Pulmonary Lesion With Ground-glass-opacity
Conditions
Keywords
Ground-glass-opacity (GGO), Lung localization, Lipiodol, Hook wire, Video assisted thoracic surgery (VATS)
Brief 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. 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.
Interventions
PROCEDURELipiodol
Lipiodol-guided lung localization technique
PROCEDUREHookwire
Hookwire-guided lung localization technique
Sponsors
Gangnam Severance Hospital
Asan Medical Center
Pusan National University Hospital
Korea University Anam Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Dankook University
Wonju Severance Christian Hospital
Severance Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | one day | Procedure-related complications such as pneumothorax, lung hemorrhage, hemoptysis, air-embolism and death |
| Procedure time | 1 hour | Total procedure time for lung localization |
| Surgery time | 12 hours | Surgery time for obtaining wedge resection specimen |
| Safety resection margin | 1 hour | 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)) |
Countries
South Korea
Outcome results
None listed