NCT02180568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

2.6 years

First QC Date

July 1, 2014

Last Update Submit

March 20, 2018

Conditions

Pulmonary Lesion With Ground-glass-opacity

Keywords

Ground-glass-opacity (GGO)Lung localizationLipiodolHook wireVideo assisted thoracic surgery (VATS)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Complication rate

    one day

  • Procedure time

    1 hour

  • Surgery time

    12 hours

  • Safety resection margin

    1 hour

Study Arms (2)

Lipiodol

EXPERIMENTAL

Lipiodol-guided lung localization technique

Procedure: LipiodolDrug: Lipiodol

Hookwire

ACTIVE COMPARATOR

Hookwire-guided lung localization technique

Procedure: Hookwire

Interventions

LipiodolPROCEDURE

Lipiodol-guided lung localization technique

Lipiodol
HookwirePROCEDURE

Hookwire-guided lung localization technique

Hookwire

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 26093953DERIVED

MeSH Terms

Interventions

Ethiodized Oil

Intervention Hierarchy (Ancestors)

Iodized OilPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Jin Hur, M.D.,Ph.D.

    Yonsei University Health System, Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 2, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

KR(1)