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| ID | Type | Description | Link |
|---|---|---|---|
| F015894 | Other Grant/Funding Number | Guerbet Korea |
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| Name | Class |
|---|---|
| Gangnam Severance Hospital | OTHER |
| Asan Medical Center | OTHER |
| Pusan National University Hospital | OTHER |
| Korea University Anam Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipiodol | Experimental | Lipiodol-guided lung localization technique |
|
| Hookwire | Active Comparator | Hookwire-guided lung localization technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipiodol | Procedure | Lipiodol-guided lung localization technique |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one day |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Procedure-related complications such as pneumothorax, lung hemorrhage, hemoptysis, air-embolism and death | one day |
| Procedure time | Total procedure time for lung localization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Hur, M.D.,Ph.D. | Yonsei University Health System, Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26093953 | Derived | 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. |
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| ID | Term |
|---|---|
| D004998 | Ethiodized Oil |
| ID | Term |
|---|---|
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 |
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| OTHER |
| Chung-Ang University Hospital | OTHER |
| Dankook University | OTHER |
| Wonju Severance Christian Hospital | OTHER |
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| Hookwire |
| Procedure |
Hookwire-guided lung localization technique |
|
| Lipiodol | Drug |
|
| 1 hour |
| Surgery time | Surgery time for obtaining wedge resection specimen | 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)) | 1 hour |
| Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |