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临床试验/NCT07300072
NCT07300072已完成不适用

Pneumothorax Risk and Pleural-Depth-Trimmed Hookwire: A Retrospective Cohort Study With Propensity Score Matching in Preoperative CT-Guided Lung Nodule Localization

Chung Shan Medical University1 个研究点 分布在 1 个国家目标入组 1,072 人开始时间: 2015年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
1,072
试验地点
1
主要终点
Iatrogenic Pneumothorax Rate

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Consecutive series of patients who underwent Preoperative Computed Tomography-Guided Lung Nodule Localization (POCTGL) at our medical center between September 2015 and January
  • 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).

排除标准

  • 未提供

结局指标

主要结局

Iatrogenic Pneumothorax Rate

时间窗: Immediately following the localization procedure, documented on the final confirmatory CT scan.

The primary outcome is the incidence of iatrogenic pneumothorax documented as air presence on post-localization Computed Tomography (CT) scans. Pneumothorax was considered significant if the airspace thickness exceeded 3 cm. The rate was assessed to identify independent risk factors and to compare the safety of the Pleural-Depth-Trimmed Hookwire (PDTH) technique against non-hookwire localization.

次要结局

  • Requirement for Catheter Aspiration(Immediately post-localization, during the POCTGL procedure documentation.)
  • Incidence of Other Adverse Events(Documented in real-time during the POCTGL procedure.)
  • Technical Factors Associated with Pneumothorax(Assessed based on real-time procedural data collected during the POCTGL procedure.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guo-Zhi Wang

Attending Physician

Chung Shan Medical University

研究点 (1)

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