Lung; NodeNCT05183945
Preoperative Computed Tomography-guided Localization for Lung Nodules: Localization Needle Versus Coil
A study testing Localization needle and Coil in people with Lung; Node, run by Xuzhou Central Hospital at 1 site in China.
Trial summary
Preoperative computed tomography-guided localization can improve technical success rates associated with sublobar lung nodule resection conducted via video-assisted thoracoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung; Node
- What is being tested?
- Localization needle and Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2022to 30 Jun 2022
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lung nodules;
- Patients with an intermediate-to-high risk of malignancy as established based upon radiological and clinical findings.
Who cannot join
- Lung nodule < 5 mm;
- Calcification nodules;
- Lung nodule which decreased in size at time of follow-up;
- Patients with distant metastases or other severe comorbidities.
Trial locations and contacts
1 site in 1 country.
About this study
Preoperative computed tomography-guided localization can improve technical success rates associated with sublobar lung nodule resection conducted via video-assisted thoracoscopic surgery. This study sought to compare the clinical efficacy of computed tomography-guided localization needle and coil insertion as approaches to preoperative lung nodule localization.
Read the detailed description
Lung nodules are frequently diagnosed and often exhibit a high potential for malignancy such that they are commonly diagnosed and treated via video-assisted thoracic surgery approaches. Preoperative computed tomography-guided localization strategies are commonly employed to improve the successful rate of video-assisted thoracic surgery-guided sublobar (wedge or segmental) resection procedures. One recent meta-analysis found coil localization to be associated with the lowest rate of complications of tested localization materials. Hook-wire has also been widely used due to its simple placement approaches. However, a number of recent reports have suggested that hook-wire insertion approaches are associated with an increased potential for frequent and potentially severe complications.
The use of a novel lung nodule localization needle strategy based on the modification of this previously described hook-wire approach has recently been employed in clinical contexts. Such localization needles have the potential to incur lower rates of detachment and complications relative to the hook-wire strategy without resulting in an increase in localization difficulty. The relative clinical efficacy of localization needle-based strategies compared to that of other localization materials, however, has yet to be established in the context of lung nodule localization.
- Conditions
- Lung; Node
- Being tested
- Localization needle, Coil
- Keywords
- Lung nodule, Localization, Coil, Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Localization needleDevice
A localization needle which is used for preoperative localization of lung nodules.
CoilDevice
A coil which is used for preoperative localization of lung nodules.
| Study group | Role | What they receive |
|---|---|---|
| Localization needle insertion | Experimental | Patients undergo localization needle insertion on day 1. Receives: Device: Localization needle |
| Coil insertion | Active comparator | Patients undergo coil insertion on day 1. Receives: Device: Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of localization
Lung nodule localization is considered technically successful if the coil tail or marked line can be visible during the video-assisted thoracoscopic surgery. procedure
Measured: From the date of randomization until the date of first documented failure localization from any cause, assessed up to 7 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start14 Jan 2022
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung; NodeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xian-Chi Li, MD, Principal investigator, Xuzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183945
- Sponsor's protocol ID
- 20211221005
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available.
Publications
Fu YF, Zhang M, Wu WB, Wang T. Coil Localization-Guided Video-Assisted Thoracoscopic Surgery for Lung Nodules. J Laparoendosc Adv Surg Tech A. 2018 Mar;28(3):292-297. doi: 10.1089/lap.2017.0484. Epub 2017 Nov 14.
PubMed 29135327
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Computed Tomography-guided Localization for Lung Nodules: Localization Needle Versus Coil
- ClinicalTrials.gov ID
- NCT05183945
- Acronym / sponsor ID
- 20211221005
- Conditions
- Lung; Node
- Keywords
- Lung nodule, Localization, Coil, Needle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 11 Jan 2022 (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.
Preoperative computed tomography-guided localization can improve technical success rates associated with sublobar lung nodule resection conducted via video-assisted thoracoscopic surgery. This study sought to compare the clinical efficacy of computed tomography-guided localization needle and coil insertion as approaches to preoperative lung nodule localization.
Detailed description
Lung nodules are frequently diagnosed and often exhibit a high potential for malignancy such that they are commonly diagnosed and treated via video-assisted thoracic surgery approaches. Preoperative computed tomography-guided localization strategies are commonly employed to improve the successful rate of video-assisted thoracic surgery-guided sublobar (wedge or segmental) resection procedures. One recent meta-analysis found coil localization to be associated with the lowest rate of complications of tested localization materials. Hook-wire has also been widely used due to its simple placement approaches. However, a number of recent reports have suggested that hook-wire insertion approaches are associated with an increased potential for frequent and potentially severe complications.
The use of a novel lung nodule localization needle strategy based on the modification of this previously described hook-wire approach has recently been employed in clinical contexts. Such localization needles have the potential to incur lower rates of detachment and complications relative to the hook-wire strategy without resulting in an increase in localization difficulty. The relative clinical efficacy of localization needle-based strategies compared to that of other localization materials, however, has yet to be established in the context of lung nodule localization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Localization needle insertion | Experimental | Device: Localization needlePatients undergo localization needle insertion on day 1. |
| Coil insertion | Active comparator | Device: CoilPatients undergo coil insertion on day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with lung nodules;
- Patients with an intermediate-to-high risk of malignancy as established based upon radiological and clinical findings.
Key exclusion criteria (4 listed)
- Lung nodule < 5 mm;
- Calcification nodules;
- Lung nodule which decreased in size at time of follow-up;
- Patients with distant metastases or other severe comorbidities.
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 |
|---|---|---|
| Localization needleA localization needle which is used for preoperative localization of lung nodules. | Device | Localization needle insertion |
| CoilA coil which is used for preoperative localization of lung nodules. | Device | Coil insertion |
Primary outcome
Technical success of localization
Time frame: From the date of randomization until the date of first documented failure localization from any cause, assessed up to 7 day.
Lung nodule localization is considered technically successful if the coil tail or marked line can be visible during the video-assisted thoracoscopic surgery. procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Background: PubMed 29135327Fu YF, Zhang M, Wu WB, Wang T. Coil Localization-Guided Video-Assisted Thoracoscopic Surgery for Lung Nodules. J Laparoendosc Adv Surg Tech A. 2018 Mar;28(3):292-297. doi: 10.1089/lap.2017.0484. Epub 2017 Nov 14.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.
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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.
Xian-Chi Li, MD principal investigator
Xuzhou Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Localization needle and Coil in people with Lung; Node, run by Xuzhou Central Hospital at 1 site in China.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. 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 China. 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?
Results are not available in the source record.
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?
Technical success of localization (time frame: From the date of randomization until the date of first documented failure localization from any cause, assessed up to 7 day.). 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 NCT05183945, which also lists 1 linked publication.
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 19 Jan 2022.