBV) tattooing strategy, providing multiple locational markers for the subsequent Video-Assisted Thoracoscopic Surgery (VATS).

Laser Angle Guide Assembly (LAGA)

The protocol incorporates the LAGA system, a device that provides visual, objective guidance for the needle trajectory. This system's primary benefit is to improve the accuracy of the initial puncture, which directly correlates with reducing the number of puncture attempts, a critical modifiable risk factor for pneumothorax confirmed by this study.

Rigorous Statistical Methodology

To provide a robust comparison despite the non-randomized, observational nature of the data, the study employed advanced statistical methods:

Generalized Estimating Equations (GEE): Used to identify independent risk factors for pneumothorax across the entire cohort. GEE was crucial for accounting for the non-independence of observations, as many patients underwent multiple procedures or had multiple nodules localized within a single session.

Propensity Score Matching (PSM): Utilized to control for selection bias inherent in marker choice (PDTH vs. dye-only). PSM was performed strictly on the first-localized nodule from each procedure, employing a 1:1 nearest-neighbor match, adjusted for key confounding variables like lobe location and specific patient position.

Clinical Implications

The study reports an overall iatrogenic pneumothorax rate of 5.6%, which is substantially lower than historical data, supporting the efficacy of the comprehensive protocol. Crucially, both GEE and PSM analyses confirmed that the use of the PDTH technique was not associated with an increased risk of pneumothorax compared to the dye-only localization group (PSM comparison: p=0.662), validating the specialized, modified hookwire technique as a safe option within this low-risk protocol.

Enrollment: 1,072 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Consecutive series of patients who underwent Preoperative Computed Tomography-Guided Lung Nodule Localization (POCTGL) at our medical center between September 2015 and January 2022.
• All included procedures were performed in patients who subsequently underwent Video-Assisted Thoracoscopic Surgery (VATS) lung resection on the same day.

Exclusion Criteria For the primary Generalized Estimating Equations (GEE) analysis:

• Nodules localized after a pneumothorax event occurred (n=59) were excluded.

Exclusion Criteria For the Propensity Score Matching (PSM) analysis:

• Nodules localized after a pneumothorax event (n=59).
• Nodules that were not the first localized nodule during the POCTGL procedure (n=495).
• Nodules associated with a previous ipsilateral VATS (n=16).

Trial design

1,072 participants in 2 patient groups

Hookwire-Localized

Description:

This group consists of lung nodules that were localized using the Pleural-Depth-Trimmed Hookwire (Hawkins II breast localization needles, pre-trimmed to exceed the nodule-to-pleura depth by 5 mm to10 mm) combined with dye tattoos. This approach was primarily used for target lesions located \>30 mm from the pleura. In the PSM analysis, this group served as the intervention group (n=237).

Treatment:

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

Non-Hookwire-Localized

Description:

This group consists of lung nodules localized using only the Patent Blue Vital Dye. This method was used for target lesions located within 20 mm of the pleura. In the PSM analysis, this group served as the comparison group (n=237).

Treatment:

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