Lung NeoplasmsSLIDINGWIRENCT06195657
Pre-operative Localization of Ground Glass Solitary Pulmonary Nodules
An observational study of Lung Neoplasms, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Objectives: The main drawback of the hook-wire technique for locating ground glass nodules before video assisted thoracoscopic surgery (VATS) resection is the risk of the hook dislodging during single lung ventilation as the lung collapses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the university hospital of Nice, France
Who may be able to join
- All patients who underwent VATS for pulmonary nodule resection in the thoracic surgery department of Nice University hospital after pre-operative hook-wire insertion using the sliding-wire technique
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-video Assisted Thoracoscopy Surgery (VATS) Localization of Ground Glass Solitary Pulmonary Nodules: the Sliding Wire Technique
Objectives: The main drawback of the hook-wire technique for locating ground glass nodules before video assisted thoracoscopic surgery (VATS) resection is the risk of the hook dislodging during single lung ventilation as the lung collapses. In order to reduce the friction of the thread in the wall, the investigators modified the technique by first positioning a catheter in the chest wall and introducing the carrying needle through the catheter. The objective was to evaluate the success rate and complications of this technique.
Material and Methods : the investigators retrospectively included all patients undergoing VATS resection of solitary lung nodules after localization using the sliding wire technique.
- Conditions
- Lung Neoplasms
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the procedure
Percentage of hook wires remaining anchored during the surgical resection of suspect nodules
Measured: Up to 4 hours
Secondary outcomes (1)
Complications
Rate of complication of the procedure
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study startMar 2012
- Primary completionNov 2021
- Study completionNov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Padovani, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195657
- Sponsor's protocol ID
- 23Imagerie04
- Acronym
- SLIDINGWIRE
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-video Assisted Thoracoscopy Surgery (VATS) Localization of Ground Glass Solitary Pulmonary Nodules: the Sliding Wire Technique
- ClinicalTrials.gov ID
- NCT06195657
- Acronym / sponsor ID
- SLIDINGWIRE / 23Imagerie04
- Conditions
- Lung Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 8 Jan 2024 (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.
Objectives: The main drawback of the hook-wire technique for locating ground glass nodules before video assisted thoracoscopic surgery (VATS) resection is the risk of the hook dislodging during single lung ventilation as the lung collapses. In order to reduce the friction of the thread in the wall, the investigators modified the technique by first positioning a catheter in the chest wall and introducing the carrying needle through the catheter. The objective was to evaluate the success rate and complications of this technique.
Material and Methods : the investigators retrospectively included all patients undergoing VATS resection of solitary lung nodules after localization using the sliding wire technique.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the university hospital of Nice, France
Key inclusion criteria (1 listed)
- All patients who underwent VATS for pulmonary nodule resection in the thoracic surgery department of Nice University hospital after pre-operative hook-wire insertion using the sliding-wire technique
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.
Primary outcome
Success rate of the procedure
Time frame: Up to 4 hours
Percentage of hook wires remaining anchored during the surgical resection of suspect nodules
1 secondary outcome
Complications
Time frame: Up to 4 hours
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 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Bernard Padovani principal investigator
Centre Hospitalier Universitaire de Nice
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 Neoplasms, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 1 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 Jan 2024. 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 France. 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?
Success rate of the procedure (time frame: Up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2024.