Pulmonary Lesion With Ground-glass-opacityLOGISNCT02180568
Lipiodol Localization for Ground-glass-opacity Minimal Surgery
A study testing Lipiodol and Hookwire in people with Pulmonary Lesion With Ground-glass-opacity, run by Severance Hospital at 1 site in South Korea.
Trial summary
The study object is to demonstrate the usefulness and safety of lipiodol localization technique for individuals undergoing ground-glass opacity (GGO) Video-assisted thoracic surgery (VATS) resection compared to hook wire localization technique. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pulmonary Lesion With Ground-glass-opacity
- What is being tested?
- Lipiodol and Hookwire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Dec 2017
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting adult patients ≥ 20 years of age
- Pulmonary lesion with a ground glass opacity(GGO)component of more than 50%
- Patient with lesion size less than 3cm
- Persistence or growth of the established lesion within a three month period
- Patient who are not contraindicated to surgery
- Patients who are willing to sign the informed consent form
Who cannot join
- Patients with solid pulmonary lesion
- Patients with multiple GGOs need multiple localization
- Patients who are contraindicated to surgery
- Patients who behave in an uncooperative manner
- Unwilling or unable to give informed consent
- Pregnant women
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul, 120-752
About this study
Official title: Validation Study to Evaluate the Safety and Efficacy of Preoperative Computed Tomography-guided Localization Technique Using Lipiodol for Patients With Ground Glass Opacity Pulmonary Lesions: A Prospective Multicenter Study
The study object is to demonstrate the usefulness and safety of lipiodol localization technique for individuals undergoing ground-glass opacity (GGO) Video-assisted thoracic surgery (VATS) resection compared to hook wire localization technique. A total of 250 participants will be enrolled in a 1:1 fashion to Lipiodol or Hook-wire groups. If the aims of this study are achieved, the use of lipiodol localization technique will be widespread their application for localization of non-palpable pulmonary lesions that are indicated for VATS resection.
- Being tested
- Lipiodol, Hookwire
- Keywords
- Ground-glass-opacity (GGO), Lung localization, Lipiodol, Hook wire, Video assisted thoracic surgery (VATS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipiodolProcedure or surgery
Lipiodol-guided lung localization technique
HookwireProcedure or surgery
Hookwire-guided lung localization technique
LipiodolDrug
| Study group | Role | What they receive |
|---|---|---|
| Lipiodol | Experimental | Lipiodol-guided lung localization technique Receives: Procedure: Lipiodol; Drug: Lipiodol |
| Hookwire | Active comparator | Hookwire-guided lung localization technique Receives: Procedure: Hookwire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success rate
Procedure success was defined as marking (lipiodol or hook-wire) the GGO lesion within 1 cm without pleural leakage of lipiodol or dislodgement of the hook-wire.
Measured: one day
Secondary outcomes (4)
Complication rate
Procedure-related complications such as pneumothorax, lung hemorrhage, hemoptysis, air-embolism and death
Measured: one day
Procedure time
Total procedure time for lung localization
Measured: 1 hour
Surgery time
Surgery time for obtaining wedge resection specimen
Measured: 12 hours
Safety resection margin
The safety specimen resection margin was categorized either as positive (grossly positive (R2), microscopically positive if tumor was at the inked surface (R1)), or negative (microscopically negative if there was no tumor at the inked surface (R0))
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2016
- Study completionDec 2017
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 Pulmonary Lesion With Ground-glass-opacityStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gangnam Severance Hospital, Asan Medical Center, Pusan National University Hospital, Korea University Anam Hospital, Chung-Ang University Hospital, Dankook University, Wonju Severance Christian Hospital
- Responsible party
- Principal investigator, Jin Hur, Severance Hospital
- Investigators
- Jin Hur, M.D.,Ph.D., Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180568
- Sponsor's protocol ID
- SEV2013-0740
- Other IDs
- F015894
- Acronym
- LOGIS
- Status last verified
- Mar 2018
- First submitted
- 1 Jul 2014
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park CH, Hur J, Lee SM, Lee JW, Hwang SH, Seo JS, Lee KH, Kwon WC, Kim TH, Choi BW; LOGIS Investigators. Lipiodol lOcalization for Ground-glass opacity mInimal Surgery: Rationale and design of the LOGIS trial. Contemp Clin Trials. 2015 Jul;43:194-9. doi: 10.1016/j.cct.2015.06.009. Epub 2015 Jun 18.
