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

NCT07300072 | Completed FDA Device

• 1 other identifier: CS2-25160
• Study Type: observational
• Target: 1,072
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pneumothorax; Lung nodule localization; Pleural-Depth-Trimmed Hookwire; Propensity score matching

Outcome Measures

Primary Outcomes (1)

• Iatrogenic Pneumothorax Rate

  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.

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

Secondary Outcomes (3)

• 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.

Study Arms (2)

Hookwire-Localized

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).

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

Non-Hookwire-Localized

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).

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

Interventions

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

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.

Non-Hookwire-Localized

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

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.

Hookwire-Localized

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The final analysis cohort included 1,072 POCTGL procedures. The procedures resulted in 1,567 evaluable lung nodules after the initial exclusion. Demographics: The median age was 55 years (IQR, 48-63). The cohort was predominantly women (74.6%) and nonsmokers (86.3%). Lesion Characteristics: The median lesion size was 6.5 mm (IQR, 5.0-8.0) , with a median depth from the pleura of 19 mm (IQR, 10.0-30.0). Procedure Type: Most procedures (90.3%) were for initial VATS , and the majority involved a single lesion (65.5%).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 402306, Taiwan

Location

Related Publications (16)

• Huang JY, Tsai SC, Wu TC, Lin FC. Puncture frequency predicts pneumothorax in preoperative computed tomography-guided lung nodule localization for video-assisted thoracoscopic surgery. Thorac Cancer. 2022 Jul;13(13):1925-1932. doi: 10.1111/1759-7714.14457. Epub 2022 May 25.

  PMID: 35614380 BACKGROUND

• Tsai SC, Wu TC, Lai YL, Lin FC. Preoperative computed tomography-guided pulmonary nodule localization augmented by laser angle guide assembly. J Thorac Dis. 2019 Nov;11(11):4682-4692. doi: 10.21037/jtd.2019.10.60.

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• Lin FC, Tsai SC, Tu HT, Lai YL, Wu TC. Computed tomography-guided localization with laser angle guide for thoracic procedures. J Thorac Dis. 2018 Jun;10(6):3824-3828. doi: 10.21037/jtd.2018.05.162.

  PMID: 30069383 BACKGROUND

• Wang J, Yao J, Xu L, Shan L, Zhai R, Gao L, Liu L, Yao F. Comparison of cyanoacrylate and hookwire for localizing small pulmonary nodules: A propensity-matched cohort study. Int J Surg. 2019 Nov;71:49-55. doi: 10.1016/j.ijsu.2019.09.001. Epub 2019 Sep 12.

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• Sun X, Fu J, Ma C, Song Z, Yang S, Jin L, Duan F. CT-guided microcoil versus hook-wire localization of pulmonary nodule prior to video-assisted thoracoscopic surgery without fluoroscopic guidance. BMC Pulm Med. 2024 Oct 8;24(1):492. doi: 10.1186/s12890-024-03306-0.

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• Han R, Wang LF, Teng F, Lin J, Xian YT, Lu Y, Wu AL. Presurgical computed tomography-guided localization of lung ground glass nodules: comparing hook-wire and indocyanine green. World J Surg Oncol. 2024 Feb 10;22(1):51. doi: 10.1186/s12957-024-03331-7.

  PMID: 38336734 BACKGROUND

• Chu S, Wei N, Lu D, Chai J, Liu S, Lv W. Comparative study of the effect of preoperative hookwire and methylene blue localization techniques on post-operative hospital stay and complications in thoracoscopic pulmonary nodule surgery. BMC Pulm Med. 2022 Sep 5;22(1):336. doi: 10.1186/s12890-022-02129-1.

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• Yang F, Zhao H, Sui X, Zhang X, Sun Z, Zhao X, Wang J. Comparative study on preoperative localization techniques using microcoil and hookwire by propensity score matching. Thorac Cancer. 2020 Jun;11(6):1386-1395. doi: 10.1111/1759-7714.13365. Epub 2020 Mar 24.

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• Yamagami T, Terayama K, Yoshimatsu R, Matsumoto T, Miura H, Nishimura T. Role of manual aspiration in treating pneumothorax after computed tomography-guided lung biopsy. Acta Radiol. 2009 Dec;50(10):1126-33. doi: 10.3109/02841850903232707.

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• Park CH, Han K, Hur J, Lee SM, Lee JW, Hwang SH, Seo JS, Lee KH, Kwon W, Kim TH, Choi BW. Comparative Effectiveness and Safety of Preoperative Lung Localization for Pulmonary Nodules: A Systematic Review and Meta-analysis. Chest. 2017 Feb;151(2):316-328. doi: 10.1016/j.chest.2016.09.017. Epub 2016 Oct 4.

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• Zaman M, Bilal H, Woo CY, Tang A. In patients undergoing video-assisted thoracoscopic surgery excision, what is the best way to locate a subcentimetre solitary pulmonary nodule in order to achieve successful excision? Interact Cardiovasc Thorac Surg. 2012 Aug;15(2):266-72. doi: 10.1093/icvts/ivs068. Epub 2012 May 9.

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• Nakashima S, Watanabe A, Obama T, Yamada G, Takahashi H, Higami T. Need for preoperative computed tomography-guided localization in video-assisted thoracoscopic surgery pulmonary resections of metastatic pulmonary nodules. Ann Thorac Surg. 2010 Jan;89(1):212-8. doi: 10.1016/j.athoracsur.2009.09.075.

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• Saito H, Minamiya Y, Matsuzaki I, Tozawa K, Taguchi K, Nakagawa T, Hashimoto M, Hirano Y, Ogawa J. Indication for preoperative localization of small peripheral pulmonary nodules in thoracoscopic surgery. J Thorac Cardiovasc Surg. 2002 Dec;124(6):1198-202. doi: 10.1067/mtc.2002.127331.

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• Suzuki K, Nagai K, Yoshida J, Ohmatsu H, Takahashi K, Nishimura M, Nishiwaki Y. Video-assisted thoracoscopic surgery for small indeterminate pulmonary nodules: indications for preoperative marking. Chest. 1999 Feb;115(2):563-8. doi: 10.1378/chest.115.2.563.

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• Chang GC, Chiu CH, Yu CJ, Chang YC, Chang YH, Hsu KH, Wu YC, Chen CY, Hsu HH, Wu MT, Yang CT, Chong IW, Lin YC, Hsia TC, Lin MC, Su WC, Lin CB, Lee KY, Wei YF, Lan GY, Chan WP, Wang KL, Wu MH, Tsai HH, Chian CF, Lai RS, Shih JY, Wang CL, Hsu JS, Chen KC, Chen CK, Hsia JY, Peng CK, Tang EK, Hsu CL, Chou TY, Shen WC, Tsai YH, Tsai CM, Chen YM, Lee YC, Chen HY, Yu SL, Chen CJ, Wan YL, Hsiung CA, Yang PC; TALENT Investigators. Low-dose CT screening among never-smokers with or without a family history of lung cancer in Taiwan: a prospective cohort study. Lancet Respir Med. 2024 Feb;12(2):141-152. doi: 10.1016/S2213-2600(23)00338-7. Epub 2023 Nov 29.

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MeSH Terms

Conditions

Pneumothorax

Interventions

Methods

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: September 1, 2015
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Start Date: Upon request, 90 days after publication. End Date: Five years following study publication.
• Access Criteria: Access to the de-identified Individual Participant Data (IPD) and supporting documentation (e.g., Statistical Analysis Plan and Analytic Code ) will be considered for qualified researchers who meet the criteria for accessing confidential data. Who: Qualified researchers who submit a detailed research proposal and sign a data access agreement. What: De-identified IPD supporting the findings, along with the study protocol and statistical analytic code. How: Requests must be submitted to the Institutional Review Board (IRB) of Chung Shan Medical University Hospital, Taichung, Taiwan, for formal review and approval. Access will be granted following a privacy risk assessment by the IRB and/or relevant institutional committees.

Locations

TW (1)