Lung NodulesNCT07300072
Pneumothorax Safety of Pleural-Depth-Trimmed Hookwires for Lung Nodule Localization
An observational study of Lung Nodules and Pneumothorax Iatrogenic Postprocedural, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Nodules, Pneumothorax Iatrogenic Postprocedural, Propensity Score Matching
- What is being tested?
- Preoperative CT-Guided Lung Nodule Localization with Pleural-Depth-Trimmed Hookwire (PDTH) Technique and Preoperative CTGuided Lung Nodule Localization with Patent Blue Vital Dye (PBVD) Localization Technique
- Type of treatment
- Surgery or procedure
- How many people
- 1,072 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2015to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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%).
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pneumothorax Risk and Pleural-Depth-Trimmed Hookwire: A Retrospective Cohort Study With Propensity Score Matching in Preoperative CT-Guided Lung Nodule Localization
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.
Read the detailed 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.
- Being tested
- Preoperative CT-Guided Lung Nodule Localization with Pleural-Depth-Trimmed Hookwire (PDTH) Technique, Preoperative CTGuided Lung Nodule Localization with Patent Blue Vital Dye (PBVD) Localization Technique
- Keywords
- Pneumothorax, Lung nodule localization, Pleural-Depth-Trimmed Hookwire, Propensity score matching
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative CT-Guided Lung Nodule Localization with Pleural-Depth-Trimmed Hookwire (PDTH) TechniqueProcedure or surgery
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.
Preoperative CTGuided Lung Nodule Localization with Patent Blue Vital Dye (PBVD) Localization TechniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: Preoperative CTGuided Lung Nodule Localization with Patent Blue Vital Dye (PBVD) Localization Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately following the localization procedure, documented on the final confirmatory CT scan.
Secondary outcomes (3)
Requirement for Catheter Aspiration
The rate of procedures requiring therapeutic intervention (catheter aspiration) for severe pneumothorax, defined as an airspace thickness exceeding 3 cm.
Measured: Immediately post-localization, during the POCTGL procedure documentation.
Incidence of Other Adverse Events
The incidence rate of other documented complications at the time of the POCTGL procedures. These complications included intolerable pain, severe cough, dizziness, and hookwire dislodgement.
Measured: Documented in real-time during the POCTGL procedure.
Technical Factors Associated with Pneumothorax
Identifying independent risk factors (e.g., number of puncture attempts, lesion order, patient position) associated with increased odds of pneumothorax using Generalized Estimating Equations (GEE) .
Measured: Assessed based on real-time procedural data collected during the POCTGL procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Sep 2015
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Lung NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,072 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-Zhi Wang, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300072
- Sponsor's protocol ID
- CS2-25160
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The individual participant data (IPD) are not publicly available due to patient confidentiality and ethical restrictions. However, de-identified IPD supporting the findings of this study will be made available upon request. Researchers who meet the criteria for access to confidential data may submit requests to the Institutional Review Board (IRB) of Chung Shan Medical University Hospital, Taichung, Taiwan, for review and approval.
Publications
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.
PubMed 35614380Tsai 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.
PubMed 31903257Lin 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.
PubMed 30069383Wang 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.
PubMed 31521836Sun 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.
PubMed 39379924Han 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.
PubMed 38336734Chu 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.
PubMed 36064381Yang 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.
PubMed 32207226Yamagami 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.
PubMed 19922309Park 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.
PubMed 27717643Zaman 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.
PubMed 22572410Nakashima 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.
PubMed 20103238Saito 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.
PubMed 12447187Suzuki 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.
PubMed 10027460Chang 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.
PubMed 38042167
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumothorax Risk and Pleural-Depth-Trimmed Hookwire: A Retrospective Cohort Study With Propensity Score Matching in Preoperative CT-Guided Lung Nodule Localization
- ClinicalTrials.gov ID
- NCT07300072
- Acronym / sponsor ID
- CS2-25160
- Keywords
- Pneumothorax, Lung nodule localization, Pleural-Depth-Trimmed Hookwire, Propensity score matching
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,072 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hookwire-Localized | – | Procedure: Preoperative CT-Guided Lung Nodule Localization with Pleural-Depth-Trimmed Hookwire (PDTH) TechniqueThis 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). |
| Non-Hookwire-Localized | – | Procedure: Preoperative CTGuided Lung Nodule Localization with Patent Blue Vital Dye (PBVD) Localization TechniqueThis 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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%).
Key inclusion criteria (8 listed)
- 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.
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative CT-Guided Lung Nodule Localization with Pleural-Depth-Trimmed Hookwire (PDTH) TechniqueThe 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 or surgery | Hookwire-Localized |
| Preoperative CTGuided Lung Nodule Localization with Patent Blue Vital Dye (PBVD) Localization TechniqueThis 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. | Procedure or surgery | Non-Hookwire-Localized |
Primary outcome
Iatrogenic Pneumothorax Rate
Time frame: 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.
3 secondary outcomes
Requirement for Catheter Aspiration
Time frame: Immediately post-localization, during the POCTGL procedure documentation.
Incidence of Other Adverse Events
Time frame: Documented in real-time during the POCTGL procedure.
Technical Factors Associated with Pneumothorax
Time frame: Assessed based on real-time procedural data collected during the POCTGL procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 35614380Huang 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.
- Background: PubMed 31903257Tsai 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.
- Background: PubMed 30069383Lin 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.
- Background: PubMed 31521836Wang 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.
- Background: PubMed 39379924Sun 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.
- Background: PubMed 38336734Han 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.
- Background: PubMed 36064381Chu 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.
- Background: PubMed 32207226Yang 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.
- Background: PubMed 19922309Yamagami 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.
- Background: PubMed 27717643Park 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.
- Background: PubMed 22572410Zaman 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.
- Background: PubMed 20103238Nakashima 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.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) are not publicly available due to patient confidentiality and ethical restrictions. However, de-identified IPD supporting the findings of this study will be made available upon request. Researchers who meet the criteria for access to confidential data may submit requests to the Institutional Review Board (IRB) of Chung Shan Medical University Hospital, Taichung, Taiwan, for review and approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Nodules and Pneumothorax Iatrogenic Postprocedural, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iatrogenic Pneumothorax Rate (time frame: Immediately following the localization procedure, documented on the final confirmatory CT scan.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07300072, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.