PubMed 26093953
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study to Evaluate the Safety and Efficacy of Preoperative Computed Tomography-guided Localization Technique Using Lipiodol for Patients With Ground Glass Opacity Pulmonary Lesions: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT02180568
- Acronym / sponsor ID
- LOGIS / SEV2013-0740
- Keywords
- Ground-glass-opacity (GGO), Lung localization, Lipiodol, Hook wire, Video assisted thoracic surgery (VATS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Collaborators
- Gangnam Severance Hospital, Asan Medical Center, Pusan National University Hospital, Korea University Anam Hospital, Chung-Ang University Hospital, Dankook University, Wonju Severance Christian Hospital
- Study start
- May 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Jul 2014 (estimated)
- 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 study object is to demonstrate the usefulness and safety of lipiodol localization technique for individuals undergoing ground-glass opacity (GGO) Video-assisted thoracic surgery (VATS) resection compared to hook wire localization technique. A total of 250 participants will be enrolled in a 1:1 fashion to Lipiodol or Hook-wire groups. If the aims of this study are achieved, the use of lipiodol localization technique will be widespread their application for localization of non-palpable pulmonary lesions that are indicated for VATS resection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipiodol | Experimental | Procedure: Lipiodol, Drug: LipiodolLipiodol-guided lung localization technique |
| Hookwire | Active comparator | Procedure: HookwireHookwire-guided lung localization technique |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Consenting adult patients ≥ 20 years of age
- Pulmonary lesion with a ground glass opacity(GGO)component of more than 50%
- Patient with lesion size less than 3cm
- Persistence or growth of the established lesion within a three month period
- Patient who are not contraindicated to surgery
Key exclusion criteria (6 listed)
- Patients with solid pulmonary lesion
- Patients with multiple GGOs need multiple localization
- Patients who are contraindicated to surgery
- Patients who behave in an uncooperative manner
- Unwilling or unable to give informed consent
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 |
|---|---|---|
| LipiodolLipiodol-guided lung localization technique | Procedure or surgery | Lipiodol |
| HookwireHookwire-guided lung localization technique | Procedure or surgery | Hookwire |
| Lipiodol | Drug | Lipiodol |
Primary outcome
Procedure success rate
Time frame: one day
Procedure success was defined as marking (lipiodol or hook-wire) the GGO lesion within 1 cm without pleural leakage of lipiodol or dislodgement of the hook-wire.
4 secondary outcomes
Complication rate
Time frame: one day
Procedure time
Time frame: 1 hour
Surgery time
Time frame: 12 hours
Safety resection margin
Time frame: 1 hour
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 22 Mar 2018.
- Derived from this study: PubMed 26093953Park CH, Hur J, Lee SM, Lee JW, Hwang SH, Seo JS, Lee KH, Kwon WC, Kim TH, Choi BW; LOGIS Investigators. Lipiodol lOcalization for Ground-glass opacity mInimal Surgery: Rationale and design of the LOGIS trial. Contemp Clin Trials. 2015 Jul;43:194-9. doi: 10.1016/j.cct.2015.06.009. Epub 2015 Jun 18.
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.
Jin Hur, M.D.,Ph.D. principal investigator
Yonsei University Health System, Severance 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 Lipiodol and Hookwire in people with Pulmonary Lesion With Ground-glass-opacity, run by Severance Hospital at 1 site in South Korea.
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 6 inclusion and 6 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 22 Mar 2018. 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 South Korea. 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?
Procedure success rate (time frame: one 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 NCT02180568, 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 22 Mar 2018.