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

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Yonsei University

Status

Completed

Conditions

Pulmonary Lesion With Ground-glass-opacity

Treatments

Procedure: Hookwire
Drug: Lipiodol

Study type

Interventional

Funder types

Other

Identifiers

NCT02180568
F015894 (Other Grant/Funding Number)
SEV2013-0740

Details and patient eligibility

About

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.

Enrollment

250 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

Lipiodol
Experimental group
Description:
Lipiodol-guided lung localization technique
Treatment:
Drug: Lipiodol
Drug: Lipiodol
Hookwire
Active Comparator group
Description:
Hookwire-guided lung localization technique
Treatment:
Procedure: Hookwire

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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