Yonsei University Health System, Severance Hospital
Seoul, 120-752, South Korea
Completed
NCT Number: NCT02180568
Lipiodol Localization for Ground-glass-opacity Minimal Surgery
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.
Completed
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Conditions
Age range
20 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Lipiodol
ProcedureLipiodol-guided lung localization technique
Hookwire
ProcedureHookwire-guided lung localization technique
Lipiodol
DrugPrimary outcomes
-
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.
Secondary outcomes
-
Complication rate
Time frame: one day
Procedure-related complications such as pneumothorax, lung hemorrhage, hemoptysis, air-embolism and death
-
Procedure time
Time frame: 1 hour
Total procedure time for lung localization
-
Surgery time
Time frame: 12 hours
Surgery time for obtaining wedge resection specimen
-
Safety resection margin
Time frame: 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))
Sponsors and collaborators
Lead sponsor
Severance Hospital
Other
Collaborators
- Asan Medical Center
- Chung-Ang University Hospital
- Dankook University
- Gangnam Severance Hospital
- Korea University Anam Hospital
- Pusan National University Hospital
- Wonju Severance Christian Hospital
Registry information
Official study 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
Acronym: LOGIS
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2017
- First posted
- Jul 2, 2014
- Registry last updated
- Mar 22, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.