Clinical trial NCT02180568: Lipiodol Localization for Ground-glass-opacity Minimal Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Lesion With Ground-glass-opacity
Keywords: Ground-glass-opacity (GGO)
Lung localization
Lipiodol
Hook wire
Video assisted thoracic surgery (VATS)
Lead sponsor: Severance Hospital
Sponsor class: OTHER
Collaborators: name: Gangnam Severance Hospital
name: Asan Medical Center
name: Pusan National University Hospital
name: Korea University Anam Hospital
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Dankook University
name: Wonju Severance Christian Hospital
First posted: 2014-07-02
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Procedure success rate
timeFrame: one day
Secondary outcomes:
measure: Complication rate
timeFrame: one day
measure: Procedure time
timeFrame: 1 hour
measure: Surgery time
timeFrame: 12 hours
measure: Safety resection margin
timeFrame: 1 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Yonsei University Health System, Severance Hospital
name: Jin Hur, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.