Lipiodol Localization for Ground-glass-opacity Minimal Surgery (LOGIS)

March 20, 2018 updated by: Jin Hur, Severance Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University Health System, Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lipiodol
Lipiodol-guided lung localization technique
Procedure: Lipiodol
Lipiodol-guided lung localization technique
Drug: Lipiodol
Active Comparator: Hookwire
Hookwire-guided lung localization technique
Procedure: Hookwire
Hookwire-guided lung localization technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: one day
Procedure-related complications such as pneumothorax, lung hemorrhage, hemoptysis, air-embolism and death
one day
Procedure time
Time Frame: 1 hour
Total procedure time for lung localization
1 hour
Surgery time
Time Frame: 12 hours
Surgery time for obtaining wedge resection specimen
12 hours
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))
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Severance Hospital

Collaborators

Pusan National University Hospital
Asan Medical Center
Korea University Anam Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Gangnam Severance Hospital
Wonju Severance Christian Hospital
Dankook University

Investigators

  • Principal Investigator: Jin Hur, M.D.,Ph.D., Yonsei University Health System, Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEV2013-0740
  • F015894 (Other Grant/Funding Number: Guerbet Korea)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Lesion With Ground-glass-opacity

Clinical Trials on Lipiodol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe